SBS - The best value in QMS software

The future of ISO 14971:2007

M

Marcelo

Inactive Registered Visitor
#1
#1
ISO TC 210 JWG 1 is meeting this week in Frankfurt to decide what to do with ISO 14971:2007 (unfortunately I was not able to attend the meeting this time). From the last meeting, there was a tendency to suggest either amend ISO 14971 or revise ISO TR 24971 or both.

In general, the possible outputs would be:
- Amend ISO 14971:2007 and/or
- Revise ISO TR 24971
- Revise ISO 14971:2007 AND revise ISO TR 24971 OR include ISO 24971 on the revision of ISO 14971 (my preference :))
 
QMS for Medical Device Companies
Elsmar Forum Sponsor
M

Marcelo

Inactive Registered Visitor
#3
#3
We are meeting this week to review comments on the DIS of ISO 14971 and ISO TR 24971. We will meet in Brazil in January to continue the work. If everything is ok, we will have the standard published in the middle of 2019, more or less.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Future of ISO 14971 - Possible revision? ISO 14971 - Medical Device Risk Management 9
K Reviewing a supplier's ISO 9001 certificate issued for a future date Registrars and Notified Bodies 10
Marc Annex SL - Format for Future ISO Management System Standards Other ISO and International Standards and European Regulations 7
S What is the future of ISO 50001 EnMS (Energy Management Systems)? Miscellaneous Environmental Standards and EMS Related Discussions 3
automoto How ISO 9001 could look in the future - ISO 9001 revision (Guide 83) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Sidney Vianna Future ISO 9001 Variations: "Lighter" and "Higher Level" Versions? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25
Sidney Vianna The ISO 9000 ecosystem - a clear(?) vision for the future of the ISO 9000 family ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Sidney Vianna The Future Structure of ISO Management System Standards Other ISO and International Standards and European Regulations 61
R The Future of ISO/TS 16949 IATF 16949 - Automotive Quality Systems Standard 9
D Current Medical Device under 9001 Excluded from future ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
W ISO 13485 Certification for Future Business ISO 13485:2016 - Medical Device Quality Management Systems 7
Q Future hopeful lead ISO Quality Auditor - Please help me here on my quest Career and Occupation Discussions 31
G What is the Future ISO/TS 16949? IATF 16949 - Automotive Quality Systems Standard 1
M ISO 9001:2006 - What is the future of ISO9000? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
B Will TS 16949 be aligned to ISO 9000:2000 in the future? IATF 16949 - Automotive Quality Systems Standard 62
D What foreign language proficiency would give the biggest edge to medical device regulatory affairs professionals in the world today or in future? Career and Occupation Discussions 6
Ronen E Informational The future of MEDDEV 2.7/1 EU Medical Device Regulations 4
M Informational Technology and innovation of human implants | Panel for the Future of Science and Technology (STOA) | European Parliament Medical Device and FDA Regulations and Standards News 0
Sidney Vianna IAQG News Future AS9147- Management of Unsalvageable Parts - Previous scrap parts AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
Sidney Vianna The Future of Spaceship Earth - The UN Sustainable Development Goals Sustainability, Green Initiatives and Ecology 1
Marc The Future of Geothermal Energy Coffee Break and Water Cooler Discussions 0
F Future Plan for IMDS (International Material Data System) RoHS, REACH, ELV, IMDS and Restricted Substances 5
J Potential Customers Asking for EIRs / 483s when evaluating a CRO for future work US Food and Drug Administration (FDA) 2
A Future as an AS9100/NADCAP Auditor AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
B Any future for someone working as Lead Quality right these days? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
8 New Job Presentation on my findings and plans for future Lean in Manufacturing and Service Industries 6
D What's the future of supplier quality engineer for your worklife? Supplier Quality Assurance and other Supplier Issues 3
Marc The future of 3-D Printing Manufacturing and Related Processes 18
somashekar BAA (Buy American Act) and the future of Asian Economy Business Continuity & Resiliency Planning (BCRP) 15
G The future of the Process Approach to Auditing General Auditing Discussions 10
Marc Predicting the Future through 19th Century French Post Cards Coffee Break and Water Cooler Discussions 1
P Contract up in 1.5 months - How to approach my manager to discuss the future Career and Occupation Discussions 15
M Future revision of ANVISA RDC 59 - Brazilian GMP Other Medical Device Regulations World-Wide 14
AnaMariaVR2 Emergence ? 2011 Future of Quality Study [ASQ] The Reading Room 4
P Future Materials Storage Issue: Is this a finding? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
8 Introducing a Balance Line - Identifying potential future pitfalls etc. Lean in Manufacturing and Service Industries 2
AnaMariaVR2 QbD, PAT, and the Future of Microbiology Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
AnaMariaVR2 QA's negligence threatens Ranbaxy's future revenue US Food and Drug Administration (FDA) 1
SteelMaiden What does the future hold for nuclear power? Coffee Break and Water Cooler Discussions 10
Marc An iMac "Touch" in the future? After Work and Weekend Discussion Topics 2
rob73 Possible future of IFU (Instruction for Use)? EU Medical Device Regulations 3
M The near future will be better? Coffee Break and Water Cooler Discussions 9
B CQI-14 (Consumer-Centric Warranty Management) certification required in the future? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 7
A If the estimates are correct Mexico could win a future Soccer World Cup Funny Stuff - Jokes and Humour 19
Marc Riding the Electromagnetic Wave of the Future World News 4
U eVaro-Future Hybrid Sportscar World News 0
A Advice for future QM (Quality Manager) in automotive Career and Occupation Discussions 29
Marc The Future - G.E.?s Breakthrough Can Put 100 DVDs on a Disc After Work and Weekend Discussion Topics 0
Marc The Future of Harley-Davidson World News 74
U The Future of Quality Management Philosophy, Gurus, Innovation and Evolution 13

Similar threads

Top Bottom