deGRANDSON Global Blog | Dr John FitzGerald (6)

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 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 ...

19 Dec 2024

Why ISO Management System Standards Matter

Regulations and Standards Related to Laboratory Management

ISO 17025

Regulations and standards are critical to ensuring laboratory operations' accuracy, reliability, and safety. These are fundamental to achieving high-quality results and maintaining the integrity of scientific work. Regulations and standards also provide a structured framework that laboratories must follow to meet both internal quality goals and external regulatory requirements. While an ...

13 Dec 2024

ISO 9001 Clauses - an Overview

ISO 9001

New to ISO 9001? If yes, start here. ISO 9001 offers a comprehensive framework for establishing a solid Quality Management System (QMS). The key to this lies within its core clauses, a set of specific requirements that form the backbone of this standard. Let's look at each in turn to understand how they can transform your organization's approach to managing your business. Note: there are 50+ ISO ...

08 Aug 2024

The Climate Change Amendment to ISO Management System Standards

Safety Calendar for May

ISO 45001

21 Sep 2023

PRRC: Are you in breach of the EU MDR and IVDR Requirement?

ISO 13485

The EU MDCG 2019-7 provides guidance on "Persons Responsible for Regulatory Compliance’ (PRRC). The European Commission (EC) has published MDCG 2019-7, Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a ‘person responsible for regulatory compliance’ (PRRC). Meeting the requirements here will challenge SMEs and start-ups, but ...