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News and Commentary on ISO Management System Standards

Dr John FitzGerald

Director & Founder of deGRANDSON Global. He spent 15 years in the manufacturing industry and 25 years training, consulting & auditing management systems
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Recent Posts

12 Jul 2021

Training ISO Internal Auditors is a must

ISO Standards require competence and that includes the competency of your Internal Auditors All the ISO Management System Standards (MSS) since 2010 (adopting the High-level Structure- HLS) require that personnel be competent in their work.  So, while there are no specific requirements in these Standards for internal auditor training courses to be given, there is an implicit requirement that they ...
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11 Jul 2021

Free ISO 13485 Implementation Handbook (100+ pages)

Get a free step-by-step guide to achieve ISO 13485 Certification This 100+ page 'instruction manual' is available free with our ISO 13485 Lead Implementer Course.  It is not for sale. But it is everything you'll need to develop, implement and maintain a management system to ISO 13485 Certification standard.
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09 Jul 2021

Integrating 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) 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 ...
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04 Jul 2021

Free ISO 14001 Implementation Handbook (100+ pages)

Get a free step-by-step guide to achieve ISO 14001 Certification This 100+ page 'instruction manual' is available free with our ISO 14001 Lead Implementer Course.  It is not for sale. But it is everything you'll need to develop, implement and maintain a management system to ISO 14001 Certification standard.
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29 Jun 2021

ISO 13485 Implementation in 33 Steps

  A valuable aid to your developing a viable MDS Project Plan - to aid you to start on time, finish on time and leave nothing vital out.  And have a successful Certification Audit the first time. The ISO 13485 Implementation Model developed by deGRANDSON Global The 33 Steps to ISO 13485:2016 Implementation is the model we have developed for implementing a medical device management system (MDMS) ...
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27 Jun 2021

Free ISO 45001 Implementation Handbook (200+ pages)

Get a free step-by-step guide to achieve ISO 45001 Certification This 200+ page 'instruction manual' is available free with our ISO 45001 Lead Implementer Course.  It is not for sale. But it is everything you'll need to develop, implement and maintain a management system to ISO 45001 Certification standard.
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23 Jun 2021

ISO 45001 Certification: 21 frequently asked questions answered

We've gathered in this post all the commonly asked questions about ISO 45001 Certification together with expert answers.  Here are those questions: What is ISO 45001? What is ISO? What is the purpose of ISO 45001? What is ISO 45001 Certification? Do You Need ISO 45001 Certification? Who Issues ISO 45001 Certification? How to Get an ISO 45001 Certificate? Who needs an Occupational Health & Safety ...
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20 Jun 2021

Free ISO 27001 Implementation Handbook (100+ pages)

Get a free step-by-step guide to achieve ISO 27001 Certification This 100+ page 'instruction manual' is available free with our ISO 27001 Lead Implementer Course.  It is not for sale. But it is everything you'll need to develop, implement and maintain a management system to ISO 27001 Certification standard.
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15 Jun 2021

ISO 27001 Certification: 27 frequently asked questions answered

We've gathered in this post all the commonly asked questions about ISO 27001 Certification together with expert answers.  Here are those questions:  What does ISO mean? What does ISO 27001 mean? What is the purpose of ISO 27001? What is an Information Security Management System (ISMS)? What is the Purpose of an ISMS? Who Needs an ISMS? What are the Benefits of an ISMS? What is ISO 27001 ...
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15 Jun 2021

10 Ways to Make the Most of ISO Internal Audits

Don't waste time and effort on ISO Internal Audits! For many, Internal Audits are a sterile and mandatory drudge, carried out solely to have some records to show the external auditor.  Such audits add no value to the organization for the resources applied. And yet many organizations extract great value from the activity, including monetary value, which will please the boss. Since internal audits ...
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