ISO 9001 Statutory and Regulatory Requirements


Q: I manage the quality managent program at my company according to ISO 9001:2008 — Quality management systems –Requirements.  I was hoping to find some assistance in the area of statutory and regulatory requirements.  Can you provide me with some help in regards to what this means in terms of the standard?

A: Statutory and regulatory requirements are product related.  They may be federal, state or local.  They would depend upon your industrial classification.  Once you have that, you can cross check the classification with the Code of Federal Regulations (CFR).  Since the CFR are subject to change, someone in your organization should be charged with the responsibility for researching updates (there are organizations that provide this service). As far as international is concerned, the country of destination would need to be researched.  Often, a customs broker can be of assistance here.

George Hummel
Voting member of the U.S. TAG to ISO/TC 176 – Quality Management and Quality Assurance
Managing Partner, Global Certification-USA
www.globalcert-usa.com/
Dayton, OH

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