ISO/IEC 17000 FDIS Released
By Brad Kelechava ISO/IEC 17000, the international standard for vocabulary and general principles related to conformity…
Effective Quality Auditors Are Catalysts for Change
By Jim L. Smith It’s rare that managers, or even most quality auditors, discuss how…
Analyzing the Changes to ISO 14971:2019
By Marcelo Trevino Historically, risk management has been a complex subject, with different stakeholders assigning different…
What Are Soft Skills?
By Melanie Ross To be an effective auditor or assessor, it takes a variety of…
Monitoring Food Suppliers: Audits or Assessment?
By Filippo Camerini and Nuno F. Soares, Ph.D. We all know that auditing is far…
Integrated Management Systems Improve Organizations
By Anjalika Singh Management system implementation reminds me of the advice my gym instructor gave…
A Softer, Gentler FDA Inspectorate?
By Shawn M. Schmitt Let’s be blunt: Device makers aren’t particularly happy when the U.S. Food…
Keeping Current
By Bill Aston Changes in every industry, standard, specification and code are inevitable. So is…
How Do You Know?
Opinion by Mike Richman The concept of doubt gets something of a bum rap. Questioning…
Myth: Your Management System Documentation Must Resemble the ISO Standard
By Inderjit Arora Every company uses a system to understand the requirements and inputs of…