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 […]
TC 210 Not Ready to Adopt Definition of Risk Outlined in Annex SL
Last week, we wrote about recent reflections on the current state of ISO 9001 and how the 2015 standard caused so much confusion with the added notion of risk-based thinking – how the standard failed to align with language in ISO 31000, while also acknowledging that the language in ISO 31000, as lauded as it […]
TC 176 Plans to Correct Mistakes Made With the Introduction of “Risk-Based Thinking” in ISO 9001:2015 | Opinion
The July issue of ASQ’s Quality Progress was one of the best issues I’ve read in a long time, with a much-appreciated emphasis on risk management and including a terrific article from Jayet Moon that served as an introduction to the new Quality Press book Foundations of Quality Risk Management, which is definitely now on […]
Recognition of EN ISO 14971 as a harmonized standard in support of the European Medical Device Regulations
Back in June, it was reported by TC 210, the committee responsible for medical device standards such as ISO 14971 and ISO 13485, that the European standard EN ISO 14971:2019 with its amendment A11:2021 had finally been cited in the Official Journal of the European Union (OJEU) as a harmonized standard in support of the […]
If you’re going to cite operator error, do it in the PFMEA
I have written often of my disdain for the tendency of some to blame the operator when things go wrong, and anyone who has worked with me or for me has heard me parrot exhortations ad nauseam to not blame operators for failure as to not rob yourself the opportunity to improve, but I think […]
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 […]