Volume 8 · Issue 12 · December 2003
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?