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 […]
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: How Can ISO 13485 Help Your Business Grow?
If you’re in the business of developing and manufacturing medical devices, then “risk” and “risk management” have become terms synonymous with your daily operations. Your most important and critical responsibility is to bring a medical device to market that provides a needed function to a patient or consumer and is also proven to be safe […]
Free Whitepaper: Implementing IATF 16949 With a Consultant vs. a DIY Approach
One of the goals of every company is to create a bigger profit and avoid losses and financial mismanagement. Among other benefits IATF 16949 brings to the company, it can be one of the tools that will help companies to enhance their image and expand their market by being qualified to apply for tenders and […]
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 […]
Free Whitepaper: Basics of ISO 9001:2015 Risk Management
Risk-based thinking is a new concept in the ISO 9001:2015 standard, and this has caused many companies to search for an easy way to manage the risk in their companies. By focusing on understanding your risks through a simple risk management process, you can focus your attention more on addressing the risks that are present […]