The Biomedical Quality Auditor Handbook was developed by the ASQ Biomedical Division in support of its mission to promote the awareness and use of quality princ

The ASQ Certified Medical Device Auditor Handbook (formerly The Biomedical Quality Auditor Handbook) was developed by the ASQ Medical Device Division (formerly

This handbook is intended to serve as a baseline of hazard analysis critical control point (HACCP) knowledge for quality auditors. HACCP is more than just failu

ISO 9001:2015 includes many changes that not only affect the companies aiming to achieve certification to it, but also auditors. This book is the resource audit

The author’s lessons learned—during more than 25 years of hands-on quality management experience in environments including manufacturing, medical devices, mil