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14 Apr 2021

ISO 9001 Continual Improvement DO's and DON'Ts

An ongoing series of Posts: Practical advice on ISO 9001:2015 Clause 10.3 The rate, extent and timescale of actions that support continual improvement are determined by the organization itself. 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 ...
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13 Apr 2021

ISO 9001 Certification: Where to start ...

Or towards implementing and maintaining a QMS  Where to begin is frequently a problem for an executive wishing to secure ISO 9001 Certification.  In this article, we'll suggest a practical 5-Step process that you can take to get started (often the most difficult part). The knowledge and information given here is essential if you and your colleagues are to make an informed as to a) whether ISO ...
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10 Apr 2021

ISO 9001 Risks and Opportunities DOs & DON'Ts

An ongoing series of Posts: Practical advice on Clause 6.1 of ISO 9001:2015 Planning has always been a familiar element of ISO 9001, but now there is an increased focus on ensuring that it is considered with Clause 4.1 ‘context of the organization’ and Clause 4.2 ‘interested parties’.
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07 Apr 2021

ISO 27005:2018 Information Security Risk Management

Third edition of this Standard published in July 2018 but rarely referenced in ISMS documentation This Standard will be, or should be, of particular interest to: IT Managers and those who implement and maintain an ISMS for their organization, Consultants and Advisers who develop, implement and maintain ISMSs, and Lead Auditors who wish for a deeper understanding of how risk should be addressed in ...
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30 Mar 2021

Definition, Classification and Regulation of Medical Devices (4 of 4)

In this post, 4 of 4, we’ll consider Medical Device Regulations in the USA, MDSAP Countries and Rest of the World.
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23 Mar 2021

Definition, Classification and Regulation of Medical Devices (3 of 4)

In this post, 3 of 4, we’ll consider Medical Device Regulations in the EU and the UK.
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22 Mar 2021

Should you implement an ISO 14001 Environmental Management System?

A management system is simply a structured framework to help you manage your people, processes and resources and, in the case of ISO 14001, your environmental impacts. Every organization, whether public or private, large or small, in developed or emerging economies, has an effect on the environment and is affected by the environment in return. There is a growing understanding that the ...
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19 Mar 2021

10 Reasons to change your ISO Certification Body

It isn’t all about getting and keeping your ISO Certificate.  Your organization needs to get value from the Certification Body Audits and, if you don’t, move to another Certification Body.  Certification Body (CB) contracts are of three year’s duration.  This is the universal norm.  Many organizations renew contracts without giving the matter much thought.  This is a mistake.  
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16 Mar 2021

Definition, Classification and Regulation of Medical Devices (2 of 4)

In this post, 2 of 4, we’ll consider the Classification of Medical Devices in the EU versus USA
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12 Mar 2021

ISO 13485 Certification for the Medical Device Supply Chain

ISO 13485 Certification for those not making Medical Devices Where do I start if I want to get Certified to ISO 13485? This is a question frequently asked by those involved in the medical device supply chain (e.g. component manufacturers and logistics companies) who have no experience with medical device manufacture. With a steady, if slow, increase in medical device companies requiring ISO 13485 ...
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