SBS - The best value in QMS software

ISO 13485:2016 - IQ/OQ Requirements applicable to Electronic Component Suppliers

M

MonteS

#1
#1
I work for a company that makes wafers for an ISO 13485-certified company, who in turn makes chips that go into medical devices. They are telling me that we MUST do IQs and OQs for our already installed equipment. True? Please detail your responses. Thanks!
 
Popular whitepapers from DISCUS
Elsmar Forum Sponsor
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#2
#2
Re: ISO 13485:2016 - IQ/OQ requirements applicable to component suppliers

Hello MonteS and welcome to the Cove :bigwave:

I have spun your post / question off the thread where you originally posted it to create a new thread, because it was an old thread from 2008 - the context of that thread was ISO 13485:2003 while now we have ISO 13485:2016.

To answer your question, I don't see an explicit requirement in ISO 13485:2016 giving rise to that request from your client. On the other hand, they can pose requirements that don't come directly from the standard. It might have something to do with the way they interpret / implement the standard inside their own operation. Did they highlight ISO 13485 as the source or trigger of their request?
 
shimonv

shimonv

Trusted Information Resource
#3
#3
Hi MonteS,
I agree with Ronen. As a component manufacturer you are not subject to ISO 13485, but your client is and its easier for them to expect more of you weather justified or not. I doubt anyone will challenge them about your IQ/OQ processes unless there is a serious investigation going on.

Anyhow, the client is the client and you need to be smart in producing retrospective report (you can do IQ and OQ together) that shows that your process consistently produces good results.

Shimon
 
M

MonteS

#4
#4
Thank you shimonv and Ronen E for your replies, and thanks Ronen E for placing me into the correct forum. This is very helpful and appreciated. The mandate came from a very experienced consultant who is helping a startup attain ISO 13485 certification. Ronen E, he may be requiring this on his own, as you mentioned. I agree shimonv that I have to be smart about this. I am definitely leaning towards doing an "IOQ" for our key processes. My company is considering including 13485 with our recently-kicked off 9001 certification journey.
 
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#5
#5
MonteS said:
My company is considering including 13485 with our recently-kicked off 9001 certification journey.
Click to expand...
Based on second-hand knowledge, I think that might be an inefficient path. Since the ISO 13485:2016 and ISO 9001:2015 updates the two standards seen to have diverged significantly and they don't mesh together as easily as they used to. Plus, I heard that people are saying that the added value of ISO 9001:2015 over an ISO 13485:2016 system doesn't justify the extra resources.

If you search Elsmar on this topic, you might find some interesting posts.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
S Inventory Listing and ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 3
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 5
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
0 ISO 13485:2016 Chapter 8 Integration of the subsections ISO 13485:2016 - Medical Device Quality Management Systems 3
T ISO 13485:2016 Clauses related to process matrix ISO 13485:2016 - Medical Device Quality Management Systems 3
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
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
J Leveraging another company's ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
M ISO 13485-2016 online certification ISO 13485:2016 - Medical Device Quality Management Systems 3
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
D Definition of equipment for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
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
A We are ISO 13485:2016 should we be audited to ISO 14971 ISO 13485:2016 - Medical Device Quality Management Systems 16
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 18
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

Similar threads

Top Bottom