Standards and Auditing


Editor's Pick
Open Access

Energize Your QMS

by Hunt, Lorri

Changes to the ISO 9001:2008 amendment are high benefit and low impact. This position stated the following: "ISO 9001:2008 has been developed to introduce clarifications to the existing requirements of ISO 9001:2000 and changes that are intended to improv...


Field Notes: Sorting It Out

by Laman, Scott A.

Medical device risk management is an interesting and rewarding profession because we perform critical analyses throughout a product’s life cycle to protect patients and users from harm....


In Tandem

by Khan, Naeem

Opportunity management, a long-neglected concept in business literature, has finally been given more of the spotlight. Usually, it’s been risk management that has gotten more attention because of its negative impacts....


Expert Answers: December 2016

by Aston, Bill

Implementation of subclause 6.1 in ISO 9001:2015—actions to address risks and opportunities ......



Featured advertisers