ISO 14971 is Changing
ISO 14971 is ChangingAs many of you may know already, ISO 14971 is changing yet again!
Changes to ISO 14971The 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 14971We 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
M: 087 2801793
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