What is the London Declaration?
Introduction The London Declaration is a landmark agreement signed by numerous countries to address the global challenge of climate change. Its primary goal is to establish international standards related to climate change and integrate climate-related language into existing international standards. This article will delve into the significance of the London Declaration, its importance in fostering […]
FDA Issues ICH Final Guidance for Continuous Manufacturing (CM) and Artificial Intelligence (AI) in Drug Manufacturing
The FDA is seeking public comments on the use of artificial intelligence (AI) in pharmaceutical manufacturing. As the use of AI continues to grow across industries, drug manufacturers are also looking to adopt AI-based technologies to improve drug discovery, formulation, process development, and quality control. According to a recent article on Endpoints News, the FDA […]
The Four Key Elements of a Successful Culture of Quality Improvement and How They are Addressed in ISO 9001
Creating a culture of quality improvement is crucial for any organization seeking to achieve excellence in its products or services. In an excellent article from Boston Consulting Group, Boudier and Bowers provide several key insights into creating such a culture. We explore the four key elements that they identified as being necessary for the successful […]
2022 Top 10 IATF Major and Minor Nonconformities Compared Year-Over-Year
IATF has published their year-end statistics for top 10 major and minor nonconformities raised during CB audits from December 2021 to December 2022. We’re taking a look back at the year-end statistics from 2021 to see how things have changed over the last 12 months. The top 10 major nonconformities from 2021 compared to 2022 […]
GM Releases Updated IATF 16949 Customer Specific Requirements Effective January 1, 2023
On December 22nd, General Motors published their updated IATF 16949 Customer Specific Requirements, with the new CSR taking effect on January 1, 2023. The full table of changes is in the image below. Aside from the replacement of BIQS requirements with GM Quality Performance Requirements, the most noteworthy change is the note: “Throughout the document: […]
IATF Releases Communique Requiring CB Auditors to Complete AIAG/VDA Harmonized FMEA Training by Q1 2023
In December of 2022, IATF published CB Communique 2022-03 – AIAG VDA Harmonized Approach to FMEA to outline details for new IATF ADP mandatory training and quiz requirements for CB auditors. New AIAG/VDA harmonized approach to FMEA training and quiz modules were made available for CB auditors starting on December 7th of this year and […]
What a QMS Isn’t: Two Common Misconceptions When Implementing a QMS
Being in the QMS consulting business, we get to work with all sorts of clients from various industries who want to implement or improve their quality management systems starting from various levels of maturity. Some have systems in place but are looking to make them more robust or more reflective of their processes, eliminating redundancies […]
What to Expect in the 2023-2024 Baldrige Excellence Framework
The Baldrige Program at NIST has been working diligently on the next revision of the Baldrige Excellence Framework; the 2023-2024 Framework with its Criteria is expected to be published in January 2023. There will be three versions: Business/Nonprofit, Health Care, and Education. In addition, the shorter version of the framework, Baldrige Excellence Builder, will be […]
ISO Releases Net Zero Guidelines at COP27 Urging the World to Double Down on the 1.5° C Target
ISO has launched the first globally agreed Net Zero Guidelines. Launched at COP27, the Net Zero guidelines seek to tackle a major roadblock for a world where greenhouse gas emissions are reduced and balanced by attempting to remedy the fragmented net zero governance landscape. This landmark publication provides much-needed guidance and clarifies key concepts and […]