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

ISO 13485 to be a Requirement in Medical Device Regulations

While ISO 13485 certification is currently not a requirement in many countries, it is rapidly becoming a de facto worldwide regulatory requirement.

23 May 2023

ISO 14001 and achieving Net Zero

Increasing environmental concerns and the urgent need to combat climate change are prompting organizations worldwide to look for ways not only to reduce their environmental impact but also to work towards achieving a net zero footprint or, at the very least, carbon neutrality.

09 May 2023

ISO 13485: Critical Subcontractors & Crucial Suppliers

EU Regulations, EN Standards, Notified Body activities (including Surprise/Unannounced Audits), UK Regulations post-Brexit, 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 implementing the ISO 13485 Standard and to compliance with the other applicable standards and requirements?chain ...

13 Apr 2023

ISO 45001 Consultancy: How to be a successful OH&S Consultant

Could you make a successful career in OH&S management consulting? What ISO 45001 training is needed?

04 Apr 2023

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

23 Mar 2023

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

A Review of the Guide 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 for the ...

22 Mar 2023

MDR Transition Deadlines extended to 2028

But it’s complicated, required deadlines vary by Class and for all devices. You need to take action now or risk having no product to sell.

21 Feb 2023

Unannounced Audits by Notified Bodies: What You Should Know

If your company is a supplier of components or materials to a medical device manufacturer, here’s information you need to be aware of taken from ISO 13485 Regulations. And it’s about unannounced audits of your business by Notified Bodies.

19 Jan 2023

Information Security Standards other than ISO 27001

01 Sep 2021

ISO 9001 & IATF 16949 Certification: What's the Difference?

IATF 16949:2016 is not a major barrier to the automotive parts market IATF 16949 is a standard developed by members of the International Automotive Task Force (IATF) that was later submitted to the International Organization for Standardization (ISO). As a standard, IATF 16949 outlines the requirements for maintaining a Quality Management System (QMS) in the automotive sector.

News & Commentary on ISO Management System Standards

News and Commentary on ISO Management System Standards

Dr John FitzGerald

Recent Posts

ISO 13485 to be a Requirement in Medical Device Regulations

ISO 14001 and achieving Net Zero

ISO 13485: Critical Subcontractors & Crucial Suppliers

ISO 45001 Consultancy: How to be a successful OH&S Consultant

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

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

MDR Transition Deadlines extended to 2028

Unannounced Audits by Notified Bodies: What You Should Know

Information Security Standards other than ISO 27001

ISO 9001 & IATF 16949 Certification: What's the Difference?

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