Reapplying for ISO 13485 certification after certificate revocation

B

blmuskrat

#1
We lost our ISO 13485:2003 with CMDCAS certificate 18 months ago and I wanted to go to ISO 13485:2016 but Canada will not recognize the 2016 version for sale of product. I am reverting to a revised corrected company QMS to the 2003 standard and want to use a new 3rd party registrar company. Do I need to devulge that I had a prior certificate to this new registrar and lost it due the QA Manager not getting the CAPA's resolved in time? The previous registrar decided not to renew certificate due to this reason, the QA person is no longer and nothing transpired for 18 months, plus their expense was exhoribatant. I've since revised the old QMS and corrected prior CAPA's to compliance to the 2003 and await the new registrar but want to know the correct process I should undertake before the new audit, thanks.
 
Elsmar Forum Sponsor
B

blmuskrat

#4
Sidney:
Just for clarification, although we lost the ISO and CMDCAS certificates 18 months go, I've been requested to revise and correct what was of the old QMS system that was in place to compliance, which I've done. Would your answer still be the same?

After we have a successful stage I and Stage II audit to ISO 13485:2003, I will implement ISO 13485:2016 later on in mid 2017.

Thanks.
 
Thread starter Similar threads Forum Replies Date
Q The scope of ISO 21534 Other Medical Device Related Standards 0
A What must be recorded? (ISO 9001:2015, subclause 10.2) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M ISO 14971:2019: Criteria for overall residual risk ISO 14971 - Medical Device Risk Management 3
B Updated IATF 16949 - Will IATF 16949 get revised when ISO 9001:202X is released? IATF 16949 - Automotive Quality Systems Standard 3
S ISO 9001:2015 vs 21 CFR Part 211 matrix Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
N Quality Compliance Officer - ISO 13485, London Job Openings, Consulting and Employment Opportunities 0
T ISO 17025: Lockout/Tagout Requirement ISO 17025 related Discussions 1
N ISO 9001 implementation in a Gold exporting business ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Does the ISO 9001:2015 standard require a disaster recovery plan or emergency response plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
E ISO 13485 QMS certification as a Supplier ISO 13485:2016 - Medical Device Quality Management Systems 8
A Environmental Compliance obligations and risks (ISO 14001:2015 6.1.3) ISO 14001:2015 Specific Discussions 3
R ISO 17025 vertical audit checklist wanted Document Control Systems, Procedures, Forms and Templates 2
A Tips and Tricks to understand ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M ISO 9001 Major Nonconformance Internal Audit Schedule/COVID-19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
T ISO 13485:2016 Clauses related to process matrix ISO 13485:2016 - Medical Device Quality Management Systems 3
K ISO 50001 Consultant wanted Paid Consulting, Training and Services 0
K Comparison wanted: ISO 15378:2018 vs. PS9000:2016 Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
B ISO 9001 - "Remote Audit Fee" Registrars and Notified Bodies 13
R Risk control measures as per ISO 14971 ISO 14971 - Medical Device Risk Management 6
John C. Abnet ISO 45001:2018 (5.4 - Consultation and participation of workers) Occupational Health & Safety Management Standards 10
Sidney Vianna What ISO Standard (under the TC 176) supports the UN Sustainable Development Goal #10? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 11
S ISO 15223-1:2020 Symbols Other Medical Device Related Standards 1
John C. Abnet ISO 9001 4.4.1 "...shall determine the processes needed..." ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 72
R ISO 10993-18 Medical Device and FDA Regulations and Standards News 1
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
R Applicable ISO standards - packaging and others Medical Device and FDA Regulations and Standards News 4
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 6
Q EN ISO 13485:2016/AC:2018 - AC:2018 being stated in the applicable harmonized standard listing Other ISO and International Standards and European Regulations 1
M ISO 10993-17 - Ancillary Medicinal substance leachables Medical Device and FDA Regulations and Standards News 1
M Medical Devices - Ancillary - ISO 10993-17 Medical Device and FDA Regulations and Standards News 6
J Leveraging another company's ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
J New Job Position - Achieving ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 4
S ISO 9001 Clause 8.2.3 - Review of the requirements for products and services in a Cafe ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A ISO 17025 - Methods validation and clients ISO 17025 related Discussions 3
A Scope of ISO 13485 certificate ISO 13485:2016 - Medical Device Quality Management Systems 1
A ASL requirement when the supplier is certified for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
D ISO 9001 certificate issued by QMS International for 10 years - legit? Registrars and Notified Bodies 17
Z Does anyone have experience with EN ISO 17664 ? IEC 62366 - Medical Device Usability Engineering 9
K Medical Device Repairs and ISO Scope ISO 13485:2016 - Medical Device Quality Management Systems 3
K Software Updates in the Field and ISO scope ISO 13485:2016 - Medical Device Quality Management Systems 2
M ISO 13485-2016 online certification ISO 13485:2016 - Medical Device Quality Management Systems 3
Z Auditor Findings ISO 14001:2015 vs. 45001:2015 ISO 14001:2015 Specific Discussions 5
S Thoughts on managing ISO 9001, 13485, IATF 16949 and 17025 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
S Supplier Management ISO 13485: 2016- Which supplier needs to fill in a self assessment form? ISO 13485:2016 - Medical Device Quality Management Systems 6
C ISO/IEC 17021-1 clause 7.1.2 - Determination of competence criteria Document Control Systems, Procedures, Forms and Templates 2
G ISO 17023 2017-11 - Suggestions for good books ISO 17025 related Discussions 0
B Timeframe for updating QMS / transitioning from ISO 14971:2012 to ISO 14971:2019 ISO 14971 - Medical Device Risk Management 10
M ISO 9001:2015 and AS6081:2012 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B Gage calibration frequency, ISO and IATF - What are the requirements Calibration Frequency (Interval) 3
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom