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 […]
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 […]
2021 Top 10 IATF 16949 Major Nonconformities
2021 is over. Let’s take a look back at the top 10 major nonconformities identified during 3rd party IATF audits in 2021 to better understand areas of the QMS in which automotive manufacturers seem to struggle most, which will give us some insight on areas in which we need to focus to improve skills, capability, […]
New FMEA Requirements in the Ford Customer Specific Requirements (CSR)
The Ford IATF 16949 Customer Specific Requirements (CSR) were updated in November of 2021 with several important changes that became effective as of January 03, 2022, and in which there will need to be evidence of implementation for Tier-1 and sub-tier suppliers by July 1, 2022. I’ve included the entire revision table of the Ford […]
Is My Product a Medical Device?
Is My Product a Medical Device? I get asked this question quite a lot. It’s important to understand the criteria of what constitutes as a medical device and how medical devices are classified so that the proper regulatory pathway is taken for pre-market clearance or approval, as well as saving yourself the trouble of going […]