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 […]
FDA Issues New Draft Guidance on Medical Device Quality System Software Assurance
21 CFR 820, the regulation that outlines the quality management system requirements for medical devices manufactured or distributed in the US, defines requirements for production and process controls in sec. 820.70 to ‘ensure that a device conforms to its specifications, with 820.70(i) listing the only requirements for software validation in automated processes, something that has […]
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 […]
FDA Releases New Draft Guidance for Remote Regulatory Assessments
RAPS Regulatory Focus reported last Friday that the US Food and Drug Administration (FDA) released draft guidance on July 22nd that formalizes its plans for using remote regulatory assessments (RRAs) for FDA-regulated products to supplement onsite inspections as we work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 […]
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 […]
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 […]
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 […]
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 […]
The FDA Poses ‘Seven Questions’ to Begin Clarifying Details of the QSR Harmonization with ISO 13485
Last week we reported the breaking news that the FDA, after years of attempts and delays, had finally released the proposed rule to harmonize the current Quality System Regulation (QSR) outlined in 21 CFR 820 with the international standard for medical device quality management system requirements, ISO 13485:2016 to generate a new resulting regulation called […]