deGRANDSON Global Blog | Dr John FitzGerald (7)

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

Checking the Effectiveness of Corrective Action

All ISO Management System Standards require that the effectiveness of Corrective Action be checked. It's rarely done well. Let's take ISO 9001:2015 as an example. ISO 9001:2015 Clause 10.2, Nonconformity and Corrective Action, requires that when a nonconformity occurs, including those arising from complaints, the organisation shall "review the effectiveness of any corrective action taken". That ...

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

28 Mar 2023

ISO 9001 and Quality Planning for Changes: DO's and DON'Ts

ISO 9001:2015 Clause 6.3 Planning for Changes - Practical Advice The purpose of Planning the Changes is to maintain the integrity of the quality management system and the organization’s ability to continue to provide conforming products and services during the change. And you will need records or other credible evidence to demonstrate compliance here. Here’s why.

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.

16 Feb 2023

[Infographic] Route to ISO Certification

07 Feb 2023

ISO 9001 Consultancy: What Makes an effective QMS Consultant?

26 Jan 2023

The IAF Logo on ISO 13485 Certificates is essential

The IAF MLA mark is now available to all CABs accredited by The European Cooperation for Accreditation (EA) Members, and be recognised and accepted by all 433 IAF members from 72 countries.

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News & Commentary on ISO Management System Standards

News and Commentary on ISO Management System Standards

Dr John FitzGerald

Recent Posts

Checking the Effectiveness of Corrective Action

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

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

ISO 9001 and Quality Planning for Changes: DO's 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

[Infographic] Route to ISO Certification

ISO 9001 Consultancy: What Makes an effective QMS Consultant?

The IAF Logo on ISO 13485 Certificates is essential

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