What does the 2008 amendment to ISO 9001 mean to you?
(by Larry Whittington)
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.
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 more clear 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.
How much revising will be needed to my current documents?
None. The changes made are in the wording of the standard, not in the requirements of the standard. It should not have an effect on your documents.
I have employee training programs in place will they need to be updated?
No, it is unlikely that the specific wording of the standard is used in your training program and as long as you are training employees on the correct requirements of the standard your training will continue to be up to date. However, any references to the 2000 version should be removed to avoid confusion.
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