IATF Launches New Statistics Feature to Track Nonconformity Data
It was a busy news day at IATF. Aside from the IATF 16949 Value Add Brochure that was published to the site today, the group also published Stakeholder Communique SC-2022-10, which announces a very welcome new feature to the IATF website: a new section called Statistics, which will be updated each month and include the […]
“The Value Add of Successful IATF 16949 Implementation” Published by IATF
The IATF has developed a brochure to highlight “The Value Add of Successful IATF 16949 Implementation” which was published on the IATF Global Oversight web page on October 27th. You can download the brochure from the IATF website or from the download link below. IATF certification of a manufacturing company in the automotive sector adds […]
Free Whitepaper: How can ISO 9001 Help Your Business Grow?
When you operate a business, you may encounter other businesses that boast about their ISO 9001 certification, or you may encounter customers who want to know if you are ISO 9001 certified. The ISO 9001 system can help you to improve your business through quality management, so this white paper helps you understand what ISO […]
IATF Updates FAQ 29 to Give New Guidance on Contingency Plans
On May 26th, 2022, the IATF posted that they had approved Stakeholder Communique SC-2022-008 Release of Sanctioned Interpretations (SIs) and Frequently Asked Questions (FAQs) related to IATF 16949:2016 and an SI for Rules 5th Edition, with the changes being effective in June. Of note, FAQ 29 was updated with guidance for developing effective contingency plans:
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 […]
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 […]
Free Whitepaper: Checklist of Mandatory Documentation Required by ISO 13485:2016
The latest version of ISO 13485 was published in 2016, which means medical device companies need to transition from the previous version of the standard and comply with the new requirements. One of the most important steps in the transition process, as well as in the initial implementation, is determining what documents and records are […]
Free Whitepaper: Clause-by-Clause Explanation of ISO 13485:2016
Striving towards quality and compliance with all applicable regulations is the mission of every modern medical device company. ISO 13485 provides a framework for how to achieve this, and the first step in the implementation is to understand what the standard really requires. This whitepaper is designed to help top management and employees in organizations […]