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.
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 […]
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: 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: 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 […]