ISO 13485 - EU countries that could request another audit

F

Fabiola

Registered
Hello,

I am looking for the countries that despite the presence of an ISO 13485 certificate, "another" audit could be requested. I have heard about Ukraine.
could someone help me?

thank you
regards
 
Sidney Vianna

Sidney Vianna

Post Responsibly
Leader
Admin
I have not heard anything along those lines, but is a well known fact that some Medical Device Authorities around the World have concerns over the "pedigree"/credibility of some ISO 13485 certificates issued by less than serious actors.

I also know that some of the people behind the IAF Certsearch database come from the Medical Device Arena and they were pushing for a way to promptly monitor the validity and provenance of ISO 13485 certificates. Unfortunately, for them, the unregulated accredited certification process has been commoditized to a point where low cost Accreditation Bodies have been allowed under the IAF umbrella and ultra-low cost certification bodies can now issue certificates to a plethora of standards, all under the IAF MLA and recognition....one certificate....recognized everywhere.....through robust and rigorous audits :sarcasm:
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Sidney Vianna Informational ISO 13485 Certificates Top 10 Countries - 2004 to 2017 ISO 13485:2016 - Medical Device Quality Management Systems 0
C Question on Finding - BSI Stage 2 ISO 13485:2016 Certification - PMS ISO 13485:2016 - Medical Device Quality Management Systems 5
J Complaints Handling ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 3
A ISO 13485 CERTIFICATION WITH REGULATORY ISO 13485:2016 - Medical Device Quality Management Systems 1
R ISO 13485:2016 DESIGN TRANSFER Forum News and General Information 0
Y Environmental Monitoring in ISO 13485 production areas ISO 13485:2016 - Medical Device Quality Management Systems 2
M Feedback process ISO 13485:2016 clause 8.2.1 ISO 13485:2016 - Medical Device Quality Management Systems 2
N ERP for ISO 13485 QMS solution, your experience, reviews ? ISO 13485:2016 - Medical Device Quality Management Systems 1
M Integrating ISO 9001:2015 audits with ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
R ISO 13485 Certification for an Internal Warehouse? ISO 13485:2016 - Medical Device Quality Management Systems 1
Q ISO 13485 Contract Manufacturer Controls and Quality System Requirements ISO 13485:2016 - Medical Device Quality Management Systems 4
J Is ISO 13485 certification necessary for Class I (non-sterile) medical devices? ISO 13485:2016 - Medical Device Quality Management Systems 7
A ISO:13485 Strategy for a Startup ISO 13485:2016 - Medical Device Quality Management Systems 5
G ISO 13485 and CE certification strategy ISO 13485:2016 - Medical Device Quality Management Systems 7
A Small Company Implementing ISO 13485 Timeline/Process/Steps Advice ISO 13485:2016 - Medical Device Quality Management Systems 5
R ISO 13485:2016 “Lifetime” of a product Manufacturing and Related Processes 4
kys123 Implications of failing an Anvisa Audit for ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 4
A Risk Assessment for ISO 13485:2016 section 7?? ISO 13485:2016 - Medical Device Quality Management Systems 11
L Annex of ISO 13485:2016 as harmonized standard (MDR/IVDR) ISO 13485:2016 - Medical Device Quality Management Systems 2
LostLouie DHF linked to ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 7
B ISO 13485 Certificate Location / Scope ISO 13485:2016 - Medical Device Quality Management Systems 9
M ISO 13485 Supplier Question ISO 13485:2016 - Medical Device Quality Management Systems 13
M ISO 13485:2016 Identification & Traceability ISO 13485:2016 - Medical Device Quality Management Systems 4
K Clause 7.5.2 of ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
J ISO 13485 and new warehousing ISO 13485:2016 - Medical Device Quality Management Systems 2
A Applying for ISO 13485 certification ISO 13485:2016 - Medical Device Quality Management Systems 8
Ed Panek Auditor Feedback ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 12
S ISO 13485 certification training Training - Internal, External, Online and Distance Learning 1
Ed Panek ISO 13485 Reporting Requirements ISO 13485:2016 - Medical Device Quality Management Systems 4
B ISO 13485 Qualification of R&D Equipment Qualification and Validation (including 21 CFR Part 11) 1
J Recognised/reputable courses for ISO 13485 Section 7.3 (Design & Development)? ISO 13485:2016 - Medical Device Quality Management Systems 1
Q ISO 13485 certificate needed if I go for MDSAP certification? ISO 13485:2016 - Medical Device Quality Management Systems 3
K ISO 13485 Design Requirement with respect to "component" manufacturers ISO 13485:2016 - Medical Device Quality Management Systems 11
P Registrar Cancelled ISO 13485 Auditors multiple times? Registrars and Notified Bodies 1
rob3027 ISO 13485 justification for design and development exclusion for medical packaging ISO 13485:2016 - Medical Device Quality Management Systems 18
A Help understanding what it takes to implement a QMS that is ISO 13485 compliant ISO 13485:2016 - Medical Device Quality Management Systems 4
FuzzyD ISO 13485:2016 Customer Assessment OFI ISO 13485:2016 - Medical Device Quality Management Systems 2
M ISO 13485 consultants and auditors with design oriented focus ISO 13485:2016 - Medical Device Quality Management Systems 7
S Brexit ISO 13485:2016 + Corrigendum - What does a UKCA DoC require? EU Medical Device Regulations 2
Aliken Recommendation for the ISO 13485 certification company ISO 13485:2016 - Medical Device Quality Management Systems 7
ISO-tired ISO 13485: file structure overview ISO 13485:2016 - Medical Device Quality Management Systems 11
M PROBLEM IN SCOPE OF ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
S ISO 13485 signing of Procedures etc. ISO 13485:2016 - Medical Device Quality Management Systems 10
N ISO 13485 Scope Reduction Other ISO and International Standards and European Regulations 2
M Can veterinary implants be ISO 13485 certified? ISO 13485:2016 - Medical Device Quality Management Systems 23
D Audit Report details when ISO 13485:2016 and cGMP 21 CFR 820 are applicable ISO 13485:2016 - Medical Device Quality Management Systems 6
R Looking for ISO 13485 Internal Audit Checklist ISO 13485:2016 - Medical Device Quality Management Systems 8
FuzzyD ISO 13485 change in process ISO 13485:2016 - Medical Device Quality Management Systems 3
R Interesting Discussion Chapter 7.5 of ISO 13485 for manufacturers of mobile medical applications ISO 13485:2016 - Medical Device Quality Management Systems 4
V ADDING NEW MEDICAL DEVICE / Product, WHEATHER THIS AFFECTS EXISTING ISO 13485 CERTIFICATION? ISO 13485:2016 - Medical Device Quality Management Systems 4

Similar threads

Top Bottom