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

Essential Documentation for ISO 13485 Certification

ISO 13485

QMSR & ISO 13485: On 02-Feb-26, the FDA Final Rule comes into force. The amendments incorporate by reference (and so align more closely with) the international standard ISO 13485:2016, Medical Devices - Quality Management Systems - Requirements for regulatory purposes. There are 139 (sic) instances in ISO 13485:2016 Standard where documentation is mentioned. In developing your documentation, ...

11 Feb 2025

ISO Internal Audit Program best practice

ISO Auditing

Don't waste time and effort on ISO Internal Audits! For many, Internal Audits are a sterile and mandatory drudge, carried out solely to obtain some records to show in an inane internal audit report to the external auditor. Such audits add no value to the organization for the resources applied. Yet, many organizations extract great value from the activity, including monetary value, which will ...

07 Feb 2025

Proper Safety Management Protects Everyone

ISO 45001

06 Feb 2025

Workplace Safety Calendar

ISO 45001

04 Feb 2025

ISO 45001 and Workplace Safety Regulations Around the World

ISO 45001

A review of workplace safety regulations across the globe and how they relate to ISO 45001 requirements. ISO 45001, the international standard for occupational health and safety (OH&S) management systems, offers a voluntary yet comprehensive framework aimed at enhancing employee safety, minimizing workplace risks, and promoting the well-being of all. While compliance with or certification to ...

01 Feb 2025

ISO 9001 Management Review: DOs & DON'Ts

ISO 9001

Practical advice on compliance with Clause 9.3 requirements: The periodic management system review is an opportunity not to be missed ISO 9001 Clause 9.3.1 requires that 'Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy, and effectiveness.' Is this just a 'rubber stamp' activity, or would you like to ...

22 Jan 2025

Workplace Safety: Global Regulatory Landscape

It is crucial for ensuring the well-being of the workforce and the sustainability of businesses worldwide. Each region brings its unique blend of cultural, economic, and legislative perspectives, shaping workplace safety standards that reflect local priorities, challenges, and advancements.

09 Jan 2025

Evidence for ISO 27001 Annex A compliance

ISO 27001

Demonstrating compliance with Annex A requirements of Annex A to your Certification Body Using ISO 27001 controls outlined in Annex A alone to address security vulnerabilities is never enough!

04 Jan 2025

ISO 9001 Internal Auditing: DOs and DON'Ts

ISO 9001

Wondering how to approach the requirements of ISO 9001 Clause 9.2? For whatever MS Standard 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) Option 2: take the best advantage of the opportunity the mandatory requirement offers. You may well ask: Is it really worth my while putting time and ...

21 Dec 2024

ISO 13485 Certification in the Medical Device Supply Chain

ISO 13485

QMSR & ISO 13485: On 02-Feb-26, the FDA Final Rule comes into force. The amendments incorporate by reference (and so align more closely with) the international standard ISO 13485:2016, Medical Devices - Quality Management Systems - Requirements for regulatory purposes. Suppliers to Medical Device Manufacturers should also have ISO 13485 Certification The medical device industry operates ...