Saturday, December 26, 2009
Wednesday, December 16, 2009
BACKGROUND TO THE ISO 9001:2008 REVISION PROCESS
BACKGROUND TO THE ISO 9001:2008 REVISION PROCESS
In order to assist organizations to have a full understanding of the new ISO 9001:2008, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development.
Prior to the commencement of a revision (or amendment) to a management system standard, ISO/Guide 72:2001 Guidelines for the justification and development of management system standards recommends that a “Justification Study” is prepared to present a case for the proposed project and that it outlines details of the data and inputs used to support its arguments. In relation to the development of ISO 9001:2008 user needs were identified from the following:
-the results of a formal “Systematic Review” on ISO 9001:2000 that was performed by the members of ISO/TC 176/SC2 during 2003-2004
-feedback from the ISO/TC 176/Working Group on “Interpretations”
-the results of an extensive worldwide “User Feedback Survey on ISO 9001 and
The Justification Study identified the need for an amendment, provided that the impact on users would be limited and that changes would only be introduced when there were clear benefits to users.
The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO 14001:2004.
A tool for assessing the impacts versus benefits for proposed changes was created to assist the drafters of the amendment in deciding which changes should be included, and to assist in the verification of drafts against the identified user needs. The following decision making principles were applied:
1) No changes with high impact would be incorporated into the standard;
2) Changes with medium impact would only be incorporated when they provided a correspondingly medium or high benefit to users of the standard;
3) Even where a change was low impact, it had to be justified by the benefits it delivered to users, before being incorporated.
The changes incorporated in this ISO 9001:2008 edition were classified in terms of impact into the following categories:
-No changes or minimum changes on user documents, including records
-No changes or minimum changes to existing processes of the organization
-No additional training required or minimal training required
-No effects on current certifications
The benefits identified for the ISO 9001:2008 edition fall into the following categories:
-Provides clarity
-Increases compatibility with ISO 14001.
-Maintains consistency with ISO 9000 family of standards.
-Improves translatability.
Thursday, November 26, 2009
Establishing Quality Objectives In ISO 9001 Standards
Establishing Quality Objectives In ISO 9001 Standards
ISO 9001 defines quality objectives as results sought or aimed for related to quality. It also suggests that these objectives be based on the quality policy and be specified at different levels in the organization, being quantified at the operational level. As with quality policy the details will be addressed later and here we will focus on what it means to establish qualityobjectives and how they relate to other objectives.
As the quality policy equates to the corporate policy, it follows that quality objectives equate to corporate objectives. All of the organization’s objectives should in some way serve to fulfil requirements of customers and other interested parties. It is also interesting to note that inISO 9001, the term requirement is defined as a need or expectation that is stated, customarily implied or obligatory. While an investor may not specify a requirement for growth in share value, it would certainly be an expectation. While an employee does not express requirements for salary increases when profits rise, it would certainly be an expectation and while society has no way other than to protest or invoke the law to impose its desires upon an organization, it certainly has the power to make organization’s comply and even change the law in extreme cases. So quality objectives do equate to corporate objectives.
Management needs to ensure that the objectives are established as a basis for action. All work serves an objective and it is the objective that stimulates action.
The reason for top management setting the objectives is to ensure that everyone channels their energies in a positive direction that serves the organizations purpose and mission.
For an objective to be established it has to be communicated, translated into action and become the focus of all achievement. Objectives are not wish lists. The starting point is the purpose and mission statement and the factors
identified as affecting the ability of the organization to accomplish its mission. It is in these areas the organization needs to excel and therefore they become the focus for action and consequently the setting of objectives. Although ISO 9001 suggests that the quality objectives should be based on the quality policy, it is more likely to be current performance, competition and opportunities arising from new technology that drive the objectives.
An objective is a result that is aimed for and is expressed as a result that is to be achieved. Objec-
tives are therefore not policies. The requirement should also not be interpreted as applicable only to
organizational functions and levels. Objectives are required at levels within the organization not levels
within the organization structure. This is clarified by the requirement for objectives to include those
needed to meet requirements for product. There are therefore five levels at which control and improve-
ment objectives need to be established:
Corporate level where the objectives are for the whole enterprise to enable it to fulfil its vision
Process level where the objectives are for specific processes to enable them to fulfil corporate goals
Product or service level where the objectives are for specific products/services or ranges of products/services to enable them to fulfil or create customer needs and expectations
Departmental or function level where the objectives are for an organizational component to enable it to fulfil corporate goals Personal level where the objectives are for the development of individual competency
A management system is not a static system but a dynamic one and if properly designed and implemented can drive the organization forward towards world class quality. All managerial activity is concerned either with maintaining performance or with making change. Change can retard or advance performance. That which advances performance is beneficial. In this regard, there are two classes of quality objectives, those serving the control of quality
(maintaining performance) and those serving the improvement of quality (making beneficial change).
maintain or to prevent from deteriorating. To maintain your performance and your position in the market you will have to continually seek improvement.
Remaining static at whatever level is not an option if your organization is to survive. Although you will be striving for improvement it is important to avoid slipping backwards with every step forwards. The effort needed to prevent regression may indeed require innovative solutions. While to the people working on such problems, it may appear that the purpose is to change the status quo, the result of their effort will be to maintain their present position not raise it to higher levels of performance. Control and improvement can therefore be perceived as one and the same thing depending on the standards being aimed for and the difficulties in meeting them.
The statements of objectives may be embodied within business plans, product development plans, improvement plans, process descriptions and even procedures.
Achievable objectives do not necessarily arise from a single thought even when the policies provide a framework. There is a process for establishing objectives.
At the strategic level, the subjects that are the focus for setting objectives are the factors that affect the organization’s ability to accomplish its mission – the critical success factors such as marketing, innovation, human resources,
physical and financial resources, productivity and profit. There may be other factors such as the support of the community, of unions, of the media as certain businesses depend on continued support from society. Customer needs, regulations, competition and other external influences shape these objectives and cause them to change frequently. The measures arise from an analysis of current performance, the competition and there will emerge the need for either improvement or control. The steps in the objective setting process are as follows:
Identifying the need
Drafting preliminary objectives
Proving the need to the appropriate level of management in terms of:
whether the climate for change is favourable
the urgency of the improvement or controls
the size of the losses or potential losses
the priorities
Identifying or setting up the forum where the question of change or control is discussed Conducting a feasibility study to establish whether the objective can be achieved with the resources that can be applied Defining achievable objectives for control and improvement
Communicating the objectives
The standard does not require that objectives be achieved but it does require that their achievement be planned and resourced. It is therefore prudent to avoid publishing objectives for meeting an unproven need and which has not
been rigorously reviewed and assessed for their feasibility. It is wasteful to plan for meeting objectives that are unachievable and it diverts resources away from more legitimate uses.
Objectives are not established until they are understood and therefore communication of objectives must be part of this process. Communication is incomplete unless the receiver understands the message but a simple yes or no is not an adequate means of measuring understanding. Measuring employee understanding of appropriate quality objectives is a subjective process. Through the data analysis carried out to meet the requirements of clause 8.4 you will have produced metrics that indicate whether your quality objectives are being achieved. If they are being achieved you could either assume your employees understand the quality objectives or you could conclude that it doesn’t matter. Results alone are insufficient evidence. The results may have been achieved by pure chance and in six months time your performance may have declined significantly. The only way to test understanding is to check the decisions people make. This can be done with a questionnaire but is more effective if one checks decisions made in the work place. Is their judgement in line with your objectives or do you have to repeatedly adjust their behaviour?
For each objective you should have a plan that defines the processes involved in its achievement. Assess these processes and determine where critical decisions are made and who is assigned to make them. Audit the decisions and ascertain whether they were contrary to the objectives. A simple example is where you have an objective of decreasing dependence upon inspection. By examining corrective actions taken to prevent recurrence of nonconformities you can detect whether a person decided to increase the level of inspection in order to catch the nonconformities or considered alternatives.
Any person found increasing the amount of inspection has clearly not understood the objective.
ISO 9001 Standards – Design and development
ISO 9001 Standards – Design and development
Planning the design and development of a product means determining the design objectives and the design strategy, the design stages, timescales, costs, resources and responsibilities needed to accomplish
them. Sometimes the activity of design itself is considered to be a planning activity but what is being planned is not the design but the product.
The purpose of planning is to determine the provisions needed to achieve an objective. In most cases, these objectives include not only a requirement for a new or modified product but also requirements governing the costs and product introduction timescales (Quality, Cost and Delivery or QCD). Remove these constraints and planning becomes less important but there are few situations when cost and time is not a constraint. It is therefore necessary to work out in advance whether the objective can be achieved within the budget and timescale. One problem with design is that it is often a journey into the unknown and the cost and time it will take cannot always be predicted. It may
in fact result in disaster and either a complete reassessment of the design objective or the technology of the design solution. This has been proven time and again with major international projects such as Concorde, the Channel Tunnel and the International Space Station. Without a best guess these projects would not get off (or under!) the ground and so planning is vital firstly to get the funding and secondly to define the known and unknown so that risks can be assessed and quantified.
Design and development plans need to identify the activities to be performed, by whom they will be perform and when they should commence and be complete. One good technique is to use a network chart (often called a PERT chart), which links all the activities together. Alternatively a bar chart may be adequate. There does need to be some narrative in addition as charts in isolation rarely conveys everything required.
Design and development is not complete until the design has been proven as meeting the design requirements, so in drawing up a design and development plan you will need to cover the planning of design verification and validation activities. The plans should identify as a minimum:
- The design requirements
- The design and development programme showing activities against time
- The work packages and names of those who will execute them (Work
packages are the parcels of work that are to be handed out either internally or to suppliers)
- The work breakdown structure showing the relationship between all the parcels of work
- The reviews to be held for authorizing work to proceed from stage to
stage
- The resources in terms of finance, manpower and facilities
- The risks to success and the plans to minimize them
- The controls that will be exercised to keep the design on course
Planning for all phases at once can be difficult as information for subsequent phases will not be available until earlier phases have been completed. So, your design and development plans may consist of separate documents, one for each phase and each containing some detail of the plans you have made for subsequent phases.
Your design and development plans may also need to be subdivided into
plans for special aspects of the design such as reliability plans, safety plans, electromagnetic compatibility plans, configuration management plans. With simple designs there may be only one person carrying out the design activities. As the design and development plan needs to identify all design and development activities, even in this situation you will need to identify who carries out the design, who will review the design and who will verify the design. The same person may perform both the design and the design verification activities, however, it is good practice to allocate design verification to another person or organization because it will reveal problems overlooked by the designer. On larger design projects you may need to employ staff of various disciplines such as mechanical engineers, electronic engineers, reliability engineers etc. The responsibilities of all these people or groups need to be identified and a useful way of parcelling up the work is to use work packages that list all the activities to be performed by a particular group. If you subcontract any of the design activities, the supplier’s plans need to be integrated with your plans and your plan should identify which activities are the supplier’s responsibility. While purchasing is dealt with in clause 7.4 of the standard, the requirements also apply to design activities.
Thursday, November 12, 2009
Thursday, October 8, 2009
Reasons a Company Becomes Certified in ISO 9001 Standards
ISO 9000 certification or registration can be an expensive process. A company must consider the reasons and promised benefits for going through this process. If a company decides to seek certification, they should consider making sure their suppliers are certified or at least compliant to the ISO 9001 standards.
Major reasonsIn the early 1990s, companies seemed to be jumping on the certification bandwagon without seriously considering the rationale for doing so. Often they did so because competitors or “everybody else” is getting registered. Today companies seriously look at the reasons and benefits for becoming registered.
The major reasons that company leadership or management decides to seek ISO 9000 certification are to gain continued or increased business and to maintain effective operations.
Improved businessA company can maintain a relationship with customers, as well as get increased business through complying to the ISO 9001 standards or becoming certified. This comes from satisfying customer demands, the desire for European business, and to advertise.
Finally, some companies want to become certified, so they can advertise that fact and give the impression of being better than their competitors.
You have seen ads with a logo stating the company is certified at some ISO 9000 level. It apparently gives those companies a leg up on competitors not registered.
Again, this seemed more important in the 1990s, but you don’t see that many companies using ISO 9000 certification as an advertising tool.
ISO 9000 is supposed to make sure your business is run in an orderly manner that will assure continued success.
One would think that a goal such as being run effectively and able to deliver goods consistently and reliably would also be desirable for a company’s own operation. Surprisingly, many companies do not consider that as a goal.
Major reasonsIn the early 1990s, companies seemed to be jumping on the certification bandwagon without seriously considering the rationale for doing so. Often they did so because competitors or “everybody else” is getting registered. Today companies seriously look at the reasons and benefits for becoming registered.
The major reasons that company leadership or management decides to seek ISO 9000 certification are to gain continued or increased business and to maintain effective operations.
Improved businessA company can maintain a relationship with customers, as well as get increased business through complying to the ISO 9001 standards or becoming certified. This comes from satisfying customer demands, the desire for European business, and to advertise.
Finally, some companies want to become certified, so they can advertise that fact and give the impression of being better than their competitors.
You have seen ads with a logo stating the company is certified at some ISO 9000 level. It apparently gives those companies a leg up on competitors not registered.
Again, this seemed more important in the 1990s, but you don’t see that many companies using ISO 9000 certification as an advertising tool.
ISO 9000 is supposed to make sure your business is run in an orderly manner that will assure continued success.
One would think that a goal such as being run effectively and able to deliver goods consistently and reliably would also be desirable for a company’s own operation. Surprisingly, many companies do not consider that as a goal.
Wednesday, September 30, 2009
ISO 9001 Standards New Blogs
Some of the new blogs on ISO 9001 Standards & ISO 14001 standards was found as below:
http://iso14000standards.blogspot.com/
http://iso-9001-standards.blogspot.com/
http://iso14001environmentmanagementsystem.blogspot.com/
http://iso9001qualitymanagementsystem.blogspot.com/
http://iso9001qualitymanual.blogspot.com/
http://iso9000standards.blogspot.com/
http://iso9001-standards.blogspot.com/
http://iso14001standards.blogspot.com/
http://iso14000standards.blogspot.com/
http://iso-9001-standards.blogspot.com/
http://iso14001environmentmanagementsystem.blogspot.com/
http://iso9001qualitymanagementsystem.blogspot.com/
http://iso9001qualitymanual.blogspot.com/
http://iso9000standards.blogspot.com/
http://iso9001-standards.blogspot.com/
http://iso14001standards.blogspot.com/
Monday, September 21, 2009
BACKGROUND TO THE ISO 9001:2008 REVISION PROCESS
BACKGROUND TO THE ISO 9001:2008 REVISION PROCESS
In order to assist organizations to have a full understanding of the new ISO 9001:2008, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development.
Prior to the commencement of a revision (or amendment)to a management system standard, ISO/Guide 72:2001 Guidelines for the justification and development of management system standards recommends that a Justification Study” is prepared to present a case for the proposed project and that it outlines details of the data and inputs used to support its arguments. In relation to the development of ISO 9001:2008 user needs were identified from the following:
- the results of a formal “Systematic Review on ISO 9001:2000 that was performed by the members of ISO/TC 176/SC2 during 2003-2004
- feedback from the ISO/TC 176/Working Group on Interpretations,
- the results of an extensive worldwide “User Feedback Survey on ISO 9001 and ISO 9004″ by ISO/TC 176/SC 2/WG 18 and similar national surveys.
The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO 14001:2004.
A tool for assessing the impacts versus benefits for proposed changes was created to assist the drafters of the amendment in deciding which changes should be included, and to assist in the verification of drafts against the identified user needs. The following decision making principles were applied:1) No changes with high impact would be incorporated into the standard;
2) Changes with medium impact would only be incorporated when they provided a correspondingly medium or high benefit to users of the standard;
3) Even where a change was low impact, it had to be justified by the benefits it delivered to users, before being incorporated.
The changes incorporated in this ISO 9001:2008 edition were classified in terms of impact into the following categorie
- No changes or minimum changes on user documents, including records
- No changes or minimum changes to existing processes of the organization
- No additional training required or minimal training required
- No effects on current certifications
The benefits identified for the ISO 9001:2008 edition fall into the following categories:
- Provides clarity
- Increases compatibility with ISO 14001.- Maintains consistency with ISO 9000 family of standards.
- Improves translatability.
In order to assist organizations to have a full understanding of the new ISO 9001:2008, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development.
Prior to the commencement of a revision (or amendment)to a management system standard, ISO/Guide 72:2001 Guidelines for the justification and development of management system standards recommends that a Justification Study” is prepared to present a case for the proposed project and that it outlines details of the data and inputs used to support its arguments. In relation to the development of ISO 9001:2008 user needs were identified from the following:
- the results of a formal “Systematic Review on ISO 9001:2000 that was performed by the members of ISO/TC 176/SC2 during 2003-2004
- feedback from the ISO/TC 176/Working Group on Interpretations,
- the results of an extensive worldwide “User Feedback Survey on ISO 9001 and ISO 9004″ by ISO/TC 176/SC 2/WG 18 and similar national surveys.
The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO 14001:2004.
A tool for assessing the impacts versus benefits for proposed changes was created to assist the drafters of the amendment in deciding which changes should be included, and to assist in the verification of drafts against the identified user needs. The following decision making principles were applied:1) No changes with high impact would be incorporated into the standard;
2) Changes with medium impact would only be incorporated when they provided a correspondingly medium or high benefit to users of the standard;
3) Even where a change was low impact, it had to be justified by the benefits it delivered to users, before being incorporated.
The changes incorporated in this ISO 9001:2008 edition were classified in terms of impact into the following categorie
- No changes or minimum changes on user documents, including records
- No changes or minimum changes to existing processes of the organization
- No additional training required or minimal training required
- No effects on current certifications
The benefits identified for the ISO 9001:2008 edition fall into the following categories:
- Provides clarity
- Increases compatibility with ISO 14001.- Maintains consistency with ISO 9000 family of standards.
- Improves translatability.
Five Steps to Implementing ISO 14001:2004
ISO 14001 provides a logical, common-sense approach for
businesses to adopt. To start it is recommended to carry out an
environmental review of the business and the Annex to the Standard
provides guidance on the approach required. The Standard then
requires a management system to be developed that addresses the
key environmental issues that were identified by the review as being
relevant to the business, through a rational programme of control and
continual improvement.
There are five key steps to ISO 14001 EMS implementation, and
subsequent operation which are clearly laid out in just three pages of
text.
The five key steps are:
1. Environmental Policy
2. Planning
3. Implementation and Operation
4. Checking and Corrective Action
5. Management Review
Step 1. Environmental Policy
The company or organisation must write an environmental policy
statement which is relevant to the business activities and approved by
top management. Their full commitment is essential if environmental
management is to work. The ISO 14001 Standard clearly sets out
what to cover in the policy. Often a one page document is sufficient.
Produce a first issue and expect to amend it several times before
assessment and registration as knowledge grows in the company.
Step 2. Planning
Plan what the EMS is to address.
Environmental aspects
First make lists of the environmental aspects (issues) that are relevant
to the business. The environmental review mentioned earlier should
provide most of this information and the Annex to ISO 14001 provides
guidance on the format for doing this.
Consider the inputs, outputs and processes/activities of the business in
relation to;
a) emissions to air
b) releases to water
c) waste management
d) contamination of land
e) use of raw materials and natural resources
f) other local environmental and community issues
Consider both site (direct) and offsite (ie. indirect) aspects that you
control or have influence over (such as suppliers) and in relation to
normal operations, shut-down and start-up conditions and reasonably
foreseeable and emergencies situations.
A simple written procedure is then required to determine which of the
aspects identified are really or probably significant (important) and
training needs, outline the key stages of the project and dates that will
lead to the target achievement).
Gradually apply environmental management programme thinking to
such things as the introduction of new products, new or improved
processes and other key activities of the business. In particular,
ensure existing projects become environmental management projects
where there is a significant environmental impact involved, so that the
EMS becomes company wide. This is a frequent oversight found
during ISO 14001 assessments. The EMS must cover the whole
business – like a net thrown over the whole business and for example
including such things as engineering and maintenance
Step 3. Implementation and Operation
Structure and responsibility
Appoint one or more people, depending on the size of the business, to
have authority and responsibility for implementing and maintaining the
EMS and provide sufficient resources. (It’s worth monitoring costs
carefully and benchmarking these against key consumption figures so
that improvements delivered by the EMS become apparent).
Training, awareness and competence
Implement a procedure to provide environmental training appropriate
to identified needs for management, the general workforce, project
teams and key plant operators. This can have far reaching benefits
on employee motivation. The workforce is usually very supportive of
moves to achieve genuine environmental improvement. Every
company has its share of cynics but even some of these can be won
over with time. Training will vary from a general briefing for the
workforce to detailed environmental auditor training.
Communication
Implement procedures to establish a system of internal and external
communication to receive environmental information and respond to it
and to circulate new information to people that need to know. This will
include: new legislation, information from suppliers, customers and
neighbours and communications both with employees and for
employees about progress with the EMS. This process can often
generate worthwhile ideas from employees themselves for future
environmental improvements.
Environmental management system documentation
The EMS itself needs to be documented with a manual, procedures
and work instructions but keep it brief and simple. The Standard
clearly states where procedures are required. Eleven system
procedures are required to maintain the EMS, plus operating work
instructions but if you already have ISO 9000, this will cover most of six
of the procedures required and a quality system can certainly be
expanded to cover ISO 14001 as well. Cross reference the EMS
manual to other environmental and quality documents to link the EMS
and to integrate it with existing business practices.
Operational control
Implement additional operating procedures (work instructions) to
control the identified significant (important) aspects of production
processes and other activities. Some of these will already exist but
may need a ‘bit of polish’. Don’t forget significant aspects that relate to
goods and services from suppliers and contractors.
Emergency preparedness and response
Implement procedures to address reasonably foreseeable
emergencies and to minimise their impact should they occur. (eg. Fire,
major spillages of hazardous materials, explosion risks etc.)
Step 4. Checking and Corrective Action
Monitoring and measurement
Implement procedures to monitor and measure the progress of
projects against the targets which have been set, the performance of
processes against the written criteria using calibrated equipment (verify
monitoring records) and regularly check (audit) the company’s
compliance with legislation that has been identified as relevant to your
business. The most effective way of doing this is through regular
progress meetings.
Nonconformance and corrective and preventive action
Implement procedures to enable appropriate corrective and
subsequent preventive action to be taken where breaches of the EMS
occur (eg. process control problems, delays in project process, noncompliance
with legislation, incidents etc.).
Records
Implement procedures to keep records generated by the
environmental management system. The Annex to the Standard
suggests those that are likely to be required.
Environmental management system audit
Implement a procedure to carry out audits of each part of the EMS and
company activities and operations to verify both compliance with the
EMS and with ISO 14001. Audit results must be reported to top
management . A typical audit cycle is one year but more critical
activities will require auditing more frequently.
Step 5. Management Review
At regular intervals (typically annual), top management must conduct
through meetings and record minutes of a review of the EMS, to
determine that it is still appropriate and effective or to make changes
where necessary. Top management will need to consider audit
results, project progress, changing circumstances and the requirement
of ISO 14001 for continual improvement, through setting and achieving
further environmental targets.
businesses to adopt. To start it is recommended to carry out an
environmental review of the business and the Annex to the Standard
provides guidance on the approach required. The Standard then
requires a management system to be developed that addresses the
key environmental issues that were identified by the review as being
relevant to the business, through a rational programme of control and
continual improvement.
There are five key steps to ISO 14001 EMS implementation, and
subsequent operation which are clearly laid out in just three pages of
text.
The five key steps are:
1. Environmental Policy
2. Planning
3. Implementation and Operation
4. Checking and Corrective Action
5. Management Review
Step 1. Environmental Policy
The company or organisation must write an environmental policy
statement which is relevant to the business activities and approved by
top management. Their full commitment is essential if environmental
management is to work. The ISO 14001 Standard clearly sets out
what to cover in the policy. Often a one page document is sufficient.
Produce a first issue and expect to amend it several times before
assessment and registration as knowledge grows in the company.
Step 2. Planning
Plan what the EMS is to address.
Environmental aspects
First make lists of the environmental aspects (issues) that are relevant
to the business. The environmental review mentioned earlier should
provide most of this information and the Annex to ISO 14001 provides
guidance on the format for doing this.
Consider the inputs, outputs and processes/activities of the business in
relation to;
a) emissions to air
b) releases to water
c) waste management
d) contamination of land
e) use of raw materials and natural resources
f) other local environmental and community issues
Consider both site (direct) and offsite (ie. indirect) aspects that you
control or have influence over (such as suppliers) and in relation to
normal operations, shut-down and start-up conditions and reasonably
foreseeable and emergencies situations.
A simple written procedure is then required to determine which of the
aspects identified are really or probably significant (important) and
training needs, outline the key stages of the project and dates that will
lead to the target achievement).
Gradually apply environmental management programme thinking to
such things as the introduction of new products, new or improved
processes and other key activities of the business. In particular,
ensure existing projects become environmental management projects
where there is a significant environmental impact involved, so that the
EMS becomes company wide. This is a frequent oversight found
during ISO 14001 assessments. The EMS must cover the whole
business – like a net thrown over the whole business and for example
including such things as engineering and maintenance
Step 3. Implementation and Operation
Structure and responsibility
Appoint one or more people, depending on the size of the business, to
have authority and responsibility for implementing and maintaining the
EMS and provide sufficient resources. (It’s worth monitoring costs
carefully and benchmarking these against key consumption figures so
that improvements delivered by the EMS become apparent).
Training, awareness and competence
Implement a procedure to provide environmental training appropriate
to identified needs for management, the general workforce, project
teams and key plant operators. This can have far reaching benefits
on employee motivation. The workforce is usually very supportive of
moves to achieve genuine environmental improvement. Every
company has its share of cynics but even some of these can be won
over with time. Training will vary from a general briefing for the
workforce to detailed environmental auditor training.
Communication
Implement procedures to establish a system of internal and external
communication to receive environmental information and respond to it
and to circulate new information to people that need to know. This will
include: new legislation, information from suppliers, customers and
neighbours and communications both with employees and for
employees about progress with the EMS. This process can often
generate worthwhile ideas from employees themselves for future
environmental improvements.
Environmental management system documentation
The EMS itself needs to be documented with a manual, procedures
and work instructions but keep it brief and simple. The Standard
clearly states where procedures are required. Eleven system
procedures are required to maintain the EMS, plus operating work
instructions but if you already have ISO 9000, this will cover most of six
of the procedures required and a quality system can certainly be
expanded to cover ISO 14001 as well. Cross reference the EMS
manual to other environmental and quality documents to link the EMS
and to integrate it with existing business practices.
Operational control
Implement additional operating procedures (work instructions) to
control the identified significant (important) aspects of production
processes and other activities. Some of these will already exist but
may need a ‘bit of polish’. Don’t forget significant aspects that relate to
goods and services from suppliers and contractors.
Emergency preparedness and response
Implement procedures to address reasonably foreseeable
emergencies and to minimise their impact should they occur. (eg. Fire,
major spillages of hazardous materials, explosion risks etc.)
Step 4. Checking and Corrective Action
Monitoring and measurement
Implement procedures to monitor and measure the progress of
projects against the targets which have been set, the performance of
processes against the written criteria using calibrated equipment (verify
monitoring records) and regularly check (audit) the company’s
compliance with legislation that has been identified as relevant to your
business. The most effective way of doing this is through regular
progress meetings.
Nonconformance and corrective and preventive action
Implement procedures to enable appropriate corrective and
subsequent preventive action to be taken where breaches of the EMS
occur (eg. process control problems, delays in project process, noncompliance
with legislation, incidents etc.).
Records
Implement procedures to keep records generated by the
environmental management system. The Annex to the Standard
suggests those that are likely to be required.
Environmental management system audit
Implement a procedure to carry out audits of each part of the EMS and
company activities and operations to verify both compliance with the
EMS and with ISO 14001. Audit results must be reported to top
management . A typical audit cycle is one year but more critical
activities will require auditing more frequently.
Step 5. Management Review
At regular intervals (typically annual), top management must conduct
through meetings and record minutes of a review of the EMS, to
determine that it is still appropriate and effective or to make changes
where necessary. Top management will need to consider audit
results, project progress, changing circumstances and the requirement
of ISO 14001 for continual improvement, through setting and achieving
further environmental targets.
ISO 9001:2008 Requirements – QMS
ISO 9001:2008 Requirements – Quality Management System
Establish, document, implement, and maintain a quality management system. Continually improve its effectiveness in accordance with ISO 9001 requirements. Implement the system to:? Determine processes needed for the quality management system (and their application throughout the organization)? Determine process sequence and interaction? Determine criteria and methods for process operation and control? Ensure resources and supporting information are available? Monitor, measure where applicable, and analyze these processes? Implement actions to achieve planned results and continual process improvementManage these processes in accordance with ISO 9001 requirements. Define the type and extent of control applied to any outsourced processes that affect product conformity to requirements.NOTE 1: Processes needed for the quality management system include the processes for management activities (see 5), provision of resources (see 6), product realization (see 7), and measurement, analysis, and improvement (see 8).NOTE 2: An outsourced process is a process the organization needs for its quality management system, and which the organization chooses to have performed by an external party.NOTE 3: Ensuring control over outsourced processes does not absolve your organization of the responsibility to conform to all customer, statutory, and regulatory requirements. The type and extent of control applied to an outsourced process can be influenced by factors such as:? Potential impact of the outsourced process on your organization’s capability to provide product that conforms to requirements? Degree to which the control for the process is shared? Capability of achieving the necessary control through the application of 7.4
Establish, document, implement, and maintain a quality management system. Continually improve its effectiveness in accordance with ISO 9001 requirements. Implement the system to:? Determine processes needed for the quality management system (and their application throughout the organization)? Determine process sequence and interaction? Determine criteria and methods for process operation and control? Ensure resources and supporting information are available? Monitor, measure where applicable, and analyze these processes? Implement actions to achieve planned results and continual process improvementManage these processes in accordance with ISO 9001 requirements. Define the type and extent of control applied to any outsourced processes that affect product conformity to requirements.NOTE 1: Processes needed for the quality management system include the processes for management activities (see 5), provision of resources (see 6), product realization (see 7), and measurement, analysis, and improvement (see 8).NOTE 2: An outsourced process is a process the organization needs for its quality management system, and which the organization chooses to have performed by an external party.NOTE 3: Ensuring control over outsourced processes does not absolve your organization of the responsibility to conform to all customer, statutory, and regulatory requirements. The type and extent of control applied to an outsourced process can be influenced by factors such as:? Potential impact of the outsourced process on your organization’s capability to provide product that conforms to requirements? Degree to which the control for the process is shared? Capability of achieving the necessary control through the application of 7.4
ISO 9001:2008 Requirements – Documentation Requirements
ISO 9001:2008 Requirements – Documentation Requirements
Include in the quality management system documentation:? Documented statements of a quality policy and quality objectives? A quality manual? Documented procedures and records required by ISO 9001? Documents and records determined by the organization to be necessary for the effective planning, operation, and control of its processesNOTE 1: Where “documented procedure” appears within the Standard, this means that the procedure is established, documented, implemented, and maintained. A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.NOTE 2: The extent of the quality management system documentation can differ from one organization to another due to:? Size of the organization and type of activities? Complexity of processes and their interactions? Competence of personnelNOTE 3: The documentation can be in any form or type of medium.4.2.2 Quality ManualEstablish and maintain a quality manual with:? Scope of the quality management system? Details and justification for any exclusions? Procedures or references to the procedures? Description of interaction between processes4.2.3 Control of Documents
Control the documents required by the quality management system. Records are a special type of document and must be controlled as required by clause 4.2.4.
Establish a documented procedure to:? Approve documents for adequacy prior to issue? Review, update as necessary, and re-approve documents? Identify the changes and current document revision status? Make relevant documents available at points of use? Ensure the documents remain legible and readily identifiable? Identify external documents and control their distribution? Prevent obsolete documents from unintended use? Apply suitable identification if obsolete documents are retained4.2.4 Control of RecordsEstablish and control records as evidence of conformity to requirements and to demonstrate the effective operation of the quality management system.Establish a documented procedure to define the controls needed for record:? Identification? Storage? Protection? Retrieval? Retention? DispositionKeep records legible, readily identifiable, and retrievable.
Include in the quality management system documentation:? Documented statements of a quality policy and quality objectives? A quality manual? Documented procedures and records required by ISO 9001? Documents and records determined by the organization to be necessary for the effective planning, operation, and control of its processesNOTE 1: Where “documented procedure” appears within the Standard, this means that the procedure is established, documented, implemented, and maintained. A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.NOTE 2: The extent of the quality management system documentation can differ from one organization to another due to:? Size of the organization and type of activities? Complexity of processes and their interactions? Competence of personnelNOTE 3: The documentation can be in any form or type of medium.4.2.2 Quality ManualEstablish and maintain a quality manual with:? Scope of the quality management system? Details and justification for any exclusions? Procedures or references to the procedures? Description of interaction between processes4.2.3 Control of Documents
Control the documents required by the quality management system. Records are a special type of document and must be controlled as required by clause 4.2.4.
Establish a documented procedure to:? Approve documents for adequacy prior to issue? Review, update as necessary, and re-approve documents? Identify the changes and current document revision status? Make relevant documents available at points of use? Ensure the documents remain legible and readily identifiable? Identify external documents and control their distribution? Prevent obsolete documents from unintended use? Apply suitable identification if obsolete documents are retained4.2.4 Control of RecordsEstablish and control records as evidence of conformity to requirements and to demonstrate the effective operation of the quality management system.Establish a documented procedure to define the controls needed for record:? Identification? Storage? Protection? Retrieval? Retention? DispositionKeep records legible, readily identifiable, and retrievable.
Saturday, September 12, 2009
Process Approach In ISO 9001 Standards
Process Approach In ISO 9001 Standards
The process approach was introduced into ISO 9001 with the year 2000 version of the standards.Prior versions used an element approach. The document Guidance on the concept and use of the process approach for management systems describes to process approach and offers an implementation paradigm.1. Identification of processes of the organization1.1. Define the purpose of the organization1.2. Define the policies and objectives of the organization1.3. Determine the processes in the organization1.4. Determine the sequence of the processes1.5. Define process ownership1.6. Define process documentation2. Planning of a process2.1. Define the activities within the process2.2. Define the monitoring and measurement requirements2.3. Define the resources needed
2.4. Verify the process and its activities against its planned objectives3. Implementation and measurement of the process4. Analysis of the process5. Corrective action and improvement of the process ImplementationThis document explains the process used to evaluate changes to the 2008 version. In particular, it explains the revision process and illustrates the impact vs. benefit analysis used to evaluate potential changes.In addition to the guidance documents, ISO maintains a web site with “official interpretations” of ISO 9001. Currently, these interpretations only include ISO 9001:2000, but, because the changes to the 2008 version were limited, they are valuable.Consider a common question. An organization needs a documented procedure for preventive action (8.5.3), and must keep records of the results of preventive action (8.5.3.d). One of the interpretation requests asks, “Does sub-clause 8.5.3 a) require organizations to demonstrate, with objective evidence in the form of records, that they have undertaken actions to determine the existence of ‘potential nonconformities and their causes’?” The answer is “No”.Auditing PracticesThe ISO 9001 Auditing Practices Group maintains a website9 with guidance and information on auditing ISO 9001 quality management systems. It is an informal group of quality management system (QMS) experts, auditors, and practitioners drawn from the ISO Technical Committee 176 Quality Management and Quality Assurance (ISO/TC 176) and the International Accreditation Forum (IAF).The website, primarily aimed at QMS auditors, consultants, and quality practitioners, is an online source of papers and presentations on auditing a QMS and reflect the process based approach.The website contains almost forty guidance documents with practical advice ranging from “How to audit top management processes” to “The role and value of the audit checklist”.
The process approach was introduced into ISO 9001 with the year 2000 version of the standards.Prior versions used an element approach. The document Guidance on the concept and use of the process approach for management systems describes to process approach and offers an implementation paradigm.1. Identification of processes of the organization1.1. Define the purpose of the organization1.2. Define the policies and objectives of the organization1.3. Determine the processes in the organization1.4. Determine the sequence of the processes1.5. Define process ownership1.6. Define process documentation2. Planning of a process2.1. Define the activities within the process2.2. Define the monitoring and measurement requirements2.3. Define the resources needed
2.4. Verify the process and its activities against its planned objectives3. Implementation and measurement of the process4. Analysis of the process5. Corrective action and improvement of the process ImplementationThis document explains the process used to evaluate changes to the 2008 version. In particular, it explains the revision process and illustrates the impact vs. benefit analysis used to evaluate potential changes.In addition to the guidance documents, ISO maintains a web site with “official interpretations” of ISO 9001. Currently, these interpretations only include ISO 9001:2000, but, because the changes to the 2008 version were limited, they are valuable.Consider a common question. An organization needs a documented procedure for preventive action (8.5.3), and must keep records of the results of preventive action (8.5.3.d). One of the interpretation requests asks, “Does sub-clause 8.5.3 a) require organizations to demonstrate, with objective evidence in the form of records, that they have undertaken actions to determine the existence of ‘potential nonconformities and their causes’?” The answer is “No”.Auditing PracticesThe ISO 9001 Auditing Practices Group maintains a website9 with guidance and information on auditing ISO 9001 quality management systems. It is an informal group of quality management system (QMS) experts, auditors, and practitioners drawn from the ISO Technical Committee 176 Quality Management and Quality Assurance (ISO/TC 176) and the International Accreditation Forum (IAF).The website, primarily aimed at QMS auditors, consultants, and quality practitioners, is an online source of papers and presentations on auditing a QMS and reflect the process based approach.The website contains almost forty guidance documents with practical advice ranging from “How to audit top management processes” to “The role and value of the audit checklist”.
ISO 9001 Standards Software
ISO 9001 Standards Software
Companies that need quality management systems realize that products like ISO 9001 software are important tools to insure their product safety, consistency and profitability. Using ISO 9001 software can help guarantee that any company can monitor productivity, customer satisfaction and product quality with reports that contain solid information.
This information is now vital to management in order for maximum efficiency in any industry. This is why ISO 9001 software is vital to any sized company. Continuous improvement means continuous profitability. Here are just a few reasons why:
o Companies increase sales because of better performance, quality, and delivery. This propels you ahead of your competition.
o ISO 9001 software helps retain employees and attract more highly qualified employees because they are assured of a controlled and consistent work environment.
o The experience of a more professional workplace boosts employee morale.
o Reduced operating costs dramatically increase your company’s productivity, leading to higher profitability.
o Customer satisfaction and higher profitability expand your market share and demand for your consistently higher product quality.
o When you’re compliant or certified to the appropriate standard, the businesses that work with you know that quality objectives, continuous improvement, and customer satisfaction are your goals.
Many companies require that their suppliers are ISO 9001 compliant; therefore, once you’re certified, your opportunities increase. ISO 9001 software has be utilized and has developed experience of helping manufacturing, service, and distribution organizations to be more efficient and more profitable through continuous improvement programs. We help you to implement the time-tested methods of continuous improvement to measure performance, analyze data, and apply the appropriate process changes. This includes using ISO 9001 software.
ISO 9001 software also offers a suite of modules to enable you to manage the document management and ISO 9001 Compliance Management process. These modules enable complete transparent system measurement with targeted action items ensuring all persons are notified of tasks and carry them out in a prompt and efficient manner. ISO 9001 software provides training in there software and also bring extensive experience in implementing the ISO 9001 software in various environments.
Companies that need quality management systems realize that products like ISO 9001 software are important tools to insure their product safety, consistency and profitability. Using ISO 9001 software can help guarantee that any company can monitor productivity, customer satisfaction and product quality with reports that contain solid information.
This information is now vital to management in order for maximum efficiency in any industry. This is why ISO 9001 software is vital to any sized company. Continuous improvement means continuous profitability. Here are just a few reasons why:
o Companies increase sales because of better performance, quality, and delivery. This propels you ahead of your competition.
o ISO 9001 software helps retain employees and attract more highly qualified employees because they are assured of a controlled and consistent work environment.
o The experience of a more professional workplace boosts employee morale.
o Reduced operating costs dramatically increase your company’s productivity, leading to higher profitability.
o Customer satisfaction and higher profitability expand your market share and demand for your consistently higher product quality.
o When you’re compliant or certified to the appropriate standard, the businesses that work with you know that quality objectives, continuous improvement, and customer satisfaction are your goals.
Many companies require that their suppliers are ISO 9001 compliant; therefore, once you’re certified, your opportunities increase. ISO 9001 software has be utilized and has developed experience of helping manufacturing, service, and distribution organizations to be more efficient and more profitable through continuous improvement programs. We help you to implement the time-tested methods of continuous improvement to measure performance, analyze data, and apply the appropriate process changes. This includes using ISO 9001 software.
ISO 9001 software also offers a suite of modules to enable you to manage the document management and ISO 9001 Compliance Management process. These modules enable complete transparent system measurement with targeted action items ensuring all persons are notified of tasks and carry them out in a prompt and efficient manner. ISO 9001 software provides training in there software and also bring extensive experience in implementing the ISO 9001 software in various environments.
Saturday, September 5, 2009
ISO 9001 Standards - How long does it take to register?
ISO 9001 Standards - How long does it take to register?
The time it takes to get ISO 9001 registered are varies. But it is talking months here, not weeks. For one thing, you have to keep running your business. You cannot simply shut down while getting registered.The entire process can be broken down into the following general phases:
a. Implementing the ISO 9001 system.
b. Operating it for the minimum time. (A minimum of three, andpreferably six, months before registration audit.)
c. Selecting a registrar. This can be done during the registrationprocess, to save time.
d. Interval between application and registration audit. This dependson the registrar’s backlog.
The time it takes to implement the ISO 9000 system depends in largepart on where you are when you start. If you already have any of thefollowing, implementation time should be relatively short:
a. A documented quality system of any kind that is active, meaningful,but not necessarily compliant with any particular standard.
b. Resources temporarily dedicated solely to implementing the ISO 9001 system.
c. The guidance of a good consultant
If you are starting from square one, implementation can take a longtime. (Unless you can shut down operations while implementing—butwho can do that?) Here are some other factors that can extend thetime it takes:
a. Multiple locations.
b. Head count.
c. Whether or not you are design responsible.
d. Corporate turmoil.
e. Lack of ongoing, consistent, persistent top management commitment.
This exhibits itself in a host of symptoms, including lack ofsufficient resources, other issues taking priority, vacillation, failureto pay attention, failure to learn and understand, and failureto lead.All that being said, experience has shown the following:
a. On average, the shortest interval for the entire process—fromlaunch through registration audit—seems to be around 6 to 9months.
b. At the other extreme, it’s been known to take 18 to 24 to 36months, even with significant resources and full managementcommitment.
On average, for the typical organization (whatever that is), you arelooking at 10 to 18 months to get the job done.
The time it takes to get ISO 9001 registered are varies. But it is talking months here, not weeks. For one thing, you have to keep running your business. You cannot simply shut down while getting registered.The entire process can be broken down into the following general phases:
a. Implementing the ISO 9001 system.
b. Operating it for the minimum time. (A minimum of three, andpreferably six, months before registration audit.)
c. Selecting a registrar. This can be done during the registrationprocess, to save time.
d. Interval between application and registration audit. This dependson the registrar’s backlog.
The time it takes to implement the ISO 9000 system depends in largepart on where you are when you start. If you already have any of thefollowing, implementation time should be relatively short:
a. A documented quality system of any kind that is active, meaningful,but not necessarily compliant with any particular standard.
b. Resources temporarily dedicated solely to implementing the ISO 9001 system.
c. The guidance of a good consultant
If you are starting from square one, implementation can take a longtime. (Unless you can shut down operations while implementing—butwho can do that?) Here are some other factors that can extend thetime it takes:
a. Multiple locations.
b. Head count.
c. Whether or not you are design responsible.
d. Corporate turmoil.
e. Lack of ongoing, consistent, persistent top management commitment.
This exhibits itself in a host of symptoms, including lack ofsufficient resources, other issues taking priority, vacillation, failureto pay attention, failure to learn and understand, and failureto lead.All that being said, experience has shown the following:
a. On average, the shortest interval for the entire process—fromlaunch through registration audit—seems to be around 6 to 9months.
b. At the other extreme, it’s been known to take 18 to 24 to 36months, even with significant resources and full managementcommitment.
On average, for the typical organization (whatever that is), you arelooking at 10 to 18 months to get the job done.
ISO 9001 Standards -What does it offer?
What does ISO 9001 Standards offer?
For one thing, it offers you continued business with customers who may be requiring you to register. That is a pretty strong benefit right there.These customers may never question your quality, but these customers depend heavily on their main suppliers. They know they can improve their quality and through-put, if you improve yours. Just because you are great does not mean you are as great as you could be. ISO 9001 mandates a continuous improvement system. You can wriggle and fudge, but if you implement that system and workit conscientiously, you cannot help but improve. Continuous improvementis not just a buzz term. It is an imperative. Just because you are great today does not mean you will be great tomorrow.Has your industry changed? Has your organizationchanged? A well-implemented ISO 9001 helps your organization adapt to change. It brings independence of individuals and consistencyof practices—two features that tend to resist declines inperformance.
What else does ISO 9001 bring you? When well implemented, an ISO 9001 quality system improves organization performance. That is,after all, the whole point. In cases where it does not, the fault tendsnot to be in the ISO 9001 process (its inherent deficiencies not withstanding). When an ISO 9000 system does not provide substantial benefits andimprovement in performance, it is usually because managementhas consciously chosen to cut corners, blow smoke, stay uninvolved, and starve the system of all but the most essential resources. “We’ll do this stupid thing, but we’re sure not goingto change the way we operate.”ISO 9001 registration brings you one more thing that your organization may not have today: International credibility. ISO 9001 is deployed and practiced in nearly 100 countries around the world. Into day’s ever-growing international economic climate, this is not a bademblem to have, however narrow the scope of your market today.
For one thing, it offers you continued business with customers who may be requiring you to register. That is a pretty strong benefit right there.These customers may never question your quality, but these customers depend heavily on their main suppliers. They know they can improve their quality and through-put, if you improve yours. Just because you are great does not mean you are as great as you could be. ISO 9001 mandates a continuous improvement system. You can wriggle and fudge, but if you implement that system and workit conscientiously, you cannot help but improve. Continuous improvementis not just a buzz term. It is an imperative. Just because you are great today does not mean you will be great tomorrow.Has your industry changed? Has your organizationchanged? A well-implemented ISO 9001 helps your organization adapt to change. It brings independence of individuals and consistencyof practices—two features that tend to resist declines inperformance.
What else does ISO 9001 bring you? When well implemented, an ISO 9001 quality system improves organization performance. That is,after all, the whole point. In cases where it does not, the fault tendsnot to be in the ISO 9001 process (its inherent deficiencies not withstanding). When an ISO 9000 system does not provide substantial benefits andimprovement in performance, it is usually because managementhas consciously chosen to cut corners, blow smoke, stay uninvolved, and starve the system of all but the most essential resources. “We’ll do this stupid thing, but we’re sure not goingto change the way we operate.”ISO 9001 registration brings you one more thing that your organization may not have today: International credibility. ISO 9001 is deployed and practiced in nearly 100 countries around the world. Into day’s ever-growing international economic climate, this is not a bademblem to have, however narrow the scope of your market today.
ISO 9001 Management Representative
The ISO 9001 Management Representative is appointed by the top management of an organization. Irrespective of other responsibilities, he/she is responsible and has the authority in
ensuring that processes needed for the quality management system are established, implemented and maintained,
reporting to top management on the performance of the quality management system and any need for improvement, and
ensuring the promotion of awareness of customer requirements throughout the organization.
The responsibility of the Management Representative also includes liaison with external parties on matters relating to the quality management system.
The Management Representative is usually assisted at the departmental level by Quality Representatives. This position is assumed by the respective Department Managers. The Quality Representatives are responsible for the quality processes which are applicable to their respective departments.
The Quality Representatives head their respective Quality Improvement Teams which are established for the purpose of monitoring processes and identifying opportunities for improvements. Members of the Quality Improvement Teams comprise of key personnel within the departments/process areas who are appointed by the Quality Representative to assist him/her at the process-level.
The Management Representative is also assisted by an appointed Document Controller whose responsibility is to implement the Control of Documents and Control of records procedures.
Collectively, the Management Representative, Quality Representatives and the Document Controller make up the Quality Management System Committee. This committee meets regularly to provide relevant inputs and resolutions for the quality management system. The structure of the Quality Management System Committee is as follows:
Management Representative – Chairman
Document Controller – Secretary
Quality Representatives – Members
[Note: The above is just an example. If you are a small organization, a QMS Committee and Quality Improvement Teams may not be necessary]
To facilitate effecetive communications, the Quality Management System Committee and the Quality Improvement Teams, respectively, meet regularly in order to ensure that communication regarding the effectiveness of the quality management system takes place. Pertinent information regarding the quality management system is then posted by the Management Representative on the Bulletin Board for the benefit of all employees. Employees are generally encouraged to provide their inputs towards the quality management system through suggestion boxes which are located at strategic locations within the organization’s premises.
Note: Some organizations employ this method but results may vary among other organizations. The key is to continually improve on these methods/processes.
ensuring that processes needed for the quality management system are established, implemented and maintained,
reporting to top management on the performance of the quality management system and any need for improvement, and
ensuring the promotion of awareness of customer requirements throughout the organization.
The responsibility of the Management Representative also includes liaison with external parties on matters relating to the quality management system.
The Management Representative is usually assisted at the departmental level by Quality Representatives. This position is assumed by the respective Department Managers. The Quality Representatives are responsible for the quality processes which are applicable to their respective departments.
The Quality Representatives head their respective Quality Improvement Teams which are established for the purpose of monitoring processes and identifying opportunities for improvements. Members of the Quality Improvement Teams comprise of key personnel within the departments/process areas who are appointed by the Quality Representative to assist him/her at the process-level.
The Management Representative is also assisted by an appointed Document Controller whose responsibility is to implement the Control of Documents and Control of records procedures.
Collectively, the Management Representative, Quality Representatives and the Document Controller make up the Quality Management System Committee. This committee meets regularly to provide relevant inputs and resolutions for the quality management system. The structure of the Quality Management System Committee is as follows:
Management Representative – Chairman
Document Controller – Secretary
Quality Representatives – Members
[Note: The above is just an example. If you are a small organization, a QMS Committee and Quality Improvement Teams may not be necessary]
To facilitate effecetive communications, the Quality Management System Committee and the Quality Improvement Teams, respectively, meet regularly in order to ensure that communication regarding the effectiveness of the quality management system takes place. Pertinent information regarding the quality management system is then posted by the Management Representative on the Bulletin Board for the benefit of all employees. Employees are generally encouraged to provide their inputs towards the quality management system through suggestion boxes which are located at strategic locations within the organization’s premises.
Note: Some organizations employ this method but results may vary among other organizations. The key is to continually improve on these methods/processes.
Structure Of ISO 9001
ISO 9001 was first published in 1987. Later, it went through three revisions in 1994, 2000 and 2008. The latest version version of the ISO 9001 standard was published on 14th November 2008. This is the structure of the standard:
Clause 1 Scope
Clause 2 Normative reference
Clause 3 Terms and definitions
Clause 4 Quality management system
Clause 5 Management responsibility
Clause 6 Resource management
Clause 7 Product realization
Clause 8 Measurement, analysis and improvement
http://www.e-wia.com
Clause 1 Scope
Clause 2 Normative reference
Clause 3 Terms and definitions
Clause 4 Quality management system
Clause 5 Management responsibility
Clause 6 Resource management
Clause 7 Product realization
Clause 8 Measurement, analysis and improvement
http://www.e-wia.com
Tuesday, September 1, 2009
ISO 9001 And ISO 14001 Information Site
ISO 9001 And ISO 14001 Information Site:
http://iso9001-procedure.blogspot.com/
http://iso-14001-ems.blogspot.com/
http://iso14001qualitymanual.blogspot.com/
http://iso14001requirements.blogspot.com/
http://iso14001certification.blogspot.com/
http://iso14001qualitysystem.blogspot.com/
http://environmentsystem.blogspot.com/
http://iso14000series.blogspot.com/
http://iso9000standard.blogspot.com/
http://six-sigma-qc.blogspot.com/
http://iso9001-documents.blogspot.com/
http://iso9001-training.blogspot.com/
http://quality-assurance-system.blogspot.com/
http://iso14001standard.blogspot.com/
http://iso9001-certification.blogspot.com/
http://iso9001-certification.blogspot.com/
http://iso9000series.blogspot.com/
http://iso9001standards.blogspot.com/
http://iso9000certification.blogspot.com/
http://isotemplate.blogspot.com/
http://iso9001training.blogspot.com/
http://qualitymanualsystem.blogspot.com/
http://iso9001-procedure.blogspot.com/
http://iso-14001-ems.blogspot.com/
http://iso14001qualitymanual.blogspot.com/
http://iso14001requirements.blogspot.com/
http://iso14001certification.blogspot.com/
http://iso14001qualitysystem.blogspot.com/
http://environmentsystem.blogspot.com/
http://iso14000series.blogspot.com/
http://iso9000standard.blogspot.com/
http://six-sigma-qc.blogspot.com/
http://iso9001-documents.blogspot.com/
http://iso9001-training.blogspot.com/
http://quality-assurance-system.blogspot.com/
http://iso14001standard.blogspot.com/
http://iso9001-certification.blogspot.com/
http://iso9001-certification.blogspot.com/
http://iso9000series.blogspot.com/
http://iso9001standards.blogspot.com/
http://iso9000certification.blogspot.com/
http://isotemplate.blogspot.com/
http://iso9001training.blogspot.com/
http://qualitymanualsystem.blogspot.com/
Monday, August 31, 2009
ISO 9000 Series and Six Sigma
ISO (International Organization for Standardization) 9000 series standards were first published in 1987, revised in 1994, and re-revised in 2000 by the ISO. The 2000 revision, denoted by ISO 9000:2000, has attracted broad expectations in industry.
As of the year 2001, more than 300,000 organizations world-wide have been certified to the ISO 9000 series standards. It embodies a consistent pair of standards, ISO 9001:2000 and ISO 9004:2000, both of which have been significantly updated and modernized. The ISO 9001:2000 standard specifies requirements for a quality management system for which third-party certification is possible, whereas ISO 9004:2000 provides guide- lines for a comprehensive quality management system and performance improvement through Self-Assessment.
The origin and historical development of ISO 9000 and Six Sigma are very different. The genesis of ISO 9000 can be traced back to the standards that the British aviation industry and the U.S. Air Force developed in the 1920s to reduce the need for inspection by approving the conformance of suppliers’ product quality. These standards developed into requirements for suppliers’ quality assurance systems in a number of western countries in the 1970s. In 1987 they were amalgamated into the ISO 9000 series standards.
Independent of ISO 9000, the same year also saw the launch of Six Sigma at Motorola and the launch of Self-Assessment by means of the Malcolm Baldrige National Quality Award in USA. Both Six Sigma and Self-Assessment can be traced back to Walter A. Shewhart and his work on variation and continuous improvement in the 1920s. It was Japanese industry that pioneered a broad application of these ideas from the 1950s through to the 1970s. When variation and continuous improvement caught the attention of some of the
American business leaders in the late 1980s, it took the form of the Malcolm Baldrige National Quality Award, on a national level, and of Six Sigma at Motorola.
Some people are wondering if the ISO 9000:2008 series standards make Six Sigma superfluous. They typically refer to clause 8 of ISO 9001: It requires that companies install procedures in operations for the measurement of processes and data analysis using statistical techniques with the demonstration of continuous improvement . They also partly refer to the ISO 9004:2000 standards that embody guidelines and criteria for Self-Assessment similar to the national quality awards.
The ISO 9000 series standards have from their early days been regarded and practiced by industry as a minimum set of requirements for doing business. The new ISO 9000:20008 stan
dards do not represent a significant change to this perspective. Six Sigma on the other hand, aims at world-class performance, based on a pragmatic framework for continuous improvement.
The author believes that Six Sigma is superior in such important areas as rate of improvement, bottom-line and top-line results, customer satisfaction, and top-level management commitment. However, considering the stronghold of ISO 9000 in industry, Six Sigma and ISO 9000 are likely to be applied by the same organization, but for very different purposes.
As of the year 2001, more than 300,000 organizations world-wide have been certified to the ISO 9000 series standards. It embodies a consistent pair of standards, ISO 9001:2000 and ISO 9004:2000, both of which have been significantly updated and modernized. The ISO 9001:2000 standard specifies requirements for a quality management system for which third-party certification is possible, whereas ISO 9004:2000 provides guide- lines for a comprehensive quality management system and performance improvement through Self-Assessment.
The origin and historical development of ISO 9000 and Six Sigma are very different. The genesis of ISO 9000 can be traced back to the standards that the British aviation industry and the U.S. Air Force developed in the 1920s to reduce the need for inspection by approving the conformance of suppliers’ product quality. These standards developed into requirements for suppliers’ quality assurance systems in a number of western countries in the 1970s. In 1987 they were amalgamated into the ISO 9000 series standards.
Independent of ISO 9000, the same year also saw the launch of Six Sigma at Motorola and the launch of Self-Assessment by means of the Malcolm Baldrige National Quality Award in USA. Both Six Sigma and Self-Assessment can be traced back to Walter A. Shewhart and his work on variation and continuous improvement in the 1920s. It was Japanese industry that pioneered a broad application of these ideas from the 1950s through to the 1970s. When variation and continuous improvement caught the attention of some of the
American business leaders in the late 1980s, it took the form of the Malcolm Baldrige National Quality Award, on a national level, and of Six Sigma at Motorola.
Some people are wondering if the ISO 9000:2008 series standards make Six Sigma superfluous. They typically refer to clause 8 of ISO 9001: It requires that companies install procedures in operations for the measurement of processes and data analysis using statistical techniques with the demonstration of continuous improvement . They also partly refer to the ISO 9004:2000 standards that embody guidelines and criteria for Self-Assessment similar to the national quality awards.
The ISO 9000 series standards have from their early days been regarded and practiced by industry as a minimum set of requirements for doing business. The new ISO 9000:20008 stan
dards do not represent a significant change to this perspective. Six Sigma on the other hand, aims at world-class performance, based on a pragmatic framework for continuous improvement.
The author believes that Six Sigma is superior in such important areas as rate of improvement, bottom-line and top-line results, customer satisfaction, and top-level management commitment. However, considering the stronghold of ISO 9000 in industry, Six Sigma and ISO 9000 are likely to be applied by the same organization, but for very different purposes.
Why is Six Sigma Fascinating in ISO 9000?
Six Sigma has become very popular throughout the whole world. There are several reasons for this popularity. First, it is regarded as a fresh quality management strategy which can replace TQC, TQM and others.
Many companies, which were not quite successful in implementing previous management strategies such as TQC and TQM, are eager to introduce Six Sigma.
Development process of Six Sigma in quality management
Six Sigma is viewed as a systematic, scientific, statistical and smarter (4S) approach for management innovation which is quite suitable for use in a knowledge-based information society.
Second, Six Sigma provides efficient manpower cultivation and utilization. It employs a “belt system” in which the levels of mastery are classified as green belt, black belt, master black belt and champion. As a person in a company obtains certain
training, he acquires a belt. Usually, a black belt is the leader of a project team and several green belts work together for the project team.
Third, there are many success stories of Six Sigma application in well known world-class companies. As mentioned earlier, Six Sigma was pioneered by Motorola and launched as a strategic initiative in 1987. Since then, and particularly from 1995, an exponentially growing number of prestigious global firms have launched a Six Sigma program. It has been noted that many globally leading companies run Six Sigma programs (see Figure 3), and it has been well known that Motorola, GE, Allied Signal, IBM, DEC, Texas Instruments, Sony, Kodak, Nokia, and Philips Electronics among others have been quite successful in Six Sigma. In Korea, the Samsung, LG, Hyundai groups and Korea Heavy Industries & Construction Company have been quite successful with Six Sigma.
Lastly, Six Sigma provides flexibility in the new millennium of 3Cs, which are:
• Change: Changing society
• Customer: Power is shifted to customer and customer demand is high
• Competition: Competition in quality and productivity
The pace of change during the last decade has been unprecedented, and the speed of change in this new millennium is perhaps faster than ever before. Most notably, the power has shifted from producer to customer. The producer-oriented industrial society is over, and the customer-oriented information society has arrived. The customer has all the rights to order, select and buy goods and services. Especially, in e-business, the customer has all-mighty power.
Six Sigma with its 4S(systematic, scientific, statistical and smarter) approaches provides flexibility in managing a business unit.
Many companies, which were not quite successful in implementing previous management strategies such as TQC and TQM, are eager to introduce Six Sigma.
Development process of Six Sigma in quality management
Six Sigma is viewed as a systematic, scientific, statistical and smarter (4S) approach for management innovation which is quite suitable for use in a knowledge-based information society.
Second, Six Sigma provides efficient manpower cultivation and utilization. It employs a “belt system” in which the levels of mastery are classified as green belt, black belt, master black belt and champion. As a person in a company obtains certain
training, he acquires a belt. Usually, a black belt is the leader of a project team and several green belts work together for the project team.
Third, there are many success stories of Six Sigma application in well known world-class companies. As mentioned earlier, Six Sigma was pioneered by Motorola and launched as a strategic initiative in 1987. Since then, and particularly from 1995, an exponentially growing number of prestigious global firms have launched a Six Sigma program. It has been noted that many globally leading companies run Six Sigma programs (see Figure 3), and it has been well known that Motorola, GE, Allied Signal, IBM, DEC, Texas Instruments, Sony, Kodak, Nokia, and Philips Electronics among others have been quite successful in Six Sigma. In Korea, the Samsung, LG, Hyundai groups and Korea Heavy Industries & Construction Company have been quite successful with Six Sigma.
Lastly, Six Sigma provides flexibility in the new millennium of 3Cs, which are:
• Change: Changing society
• Customer: Power is shifted to customer and customer demand is high
• Competition: Competition in quality and productivity
The pace of change during the last decade has been unprecedented, and the speed of change in this new millennium is perhaps faster than ever before. Most notably, the power has shifted from producer to customer. The producer-oriented industrial society is over, and the customer-oriented information society has arrived. The customer has all the rights to order, select and buy goods and services. Especially, in e-business, the customer has all-mighty power.
Six Sigma with its 4S(systematic, scientific, statistical and smarter) approaches provides flexibility in managing a business unit.
Sunday, August 30, 2009
Templates for Quality Manuals and Forms
Using templates for ISO 9001 quality manuals, procedures and forms can have huge benefits for an organization. Templates are usually in the form of existing and proven manuals, procedures and forms. Follow the link for more information on the use of Templates.
The ISO 9000 quality manual and the ISO 9000 quality procedures are a vital part of any ISO 9001 quality system.
You can get a huge head start by purchasing a good template quality manual (a sample quality manual that you can use as a good example and that you can modify to make it your own quality manual). There are numerous companies that sell ISO 9000 quality manuals that you can use as templates to create your own quality manual.
We urge you to carefully evaluate them before making a purchase decision as we found the majority to be convoluted, bureaucratic and cumbersome.
The ISO 9000 quality manual and the ISO 9000 quality procedures are a vital part of any ISO 9001 quality system.
You can get a huge head start by purchasing a good template quality manual (a sample quality manual that you can use as a good example and that you can modify to make it your own quality manual). There are numerous companies that sell ISO 9000 quality manuals that you can use as templates to create your own quality manual.
We urge you to carefully evaluate them before making a purchase decision as we found the majority to be convoluted, bureaucratic and cumbersome.
ISO 9000 Series and Six Sigma
ISO (International Organization for Standardization) 9000 series standards were first published in 1987, revised in 1994, and re-revised in 2000 by the ISO. The 2000 revision, denoted by ISO 9000:2000, has attracted broad expectations in industry.
As of the year 2001, more than 300,000 organizations world-wide have been certified to the ISO 9000 series standards. It embodies a consistent pair of standards, ISO 9001:2000 and ISO 9004:2000, both of which have been significantly updated and modernized. The ISO 9001:2000 standard specifies requirements for a quality management system for which third-party certification is possible, whereas ISO 9004:2000 provides guide- lines for a comprehensive quality management system and performance improvement through Self-Assessment.
The origin and historical development of ISO 9000 and Six Sigma are very different. The genesis of ISO 9000 can be traced back to the standards that the British aviation industry and the U.S. Air Force developed in the 1920s to reduce the need for inspection by approving the conformance of suppliers’ product quality. These standards developed into requirements for suppliers’ quality assurance systems in a number of western countries in the 1970s. In 1987 they were amalgamated into the ISO 9000 series standards.
Independent of ISO 9000, the same year also saw the launch of Six Sigma at Motorola and the launch of Self-Assessment by means of the Malcolm Baldrige National Quality Award in USA. Both Six Sigma and Self-Assessment can be traced back to Walter A. Shewhart and his work on variation and continuous improvement in the 1920s. It was Japanese industry that pioneered a broad application of these ideas from the 1950s through to the 1970s. When variation and continuous improvement caught the attention of some of the American business leaders in the late 1980s, it took the form of the Malcolm Baldrige National Quality Award, on a national level, and of Six Sigma at Motorola.
Some people are wondering if the ISO 9000:2000 series standards make Six Sigma superfluous. They typically refer to clause 8 of ISO 9001: “Measurement, analysis, improvement.”
It requires that companies install procedures in operations for the measurement of processes and data analysis using statistical techniques with the demonstration of continuous improvement . They also partly refer to the ISO 9004:2000 standards that embody guidelines and criteria for Self-Assessment similar to the national quality awards.
The author firmly believes that Six Sigma is needed regardless of whether a company is compliant with the ISO 9000 series. The two initiatives are not mutually exclusive and the objectives in applying them are different. A Six Sigma program is applied in organizations based on its top-line and bottom-line rationales. The primary objective for applying the ISO 9000 series standards is to demonstrate the company’s capability to consistently provide conforming products and/or services. Therefore, the ISO 9000 series standard falls well short of making Six Sigma superfluous.
The ISO 9000 series standards have from their early days been regarded and practiced by industry as a minimum set of requirements for doing business. The new ISO 9000:2000 stan
dards do not represent a significant change to this perspective. Six Sigma on the other hand, aims at world-class performance, based on a pragmatic framework for continuous improvement.
The author believes that Six Sigma is superior in such important areas as rate of improvement, bottom-line and top-line results, customer satisfaction, and top-level management commitment. However, considering the stronghold of ISO 9000 in industry, Six Sigma and ISO 9000 are likely to be applied by the same organization, but for very different purposes.
As of the year 2001, more than 300,000 organizations world-wide have been certified to the ISO 9000 series standards. It embodies a consistent pair of standards, ISO 9001:2000 and ISO 9004:2000, both of which have been significantly updated and modernized. The ISO 9001:2000 standard specifies requirements for a quality management system for which third-party certification is possible, whereas ISO 9004:2000 provides guide- lines for a comprehensive quality management system and performance improvement through Self-Assessment.
The origin and historical development of ISO 9000 and Six Sigma are very different. The genesis of ISO 9000 can be traced back to the standards that the British aviation industry and the U.S. Air Force developed in the 1920s to reduce the need for inspection by approving the conformance of suppliers’ product quality. These standards developed into requirements for suppliers’ quality assurance systems in a number of western countries in the 1970s. In 1987 they were amalgamated into the ISO 9000 series standards.
Independent of ISO 9000, the same year also saw the launch of Six Sigma at Motorola and the launch of Self-Assessment by means of the Malcolm Baldrige National Quality Award in USA. Both Six Sigma and Self-Assessment can be traced back to Walter A. Shewhart and his work on variation and continuous improvement in the 1920s. It was Japanese industry that pioneered a broad application of these ideas from the 1950s through to the 1970s. When variation and continuous improvement caught the attention of some of the American business leaders in the late 1980s, it took the form of the Malcolm Baldrige National Quality Award, on a national level, and of Six Sigma at Motorola.
Some people are wondering if the ISO 9000:2000 series standards make Six Sigma superfluous. They typically refer to clause 8 of ISO 9001: “Measurement, analysis, improvement.”
It requires that companies install procedures in operations for the measurement of processes and data analysis using statistical techniques with the demonstration of continuous improvement . They also partly refer to the ISO 9004:2000 standards that embody guidelines and criteria for Self-Assessment similar to the national quality awards.
The author firmly believes that Six Sigma is needed regardless of whether a company is compliant with the ISO 9000 series. The two initiatives are not mutually exclusive and the objectives in applying them are different. A Six Sigma program is applied in organizations based on its top-line and bottom-line rationales. The primary objective for applying the ISO 9000 series standards is to demonstrate the company’s capability to consistently provide conforming products and/or services. Therefore, the ISO 9000 series standard falls well short of making Six Sigma superfluous.
The ISO 9000 series standards have from their early days been regarded and practiced by industry as a minimum set of requirements for doing business. The new ISO 9000:2000 stan
dards do not represent a significant change to this perspective. Six Sigma on the other hand, aims at world-class performance, based on a pragmatic framework for continuous improvement.
The author believes that Six Sigma is superior in such important areas as rate of improvement, bottom-line and top-line results, customer satisfaction, and top-level management commitment. However, considering the stronghold of ISO 9000 in industry, Six Sigma and ISO 9000 are likely to be applied by the same organization, but for very different purposes.
Migration to ISO 9001:2008
Migration To ISO 9001:2008The International Accreditation Forum (IAF) and the International Organization forStandardization (ISO) have agreed on an implementation plan to ensure a smooth transition ofaccredited certification to ISO 9001:2008, the latest version of the world’s most widely usedstandard for quality management systems (QMS).
The details of the plan are given in the jointcommuniqué by the two organizations which appears below.Like all of ISO’s more than 17 000 standards, ISO 9001 is periodically reviewed to ensure that itis maintained at the state of the art and a decision taken to confirm, withdraw or revise thedocument.ISO 9001:2008, which is due to be published before the end of the year, will replace the year2000 version of the standard which is implemented by both business and public sectororganizations in 170 countries.
Although certification is not a requirement of the standard, theQMS of about one million organizations have been audited and certified by independentcertification bodies (also known in some countries as registration bodies) to ISO 9001:2000.ISO 9001 certification is frequently used in both private and public sectors to increaseconfidence in the products and services provided by certified organizations, between partnersin business-to-business relations, in the selection of suppliers in supply chains and in the rightto tender for procurement contracts.ISO is the developer and publisher of ISO 9001, but does not itself carry out auditing andcertification. These services are performed independently of ISO by certification bodies.
ISO 9001 does not control such bodies, but does develop voluntary International Standards toencourage good practice in their activities on a worldwide basis. For example, ISO/IEC17021:2006 specifies the requirements for bodies providing auditing and certification ofmanagement systems.Certification bodies that wish to provide further confidence in their services may apply to be“accredited” as competent by an IAF recognized national accreditation body. ISO/IEC17011:2004 specifies the requirements for carrying out such accreditation. IAF is aninternational association whose membership includes the national accreditation bodies of 49economies.ISO technical committee ISO/TC 176, Quality management and quality assurance, which isresponsible for the ISO 9000 family of standards, is preparing a number of support documentsexplaining what the differences are between ISO 9001:2008 and the year 2000 version, whyand what they mean for users. Once approved, these documents will be posted on the ISOWeb site – probably in October 2008.
ISO (International Organization for Standardization) and the IAF (International AccreditationForum) have agreed an implementation plan to ensure a smooth migration of accreditedcertification to ISO 9001:2008, after consultation with international groupings representingquality system or auditor certification bodies, and industry users of ISO 9001 certificationservices.ISO 9001:2008 does not contain any new requirementsThey have recognized that ISO 9001:2008 introduces no new requirements.
ISO 9001:2008 only introduces clarifications to the existing requirements of ISO 9001:2000 based on eightyears of experience of implementing the standard world wide with about one millioncertificates issued in 170 countries to date. It also introduces changes intended to improveconsistency with ISO14001:2004The agreed implementation plan in relation to accredited certification is therefore thefollowing:Accredited certification to the ISO 9001:2008 shall not be granted until the publication of ISO9001:2008 as an International Standard.
Certification of conformity to ISO 9001:2008 and/or national equivalents shall only be issuedafter official publication of ISO 9001:2008 (which should take place before the end of 2008)and after a routine surveillance or recertification audit against ISO 9001:2008.Validity of certifications to ISO 9001:2008 One year after publication of ISO 9001:2008 all accredited certifications issued (newcertifications or recertifications) shall be to ISO 9001:2008.Twenty four months after publication by ISO of ISO 9001:2008, any existing certification issuedto ISO 9001:2008 shall not be valid.
The details of the plan are given in the jointcommuniqué by the two organizations which appears below.Like all of ISO’s more than 17 000 standards, ISO 9001 is periodically reviewed to ensure that itis maintained at the state of the art and a decision taken to confirm, withdraw or revise thedocument.ISO 9001:2008, which is due to be published before the end of the year, will replace the year2000 version of the standard which is implemented by both business and public sectororganizations in 170 countries.
Although certification is not a requirement of the standard, theQMS of about one million organizations have been audited and certified by independentcertification bodies (also known in some countries as registration bodies) to ISO 9001:2000.ISO 9001 certification is frequently used in both private and public sectors to increaseconfidence in the products and services provided by certified organizations, between partnersin business-to-business relations, in the selection of suppliers in supply chains and in the rightto tender for procurement contracts.ISO is the developer and publisher of ISO 9001, but does not itself carry out auditing andcertification. These services are performed independently of ISO by certification bodies.
ISO 9001 does not control such bodies, but does develop voluntary International Standards toencourage good practice in their activities on a worldwide basis. For example, ISO/IEC17021:2006 specifies the requirements for bodies providing auditing and certification ofmanagement systems.Certification bodies that wish to provide further confidence in their services may apply to be“accredited” as competent by an IAF recognized national accreditation body. ISO/IEC17011:2004 specifies the requirements for carrying out such accreditation. IAF is aninternational association whose membership includes the national accreditation bodies of 49economies.ISO technical committee ISO/TC 176, Quality management and quality assurance, which isresponsible for the ISO 9000 family of standards, is preparing a number of support documentsexplaining what the differences are between ISO 9001:2008 and the year 2000 version, whyand what they mean for users. Once approved, these documents will be posted on the ISOWeb site – probably in October 2008.
ISO (International Organization for Standardization) and the IAF (International AccreditationForum) have agreed an implementation plan to ensure a smooth migration of accreditedcertification to ISO 9001:2008, after consultation with international groupings representingquality system or auditor certification bodies, and industry users of ISO 9001 certificationservices.ISO 9001:2008 does not contain any new requirementsThey have recognized that ISO 9001:2008 introduces no new requirements.
ISO 9001:2008 only introduces clarifications to the existing requirements of ISO 9001:2000 based on eightyears of experience of implementing the standard world wide with about one millioncertificates issued in 170 countries to date. It also introduces changes intended to improveconsistency with ISO14001:2004The agreed implementation plan in relation to accredited certification is therefore thefollowing:Accredited certification to the ISO 9001:2008 shall not be granted until the publication of ISO9001:2008 as an International Standard.
Certification of conformity to ISO 9001:2008 and/or national equivalents shall only be issuedafter official publication of ISO 9001:2008 (which should take place before the end of 2008)and after a routine surveillance or recertification audit against ISO 9001:2008.Validity of certifications to ISO 9001:2008 One year after publication of ISO 9001:2008 all accredited certifications issued (newcertifications or recertifications) shall be to ISO 9001:2008.Twenty four months after publication by ISO of ISO 9001:2008, any existing certification issuedto ISO 9001:2008 shall not be valid.
Preparing the ISO 9001 quality manual
The standard requires a quality manual to be establishedand maintained that includes the scope of the qualitymanagement system, the documented procedures or refer-ence to them and a description of the sequence andinteraction of processes included in the quality manage-ment system.
ISO 9000 defines a quality manual as a documentspecifying the quality management system of an organi-zation. It is therefore not intended that themanual be a response to the requirements ofISO 9001. As the top-level document describingthe management system it is a system descriptiondescribing how the organization is managed.Countless quality manuals produced to satisfy ISO 9000 :2008, were nomore than 20 sections that paraphrased the requirements of the standard.Such documentation adds no value. They are of no use to managers, staff orauditors. Often thought to be useful to customers, organizations would gainno more confidence from customers than would be obtained from theirregistration certificate.
This requirement responds to the System Approach Principle.A description of the management system is necessary as a means of showinghow all the processes are interconnected and how they collectively deliver thebusiness outputs. It has several uses as :a means to communicate the vision, values, mission, policies and objectivesof the organizationa means of showing how the system has been designeda means of showing linkages between processesa means of showing who does whatan aid to training new peoplea tool in the analysis of potential improvementsa means of demonstrating compliance with external standards and regulations
When formulating the policies, objectives and identifying the processes toachieve them, the manual provides a convenient vehicle for containing suchinformation. If left as separate pieces of information, it may be more difficult tosee the linkages.The requirement provides the framework for the manual. Its content maytherefore include the following:1 Introduction(a) Purpose (of the manual)(b) Scope (of the manual)(c) Applicability (of the manual)(d) Definitions (of terms used in the manual)2 Business overview(a) Nature of the business/organization – its scope of activity, its productsand services(b) The organization’s interested parties (customers, employees, regulators,shareholders, suppliers, owners etc.)(c) The context diagram showing the organization relative to its externalenvironment(d) Vision, values(e) Mission3 Organization(a) Function descriptions(b) Organization chart(c) Locations with scope of activity4 Business processes(a) The system model showing the key business processes and how they areinterconnected(b) System performance indicators and method of measurement(c) Business planning process description(d) Resource management process description(e) Marketing process description(f) Product/service generation processes description(g) Sales process description(h) Order fulfilment process description5 Function matrix (Relationship of functions to processes)6 Location matrix (Relationship of locations to processes)7 Requirement deployment matrices(a) ISO 9001 compliance matrix(b) ISO 14001 compliance matrix(c) Regulation compliance matrices (FDA, Environment, Health, Safety,CAA etc.)8 Approvals (List of current product, process and system approvals)
ISO 9000 defines a quality manual as a documentspecifying the quality management system of an organi-zation. It is therefore not intended that themanual be a response to the requirements ofISO 9001. As the top-level document describingthe management system it is a system descriptiondescribing how the organization is managed.Countless quality manuals produced to satisfy ISO 9000 :2008, were nomore than 20 sections that paraphrased the requirements of the standard.Such documentation adds no value. They are of no use to managers, staff orauditors. Often thought to be useful to customers, organizations would gainno more confidence from customers than would be obtained from theirregistration certificate.
This requirement responds to the System Approach Principle.A description of the management system is necessary as a means of showinghow all the processes are interconnected and how they collectively deliver thebusiness outputs. It has several uses as :a means to communicate the vision, values, mission, policies and objectivesof the organizationa means of showing how the system has been designeda means of showing linkages between processesa means of showing who does whatan aid to training new peoplea tool in the analysis of potential improvementsa means of demonstrating compliance with external standards and regulations
When formulating the policies, objectives and identifying the processes toachieve them, the manual provides a convenient vehicle for containing suchinformation. If left as separate pieces of information, it may be more difficult tosee the linkages.The requirement provides the framework for the manual. Its content maytherefore include the following:1 Introduction(a) Purpose (of the manual)(b) Scope (of the manual)(c) Applicability (of the manual)(d) Definitions (of terms used in the manual)2 Business overview(a) Nature of the business/organization – its scope of activity, its productsand services(b) The organization’s interested parties (customers, employees, regulators,shareholders, suppliers, owners etc.)(c) The context diagram showing the organization relative to its externalenvironment(d) Vision, values(e) Mission3 Organization(a) Function descriptions(b) Organization chart(c) Locations with scope of activity4 Business processes(a) The system model showing the key business processes and how they areinterconnected(b) System performance indicators and method of measurement(c) Business planning process description(d) Resource management process description(e) Marketing process description(f) Product/service generation processes description(g) Sales process description(h) Order fulfilment process description5 Function matrix (Relationship of functions to processes)6 Location matrix (Relationship of locations to processes)7 Requirement deployment matrices(a) ISO 9001 compliance matrix(b) ISO 14001 compliance matrix(c) Regulation compliance matrices (FDA, Environment, Health, Safety,CAA etc.)8 Approvals (List of current product, process and system approvals)
Saturday, August 29, 2009
Differences between ISO 9001 & ISO 9001:2000
The Evolution
There really is no difference between ISO 9001 and ISO 9001:2000. These terms are all used to describe the ISO 9001 standard.
The Evolution Leading to ISO 9001:2000 Standard
Prior to December 2000, there used to be an ISO 9001, an ISO 9002 and an ISO 9003 standard. Without focusing on the technical differences between them, people would just simply refer to each as ISO 9000.
In December 2000, ISO 9001, ISO 9002, and ISO 9003 all were merged into a revised ISO 9001 standard. In order to distinguish between the previous ISO 9001 version, the current standard is often referred to as ISO 9001:2000. However, many people don’t know about all the other standards that the International Organization for Standardization published, and they simply refer to the most famous standard (ISO 9001) as ISO.
The Impact on the ISO 9001:2000 Assessment
The ISO 9001:2000 standard is a radical revision of the prior ISO 9000 standard. It requires companies that have previously been certified to update their current quality systems. It also changes the ground rules for all the organizations that are seeking or who will seek registration in the future. National standards bodies, registrars, consultants, and the other groups who support the standard must now contend with a new set of challenges and opportunities.
Like its predecessor, ISO 9001:2000 is really a series of three interrelated standards. Each has a different function: ISO 9000 deals with fundamentals and vocabulary; ISO 9001, the heart of the new revision, states the requirements for the new system; ISO 9004 provides guidance for implementation, and fleshes out ISO 9001.
There really is no difference between ISO 9001 and ISO 9001:2000. These terms are all used to describe the ISO 9001 standard.
The Evolution Leading to ISO 9001:2000 Standard
Prior to December 2000, there used to be an ISO 9001, an ISO 9002 and an ISO 9003 standard. Without focusing on the technical differences between them, people would just simply refer to each as ISO 9000.
In December 2000, ISO 9001, ISO 9002, and ISO 9003 all were merged into a revised ISO 9001 standard. In order to distinguish between the previous ISO 9001 version, the current standard is often referred to as ISO 9001:2000. However, many people don’t know about all the other standards that the International Organization for Standardization published, and they simply refer to the most famous standard (ISO 9001) as ISO.
The Impact on the ISO 9001:2000 Assessment
The ISO 9001:2000 standard is a radical revision of the prior ISO 9000 standard. It requires companies that have previously been certified to update their current quality systems. It also changes the ground rules for all the organizations that are seeking or who will seek registration in the future. National standards bodies, registrars, consultants, and the other groups who support the standard must now contend with a new set of challenges and opportunities.
Like its predecessor, ISO 9001:2000 is really a series of three interrelated standards. Each has a different function: ISO 9000 deals with fundamentals and vocabulary; ISO 9001, the heart of the new revision, states the requirements for the new system; ISO 9004 provides guidance for implementation, and fleshes out ISO 9001.
Friday, August 28, 2009
ISO 9001:2008 Quality Management System Standard
ISO 9001:2008 is the world most successful standard addressing best practice in the application of quality management systems.
The standard is based around the principles of customer satisfaction, continual improvement and the development of a process based quality management system. Although not referenced in the standard itself the ISO 9001:2008 document is underpinned by eight key quality management principles;
ISO 9001:2008 has been written to ensure that its guiding principles are equally relevant to all sectors of industry and to all types of organisation. Although containing requirements to control the key processes within an organisation, it only requires six documented procedures. The standard emphasises the need for an organisation to continually monitor their own processes and systems, with many clauses making reference to self monitoring or measurement or both. This emphasis aims for an integrated approach to business processes. Instead of operating to a business plan on one hand and a quality management system on the other, the standard aims to integrate both of these functions into one system.
What is a quality management system?
ISO 9001:2008 is a standard that specifies criteria for a quality management system (QMS). A QMS incorporates those elements of an organisations management system that direct and control it with regard to quality. Such a system will need to be supported by top management who will need to be able to demonstrate management commitment.
How do you demonstrate management commitment?
Management commitment is one of the cornerstones of ISO 9001:2008, requiring top management to develop and improve the QMS throughout the organisation. This commitment can be demonstrated by a number of methods including creating a quality policy, conducting management reviews and establishing quality objectives.
What is a quality policy?
ISO 9001:2008 specifies that an organisation must have a quality policy that documents the organisations overall intentions and direction related to quality as formally expressed by top management. Such a policy will include a commitment to comply with ISO 9001:2008, to continuously improve the QMS and to set and monitor measurable quality objectives.
What are quality objectives?
The quality objectives are those targets sought or aimed for by the organisation that are related to quality. These quality objectives must be SMART (suitable, measurable, achievable, reviewed and timely). Examples of quality objectives might be; to reduce machine down time by 20% or to reduce rework costs by ?00 p/m. Whatever quality objectives are chosen they must be meaningful and adequately resourced by the organisation.
What is a management review?
A management review is a key element of how the top management of an organisation can assess its performance in terms of the objectives it sets itself, the requirements set by the standard and how its systems are operating. Normally, a management review is a regular meeting of the top management team and uses the information that the organisation systems have derived. It is a useful forum to review and revise quality objectives.
What are internal audits and why do I need to carry them out?
Internal audit is one of the key monitoring processes required by the standard and functions as a check on the organisation systems. It is the opportunity for an organisation to determine compliance to the systems it has established and maintained to meet the needs of its customers and identify opportunities for improvement. Internal audit can be seen as a ealth check?for an organisation.
The ore?of ISO 9001:2008, Product realisation
Clause 7 of ISO 9001:2008 contains the core processes that most organisations carry out. Any clause or sub-clause in section 7 can be excluded from an organisations quality management system if it can be justifiably excluded. Examples of common exclusions are clause 7.3 design and development, clause 7.5.3 traceability and clause 7.6 the control of monitoring and measuring devices. Clauses can only be excluded if their exclusion does not affect the company ability to provide a product or service that meets customer requirements.
These core processes should be managed and controlled via the quality management system, and are evaluated for effectiveness and suitability by the internal audits with feed back into the management review.
This is a clear demonstration of one of the key principles of ISO 9001:2008, continuous improvement by critical self-evaluation. The output from the self-evaluation is fed into a planning stage to determine actions needed to improve the system. Following the planning and consultation comes the action phase where the proposed changes are implemented. Then the cycle starts again by checking that the changes are effective and meaningful by self-evaluation.
Other requirements of section 7 are;
Product planning to ascertain and then implement the necessary controls and resources to ensure product realisation.
Purchasing control to verify purchased product against comprehensive purchasing information and the selection and evaluation of suppliers.
Production and service provision to ensure that this activity is carried out in controlled conditions and that any processes that cannot be verified during production are validated to ensure capability. Where appropriate the product must be identified, and if required, traceable at all stages of production. Any customer property must be identified and protected from harm and all products must be stored and handled in such a way to preserve product conformity.
Any monitoring and measuring devices needed to provide evidence of product conformity must be identified and if necessary calibrated.
But what about the customer?
All of the clauses in ISO 9001:2008 are in some way focused towards meeting and exceeding the customer expectations. For example the requirement of management to determine and communicate the importance of customer requirements throughout the organisation, and the review of customer orders to ensure that they can be met. Companies are required to implement methods for effective communication with the client at all stages of the business including ascertaining customer satisfaction after the product or service has been delivered as well as resolving customer complaints.
Finally?
ISO 9001:2008 is widely acclaimed as being the pre-eminent specification for quality management systems, it requires a company to look at itself and ask the question, 'how can we improve?' An ISO 9001:2008 management system should be an essential part of any business process, requiring continual improvement by self-evaluation with a goal of ensuring that current and future customer expectation can be met and exceeded.
If you have any queries concerning ISO 9001:2008 please visit http://www.iso-consults.com/
The standard is based around the principles of customer satisfaction, continual improvement and the development of a process based quality management system. Although not referenced in the standard itself the ISO 9001:2008 document is underpinned by eight key quality management principles;
- a customer focused organisation
- leadership
- the involvement of people
- ensuring a process approach
- a systematic approach to management
- a factual approach to decision making
- mutually beneficial supplier relations
- continuous improvement
ISO 9001:2008 has been written to ensure that its guiding principles are equally relevant to all sectors of industry and to all types of organisation. Although containing requirements to control the key processes within an organisation, it only requires six documented procedures. The standard emphasises the need for an organisation to continually monitor their own processes and systems, with many clauses making reference to self monitoring or measurement or both. This emphasis aims for an integrated approach to business processes. Instead of operating to a business plan on one hand and a quality management system on the other, the standard aims to integrate both of these functions into one system.
What is a quality management system?
ISO 9001:2008 is a standard that specifies criteria for a quality management system (QMS). A QMS incorporates those elements of an organisations management system that direct and control it with regard to quality. Such a system will need to be supported by top management who will need to be able to demonstrate management commitment.
How do you demonstrate management commitment?
Management commitment is one of the cornerstones of ISO 9001:2008, requiring top management to develop and improve the QMS throughout the organisation. This commitment can be demonstrated by a number of methods including creating a quality policy, conducting management reviews and establishing quality objectives.
What is a quality policy?
ISO 9001:2008 specifies that an organisation must have a quality policy that documents the organisations overall intentions and direction related to quality as formally expressed by top management. Such a policy will include a commitment to comply with ISO 9001:2008, to continuously improve the QMS and to set and monitor measurable quality objectives.
What are quality objectives?
The quality objectives are those targets sought or aimed for by the organisation that are related to quality. These quality objectives must be SMART (suitable, measurable, achievable, reviewed and timely). Examples of quality objectives might be; to reduce machine down time by 20% or to reduce rework costs by ?00 p/m. Whatever quality objectives are chosen they must be meaningful and adequately resourced by the organisation.
What is a management review?
A management review is a key element of how the top management of an organisation can assess its performance in terms of the objectives it sets itself, the requirements set by the standard and how its systems are operating. Normally, a management review is a regular meeting of the top management team and uses the information that the organisation systems have derived. It is a useful forum to review and revise quality objectives.
What are internal audits and why do I need to carry them out?
Internal audit is one of the key monitoring processes required by the standard and functions as a check on the organisation systems. It is the opportunity for an organisation to determine compliance to the systems it has established and maintained to meet the needs of its customers and identify opportunities for improvement. Internal audit can be seen as a ealth check?for an organisation.
The ore?of ISO 9001:2008, Product realisation
Clause 7 of ISO 9001:2008 contains the core processes that most organisations carry out. Any clause or sub-clause in section 7 can be excluded from an organisations quality management system if it can be justifiably excluded. Examples of common exclusions are clause 7.3 design and development, clause 7.5.3 traceability and clause 7.6 the control of monitoring and measuring devices. Clauses can only be excluded if their exclusion does not affect the company ability to provide a product or service that meets customer requirements.
These core processes should be managed and controlled via the quality management system, and are evaluated for effectiveness and suitability by the internal audits with feed back into the management review.
This is a clear demonstration of one of the key principles of ISO 9001:2008, continuous improvement by critical self-evaluation. The output from the self-evaluation is fed into a planning stage to determine actions needed to improve the system. Following the planning and consultation comes the action phase where the proposed changes are implemented. Then the cycle starts again by checking that the changes are effective and meaningful by self-evaluation.
Other requirements of section 7 are;
Product planning to ascertain and then implement the necessary controls and resources to ensure product realisation.
Purchasing control to verify purchased product against comprehensive purchasing information and the selection and evaluation of suppliers.
Production and service provision to ensure that this activity is carried out in controlled conditions and that any processes that cannot be verified during production are validated to ensure capability. Where appropriate the product must be identified, and if required, traceable at all stages of production. Any customer property must be identified and protected from harm and all products must be stored and handled in such a way to preserve product conformity.
Any monitoring and measuring devices needed to provide evidence of product conformity must be identified and if necessary calibrated.
But what about the customer?
All of the clauses in ISO 9001:2008 are in some way focused towards meeting and exceeding the customer expectations. For example the requirement of management to determine and communicate the importance of customer requirements throughout the organisation, and the review of customer orders to ensure that they can be met. Companies are required to implement methods for effective communication with the client at all stages of the business including ascertaining customer satisfaction after the product or service has been delivered as well as resolving customer complaints.
Finally?
ISO 9001:2008 is widely acclaimed as being the pre-eminent specification for quality management systems, it requires a company to look at itself and ask the question, 'how can we improve?' An ISO 9001:2008 management system should be an essential part of any business process, requiring continual improvement by self-evaluation with a goal of ensuring that current and future customer expectation can be met and exceeded.
If you have any queries concerning ISO 9001:2008 please visit http://www.iso-consults.com/
ISO 9001 Quality Policy
Sample of corporate ISO 9001 Quality Policy:
On customers
We will listen to our customers, understand and balance their needs and
expectations with those of our suppliers, employees, investors and society and
endeavour to give full satisfaction to all parties.
On leadership
We will establish and communicate our vision for the organization and through
our leadership exemplify core values to guide the behaviour of all to achieve our
vision.
On people
We will involve our people in the organization’s development, utilize their
knowledge and experience, recognize their contribution and provide an environ-
ment in which they are motivated to realize their full potential.
On processes and systems
We will take a process approach towards the management of work and manage our
processes as a single system of interconnected processes that delivers all the
organization’s objectives.
On continual improvement
We will provide an environment in which every person is motivated to
continually improve the efficiency and effectiveness of our products, processes and
our management system.
On decisions
We will base our decisions on the logical and intuitive analysis of data collected
where possible from accurate measurements of product, process and system
characteristics.
On supplier relationships
We will develop alliances with our suppliers and work with them to jointly
improve performance.
http://www.iso-consults.com
http://www.iso9001store.com
http://www.iso14000store.com
On customers
We will listen to our customers, understand and balance their needs and
expectations with those of our suppliers, employees, investors and society and
endeavour to give full satisfaction to all parties.
On leadership
We will establish and communicate our vision for the organization and through
our leadership exemplify core values to guide the behaviour of all to achieve our
vision.
On people
We will involve our people in the organization’s development, utilize their
knowledge and experience, recognize their contribution and provide an environ-
ment in which they are motivated to realize their full potential.
On processes and systems
We will take a process approach towards the management of work and manage our
processes as a single system of interconnected processes that delivers all the
organization’s objectives.
On continual improvement
We will provide an environment in which every person is motivated to
continually improve the efficiency and effectiveness of our products, processes and
our management system.
On decisions
We will base our decisions on the logical and intuitive analysis of data collected
where possible from accurate measurements of product, process and system
characteristics.
On supplier relationships
We will develop alliances with our suppliers and work with them to jointly
improve performance.
http://www.iso-consults.com
http://www.iso9001store.com
http://www.iso14000store.com
Managing processes In ISO 9001 Standard
Managing processes In ISO 9001 Standard
The standard requires the organization to manage the identified processes in accordance with the requirements of ISO 9001. The first stage in managing a process is to establish what it is you are trying to achieve, what requirements you need to satisfy, what goals you are aiming at; then establish how you will measure your achievements. The next stage is to define the process you will employ to deliver the results. Managing the process then involves managing all the inherent
characteristics of the process in such a manner that the requirements of customers and interested parties are fulfilled by the process outcomes. This means:
Managing the process inputs
Managing the work
Managing the physical resources
Managing the financial resources
Managing the human resources
Managing the constraints
Managing the outputs
Process management is therefore much more than managing activities and therefore when describing processes, one needs more than a flow chart of activities. The chart is a diagrammatical representation of a process but only one aspect. One can also add numerical data to the charts to indicate resources, cycle times, delays, costs etc. but the intangible factors of the human environment cannot be reduced to numerical data to add to the charts.
The notes to clause 4.1 of ISO 9001 need some explanation. It is stated that the processes needed for the management system include management activities, provision of resources, product realization and measurement. This note could cause confusion because it suggests that these are the processes that are needed for the management system. It would be unwise to use this as the model and far better to identify the processes from observing how the business operates. The term provision of resources should be Resource Management, which is the
collection of processes covering financial, human and physical resources.
Product realization is also a collection of processes such as design, production, service delivery, etc. Measurement is not a single process but a sub-process within each process. Grouping all the measurement processes together serves no useful purpose except it matches the standard – a purpose of little value in managing the organization.
The second note refers to outsourcing processes although it is difficult to imagine that management activities, product realization or measurement would be outsourced in its entirety. It is likely that market research; design, product verification, equipment calibration and other specialized services may be outsourced. While outsourcing comes under purchasing, it is correct to point out that the organization should control any outsourced processes. The supplier of the process is usually referred to as a subcontractor because they provide services to the organization’s requirements not their own. Control of subcontractors is covered by clause 7.4 but in meeting clause 7.4.3, you need to treat suppliers and subcontractors differently.
The standard requires the organization to manage the identified processes in accordance with the requirements of ISO 9001. The first stage in managing a process is to establish what it is you are trying to achieve, what requirements you need to satisfy, what goals you are aiming at; then establish how you will measure your achievements. The next stage is to define the process you will employ to deliver the results. Managing the process then involves managing all the inherent
characteristics of the process in such a manner that the requirements of customers and interested parties are fulfilled by the process outcomes. This means:
Managing the process inputs
Managing the work
Managing the physical resources
Managing the financial resources
Managing the human resources
Managing the constraints
Managing the outputs
Process management is therefore much more than managing activities and therefore when describing processes, one needs more than a flow chart of activities. The chart is a diagrammatical representation of a process but only one aspect. One can also add numerical data to the charts to indicate resources, cycle times, delays, costs etc. but the intangible factors of the human environment cannot be reduced to numerical data to add to the charts.
The notes to clause 4.1 of ISO 9001 need some explanation. It is stated that the processes needed for the management system include management activities, provision of resources, product realization and measurement. This note could cause confusion because it suggests that these are the processes that are needed for the management system. It would be unwise to use this as the model and far better to identify the processes from observing how the business operates. The term provision of resources should be Resource Management, which is the
collection of processes covering financial, human and physical resources.
Product realization is also a collection of processes such as design, production, service delivery, etc. Measurement is not a single process but a sub-process within each process. Grouping all the measurement processes together serves no useful purpose except it matches the standard – a purpose of little value in managing the organization.
The second note refers to outsourcing processes although it is difficult to imagine that management activities, product realization or measurement would be outsourced in its entirety. It is likely that market research; design, product verification, equipment calibration and other specialized services may be outsourced. While outsourcing comes under purchasing, it is correct to point out that the organization should control any outsourced processes. The supplier of the process is usually referred to as a subcontractor because they provide services to the organization’s requirements not their own. Control of subcontractors is covered by clause 7.4 but in meeting clause 7.4.3, you need to treat suppliers and subcontractors differently.
Scope of the ISO 9001 quality management system
Scope of the ISO 9001 quality management system
The standard requires the quality manual to include the scope of the quality management system including details of justification for any exclusion.
The standard addresses activities that may not be relevant or applicable to an organization. The permissible exclusions are explained in section 1.2 of ISO 9001. Here it states that the organization may only exclude requirements that neither affect the organization’s ability, nor its responsibility to provide product that meets customer and applicable regulatory requirements. The requirements for which exclusion is permitted are limited to those in section 7 of the standard.
Under ISO 9000 :2008, it was possible for organizations to exclude functions and processes of their organization that may have been difficult to control or were not part of the order fulfilment cycle. Organizations that designed their own products but not for specific customers could escape bringing these operations into the management system. Marketing was omitted because it
operated before placement of order. Accounting, Administration, Maintenance, Publicity, Public Relations and After Sales Support functions were often omitted because there were no requirements in the standard that specifically dealt with such activities. As there is no function in an organization that does not directly or indirectly serve the satisfaction of interested parties, it is unlikely that any function or process will now be excluded from the management system.
This requirement responds to the System Approach Principle.
It is sensible to describe the scope of the management system so as to ensure effective communication. The scope of the management system is one area that generates a lot of misunderstanding particularly when dealing with auditors, consultants and customers. When you claim you have a management system that meets ISO 9001 it could imply that you design, develop, install and service the products you supply, when in fact you may only be a distributor.
Why you need to justify specific exclusions is uncertain because it is more practical to
justify inclusions.
The scope of the management system is the scope of the organization. There is no longer any reason to exclude locations, activities, functions or processes for which there is no requirement in the standard. The reason is because the ISO 9000 family now serves customer satisfaction and is not limited to quality assurance as were the 1994 versions of ISO 9001, ISO 9002 and ISO 9003.
It is not appropriate to address exclusions by inserting pages in the manual corresponding to the sections of the standard and adding justification if not within the scope of the management system – such as ‘We don’t do this!’. It is much more appropriate to use an appendix as indicated previously in the manual contents list. By describing the nature of the business, you are establishing boundary conditions. If in doing so you do not mention that you design products, it will be interpreted that design is not applicable. For exclusions relative to detail requirements, the Compliance Matrix may suffice but for an unambiguous solution, it is preferable to produce an exposition that addresses each requirement of the standard.
The standard requires the quality manual to include the scope of the quality management system including details of justification for any exclusion.
The standard addresses activities that may not be relevant or applicable to an organization. The permissible exclusions are explained in section 1.2 of ISO 9001. Here it states that the organization may only exclude requirements that neither affect the organization’s ability, nor its responsibility to provide product that meets customer and applicable regulatory requirements. The requirements for which exclusion is permitted are limited to those in section 7 of the standard.
Under ISO 9000 :2008, it was possible for organizations to exclude functions and processes of their organization that may have been difficult to control or were not part of the order fulfilment cycle. Organizations that designed their own products but not for specific customers could escape bringing these operations into the management system. Marketing was omitted because it
operated before placement of order. Accounting, Administration, Maintenance, Publicity, Public Relations and After Sales Support functions were often omitted because there were no requirements in the standard that specifically dealt with such activities. As there is no function in an organization that does not directly or indirectly serve the satisfaction of interested parties, it is unlikely that any function or process will now be excluded from the management system.
This requirement responds to the System Approach Principle.
It is sensible to describe the scope of the management system so as to ensure effective communication. The scope of the management system is one area that generates a lot of misunderstanding particularly when dealing with auditors, consultants and customers. When you claim you have a management system that meets ISO 9001 it could imply that you design, develop, install and service the products you supply, when in fact you may only be a distributor.
Why you need to justify specific exclusions is uncertain because it is more practical to
justify inclusions.
The scope of the management system is the scope of the organization. There is no longer any reason to exclude locations, activities, functions or processes for which there is no requirement in the standard. The reason is because the ISO 9000 family now serves customer satisfaction and is not limited to quality assurance as were the 1994 versions of ISO 9001, ISO 9002 and ISO 9003.
It is not appropriate to address exclusions by inserting pages in the manual corresponding to the sections of the standard and adding justification if not within the scope of the management system – such as ‘We don’t do this!’. It is much more appropriate to use an appendix as indicated previously in the manual contents list. By describing the nature of the business, you are establishing boundary conditions. If in doing so you do not mention that you design products, it will be interpreted that design is not applicable. For exclusions relative to detail requirements, the Compliance Matrix may suffice but for an unambiguous solution, it is preferable to produce an exposition that addresses each requirement of the standard.
Preparing the ISO 9001 quality manual
Preparing The ISO 9001 Quality Manual
The standard requires a quality manual to be established
and maintained that includes the scope of the quality
management system, the documented procedures or refer-
ence to them and a description of the sequence and
interaction of processes included in the quality manage-
ment system.
ISO 9000 defines a quality manual as a document
specifying the quality management system of an organi-
zation. It is therefore not intended that the
manual be a response to the requirements of
ISO 9001. As the top-level document describing
the management system it is a system description
describing how the organization is managed.
Countless quality manuals produced to satisfy ISO 9000 :2008, were no
more than 20 sections that paraphrased the requirements of the standard.
Such documentation adds no value. They are of no use to managers, staff or
auditors. Often thought to be useful to customers, organizations would gain
no more confidence from customers than would be obtained from their
registration certificate.
This requirement responds to the System Approach Principle.
A description of the management system is necessary as a means of showing
how all the processes are interconnected and how they collectively deliver the
business outputs. It has several uses as :
a means to communicate the vision, values, mission, policies and objectives
of the organization
a means of showing how the system has been designed
a means of showing linkages between processes
a means of showing who does what
an aid to training new people
a tool in the analysis of potential improvements
a means of demonstrating compliance with external standards and regulations
When formulating the policies, objectives and identifying the processes to
achieve them, the manual provides a convenient vehicle for containing such
information. If left as separate pieces of information, it may be more difficult to
see the linkages.
The requirement provides the framework for the manual. Its content may
therefore include the following:
1 Introduction
(a) Purpose (of the manual)
(b) Scope (of the manual)
(c) Applicability (of the manual)
(d) Definitions (of terms used in the manual)
2 Business overview
(a) Nature of the business/organization – its scope of activity, its products
and services
(b) The organization’s interested parties (customers, employees, regulators,
shareholders, suppliers, owners etc.)
(c) The context diagram showing the organization relative to its external
environment
(d) Vision, values
(e) Mission
3 Organization
(a) Function descriptions
(b) Organization chart
(c) Locations with scope of activity
4 Business processes
(a) The system model showing the key business processes and how they are
interconnected
(b) System performance indicators and method of measurement
(c) Business planning process description
(d) Resource management process description
(e) Marketing process description
(f) Product/service generation processes description
(g) Sales process description
(h) Order fulfilment process description
5 Function matrix (Relationship of functions to processes)
6 Location matrix (Relationship of locations to processes)
7 Requirement deployment matrices
(a) ISO 9001 compliance matrix
(b) ISO 14001 compliance matrix
(c) Regulation compliance matrices (FDA, Environment, Health, Safety,
CAA etc.)
8 Approvals (List of current product, process and system approvals)
The standard requires a quality manual to be established
and maintained that includes the scope of the quality
management system, the documented procedures or refer-
ence to them and a description of the sequence and
interaction of processes included in the quality manage-
ment system.
ISO 9000 defines a quality manual as a document
specifying the quality management system of an organi-
zation. It is therefore not intended that the
manual be a response to the requirements of
ISO 9001. As the top-level document describing
the management system it is a system description
describing how the organization is managed.
Countless quality manuals produced to satisfy ISO 9000 :2008, were no
more than 20 sections that paraphrased the requirements of the standard.
Such documentation adds no value. They are of no use to managers, staff or
auditors. Often thought to be useful to customers, organizations would gain
no more confidence from customers than would be obtained from their
registration certificate.
This requirement responds to the System Approach Principle.
A description of the management system is necessary as a means of showing
how all the processes are interconnected and how they collectively deliver the
business outputs. It has several uses as :
a means to communicate the vision, values, mission, policies and objectives
of the organization
a means of showing how the system has been designed
a means of showing linkages between processes
a means of showing who does what
an aid to training new people
a tool in the analysis of potential improvements
a means of demonstrating compliance with external standards and regulations
When formulating the policies, objectives and identifying the processes to
achieve them, the manual provides a convenient vehicle for containing such
information. If left as separate pieces of information, it may be more difficult to
see the linkages.
The requirement provides the framework for the manual. Its content may
therefore include the following:
1 Introduction
(a) Purpose (of the manual)
(b) Scope (of the manual)
(c) Applicability (of the manual)
(d) Definitions (of terms used in the manual)
2 Business overview
(a) Nature of the business/organization – its scope of activity, its products
and services
(b) The organization’s interested parties (customers, employees, regulators,
shareholders, suppliers, owners etc.)
(c) The context diagram showing the organization relative to its external
environment
(d) Vision, values
(e) Mission
3 Organization
(a) Function descriptions
(b) Organization chart
(c) Locations with scope of activity
4 Business processes
(a) The system model showing the key business processes and how they are
interconnected
(b) System performance indicators and method of measurement
(c) Business planning process description
(d) Resource management process description
(e) Marketing process description
(f) Product/service generation processes description
(g) Sales process description
(h) Order fulfilment process description
5 Function matrix (Relationship of functions to processes)
6 Location matrix (Relationship of locations to processes)
7 Requirement deployment matrices
(a) ISO 9001 compliance matrix
(b) ISO 14001 compliance matrix
(c) Regulation compliance matrices (FDA, Environment, Health, Safety,
CAA etc.)
8 Approvals (List of current product, process and system approvals)
Subscribe to:
Posts (Atom)