Wednesday, November 26, 2008

Significant Changes cited in 2008 Revised ISO 9001

Changes Cited in 2008 Revised issue of ISO 9001 is been summed up as below

Clause 0.2 (Process approach):
• Text added to emphasize the importance of processes being capable of achieving desired outputs
Clause 1.1 (Scope)
• Clarification that 'product' also includes intermediate product
• Explanation regarding statutory, regulatory and legal requirements
Clause 4.1 (General requirements)
• Notes added to explain more about outsourcing
• Types of control that may be applied to outsourced processes
Relationship to clause 7.4 (Purchasing)
• Clarification that outsourced processes are still responsibility of the organization and must be included in the quality management system
Clause 4.2.1 (Documentation)
• Clarification that QMS documentation also includes records
• Documents required by the standard may be combined
• ISO 9001 requirements may be covered by more than one documented procedure
Clause 4.2.3 (Document control)
• Clarification that only external documents relevant to the QMS need to be controlled
Clause 4.2.4 (Records control):
• Editorial changes only (better alignment with ISO 14001)
Clause 5.5.2 (Management representative)
• Clarifies that this must be a member of the organization's own management
Clause 6.2.1 (Human resources)
• Clarification that competence requirements are relevant for any personnel who are involved in the operation of the quality management system
Clause 6.3 (Infrastructure):
• Includes information systems as example
Clause 6.4 (Work environment)
• Clarifies that this includes conditions under which work is performed and includes, for example physical, environmental and other factors such as noise, temperature, humidity, lighting, or weather
Clause 7.2.1 (Customer related processes)
• Clarifies that post-delivery activities may include:
• Actions under warranty provisions
• Contractual obligations such as maintenance services
• Supplementary services such as recycling or final disposal
Clause 7.3.1 (Design & development planning)
• Clarifies that design and development review, verification and validation have distinct purposes
• These may be conducted and recorded separately or in any combination as suitable for the product and the organization
Clause 7.3.3(Design & development outputs):
• Clarifies that information needed for production and service provision includes preservation of the product
Clause 7.5.4 (Customer property):
• Explains that both intellectual property and personal data should be considered as customer property
Clause 7.6 (Now called Control of Monitoring and Measuring equipment )
• Explanatory notes added regarding the use of computer software: 'Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.'
Clause 8.2.1 (Customer satisfaction)
• Note added to explain that monitoring of customer perception may include input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, and dealer reports
Clause 8.2.3 (Monitoring / Measurement of process)
• Note added to clarify that when deciding on appropriate methods, the organization should consider impact on the conformity to product requirements and on the effectiveness of the quality management system.

What will the ISO 9001:2008 amendment mean to you?
If you already have your ISO 9001 registration in place, or are in the process of building it, the changes will have minimal impact on your system. The amendment has focused on clarification of, not the addition or removal of, any requirements. If you are complying now, you will still be meeting requirements when the new amendment is published. What it may mean to you is less confusion in interpretation of requirements.

As you read the standard, notice how much meaning each word actually has. Teams of experts have carefully crafted the wording of each paragraph, each sentence and each bullet with the goal of registrars, auditors and users of the standard worldwide reading the same meaning into the standard as the committees intended. It is a challenging goal, and not always met. When there are questions on interpretation, a request can be made to the committee for an official interpretation. You can see these requests and the official interpretations at

The 2008 amendment addresses some of these interpretation issues, as well as compatibility with other standards, and clarification of requirements. For example, the requirement on appointing a management representative has been reworded to clarify that it must be a member of the organization's management. The word "organization" has been added as a clarification. It has not changed the requirement, which was stated as "member of management". Another example is the change to address confusion between the use of the terms monitoring equipment and measuring devices. The word "devices" has been replaced with "equipment". Clause 7.6 is now "Control of monitoring and measuring equipment".

Other changes include the rewording of requirements for records and documents in several places to make it clearer where these are required. In clause 4.2 Documentation Requirements "including records" has been added to the requirement for "documents, including records, determined by the organization to be necessary...". This clarifies that not only must the records specifically required by the standard be maintained, but records that you identify as necessary to ensure effective planning, operation and control are also required.

Eleven new notes have been added to provide more clarification, and common points of confusion being better defined. Outsourcing is one area where significant clarification has been added, with three additional notes to help the user with interpretation. In several places the term "product quality" has been replaced with "conformity to product requirements", putting the emphasis on conformity.

The proposed changes are numerous, but the message for most users is to review the new amendment for a better understanding of the requirements, but do not anticipate making major changes to your quality management system.

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