ISO 9001 addresses process quality standards, not product quality standards. It does not involve inspection to see if a part meets a specification. It addresses examining the process and the controls used during its manufacture. The concept is that if everything in the process is good, it will produce a good product
Thursday, November 26, 2009
Establishing Quality Objectives In ISO 9001 Standards
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
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
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
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
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.