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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

[Update 2024] Twenty official ISO 9001 Guidance Documents

Documentation

Must read for Consultants, Lead Auditors & other CB officers The ISO Technical Committee 176 (ISO/TC 176) on Quality Management, the committee responsible for the ISO 9000 family of Quality Management System (QMS) standards, also publishes many supporting documents (called Guidance Documents) to supplement the implementation and improvement of effective quality management systems. Most of ...

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 ...

14 Sep 2023

Cyber Security in Medical Device Management

ISO 13485, ISO 27001

Did you know that cybersecurity is addressed under ISO 13485:2016 Clause 7.3 requirements? The Royal Academy of Engineering (RAE UK) report ‘Cyber Safety and Resilience’ (March 2018) suggests that the healthcare sector can learn from other industries when it comes to guarding against ransomware attacks, data breaches and hacking of connected health devices. That was just the beginning. Since ...

08 Aug 2023

Preparing for the first ISO 13485 Certification Audit

ISO 13485

Your old ISO 9001 QMS 'dolled up' with the language of the 2016 Standard is not going to be adequate. When you are first audited against ISO 13485:2016, the Auditors, whether a Notified Body or Certification Body, will, as usual, be seeking objective evidence of your compliance with the Standard. Being an audit against ISO 13485, a different style of Quality Management System standard, the extent ...

11 Jul 2023

ISO 9001 Knowledge Management - DOs and DON'Ts

ISO 9001, ISO Standard Implementation

Practical advice on ISO 9001:2015 Clause 7.1.6 This requirement in ISO 9001:2015 needs to be addressed more effectively, and more importantly, the valuable opportunity it provides is frequently ignored.

29 Jun 2023

Typical errors in implementing ISO 27001

ISO 27001

Securing certification to this Information Security standard requires a collective effort. Implementing ISO 27001, the international standard for information security management systems (ISMS), can be complex, and there are several common errors that organizations may need to correct during the implementation process.

27 Jun 2023

ISO 9001 Continual Improvement - DO's and DON'Ts

ISO 9001

Practical advice on ISO 9001:2015 Clause 10.3 The organization itself determines the rate, extent, and timescale of actions that support continual improvement. Quality Management System (QMS) performance can be enhanced by applying an improvement to the quality management system as a whole or improving one or more of its elements. Your ISO 9001 Implementation Project offers a real opportunity to ...

13 Jun 2023

ISO 27001 Can include All Information Security Regulations

ISO 27001

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.

News and Commentary on ISO Management System Standards

Dr John FitzGerald

Recent Posts

[Update 2024] Twenty official ISO 9001 Guidance Documents

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

Cyber Security in Medical Device Management

Preparing for the first ISO 13485 Certification Audit

ISO 9001 Knowledge Management - DOs and DON'Ts

Typical errors in implementing ISO 27001

ISO 9001 Continual Improvement - DO's and DON'Ts

ISO 27001 Can include All Information Security Regulations

MDR Transition Deadlines extended to 2028

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

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