Standard Issues

2020

Standard Issues: Fundamental to Success

by Cressionnie, L.L. “Buddy”

ISO 9001:2000 was transformational with its introduction of the process approach. Now, almost 20 years later, some organizations still have not embraced the process approach, and some auditors aren’t auditing according to the process approach....


Standard Issues: Going Through Changes

by Mehta, Bob

When working in a highly-regulated environment such as the medical technology (med-tech) industry, there is one basic concept all quality and regulatory professionals can take to the proverbial bank: regulations will change....



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