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

Most SaMD to be reclassified as MDR Class 1

ISO 13485

The proposed EU MDR changes for Software as a Medical Device (SaMD) will be revolutionary. And will be a relief for SMEs, University spin-offs, and Start-Ups, for whom a 6-figure buy-in for Notified Body services has been an insurmountable barrier. Currently, Europe-based developers of SaMD and those in other locations are avoiding the EU market and initially launching their products in the USA ...

17 Feb 2026

deGRANDSON: your best choice

ISO Auditing

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05 Feb 2026

ISO 9001 Analysis and Evaluation - DOs & DON'Ts

ISO 9001

Practical advice on implementing ISO 9001:2015 Clause 9.1.3 This article examines a subclause in ISO 9001:2015, Performance Evaluation, namely 9.1.3, Analysis & Evaluation. Peter Drucker, the management guru (allegedly) said: 'If you can't measure it, you can't manage it'. And this certainly applies to Management. The reality is that many Quality Managers, or equivalent, ignore the ...

20 Jan 2026

ISO 13485 Risk Evaluation in Medical Devices explained

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. Two distinct and different requirements in ISO 13485:2016 for the management of risk. From Dr John FitzGerald: Misinformation ...

13 Jan 2026

Environmental Aspects - the ISO 14001 requirements

ISO 14001

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.

08 Jan 2026

ISO 9001 Documentation: DOs and DON'Ts

ISO 9001

An ongoing series of Posts: Practical advice on ISO 9001:2015 Clause 7.5, Documented Information The standard refers to documentation in general, not to documents (statements of intent, subject to change) or records (a history of what we have done and may not be changed). Good document control can, therefore, be challenging. In this post, we set out what constitutes best practice. NOTE: The ...

30 Dec 2025

ISO 9001 Competence & Awareness: DOs and DON'Ts

ISO 9001

Practical advice on ISO 9001:2015 Clauses 7.2, 7.3, and 7.4 ISO 9001 Clauses 7.2, 7.3, and 7.4 are critical to the effective implementation and maintenance of an organization's Quality Management System (QMS). ISO 9001 Clause 7.2 emphasizes the importance of having competent personnel within an organization. ISO 9001 Clause 7.3 emphasizes the importance of ensuring that all employees are aware of ...

25 Dec 2025

The 20 official ISO 9001 Guidance Documents

Documentation

A 'must read' for Consultants, Lead Auditors & other CB officers The ISO Technical Committee 176 (ISO/TC 176) on Quality Management, the committee responsible for the ISO 9000 family of Quality Management System (QMS) standards, also publishes many supporting documents (Guidance Documents) to support the implementation and improvement of effective quality management systems. Some of these ...

16 Dec 2025

Cybersecurity for Medical Devices

ISO 13485, ISO 27001

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. Did you know that cybersecurity is addressed in ISO 13485:2016, Clause 7.3? Whether you are marketing a Medical Device ...

27 Nov 2025

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 ...