deGRANDSON Global Blog | Dr John FitzGerald (2)

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

ISO 9001 Knowledge Management - DOs & DON'Ts

ISO 9001, ISO Standard Implementation

Practical advice on ISO 9001:2015 Clause 7.1.6 Generally speaking, this requirement in ISO 9001:2015 needs to be addressed more effectively, and, more importantly, the valuable opportunity it provides is often overlooked. Too often, a 'throw-away' statement in a quality manual is used here without any serious consideration of the consequences to the business of the loss of knowledge that ...

20 Nov 2025

Swiss Cheese Model of Risk Mitigation explained

Risk Management

Which is better when it comes to risk reduction: One major risk control that is 95% effective OR 4 minor controls, each of which is 60% effective? In applying ISO/IEC 27001:2022 to an information security management system (ISMS), one of the requirements in Clause 6.1.3.c) states: 'Compare the controls determined in 6.1.3 b) above with those of Annex A and verify that no necessary controls have ...

30 Sep 2025

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

ISO 9001

Ladies & Gentlemen of ISO/TC 176, I wrote this letter in May 2024, hoping that it might receive some attention. But no. The current DIS contains no significant improvements and, taken at face value, appears to be solely for financial gain, offering nothing to restore the esteem in which the ISO 9001 Standard was once held, nor does it provide tangible benefits to certified organizations and ...

25 Sep 2025

FDA QMSR and ISO 13485 – what you need to know

ISO 13485

On 02-Feb-26, the FDA Final Rule, amending the Current Good Manufacturing Practice (cGMP) requirement of the Quality System Regulation (QSR) of medical device manufacture, comes into force. The amendments incorporate by reference (and so align more closely with) the international standard ISO 13485:2016, Medical Devices - Quality Management Systems - Requirements for regulatory purposes. The new ...

16 Sep 2025

Preparing for your first ISO 13485 Certification Audit

ISO 13485

QMSR & ISO 13485: On 02-Feb-26, the FDA Final Rule comes into force. The amendments incorporate by reference (and so align more closely with) the international standard ISO 13485:2016, Medical Devices - Quality Management Systems - Requirements for regulatory purposes. Your old ISO 9001 QMS 'dolled up' with the language of the 2016 Standard is not going to be adequate. When you are first ...

02 Sep 2025

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

ISO 13485

QMSR & ISO 13485: On 02-Feb-26, the FDA Final Rule comes into force. The amendments incorporate by reference (and so align more closely with) the international standard ISO 13485:2016, Medical Devices - Quality Management Systems - Requirements for regulatory purposes. Great opportunities for Suppliers to the Medical Device Sectors on both sides of the Atlantic. In February 2026, the FDA ...

28 Aug 2025

ISO 27001 Implementation Errors You Need to Avoid

ISO 27001

Securing certification to this Information Security standard requires a collective effort. Implementing ISO 27001, the international standard for Information Security Management Systems (ISMS), can be complex, and several common errors may need to be corrected during the implementation process.

22 Aug 2025

[Video] deGRANDSON Global Courses explainer

ISO 27001

21 Aug 2025

ISO Management System Standards Revisions 2025-2030

ISO 9001

ISO 9001 and other Management System Standards, 2025 to 2030 While there are more than 50 ISO Management System Standards, only about twelve are frequently used. It is these few that we will concentrate on in this post. While many new revisions of these standards are planned, the nature and significance of those changes have yet to emerge. Much will depend on the new revision of ISO 9001, which ...

14 Aug 2025

ISO 9001 Continual Improvement - DOs and DON'Ts

ISO 9001

Practical advice on ISO 9001:2015 Clause 10.3 The organization itself determines the rate, extent, and timescale of actions that support continual improvement. Quality Management System (QMS) performance can be enhanced by applying an improvement to the quality management system as a whole or improving one or more of its elements. Your ISO 9001 Implementation Project offers a real opportunity to ...