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Volume 8 · Issue 12 · December 2003


Page 29…

The ISO 9000:2000 PSI IDEAS Q&A—Regulatory Requirements

The IDEAS Q&A is aimed at providing a variety of perspectives on requirements of ISO 9001:2000 and the challenges they present to users. Question 17 is: The term “regulatory requirements” is cited in 5 clauses/subclauses of ISO 9001:2000. What should be expected to be done by and/or on behalf of an organization to address these mentions of regulatory requirements? What will/should an audit team (internal or external) look for in order to determine that the organization has achieved conformance with what ISO 9001:2000 requires in this area?