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FDA Releases New Draft Guidance for Remote Regulatory Assessments
RAPS Regulatory Focus reported last Friday that the US Food and Drug Administration (FDA) released draft guidance on July 22nd that formalizes its plans for using remote regulatory assessments (RRAs) for FDA-regulated products to supplement onsite inspections as we work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:
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 […]