deGRANDSON Global Blog | Dr John FitzGerald (9)

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

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 ...

22 Mar 2023

MDR Transition Deadlines extended to 2028

ISO 13485

But it’s complicated, required deadlines vary by Class and for all devices. You need to take action now or risk having no product to sell.

01 Sep 2021

ISO 9001 & IATF 16949 Certification: What's the Difference?

ISO 9001

IATF 16949:2016 is not a major barrier to the automotive parts market IATF 16949 is a standard developed by members of the International Automotive Task Force (IATF) that was later submitted to the International Organization for Standardization (ISO). As a standard, IATF 16949 outlines the requirements for maintaining a Quality Management System (QMS) in the automotive sector.