deGRANDSON Global Blog | Dr John FitzGerald

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 Internal Auditing: DOs and DON'Ts

Practical advice on ISO 9001:2015 Clause 9.2 NOTE: The advice here applies to all Management System Standards (MSS) and not just to implementing ISO 9001:2015. For whatever MSS you need to conduct internal audits, you have two basic approaches to choose from: Option 1: do the minimum necessary to satisfy the Certification Body (CB) [or Accreditation Board (AB)] Auditors Option 2: take the best ...

09 Jul 2024

Becoming an ISO Lead Auditor

Let's begin with the question: What do ISO Lead Auditors do? When the expression ISO Auditors or Lead Auditors is used, it refers to an auditor who leads an ISO management system audit, usually independent of the organization being audited.

18 Jun 2024

ISO 13485 - What Suppliers to the Medical Device Sector Need to Know

Many organizations with the potential to supply components, packaging, and other goods and services (incl. logistics) to the Medical Device Sector are scared off by talk of CE Marking, Notified Bodies, regulatory inspections, unannounced/surprise audits, and the like. It's all nonsense (well, almost all). You don't believe me? Then read on. There could be a lot of high-margin business that you're ...

13 Jun 2024

ISO 9001 Analysis and Evaluation - DOs and DON'Ts

Practical advice on implementing ISO 9001:2015 Clause 9.1.3 This article will consider a sub-clause in ISO 9001 Part 9, Performance Evaluation, of the Quality Standard, namely, 9.1.3, Analysis & Evaluation. NOTE: While the exact wording may differ from Standard to Standard, the advice given here also applies to ISO 14001, ISO 27001, ISO 45001, and other standards that have the same HLS ...

04 Jun 2024

ISO 31010 Risk Management Courses

Be an internationally certified Risk Management Professional We have three Risk Management Courses. These are... Course 725: ISO-IEC 31010, Risk Management - Foundation Course 726: ISO-IEC 31010, Risk Management - Advanced Course 725: ISO-IEC 31010, Risk Management - Expert (launched June 2024). For background on the ISO Risk Assessment Standards and details of the Courses, read on...

08 May 2024

Open Letter to ISO/TC 176 regarding the ISO 9001 Revision

Ladies & Gentlemen of ISO/TC 176, With renewed dismay, I read of the contents of ISO/CD 9001:2024 (albeit a leaked copy from a usually reliable source). It seems we have another revision that will do nothing to restore the esteem in which the ISO 9001 Standard was once held and nothing to provide tangible benefits to certified organizations and their customers. So, I challenge you to make ...

25 Apr 2024

Measuring Information Security Effectiveness with ISO 27004

ISO 27001 provides no guidance and is of little help In deciding what to monitor and measure regarding your Information Security Management System (ISMS), ISO 27001 specifies no mandatory requirements (as emphasized in our ISO 27001 training courses). Thankfully, ISO 27004 provides guidelines and principles for measuring and reporting the effectiveness of an organization's ISMS. The standard ...

04 Apr 2024

Environmental Aspects - meeting ISO 14001 requirements

Systematically identifying relevant ISO 14001 environmental aspects in implementing an EMS. This is fundamental to the effectiveness of an Environmental Management System (EMS) and to ensuring that your organization meets ISO 14001 certification requirements.

19 Mar 2024

ISO 14971: Choosing the right Risk Management Tools

Using FMEA alone is a lazy choice and 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.

13 Mar 2024

The Climate Change Amendment to ISO Management System Standards

The ISO Committee for Conformity Assessment (CASCO) has added a reference to “climate change” within all management systems standards operating according to Annex SL. What is ISO 9001:2015, Amendment 1:2024 They have stated that this is a clarification rather than a new requirement. Therefore, the publication year of the affected Annex SL standards will not change. As a ‘clarification,’ there is ...

News & Commentary on ISO Management System Standards

News and Commentary on ISO Management System Standards

Dr John FitzGerald

Recent Posts

ISO 9001 Internal Auditing: DOs and DON'Ts

Becoming an ISO Lead Auditor

ISO 13485 - What Suppliers to the Medical Device Sector Need to Know

ISO 9001 Analysis and Evaluation - DOs and DON'Ts

ISO 31010 Risk Management Courses

Open Letter to ISO/TC 176 regarding the ISO 9001 Revision

Measuring Information Security Effectiveness with ISO 27004

Environmental Aspects - meeting ISO 14001 requirements

ISO 14971: Choosing the right Risk Management Tools

The Climate Change Amendment to ISO Management System Standards

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