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 […]
TC 176 Orders Design Specification for ISO 9001 Early Revision – But is it Needed?
ISO standards, by ISO’s procedures, go through a review every five years for the purpose of ensuring that all content is still relevant, and that technology has not caused the standard to become obsolete. This is very critical for technical standards, but less so for management standards, which are typically codifying management best practices that […]
TC 176 Approves New Interpretation of ISO 9001:2015 Clause 8.2.3.1
ISO/TC 176, the Technical Committee responsible for the flagship quality management standard ISO 9001, among several others, has recently approved a request for interpretation regarding ISO 9001:2015, clause 8.2.3.1.
IATF Updates Rules 5th Edition FAQ in Response to Ongoing Semiconductor Shortage
On April 7th, 2022, IATF reported that the organization had approved Stakeholder Communique SC-2022-006 Rules 5th Edition FAQ and Sanctioned Interpretations. Of special note is the update to FAQ 8, which poses the question as to whether additional audit time should be added if poor OEM scorecard performance is caused by the ongoing semiconductor shortage […]
IATF Approves Communique SC-2022-007 in Response to Ongoing Conflict in Ukraine
On 4/8/2022, the IATF approved Stakeholder Communique SC-2022-007 IATF certification activities in Ukraine. The purpose of this Communiqué is to advise all IATF Stakeholders regarding global waivers and measures of the IATF (International Automotive Task Force) in response to the situation in Ukraine. First and foremost, the thoughts of the IATF are with the Ukrainian […]
PECB Signs a Partnership Agreement with Isometric Consulting
February, 2022 – PECB, a global provider of professional ISO standards trainings and certifications, has signed a partnership agreement with Isometric Consulting to expand its presence in North America market. Based on the agreement, Isometric Consulting will begin to provide services related to ISO standards. “This partnership addresses a specific market need. Organizations are looking to […]
The FDA Poses ‘Seven Questions’ to Begin Clarifying Details of the QSR Harmonization with ISO 13485
Last week we reported the breaking news that the FDA, after years of attempts and delays, had finally released the proposed rule to harmonize the current Quality System Regulation (QSR) outlined in 21 CFR 820 with the international standard for medical device quality management system requirements, ISO 13485:2016 to generate a new resulting regulation called […]
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 […]