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 […]
Is ISO 9001 Undergoing a Midlife Crisis? | Opinion
ASQ has recently posed a plethora of introspective and analytical articles in its flagship Quality Progress magazine on the current state of the ISO 9001 standard, its waning influence in the world, and even questioning the efficacy of its use. These, I’ve found, are an invigorating and honest look at the world’s most popular and […]
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 […]
FDA Releases New Draft Guidance for Remote Regulatory Assessments
RAPS Regulatory Focus reported last Friday that the US Food and Drug Administration (FDA) released draft guidance on July 22nd that formalizes its plans for using remote regulatory assessments (RRAs) for FDA-regulated products to supplement onsite inspections as we work our way out of pandemic protocols and codify “new-normal” modes of operation. The 17-page draft […]
Free Whitepaper: How to Integrate ISO 9001, ISO 14001, and ISO 45001?
There is an ever-increasing competition in the market with a higher awareness of both environmental and health & safety performance for companies. This awareness is driving businesses to implement three of the ISO standards, ISO 9001 (click here to learn more about ISO 9001), ISO 14001 (click here to learn more about ISO 14001) and […]
Free Whitepaper: How can ISO 9001 Help Your Business Grow?
When you operate a business, you may encounter other businesses that boast about their ISO 9001 certification, or you may encounter customers who want to know if you are ISO 9001 certified. The ISO 9001 system can help you to improve your business through quality management, so this white paper helps you understand what ISO […]
FDA Virtual Inspections Are Here to Stay – And That’s a Good Thing
The FDA may be easing from its pandemic response mode, but, like any industry and nearly every organization, two years of pandemic have normalized remote work for the agency and forced improvement in remote inspections. The FDA announced during the annual Drug Information Association (DIA) meeting on June 22nd that they do not plan to […]
IATF Updates FAQ 29 to Give New Guidance on Contingency Plans
On May 26th, 2022, the IATF posted that they had approved Stakeholder Communique SC-2022-008 Release of Sanctioned Interpretations (SIs) and Frequently Asked Questions (FAQs) related to IATF 16949:2016 and an SI for Rules 5th Edition, with the changes being effective in June. Of note, FAQ 29 was updated with guidance for developing effective contingency plans:
ISO 9001 Auditing Practices Group Updates Auditing Competence Guidelines
The ISO 9001 Auditing Practices Group is constituted as an informal group of quality management system (QMS) experts, auditors and practitioners, drawn from the ISO Technical Committee 176 Quality Management and Quality Assurance (ISO/TC 176) and the International Accreditation Forum (IAF). On June 1, 2022, the group revised its guidance for auditing competence and published the revised document on […]