deGRANDSON Global Blog | Dr John FitzGerald (7)

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

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 ...

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.

29 Jun 2023

Typical errors in implementing 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

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 ...

15 Jun 2023

ISO 9001 Risks and Opportunities - DO's & DON'Ts

ISO 9001:2015 Clause 6.1, Actions to address risks and opportunities - Practical Advice Planning has always been a major element of ISO 9001, and in the 2015 Edition, there is an increased focus on ensuring that Clause 4.1, ‘context of the organisation’ and Clause 4.2 ‘, interested parties’, are considered. Clause 6.1 requires that both the risks and the opportunities arising are addressed. A ...

13 Jun 2023

ISO 27001 Can include All Information Security Regulations

01 Jun 2023

ISO Certification Body - time for a change?

It isn’t just about getting an ISO Certificate. Your organization needs to get value from the Certification Body Audits and, if you don’t, move to another Certification Body. We at deGRANDSON Global are regularly asked about a policy for changing Certification Bodies. Certification Body (CB) contracts are of three years duration. This is the universal norm. Unfortunately, many organizations renew ...

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News & Commentary on ISO Management System Standards

News and Commentary on ISO Management System Standards

Dr John FitzGerald

Recent Posts

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

Typical errors in implementing ISO 27001

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

ISO 9001 Risks and Opportunities - DO's & DON'Ts

ISO 27001 Can include All Information Security Regulations

ISO Certification Body - time for a change?

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