ISO 9001:2008

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Revisions from ISO 9001:2000

Introduction:

ISO 9001 is now in its fourth edition. Starting with the 1987 initial edition, it changed in 1994 and again in 2000. The 2000 change was pretty extensive. It introduced the concept of process auditing and added a lot of emphasis to the importance of top management to the effectiveness of quality management systems. In November 2008, the fourth edition was released.

Discussion:

On November 13, 2008, the fourth edition of ISO 9001 became official. It is referred to as ISO 9001:2008. The good news is that it contains no substantive changes or new requirements. The changes that were made were done for two reasons: 1) clarifications to the requirements of ISO 9001:2000; 2) to improve alignment with ISO 14001:2004.

The ANSI-ASQ National Accreditation Board (ANAB) has issued two Heads-up documents that deal with the changes and transition process for moving from ISO 9001:2000 to ISO 9001:2008. These can be accessed from the ANAB web page www.anab.org. Refer to Heads-up numbers 129 (migration) and 135 (where/how to buy the standard.)

The transition/migration process has the following requirements:

  • Twelve months after the release of ISO 9001:2008, all new and re-certification audits must be done to the ISO 9001:2008 standard.
  • Twenty-four months after release of ISO 9001:2008, all ISO 9001:2000 certificates will be invalid.
  • Upgrading from ISO 9001:2000 to ISO 9001:2008 requires a surveillance or re-certification audit to be conducted.

If you are certified to ISO 9001:2000, you can continue with that revision level for a period of time depending where your organization is within its current three-year certificate cycle. Each certification/registration body (CRB) will have its own practices/rules regarding when and under what conditions an existing certification can be upgraded to ISO 9001:2008. However, in all cases, there must be either a surveillance or re-certification audit executed before an ISO 9001:2000 certificate can be upgraded to ISO 9001:2008.

How can an organization demonstrate to its CRB that is has reviewed the changes to ISO 9001:2000, analyzed the new/changed wording of ISO 9001:2008 and, if required, made modifications to its quality management system (QMS)? One way is to use the following checklist. It has been developed based on the key clauses of ISO 9001:2008, clauses 4 thru 8.

How to Use the Checklist:

  • First and foremost – obtain at least one copy of ISO 9001:2008. (See ANAB Heads-up No. 135 for directions on how to obtain a copy.)
  • Next, determine if the existing documented QMS and actual practices meet the requirements of ISO 9001:2008. The checklist has three categories:
    • Meets this requirement
    • Needs some modification
    • Clause not applicable.
  • (If you check this box, remember that only sub-clauses in section 7 can be claimed to be not applicable, and your scope statement and related documentation must contain justification for such exclusions.)
  • For each clause/sub-clause, use the Comments/Notation cells to annotate where the requirement is met. This may be a reference to a document, policy, procedure, work instruction, process document, etc.
  • When completed, notify your CRB that you are ready to be audited in accordance with the requirements of ISO 9001:2008. The completed checklist will provide one form of objective evidence (at the minimum, it will be a solid audit-trail) that your organization has completed an analysis of ISO 9001:2008 and, if applicable, made required changes to its QMS.

Download ISO 9001:2008 Checklist

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