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News and Commentary on ISO Management System Standards

Dr John FitzGerald

Director and founder of deGRANDSON Global. After 15 years in the manufacturing industry, John has spent the past 25 years training, consulting and auditing ISO 9001 and other management systems.
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Recent Posts

13 May 2021

ISO 13485 Certification Process: How and What to Prepare

Your old Quality Management System 'dolled up' with the language of the revised 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. This being an audit against the ISO 13485 revision of 2016, the extent of the ...
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06 May 2021

Certified ISO Auditors need further training - it's about Competency

Question: What do all internal auditors, external auditors, audit programme managers, ISO consultants have in common?  Or should have? Answer: Competency.   Repeatedly, ISO management system standards tell us that true competence has four elements, namely, Element 1. Auditing Skills, Element 2: Knowledge of the standard Element 3: Technical expertise appropriate to the processes being audited, ...
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30 Apr 2021

ISO 9001 Knowledge Management: DOs and DON'Ts

Practical advice on Clause 7.1.6 of ISO 9001:2015 This requirement in ISO 9001:2015 is often poorly addressed and more importantly, the valuable opportunity it provides is frequently ignored.
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28 Apr 2021

ISO 9001 Competence, Awareness, and Communication: DOs and DON'Ts

  Practical advice on ISO 9001:2015 Clause 7.2, 7.3, and 7.4  ISO 9001 Certification will not be achieved unless your effective management of the human resources of your organization can be demonstrated. But, before getting into the DO's and DON’Ts of implementing ISO 9001 Clauses 7.2, 7.3, and 7.4, let’s look at the practicalities involved with each of these terms:
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27 Apr 2021

ISO 14001 Certification – Frequently Asked Questions

We've gathered in this post all the commonly asked questions about ISO 14001 Certification together with expert answers.  Here are those questions: What is ISO 14001? What is ISO? What is the purpose of ISO 14001? What is ISO 14001 Certification? Do You Need ISO 14001 Certification? Who Issues ISO 14001 Certification? How to Get an ISO 14001 Certificate? Who needs an Environmental Management ...
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21 Apr 2021

The International Medical Device Regulatory Scene – April 2021

  The 2020s will be a period of continuous Regulatory change The only certainty about this section is that its content is almost certainly out-of-date. It is not an exaggeration to describe the current European regulatory scene as chaotic and the situation across the globe as being in a state of flux. The situation described here refers to the situation at the time of writing, early January 2021. ...
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20 Apr 2021

ISO 9001 Certification: Frequently Asked Questions

We've gathered in this post all the commonly asked questions about ISO 9001 Certification together with expert answers.  Here are those questions:  What is ISO? What is ISO 9001? What is the purpose of ISO 9001? What is a Quality Management System? What is the Purpose of a Quality Management System? Who Needs a Quality Management System? What are the Benefits of a Quality Management System? What ...
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18 Apr 2021

ISO 9001 Quality Objectives: DOs and DON'Ts

Practical advice on Clause 6.2 of ISO 9001:2015 ISO 9001 Implementation Projects frequently run into difficulties when addressing the requirements here.  Here's how you can avoid such difficulties.   The term Quality Objectives is defined in ISO 9000:2015 as an objective related to quality.  Not very helpful.  ISO/TS 9002 is better. It says: ‘Quality objectives should be established at relevant ...
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17 Apr 2021

12 Reasons Why deGRANDSON Global's e-Learning System Works

  The reality behind the myths about e-Learning [1 of 2] There's much interest in e-learning these days; but, does it work? What should you expect from a well-designed, well-developed, and well-delivered e-Learning Course?
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17 Apr 2021

12 More Reasons Why deGRANDSON's e-Learning System Works

    The reality behind the myths about e-Learning [2 of 2] As we stated in our first article on this subject, much has changed in recent years with e-learning courses. However, the myths about e-learning persist. In this article, we will examine 12 more e-learning features that counter them.
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