ISO 9001 : 2008

    ISO 9000 is a family of standards for quality management systems. ISO 9000 is maintained by ISO, the International Organization for Standardization and is administered by accreditation and certification bodies. The rules are updated, as the requirements motivate changes over time.Some of the requirements in ISO 9001:2008 (which is one of the standards in the ISO 9000 family) include:

- a set of procedures that cover all key processes in the business
- monitoring processes to ensure they are effective
- keeping adequate records
- checking output for defects, with appropriate and corrective action where necessary
- regularly reviewing individual processes and the quality system itself for effectiveness
- facilitating continual improvement

    A company or organization that has been independently audited and certified to be in conformance with ISO 9001 may publicly state that it is "ISO 9001 certified" or "ISO 9001 registered". Certification to an ISO 9001 standard does not guarantee any quality of end products and services; rather, it certifies that formalized business processes are being applied.

ISO 9001:2008 FAQs
1. I am an existing 9001:2000 client, how do I transition to ISO 9001:2008?
See website (www.uk.sgs.com/9001transition)
2. From where can we buy a copy of ISO 9001:2008?
The Standard is available from ISO (the International Organization for Standardization) or from BSI in the UK.
3. Is there a document available which outlines only the changes and easily available?
Yes. Appendix B in ISO 9001:2008 shows only the changes.
4. Are the requirements in ISO 9004:2000 incorporated into the 2008 standard?
ISO 9004, Guidelines for Performance Improvement, is planned to be issued in 2009.
5. For a company that has an effective and compliant system to ISO 9001:2000, will the transition audit to the 2008 version, just be a formality?
No audit is "just a formality". You will need to ensure that your QMS meets the requirements of ISO 9001:2008.
6. How does ISO 9001:2008 impact on related standards (e.g. AS9100, ISO 13485)?
These standards remain aligned with 9001:2000 at present, so there is no impact.

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