deGRANDSON Global Blog | Dr John FitzGerald (4)

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/TS 9002 - Guideline to ISO 9001:2015 Implementation

ISO 9001

A Review of the Guide to ISO 9001 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 ...

29 Apr 2025

Unannounced Audits by Notified Bodies: What you need to Know

ISO 13485

If your company supplies components or materials to an EU medical device manufacturer, here is the information you need to be aware of, as outlined in the ISO 13485 Regulations. And it's about unannounced audits of your business by Notified Bodies.

22 Apr 2025

The IAF Logo on your ISO 13485 Certificate?

ISO 13485

The IAF MLA mark is now available to all CABs accredited by The European Cooperation for Accreditation (EA) Members and is recognized and accepted by all 563 IAF members from 81 countries.

22 Apr 2025

Workplace Safety Overview

ISO 45001

Workplace safety is a crucial part of responsible business conduct and societal welfare involving workers, employers, governments, and the broader community. This article offers an overview of global workplace safety, covering the nature of work-related diseases, injuries, and illnesses, prevalent occupational health and safety (OHS) incidents, underlying issues leading to workplace safety ...

18 Apr 2025

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

ISO 9001

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 ...

08 Apr 2025

Combining ISO 17025 and ISO 9001 for Laboratories

ISO 17025, ISO 9001

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 ...

27 Mar 2025

Checking the Effectiveness of Corrective Action

ISO Standard Implementation

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 ...

18 Mar 2025

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

ISO 9001

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

ISO Auditing

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 examine internal auditing of the two most popular management system standards: ISO 9001, the quality management system (QMS) standard, and ISO 14001, the ...

20 Feb 2025

ISO 9001 vs Other ISO Standards

ISO 9001

Is ISO 9001 always the best choice? Over 90% of all ISO Management System certifications are for ISO 9001, leaving less than 10% to cover the other 50+ ISO Management System Standards. When organizations seek to enhance their management systems, they often get confused about whether to implement ISO 9001 for a broad quality management foundation or to dive directly into a specialized standard ...