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

GDPR, ISO 27701 and ISO 27001: natural combination

In 2018, many organizations, not only those based in the EU, spent much time and money on compliance with the General Data Protection Regulation (GDPR). But what actions should we take now to ensure ongoing compliance? It's not enough to have policies and procedures to demonstrate that you comply with the requirements. If there is a data breach or similar event, you will be challenged to ...

05 Nov 2024

ISO 45001 requires Risk Management and Risk-based Thinking

You'll need OH&S Risk Management Methods & Tools Unlike ISO 9001, the Occupational Health and Safety Management System (OHSMS) Standard requires the application of OH&S Risk Management Methods in Clause 6.1.

31 Oct 2024

Combining ISO 17025 and ISO 9001 for Laboratories is not easy

29 Oct 2024

ISO Auditor Competence: who decides on it?

Being in a professional ISO auditor register isn't enough Competence is defined as the ‘ability to apply knowledge and skills to achieve intended results.’ And so it is with ISO Auditor Competence. Your Lead Auditor Certificate alone does not ensure competence. Nor, when competent, do you suddenly become incompetent three years after receiving your certificate. Confused? Don't be. For Lead ...

24 Oct 2024

Medical Devices: Managing Residual Risk and Risk Tolerance

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

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?

You've got the Certificate, but are you certified to the ISO Standard or accredited? It may seem unimportant in the scheme of things, but people, like potential customers, will judge you based on your correct use of technical and allied terms.

15 Oct 2024

10 Reasons Why ISO 14001 Matters to SMEs

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

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 ...

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News & Commentary on ISO Management System Standards

News and Commentary on ISO Management System Standards

Dr John FitzGerald

Recent Posts

GDPR, ISO 27701 and ISO 27001: natural combination

ISO 45001 requires Risk Management and Risk-based Thinking

Combining ISO 17025 and ISO 9001 for Laboratories is not easy

ISO Auditor Competence: who decides on it?

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

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