Q: I manage the quality management 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.
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Imaging Core Lab Takes Quality Beyond Regulatory Requirements With ISO 9001, ASQ Knowledge Center case study, Open Access
Medical Metrics Inc. (MMI), had an existing quality management system structured to meet FDA regulations, but it was missing a framework to help drive organizationwide improvement. MMI worked with an external consultant to create an integrated management system—a fusion of regulatory requirements with the ISO 9001 framework—and received certification to the standard in less than seven months. Read More.
Sarbanes-Oxley And ISO 9000, Quality Progress, Open Access
Critics say ISO 9000 doesn’t compare favorably to quality programs such as the Baldrige criteria, lean and Six Sigma. But ISO 9001’s emphasis on documentation is a major asset from a legal perspective. Quality professionals can help companies comply with Sarbanes-Oxley while enhancing their organizational status. Read More.