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

ISO 9001 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. NOTE: The advice given here also applies to ...

10 Apr 2025

ISO 14971: Risk Management for Medical Devices

Using FMEA alone is a lazy choice and is no longer acceptable ISO 14971, Medical Devices - Application of risk management to medical devices, is frequently misapplied, and if your ISO 13485 QMS Manual claims to use ISO 14971, you'd better use it properly.

08 Apr 2025

Combining ISO 17025 and ISO 9001 for Laboratories

It is not unusual for your lab to be simultaneously certified to both standards. But are you doing it effectively and efficiently? It's not uncommon for Laboratories to be certified to more than one Standard. For example, a Calibration Laboratory may be accredited to ISO 17025, the ISO standard for calibration of testing laboratories, and certified to ISO 9001, the ISO standard for quality ...

01 Apr 2025

[Infographic] The Route to ISO Certification

The 12-step ISO Certification process is explained. Once your ISO Management System (ISO 9001, ISO 13485, ISO 27001, etc.) has been implemented, what are the next steps to achieving certification? Where does the Certification Body fit in Even though we're not a certification body, the deGRANDSON Global business primarily provides ISO training for auditors, so we'd like to give you a quick ...

27 Mar 2025

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. Note: The process is identical for all the ISO Management System Standards, ISO 14001, ISO 45001, ISO 13485, etc. ISO 9001:2015 Clause 10.2, Nonconformity and Corrective Action, requires that when a nonconformity occurs, including those ...

25 Mar 2025

Why ISO 21001 and not ISO 17024 or EXEMPLAR or IRCA Approval?

deGRANDSON Global holds ISO 21001 Certification, a university-grade accreditation, because it's the only one that matters. Without independent auditing to confirm compliance, it's only a badge! We started by asking what would be the best choice of Learning Provider qualification for Lead Auditors, Consultants, and others wishing to audit, implement, or maintain ISO Management Systems to a high ...

18 Mar 2025

ISO 9001 Consultancy: do you have a future as a QMS Consultant?

Quality Management System consultants are professionals or consulting firms specialized in assisting organizations in implementing, maintaining, and improving their Quality Management Systems (QMS) in accordance with the ISO 9001 standard. 

28 Feb 2025

Why Checking the Competency of ISO Internal Auditors is Essential

Question: What's the one thing that ISO Auditor Training can't give you? Answer: Competency. ISO Management System Standards require competence in internal auditing, and ISO training is essential to building such competence. This post will consider internal auditing of the two most popular management system standards: ISO 9001, the quality management system (QMS)standard, and ISO 14001, the ...

28 Feb 2025

GDPR, ISO 27701 and ISO 27001: natural combination

In 2018, many organizations, not only those based in the EU, spent much time and money on compliance with the General Data Protection Regulation (GDPR). But what actions should we take now to ensure ongoing compliance? It's not enough to have policies and procedures to demonstrate that you comply with the requirements. If there is a data breach or similar event, you will be challenged to ...

28 Feb 2025

Comparing ISO 27000 Series of 50+ Standards, Guides, etc

Currently, the ISO 27000 family includes fifty-seven (57) standards, guidelines, and other documents on information security. The total number is regularly changing, with the occasional withdrawal of some standards and the regular addition of others (several drafts of new standards have not been included here). How, then, is one to know which ones are mandatory and which are ...

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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 Planning for Changes: DO's and DON'Ts

ISO 14971: Risk Management for Medical Devices

Combining ISO 17025 and ISO 9001 for Laboratories

[Infographic] The Route to ISO Certification

Checking the Effectiveness of Corrective Action

Why ISO 21001 and not ISO 17024 or EXEMPLAR or IRCA Approval?

ISO 9001 Consultancy: do you have a future as a QMS Consultant?

Why Checking the Competency of ISO Internal Auditors is Essential

GDPR, ISO 27701 and ISO 27001: natural combination

Comparing ISO 27000 Series of 50+ Standards, Guides, etc

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