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.
Thursday, October 8, 2009
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”.
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