deGRANDSON Global Blog | Dr John FitzGerald

News and Commentary on ISO Management System Standards

Dr John FitzGerald

Director & Founder of deGRANDSON Global. Spent 15 years in the manufacturing industry and 25 years training, consulting & auditing management systems

The Climate Change Amendment to ISO Management System Standards

The ISO Committee for Conformity Assessment (CASCO) has added a reference to “climate change” within all management systems standards operating according to Annex SL. What is ISO 9001:2015, Amendment 1:2024 They have stated that this is a clarification rather than a new requirement. Therefore, the publication year of the affected Annex SL standards will not change. As a ‘clarification,’ there is ...

08 Aug 2024

ISO 13485 Risk Evaluation for Medical Devices explained

There are two distinct and different requirements in ISO 13485:2016 for the management of risk. From Dr John FitzGerald: Misinformation about risk management is already too easy to find regarding the adoption of ISO 13485 in the FDA's QMSR regulations, which will come into force in February 2026. If you follow the advice of these self-appointed experts, you will likely become confused and perhaps ...

30 Jul 2024

ISO 13485 Certification in the Medical Device Supply Chain

The medical device industry operates within a highly regulated landscape where product quality, safety, and reliability are critical. In this complicated world, ISO 13485 is an essential guide in helping medical device manufacturers and suppliers achieve excellence in quality management. Today, let's look at how ISO 13485 compliance can affect the medical device supply chain from the starting ...

18 Jun 2024

ISO 13485 - What Suppliers to the Medical Device Sector Need to Know

Many organizations with the potential to supply components, packaging, and other goods and services (incl. logistics) to the Medical Device Sector are scared off by talk of CE Marking, Notified Bodies, regulatory inspections, unannounced/surprise audits, and the like. It's all nonsense (well, almost all). You don't believe me? Then read on. There could be a lot of high-margin business that you're ...

13 Jun 2024

ISO 9001 Analysis and Evaluation - DOs and DON'Ts

Practical advice on implementing ISO 9001:2015 Clause 9.1.3 This article will consider a sub-clause in ISO 9001 Part 9, Performance Evaluation, of the Quality Standard, namely, 9.1.3, Analysis & Evaluation. NOTE: While the exact wording may differ from Standard to Standard, the advice given here also applies to ISO 14001, ISO 27001, ISO 45001, and other standards that have the same HLS ...

08 May 2024

Open Letter to ISO/TC 176 regarding the ISO 9001 Revision

Ladies & Gentlemen of ISO/TC 176, With renewed dismay, I read of the contents of ISO/CD 9001:2024 (albeit a leaked copy from a usually reliable source). It seems we have another revision that will do nothing to restore the esteem in which the ISO 9001 Standard was once held and nothing to provide tangible benefits to certified organizations and their customers. So, I challenge you to make ...

25 Apr 2024

Measuring Information Security Effectiveness with ISO 27004

ISO 27001 provides no guidance and is of little help In deciding what to monitor and measure regarding your Information Security Management System (ISMS), ISO 27001 specifies no mandatory requirements (as emphasized in our ISO 27001 training courses). Thankfully, ISO 27004 provides guidelines and principles for measuring and reporting the effectiveness of an organization's ISMS. The standard ...

04 Apr 2024

Environmental Aspects - meeting ISO 14001 requirements

Systematically identifying relevant ISO 14001 environmental aspects in implementing an EMS. This is fundamental to the effectiveness of an Environmental Management System (EMS) and to ensuring that your organization meets ISO 14001 certification requirements.

19 Mar 2024

ISO 14971: Choosing the right Risk Management Tools

Using FMEA alone is a lazy choice and no longer acceptable ISO 14971, Medical Devices - Application of risk management to medical devices is frequently misapplied, and if your ISO 13485 QMS Manual claims to use ISO 14971, you'd better use it properly.

03 Mar 2024

Scenarios are a key difference with deGRANDSON e-Learning

All our Courses are true e-Learning and include extensive Scenarios The many short- and long-term scenarios presented are unique to e-learning with deGRANDSON Global. Altogether, they help bridge the void between theory learned in a classroom-like situation and the practice, and challenge, of face-to-face auditing. You get the opportunity to practice what you've learned before engaging in a ...

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News & Commentary on ISO Management System Standards

News and Commentary on ISO Management System Standards

Dr John FitzGerald

Recent Posts

The Climate Change Amendment to ISO Management System Standards

ISO 13485 Risk Evaluation for Medical Devices explained

ISO 13485 Certification in the Medical Device Supply Chain

ISO 13485 - What Suppliers to the Medical Device Sector Need to Know

ISO 9001 Analysis and Evaluation - DOs and DON'Ts

Open Letter to ISO/TC 176 regarding the ISO 9001 Revision

Measuring Information Security Effectiveness with ISO 27004

Environmental Aspects - meeting ISO 14001 requirements

ISO 14971: Choosing the right Risk Management Tools

Scenarios are a key difference with deGRANDSON e-Learning

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