Migration (Transition) to ISO 13485:2016 from ISO 13485:2003

sriramsl

Involved In Discussions
#1
Dear all
I am starting the ISO 13485:2006 Migration from 2003.I have done a gap analysis between 2003 and 2016 and with respect to our processes and documents.
It will be great if the experts can share your inputs / gap analysis or related documents so that I can ensure that I don't miss out anything as well as do it diligently
Thanks for your help in advance
Regards
Sriram
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
Marc Thoughts about the vBulletin to Xenforo Software Migration - 2 October 2018 Forum News and General Information 4
P Study concerning adoption of and migration to ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
R Network/Computer Data Migration Sampling GMP Software Quality Assurance 1
B What is the process of migration to ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
L Movement (Migration) of Data between Applications Quality Assurance and Compliance Software Tools and Solutions 5
D Data Migration Validation - AGILE to (ARAS) Innovator Software Quality Assurance 3
G Document Migration from Powerway Document Control Systems, Procedures, Forms and Templates 2
A Regulatory Standards for Migration of Certain Potentially Harmful Elements Other ISO and International Standards and European Regulations 4
E Are QS-9000 to TS 16949 migration benefits noticeable? IATF 16949 - Automotive Quality Systems Standard 9
T Brexit Transition Arrangements & Import into the EU EU Medical Device Regulations 3
J MDD to MDR transition - Time required for the implementation of the MDR EU Medical Device Regulations 7
S MDR consultants - in search of recommendations for a consultant for MDR transition. Paid Consulting, Training and Services 7
K Annex XVI Device Transition Timeline under the MDR EU Medical Device Regulations 2
B ISO 9001:2015 Transition: Much Easier Than You Think! Misc. Quality Assurance and Business Systems Related Topics 0
M UDI transition period and implementation EU Medical Device Regulations 6
M Informational The US FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication Medical Device and FDA Regulations and Standards News 0
O New MDR 2017/745 Transition Strategy - 2019 Manufacturing and Related Processes 3
A How to manage the QMS system and SOP during the transition from MDD to MDR EU Medical Device Regulations 4
S When is the last date for transition to ISO/IEC 80079-34:2018? Other ISO and International Standards and European Regulations 0
K CE mark transition and new regulations CE Marking (Conformité Européene) / CB Scheme 0
Ronen E Informational ISO 13485:2016 Transition Period End - 1 March 2019 ISO 13485:2016 - Medical Device Quality Management Systems 0
T MDR Guidance Book - Useful for MDR transition? EU Medical Device Regulations 1
M Medical Device News EU – Transition Timelines from the Directives to the Regulations – Medical Devices and in vitro Diagnostic Medical Devices Medical Device and FDA Regulations and Standards News 13
H Transition to ISO 13485:2016 together with ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 12
Ed Panek Transition to IEC 60601 4th Edition - Risk Analysis and test submissions CE Marking (Conformité Européene) / CB Scheme 2
M Medical Device News Health Canada - Medical Device Single Audit Program (MDSAP) Transition Plan Canada Medical Device Regulations 2
M Medical Device News FDA News - 26-09-18 - FDA Reveals Vision for the Transition to ISO 13485 Other US Medical Device Regulations 1
M MDSAP Transition - Health Canada Website Notice on Apr 13 2018 Canada Medical Device Regulations 1
O IEC 60601-1-2 4th edition transition deadline Dec 31 2018 CE Marking (Conformité Européene) / CB Scheme 1
qualprod Transition and recertification at the same time? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
P How To Transition From AS9100c to AS9100 Rev. D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
A ISO 14001:2015 transition from the 2004 standard ISO 14001:2015 Specific Discussions 8
F IATF 16949:2016 transition audit - Internal Audit Closures IATF 16949 - Automotive Quality Systems Standard 13
W AS9120A to AS9120B transition AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
L Transition date to IEC 60601-1-11:2015 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Q Surveillance Audit of 2008 before Transition Audit to ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
B Going into IATF 16949 transition without Internal Audits IATF 16949 - Automotive Quality Systems Standard 4
pammesue We have done NOTHING toward the ISO 9001 transition ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
S Management representative transition checklist IEC 27001 - Information Security Management Systems (ISMS) 7
O ISO 9001:2015 Transition Internal Audit completion thread ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
A ISO 14001:2015 transition audit - Major NC due to the procedure and audit plan ISO 14001:2015 Specific Discussions 10
T ISO 9001:2008 to 2015 transition - How much work to change? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
R ISO 9001:2015 Transition Quality Manual Update - Redundant Content ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
G Upkeep of ISO 9001:2008 during Transition TO ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D AS9110 Re-Certification & Transition Audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
S Is there enough time left to transition to ISO 13485:2016 and MDSAP? ISO 13485:2016 - Medical Device Quality Management Systems 1
M AS9100 Rev. D Transition Audit - Number of Audit Days AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
G Effect of ISO9001 2015 transition on ISO IEC 80079-34 Other ISO and International Standards and European Regulations 2
R Who here is Using a Consultant for ISO 9001 Transition? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Sidney Vianna One year to ISO 9001 and 14001 transition deadline. ISO & IAF communique' ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12

Similar threads

Top Bottom