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 […]
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 9001:2015
Striving toward quality and customer satisfaction is the mission of every modern company. ISO 9001 provides a framework on how to achieve this, and the first step in the implementation is to really understand what the standard requires. This white paper is designed to help top management and employees in organizations that decided to establish […]
Free Whitepaper: Checklist of Mandatory Documentation Required by ISO 9001:2015
It is easy to become overwhelmed with documentation in the belief that every single process that is in place in an organization must be documented, without realizing that this is not necessary to meet the requirements of the ISO 9001 standard. The 2015 revision of the standard become more liberal regarding documentation requirements, meaning that […]
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 […]