We are ISO 13485:2016 should we be audited to ISO 14971

Elsmar Forum Sponsor

indubioush

Quite Involved in Discussions
#4
You are correct. It is not required. However, it is expected that a medical device manufacturer will follow this standard for risk management. There is no need to have a certification to this standard. However, when your company is performing internal audits, it is a good idea to include a ISO 14971 audit.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
By whom? And, if it is not required, why would they expect it?
1. NBs - Other than being harmonized (the preferred path) under the MDD, it's considered state of the art.
2. IEC 60601 (where it applies) directly relies on it.

Theoretically, medical devices risk management can be done "free style" (not to ISO 14971), but in most practical senses it will be much more difficult/complicated. Why? Because. Don't get me started.
 
#7
By whom? And, if it is not required, why would they expect it?
Auditors/ NBs. They will look for compliance to any standard that is applicable. MDR and ISO 13485 call out the importance of risk management, and a recognized standard exists for MD risk management. (It's a great standard BTW, very helpful). We are audited against ISO 11607 and ISO 11137 because we have gamma sterilized products.
 

kreid

Involved In Discussions
#8
If you have not claimed compliance to ISO 14971, then you do not have to comply.
As above, there will be expectations by external agencies that you will have complied with 14971, but if you can demonstrate that you have complied with the regulation of the markets you are accessing (rather than any recognised/harmonised standard) then that will trump anything else.
You are required to comply with the regulations not international standards.
Though there will be some here who may point to subtleties around 13485/Canada/MDSAP.
 
#10
We are ISO 13485:2016 should we be audited to ISO14971
Within ISO 13485:2016 there are several references to ISO 14971.

It´s important to understand whether you are a medical device manufacturer or not. (Also suppliers and others can have ISO 13485).
If you manufacture medical devices in Europe, you´ll hardly be able to register them without ISO 14971.
But you do not get a certificate for ISO 14971 like you get one for ISO 13485.
For example, in case you comply to any other standard, you also do not get a certificate for each of them.
 
Thread starter Similar threads Forum Replies Date
S Supplier Management ISO 13485: 2016- Which supplier needs to fill in a self assessment form? ISO 13485:2016 - Medical Device Quality Management Systems 1
D Definition of equipment for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 0
M ISO 13485:2016 Complaint Definition Clarity Customer Complaints 2
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
P ISO 13485:2016 MDSAP Certification Fee Survey ISO 13485:2016 - Medical Device Quality Management Systems 6
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 12
H ISO 13485:2016 Gap Analysis by NB ISO 13485:2016 - Medical Device Quality Management Systems 7
S SOP for ISO 13485:2016 Quality related Software validation ISO 13485:2016 - Medical Device Quality Management Systems 9
JoCam Difference between Approval and Registration - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
K ISO 13485:2016, Clause 4.2.3 Medical Device File ISO 13485:2016 - Medical Device Quality Management Systems 4
T Document control ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
E Equipment Qualification - IQ/OQ per ISO 13485:2016 section 7.5.6 Process validation ISO 13485:2016 - Medical Device Quality Management Systems 7
S Clinical Evaluation - Is this an ISO 13485:2016 requirement? ISO 13485:2016 - Medical Device Quality Management Systems 4
L ISO 13485:2016 Clause 8.4 - Analysis of Audit Observations ISO 13485:2016 - Medical Device Quality Management Systems 8
S When is ISO 13485:2016 6.4.2 Contamination Control appropriate? ISO 13485:2016 - Medical Device Quality Management Systems 11
L Templates for three ISO 13485:2016 SOPs ISO 13485:2016 - Medical Device Quality Management Systems 8
C What falls under the 'Customer Property' according to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 10
M Is it possible to get iso 13485:2016 certified as a one man band ISO 13485:2016 - Medical Device Quality Management Systems 1
F ISO 13485:2016 Quality Policy Requirements Other ISO and International Standards and European Regulations 10
M Contract Manufacturers and MDF Responsibilities, ISO 13485:2016, Clause 4.2.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
J ISO 13485:2016 sample exam/test ISO 13485:2016 - Medical Device Quality Management Systems 3
M Informational Questionário – Análise crítica sistemática – ISO 13485:2016 (Portuguese-only) Medical Device and FDA Regulations and Standards News 0
M Informational ISO 13485:2016 under systematic review Medical Device and FDA Regulations and Standards News 5
C Updates on Documentation for outsourced OEM from ISO 13485:2003 to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 4
GStough Informational SN EN ISO 9001:2015 and SN EN ISO 13485:2016 on Same Certificate? Registrars and Notified Bodies 7
E MDSAP Audit - Our QMS conforms to ISO 13485:2016 and FDA GMP Canada Medical Device Regulations 9
Ronen E Informational ISO 13485:2016 Transition Period End - 1 March 2019 ISO 13485:2016 - Medical Device Quality Management Systems 0
B ISO 9001:2015 vs ISO 13485:2016 for MDR Compliance EU Medical Device Regulations 4
T ISO 13485:2016 - Processes exempt from process validation ISO 13485:2016 - Medical Device Quality Management Systems 12
C Medical device manufacturing (class 2 ISO 13485:2016) - Is a Deviation allowed? Other Medical Device Related Standards 5
J EU ISO 13485:2016 Recertification Audit - Effect of 10 Minor Nonconformances EU Medical Device Regulations 2
E Template of a Management Review Agenda or Report in compliance with ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 6
J ISO 13485:2016 Section 6.2 - Documenting the process for establishing competence ISO 13485:2016 - Medical Device Quality Management Systems 6
Q Any good Checklists for ensuring SOPs cover ISO 13485:2016 and 21CFR 820? ISO 13485:2016 - Medical Device Quality Management Systems 3
H Transition to ISO 13485:2016 together with ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 12
B Classes/ Online Training on ISO 13485:2016 and FDA QSR Part 820 ISO 13485:2016 - Medical Device Quality Management Systems 5
T Software Validation Certificate (ISO 13485:2016) ISO 13485:2016 - Medical Device Quality Management Systems 19
D ISO: 13485:2016 Sec. 7.5.2 (C) - Requirements for cleanliness of product or contamination control ISO 13485:2016 - Medical Device Quality Management Systems 2
M Internal Audit Assessment Criteria - ISO 13485:2016 Internal Auditing 21
C Software validation (4.1.6 ISO 13485:2016) ISO 13485:2016 - Medical Device Quality Management Systems 20
L Does anybody have quiz's available? ISO 13485:2016 Training Material Training - Internal, External, Online and Distance Learning 2
G ISO 13485:2016 and regulatory requirements - Contract Manufacturing ISO 13485:2016 - Medical Device Quality Management Systems 22
S ISO 13485:2016 and GDRP EU 2016/679 ISO 13485:2016 - Medical Device Quality Management Systems 5
JoshuaFroud Interpretation of Clause 5.5.2 in ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
R CNC Software Validation requirements as per ISO 13485:2016 Other ISO and International Standards and European Regulations 8
A ISO 13485:2016 Applicable regulatory requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
R ISO 13485:2016 Registration - NC on full cycle of internal audits ISO 13485:2016 - Medical Device Quality Management Systems 7
C Will anyone please share training material for ISO:13485:2016 for best practices Training - Internal, External, Online and Distance Learning 0
T ISO 13485: 2016 Internal Audit - Is sampling on projects allowed? ISO 13485:2016 - Medical Device Quality Management Systems 6
D Where I can find an ISO 13485:2016 Audit Schedule example? ISO 13485:2016 - Medical Device Quality Management Systems 4

Similar threads

Top Bottom