ISO 9001 Auditing Practices Group Updates Auditing Competence Guidelines
The ISO 9001 Auditing Practices Group is constituted as an informal group of quality management system (QMS) experts, auditors and practitioners, drawn from the ISO Technical Committee 176 Quality Management and Quality Assurance (ISO/TC 176) and the International Accreditation Forum (IAF). On June 1, 2022, the group revised its guidance for auditing competence and published the revised document on […]
After a Global Pandemic, Are Fully Remote QMS Audits Truly Effective?
Although ISO 19011—“Guidelines for auditing management systems” has included language about remote QMS audits since the 2018 revision, this became a reality for many of us in March 2020 with the onset of Covid-19 and the mass lockdowns that ensued. Many of us have been exclusively auditing quality management systems remotely for a year and […]
After Years of Delays, FDA Finally Issues Proposed Rule to Harmonize QSR to ISO 13485
After four long years and constantly slipping timelines, the FDA is finally making good on efforts to harmonize its Quality System Regulation (QSR), defined in 21 CFR 820, with the international standard for medical device quality management systems, ISO 13485, with a proposed rule issued Tuesday, 2/22/2022, with the resulting regulation being dubbed the Quality […]
IAOB Discuss The Top 10 IATF 16949 Minor Nonconformities in 2021
Last week, we discussed a video series from IAOB covering the top 10 IATF 16949 major nonconformities addressed by CB auditors in 2021 (you can read that article HERE). Today, we’re continuing this discussion with IAOB’s conversation around the top 10 minor nonconformities issued last year. It’s always important to take this time to reflect […]
A Registrar’s Perspective on the Effectiveness of Remote QMS Auditing
We’ve written extensively about remote auditing in the wake of nearly two years of the pandemic, but primarily from the perspective of an auditor or a client organization. Watch the video from Quality Digest as they interview Paul Butcher, CEO of LRQA, to get some insight on remote auditing from a registrar’s perspective.