deGRANDSON Global Blog | Dr John FitzGerald (5)

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 14971: Choosing the right Risk Management Tools

Using FMEA alone is a lazy choice and no longer acceptable ISO 14971, Medical Devices - Application of risk management to medical devices is frequently misapplied, and if your ISO 13485 QMS Manual claims to use ISO 14971, you'd better use it properly.

23 Feb 2024

FDA QMSR and ISO 13485 – what you need to do

On 02-Feb-24, the FDA published its Final Rule, amending the Current Good Manufacturing Practice (cGMP) requirement of the Quality System Regulation (QSR) of medical device manufacture. 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. The new ...

08 Feb 2024

ISO 9001 and Quality System Documentation: DO's and DON'Ts

An ongoing series of Posts: Practical advice on ISO 9001:2015 Clause 7.5, Documented Information. NOTE: The advice given here also applies to ISO 14001, ISO 27001, ISO 45001 and other standards having the same HLS structure as ISO 9001.

25 Jan 2024

ISO 9001 Clauses 7.2, 7.3, and 7.4: DO's and DON'Ts

Practical advice on ISO 9001:2015 Clauses 7.2, 7.3, and 7.4 ISO 9001 Clauses 7.2, 7.3, and 7.4 play a crucial role in the effective implementation and maintenance of a Quality Management System (QMS) within an organization. ISO 9001 Clause 7.2 emphasizes the importance of having competent personnel within an organization, ISO 9001 Clause 7.3 emphasizes the importance of ensuring that all ...

18 Jan 2024

[Update 2024] Twenty official ISO 9001 Guidance Documents

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?

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

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 then ...

08 Aug 2023

Preparing for the first ISO 13485 Certification Audit

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 ...

18 Jul 2023

ISO 45000 and Other Industrial Safety Related Standards

In addition to ISO 45001, there are several other Standards in the ISO 45000 Series that you should consider and, perhaps, include in the scope of your OHSMS. If your organization is certified to ISO 45001, your Certification Body will add mention of any of these other OH&S Standards to your ISO 45001 Certificate. So, all interested parties will be aware of your commitment to Occupational ...

11 Jul 2023

ISO 9001 Knowledge Management - DOs and DON'Ts

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.

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News & Commentary on ISO Management System Standards

News and Commentary on ISO Management System Standards

Dr John FitzGerald

Recent Posts

ISO 14971: Choosing the right Risk Management Tools

FDA QMSR and ISO 13485 – what you need to do

ISO 9001 and Quality System Documentation: DO's and DON'Ts

ISO 9001 Clauses 7.2, 7.3, and 7.4: DO's and DON'Ts

[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 45000 and Other Industrial Safety Related Standards

ISO 9001 Knowledge Management - DOs and DON'Ts

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