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

FDA QMSR and ISO 14971: What you need to know

ISO 14971

Don't believe everything you read about ISO 14971! The FDA's 'Medical Devices; Quality System Regulation Amendments' website explicitly states: All sections of ISO 13485 apply to device manufacturers. While there is much mention of 'incorporating by reference' and many misguided interpretations of that phrase, don't let anyone mislead you. To reiterate, the FDA's website explicitly states that ...

25 Jun 2025

Information Security Standards other than ISO 27001

There are many popular data security standards other than ISO 27001 Frequently, cybersecurity standards other than ISO 27001 and the 47+ subsidiary standards of the ISO 27000 series are incorporated into Information Security Management Systems (ISMSs). Auditors of ISMS and those negotiating with customers on information security issues need knowledge of and the use/application of these standards. ...

24 Jun 2025

CPD - Continued Professional Development - for all

Free Continued Professional Development Model from deGRANDSON Global CPD is an ongoing process essential for maintaining professional standards and enhancing career development. By systematically engaging in CPD, you can ensure you remain competent, competitive, and capable of providing high-quality services in your chosen field. But why does CDP Matter so much?

19 Jun 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 ...

12 Jun 2025

ISO 9001 Context of the Organization (COTO): DOs & DON'Ts

ISO 9001

Practical advice on ISO 9001:2015 Clauses 4.1 and 4.2 In this article, we will consider the first two ISO 9001 clauses in Part 4 of the Quality Standard, ISO 9001:2015, namely, Context of the Organization. NOTE: The advice given here also applies to ISO 14001, ISO 27001, ISO 45001, and other standards having the same HLS structure as ISO 9001.

21 May 2025

ISO/TS 9002 - Guideline to ISO 9001:2015 Implementation

ISO 9001

A Review of the Guide to ISO 9001 published by ISO/TC 176 Late 2016 saw the publication of ISO/TS 9002:2016 Quality management systems -- Guidelines for the application of ISO 9001:2015. Originally to have been published simultaneously with the revised ISO 9001 Standard in 2015, the delay resulted in it getting little publicity and so it has been largely ignored. It is full of valuable guidance ...

14 May 2025

ISO 13485: Critical Subcontractors & Crucial Suppliers

ISO 13485

EU Regulations, EN Standards, Notified Body activities (including Surprise/Unannounced Audits), UK Regulations post-Brexit, and MDSAP – all are changes that will impact your company’s Medical Device Management System (MDMS). What strategy should you, as a supplier to the sector, adopt to implement the ISO 13485 Standard and to comply with the other applicable standards and requirements? Your ISO ...

29 Apr 2025

Unannounced Audits by Notified Bodies: What you need to Know

ISO 13485

If your company supplies components or materials to an EU medical device manufacturer, here is the information you need to be aware of, as outlined in the ISO 13485 Regulations. And it's about unannounced audits of your business by Notified Bodies.

22 Apr 2025

Why Lab Management and Accreditation to ISO 17025 Matters

ISO 17025

Clearly defined and strictly followed laboratory quality controls are a must when offering laboratory services of any kind. New businesses rarely ponder the benefits of being accredited to ISO 17025 however, even the smallest organization has a lot to gain from an accredited Testing and/or Calibration Laboratory Management System (TCLMS). Startup priorities, and the fact that it takes a minimum ...

22 Apr 2025

The IAF Logo on your ISO 13485 Certificate?

ISO 13485

The IAF MLA mark is now available to all CABs accredited by The European Cooperation for Accreditation (EA) Members and is recognized and accepted by all 563 IAF members from 81 countries.

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News and Commentary on ISO Management System Standards

Dr John FitzGerald

Recent Posts

FDA QMSR and ISO 14971: What you need to know

Information Security Standards other than ISO 27001

CPD - Continued Professional Development - for all

FDA QMSR and ISO 13485 – what you need to know

ISO 9001 Context of the Organization (COTO): DOs & DON'Ts

ISO/TS 9002 - Guideline to ISO 9001:2015 Implementation

ISO 13485: Critical Subcontractors & Crucial Suppliers

Unannounced Audits by Notified Bodies: What you need to Know

Why Lab Management and Accreditation to ISO 17025 Matters

The IAF Logo on your ISO 13485 Certificate?

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