deGRANDSON Global Blog | Dr John FitzGerald (8)

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

Medical Devices: Managing Residual Risk and Risk Tolerance

ISO 13485

Managing residual risk and understanding risk tolerance are crucial aspects of ISO 13485 compliance. ISO 13485:2016 is an international standard that outlines the requirements for a quality management system (QMS) in the medical device industry. Clause 7.1 requires risk management in relation to operations and, in a note (not, therefore, a requirement), refers to ISO 14971. How, then, should you ...

22 Oct 2024

ISO 27001 in Manufacturing & Service Industries - 12 FAQs

ISO 27001

Have you considered this possibility? If you wait until this message greets you at work, a Notebook PC is stolen from a company vehicle, or staff members are working on their own PCs from home, it will be too late. It's not a question of whether your business will be targeted. You're already a target but have been lucky to date.

17 Oct 2024

ISO Accreditation vs ISO Certification: what's the difference?

10 Reasons Why ISO 14001 Matters to SMEs

ISO 14001

Even the smallest organization has a lot to gain from a certified Environmental Management System (EMS) New businesses often ponder the benefits of ISO 14001 Certification and, being busy with start-up priorities, postpone certification until it is asked for in a tender document or by a prospective customer. At that point, it is, of course, too late. Optimistically, getting certified takes at ...

08 Aug 2024

The Climate Change Amendment to ISO Management System Standards

ISO 13485 Risk Evaluation for Medical Devices explained

ISO 13485

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 ...

13 Jun 2024

ISO 9001 Analysis and Evaluation - DOs and DON'Ts

ISO 9001

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 ...

25 Apr 2024

Measuring Information Security Effectiveness with ISO 27004

ISO 27001

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 ...

23 Apr 2024

Safety Calendar for May

ISO 45001

21 Sep 2023

PRRC: Are you in breach of the EU MDR and IVDR Requirement?

ISO 13485

The EU MDCG 2019-7 provides guidance on "Persons Responsible for Regulatory Compliance’ (PRRC). The European Commission (EC) has published MDCG 2019-7, Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a ‘person responsible for regulatory compliance’ (PRRC). Meeting the requirements here will challenge SMEs and start-ups, but ...

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News and Commentary on ISO Management System Standards

Dr John FitzGerald

Recent Posts

Medical Devices: Managing Residual Risk and Risk Tolerance

ISO 27001 in Manufacturing & Service Industries - 12 FAQs

ISO Accreditation vs ISO Certification: what's the difference?

10 Reasons Why ISO 14001 Matters to SMEs

The Climate Change Amendment to ISO Management System Standards

ISO 13485 Risk Evaluation for Medical Devices explained

ISO 9001 Analysis and Evaluation - DOs and DON'Ts

Measuring Information Security Effectiveness with ISO 27004

Safety Calendar for May

PRRC: Are you in breach of the EU MDR and IVDR Requirement?

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