Which Medical Device Quality System Is Right for You?
by William I. White In structuring quality management systems, most medical device companies choose a…
Competence vs. Qualification Personnel Certification Programs
by Dr. George J. Anastasopoulos Personnel certification has been and will continue to remain a…
All Kinds of Audits—One Audit Program
By Denise Robitaille We often get so focused on doing things a certain way…
Understanding the Risk Type of Auditors
By Geoff Trickey, Managing Director, Psychological Consultancy Ltd (PCL) The amount of risk that people are…
ASQ Seeks Members for Committee to Revise ISO 19011
ASQ is administering the U.S. committee to revise ISO 19011, Guidelines for auditing management systems.…
Global Audits and Auditor Competence
By Peter Holtmann Performing global audits or international audits can be tricky. Culture, trust,…
Auditing Business Is a Family Affair…
Jenine Turner is a woman of many hats—director of an auditing and consulting firm, farmer,…
Objective Auditing Meets ISO 9001:2015
Auditors can help organizations understand context and risk By Inderjit Arora Objective auditing has always…
Career Pathway Auditing Survey Interview with Peter Holtmann
Exemplar Global conducted an extensive global survey of auditors via LinkedIn in 2015. More than…
ISO Releases ISO 13485:2016 Medical Devices Standard
The International Organization for Standardization (ISO) recently released ISO 13485:2016 Medical devices—Quality management systems—Requirements for…