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

ISO 9001 Knowledge Management - DOs and DON'Ts

Practical advice on ISO 9001:2015 Clause 7.1.6 This requirement in ISO 9001:2015 needs to be addressed more effectively, and more importantly, the valuable opportunity it provides is frequently ignored.

29 Jun 2023

Typical errors in implementing 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 there are several common errors that organizations may need to correct during the implementation process.

27 Jun 2023

ISO 9001 Continual Improvement - DO's and DON'Ts

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 ...

15 Jun 2023

ISO 9001 Risks and Opportunities - DO's & DON'Ts

ISO 9001:2015 Clause 6.1, Actions to address risks and opportunities - Practical Advice Planning has always been a major element of ISO 9001, and in the 2015 Edition, there is an increased focus on ensuring that Clause 4.1, ‘context of the organisation’ and Clause 4.2 ‘, interested parties’, are considered. Clause 6.1 requires that both the risks and the opportunities arising are addressed. A ...

13 Jun 2023

ISO 27001 Can include All Information Security Regulations

01 Jun 2023

ISO Certification Body - time for a change?

It isn’t just about getting an ISO Certificate. Your organization needs to get value from the Certification Body Audits and, if you don’t, move to another Certification Body. We at deGRANDSON Global are regularly asked about a policy for changing Certification Bodies. Certification Body (CB) contracts are of three years duration. This is the universal norm. Unfortunately, many organizations renew ...

30 May 2023

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 ...

04 May 2023

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 organization shall "review the effectiveness of any corrective action taken." That ...

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News & Commentary on ISO Management System Standards

News and Commentary on ISO Management System Standards

Dr John FitzGerald

Recent Posts

ISO 9001 Knowledge Management - DOs and DON'Ts

Typical errors in implementing ISO 27001

ISO 9001 Continual Improvement - DO's and DON'Ts

ISO 9001 Risks and Opportunities - DO's & DON'Ts

ISO 27001 Can include All Information Security Regulations

ISO Certification Body - time for a change?

ISO 13485 to be a Requirement in Medical Device Regulations

ISO 14001 and achieving Net Zero

ISO 13485: Critical Subcontractors & Crucial Suppliers

Checking the Effectiveness of Corrective Action

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