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What is the difference between the EN and ISO versions of 14971:2019? Part 1
14th September 2020

What is the difference between the EN and ISO versions of 14971:2019? Part 2
14th September 2020

Is Analysis of Multiple-Fault Conditions a Requirement of ISO14971?
14th September 2020

more...


ISO 14971 is Changing

ISO 14971 is Changing

As many of you may know already, ISO 14971 is changing yet again! 

Changes to ISO 14971

The new standard will be known as ISO 14971: 2019. The most significant changes will be that most of the guidance currently contained in the standard will be transferred to a separate guidance document, ISO TR 24971. The purpose of this change is to align the format of ISO 14971 with that of other standards. 
There will be other changes also but these will be minor changes in nature. The revised standard will now be slightly closer to the current EN version (EN 14971: 2012) but most of the major differences will remain the same. 

Tentative Publication Dates for Revised ISO 14971

We enquired about the proposed dates of the above revisions and we were in contact with Eamonn Hoxey of EV Hoxey Ltd. Eamonn has written excellent articles on the revision of ISO 14971. He advised us of the following tentative timetable for the voting on and publication of the revised ISO 14971 as follows: 
Final Vote: Opens in early May and closes in late June 2019. 
Publication: Possibly as early as July 2019.

Training on ISO 14971 

We provide training on ISO 14971 and related courses through our training partner SQT Training. Find out more about ISO 14971 Training   

About the Author, John Lafferty 


John Lafferty is a Quality and Validation Consultant to the Medical Device industry. His specialities include MDSAP, ISO 13485, ISO 14971 and MDR. John is the holder of a Degree in Manufacturing Technology, Certificate in Training & Continuing Education and a Certificate in Quality Management. He has over 25 years’ experience in the medical device and pharmaceutical industry. He was a Senior Manager of a multinational Medical Devices plant where he managed the Quality, Regulatory, Environmental and Health & Safety Management Systems. He has successfully completed numerous consultancy projects with medical device manufacturers in Ireland and throughout Europe. John is also a Life Sciences Tutor with SQT Training

Contact Details
M: 087 2801793  
E-Mail: john.lafferty@northridge.ie  
Website: www.northridge.ie  
LinkedIn https://ie.linkedin.com/in/johnlaffertynorthridge  
Twitter: @northridgequal

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