Seems like certification to ISO 14971 is now available

Ronen E

Problem Solver
Staff member
Moderator
#1
Just something I came across by chance (maybe this is old news):

http://www.bsiamerica.com/en-us/Sec...14971-Risk-management-certification-program-/

I have no affiliation with BSI, and I haven't looked into that specific program yet. I thought it might be relevant because it was stated here before that certification to ISO 14971 is not available (though I couldn't find the specific post).

Happy holidays,
Ronen.
 
Elsmar Forum Sponsor

sagai

Quite Involved in Discussions
#2
Thank you for sharing, however I have my own doubts about such certification. I have not seen even a real, value added ISO13485 third party audit in the last couple of years, not to mention any more specific one than that.
Actually, there is a temptation to contact BSI for further details ... :mad:
:thanx:
Szabolcs
 

Marcelo

Inactive Registered Visitor
#3
UL has been offering a 14971 certification for some time....they even same some problems with it, as I remember correctly, because they said that an ISO 14971 certification was required to comply with IEC 60601 third edition (it is not).
 
P

phloQS

#5
Dear all,

I do not understand why a certification of the risk management process should be necessary. Our NB proofs the process during 13485 audit, because it is part of our QMS and the output, the risk managementfile is controlled as part of the technical documentation.

Regards

phloQS
 

Marcelo

Inactive Registered Visitor
#6
I do not understand why a certification of the risk management process should be neccessary. Our NB proofs the process during 13485 audit, because it is part of our QMS and the output, the riskmanagementfile is controlled as part of the technical documentation.
An ISO 13485 audit does not verify compliance with ISO 14971, this is a common misconception. If there´s any need to verify compliance with ISO 14971 in full, you need and ISO 14971 audit.
 
P

phloQS

#7
But who needs this? The ISO 13485 only says that you have to establish a risk management process. ISO 14971 is one possibility. As part of QMS, this process must be reviewed by the NB and it must be sufficient for the compliance with ISO 13485.
Many other standards refer to risk management procedures and especially to the 14971 procedure. But I do not know any standard which says you have to use it.
 
Last edited by a moderator:

Marcelo

Inactive Registered Visitor
#8
But who needs this? The ISO 13485 only says that you have to establish a risk management process. Iso14971 is one possibility. As part of QMS this process must be reviewed by the NB and it must be sufficient for the compliance with ISO13485.
That´s why I said, "I'F there´s any need to verify compliance with ISO 14971 in full.

For ISO 13485, you do not need this (anyway, the new version of ISO 13485 will problably have a direct requirement to ISO 1485, but you still won´t need to verify compliance with ISO 14971).


Many other standards refer to risk management procedures and especially to the 14971 procedure. But I do noz know any standard which says you have to use it.
When it´s part of a requirement, you DO have to use it (for example, the new version of IEC 60601-1. But even in this case, you do not need to assess compliance to ISO 14971).
 
Thread starter Similar threads Forum Replies Date
Sidney Vianna ISO seems not to be aware that ILO is not very happy with ISO's work on OHS Occupational Health & Safety Management Standards 5
Genofear Customer wants to audit our supplier audits - seems inappropriate General Auditing Discussions 11
A Cpk Formula seems off, need help!? Capability, Accuracy and Stability - Processes, Machines, etc. 11
I When the client seems to get involved in functions of our organization Quality Manager and Management Related Issues 6
M GM Cruze Recall - Seems that the Cruze can catch fire World News 6
optomist1 Correlation and Causation - Causation seems to be Ambiguous and Slippery Quality Tools, Improvement and Analysis 7
S Minor nonconformance seems more opinion ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
ScottK CE Marking Issue- this seems illegal to me... CE Marking (Conformité Européene) / CB Scheme 9
J EC Certification transfer from CMO to Legal Manufacturer Possible? CE Marking (Conformité Européene) / CB Scheme 0
A Can a organization use a disclaimer "pending AS9100 Certification" in Marketing Information? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
S Certification Body Changeover - Transfer of Certificate Registrars and Notified Bodies 9
N Traditional 510K Submission-Financial Certification or Disclosure Statement 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
J Quality Objective for QMS prior to Certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
J Where to get a Black belt certification ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 13
D ISO 13485 & CE Certification for Surgical Gloves CE Marking (Conformité Européene) / CB Scheme 0
K MDR Class 1 Self Certification - Competent Authority or Notified Body? EU Medical Device Regulations 6
R GMDN and UMDNS Codes certification EU Medical Device Regulations 0
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 2
R IATF 16949 Certification for new site with transferred product--what is the impact with CSR and scorecards? IATF 16949 - Automotive Quality Systems Standard 0
B IATF 16949 Cert Expire- New certification body IATF 16949 - Automotive Quality Systems Standard 5
C Budgetary cost to obtain ASME NQA-1 Quality Program Certification Quality Management System (QMS) Manuals 0
V Certified Auditor - Need of additional certification specific to industry ( GMPs) ASQ vs ECA vs others Professional Certifications and Degrees 1
Le Chiffre Online training available for ISO/IEC 17021-1: Requirements for bodies providing audit and certification of management systems Training - Internal, External, Online and Distance Learning 3
B Cybersecurity Maturity Model Certification for military customers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
M Scope for ISO 13485 Certification of a Translation Service Provider ISO 13485:2016 - Medical Device Quality Management Systems 17
A ISO 13485 Certification for Resin Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
X ISO 17025 certification for Laboratory for online gambling products ISO 17025 related Discussions 3
N 93/42/EEC certification without ISO 13485 EU Medical Device Regulations 3
V New Product Model CE Mark Certification under MDR EU Medical Device Regulations 0
H What ISO certification is for an IT department? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
P ISO 9001 certification with zero customers? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
E ISO 13485 QMS certification as a Supplier ISO 13485:2016 - Medical Device Quality Management Systems 8
G IATF Rules for COVID 5th revision - Re-certification audit timing IATF 16949 - Automotive Quality Systems Standard 3
J New Job Position - Achieving ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 5
M ISO 13485-2016 online certification ISO 13485:2016 - Medical Device Quality Management Systems 3
K USB VID/PID certification Various Other Specifications, Standards, and related Requirements 2
L IATF 16949 certification costs IATF 16949 - Automotive Quality Systems Standard 3
J How much to charge for helping a startup company with initial ISO 13485 certification? Consultants and Consulting 3
R Medical Device Software Certification IEC 62304 - Medical Device Software Life Cycle Processes 1
R China Quality Certification Various Other Specifications, Standards, and related Requirements 1
S Requirements to obtain ISO 50001 Certification ISO 14001:2015 Specific Discussions 2
N Any experience with Registrars that deny Certification to a Registrant? Registrars and Notified Bodies 4
P ISO Class 8 particle count (annual certification vs monitoring) ISO 13485:2016 - Medical Device Quality Management Systems 4
T ISO/IEC 17065 certification scheme Help Other ISO and International Standards and European Regulations 7
T Help to Suggest name for a new certification and inspection company Coffee Break and Water Cooler Discussions 7
J Hitrust Certification (HIPPA etc.) Other Medical Device Regulations World-Wide 0
T Letter to file for Product Certification CE Marking (Conformité Européene) / CB Scheme 0
P ISO 13485:2016 MDSAP Certification Fee Survey ISO 13485:2016 - Medical Device Quality Management Systems 6
O ANATEL certification of Medical Device Other Medical Device Regulations World-Wide 0
M What happens to certifications if the issuing certification body loses accreditation? Supplier Quality Assurance and other Supplier Issues 2

Similar threads

Top Bottom