The ISO 9001:2000 standard has been updated and the new version was released in November 2008. The new standard is ISO 9001:2008. The changes are minor in nature and primarily clarifications.

Because of the limited changes, the International Organization for Standardization (ISO) and the International Accreditation Forum (IAF) has issued an agreed implementation plan:

• One year after publication of ISO 9001:2008 all certification and re-certifications will be to ISO 9001:2008.
• Two years after publication all certifications to ISO 9001:2000 will be invalid.

We do not anticipate your registrar will ask for more time during the surveillance or re-certification audits to transition your company to the new standard. The transition will happen over the next two years starting right away. There is no option; you must transition to the new standard. The good news is the changes are minor and will take little effort on your part.

To update your programs to the new standard we recommend the following:

1) Get a copy of the new standard. The standard can be purchased through ASQ and ISO.

2) Review Annex B in the standard (pages 20-25). We recommend one or two people sit down and go through this Annex. It lists all the changes and you can decide if any of them require you to change any of your documents. Keep a record of the review and report on it in your management review meeting. Your registrar will want to see the record of your discussions so keep enough detail in your management review meeting minutes to provide the needed evidence.

3) Review your documents for references to ISO 9001:2000 and change to ISO 9001:2008. Some common documents you might find this reference in, include: your quality manual, records table, and Internal Audit procedure and forms. The reference may be in other documents and if you can do a search on 2000 it might help you locate all occurrences. For the most part all you should have to do to update your ISO 9001 program is update the reference to ISO 9001:2000 to ISO 9001:2008.

Note: Pay special attention to the expanded definition regarding outsourcing. This may impact your quality management system and your supplier controls.

We expect your registrar should be asking you to switch at your next audit. Please let us know if you have any questions or need more information.

These are recommendations only – please discuss your plans with your registrar.

Brief summary of the changes:

The changes are primarily in language and terminology, clarifying some elements of the 2000 version. Some notable changes:

4.1 There is more discussion on outsourcing and the degree of control you need to maintain.

4.2.1 It now explains you can cover more than one required document in a single procedure (e.g.; you can combine corrective and preventive action in one procedure).

6.3 Now includes information systems.

7.6 The word "devices" has gratefully been changed to "equipment".

8.2.1 There is more discussion about monitoring customer perception.

There are several other changes in wording.

If you have any questions or concerns about the standard, please contact us.