ISO 13485 Supplier Question

#1
Hi Everyone,

Our company is a Class I Accessories like chargers, remote control etc for hearing aids. I would like to request for some opinions on supplier questions we have. As i am having tough time working on this question one of my friend referred me to this forum.

Is it okay for supplier who will be the ODM, not having ISO 13485 certified? They are responsible for design and manufacturing of the accessories. They are 9001 certified.

What will be the implications if we wanted to go with them?

Thank You!
 
Elsmar Forum Sponsor

LUFAN

Involved In Discussions
#2
It's up to you to define requirements for your suppliers. It should be inherently risk based such that a supplier providing sterilization services has far stricter requirements than a widget. There's no requirement for suppliers to have certifications to anything, but if its specialized, you would want to define that, for example, your calibration house accredited to ISO 17025, etc.
 
#3
Thank you Lufan-Here the supplier is the ODM - original device manufacturer who will be designing and manufacturing the device till the end. Our company only distributes those accessories. Technically, they will be the legal manufacturers.
 

LUFAN

Involved In Discussions
#4
Technically, they will be the legal manufacturers.
They are or they are not. That cannot be in a gray area.

Are you buying finished devices from the supplier to distribute yourself, or are they utilizing your company's services to distribute on their behalf?

I assume it's the first. As such, they likely should be a high risk supplier (also likely critical) to your organization as a single source. You're going to want to categorize that type of supplier requiring items like a quality agreement denoting who is responsible for what (Complaints/MDR, Etc.), onsite audit of their manufacturing process, change notification agreement, etc. In your quality agreement, you are going to want to specify they are responsible for adhering to XYZ Quality System requirements. If you want to bind them to certify to 13485, that's where to do it, but generally in the United States, QSR/QMSR is/will be sufficient.
 

kys123

Starting to get Involved
#5
I fully agree with LUFAN, but I guess we both are assuming that you are based in and selling to countries within the EU, is that correct?
 
#7
They are or they are not. That cannot be in a gray area.

Are you buying finished devices from the supplier to distribute yourself, or are they utilizing your company's services to distribute on their behalf?

I assume it's the first. As such, they likely should be a high risk supplier (also likely critical) to your organization as a single source. You're going to want to categorize that type of supplier requiring items like a quality agreement denoting who is responsible for what (Complaints/MDR, Etc.), onsite audit of their manufacturing process, change notification agreement, etc. In your quality agreement, you are going to want to specify they are responsible for adhering to XYZ Quality System requirements. If you want to bind them to certify to 13485, that's where to do it, but generally in the United States, QSR/QMSR is/will be sufficient.

They are Legal manufacturers. We provide the product specification and requirements. They Design and manufacture for us and we distribute them finally.
 

LUFAN

Involved In Discussions
#10
Their name will be on the label as Legal manufacturers. Ours is listed as Distributed by.
Make sure you sign a quality agreement and you formally define them as the legal manufacturer on top of any addition certification requirements you want to hold them to. That said, seeing as they are the legal manufacturer, you're going to want to at minimum require 21CFR820 and probably ISO 13485/QMSR in next few years. That said, seems odd a hearing aid manufacturer would have picked 9001 over 13845 to begin with.

The arrangement you described is a bit odd but if they are willing to be the legal manufacturer and accept the liability, go for it.
 
Thread starter Similar threads Forum Replies Date
E ISO 13485 QMS certification as a Supplier ISO 13485:2016 - Medical Device Quality Management Systems 8
A ASL requirement when the supplier is certified for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
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
L How to deal with an ISO 13485 Supplier Audit nonconformance ISO 13485:2016 - Medical Device Quality Management Systems 17
R Supplier evaluation and business needs in the context of ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 2
C Approving AWS as a supplier (ISO 13485) ISO 13485:2016 - Medical Device Quality Management Systems 4
V Determining FDA 820 (registration) vs ISO 13485 - Supplier gives us the kit ISO 13485:2016 - Medical Device Quality Management Systems 1
N ISO 13485:2016 - Supplier Selection Criteria ISO 13485:2016 - Medical Device Quality Management Systems 3
alonFAI How to define a Risk Based Approach for Supplier Management per ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
T ISO 13485:2016 Clause 7.4.2 regarding Supplier Quality Agreements ISO 13485:2016 - Medical Device Quality Management Systems 11
S ISO 13485 Definitions - Medical Device Component Supplier ISO 13485:2016 - Medical Device Quality Management Systems 4
P Using an ISO 9001 supplier for an ISO 13485 Company/CE Marking Other ISO and International Standards and European Regulations 1
M ISO 13485 Calibration Supplier Evaluation Requirements question Other ISO and International Standards and European Regulations 2
A ISO 13485 Supplier Monitoring Minimum Requirements Supplier Quality Assurance and other Supplier Issues 3
T One Supplier Audit Checklist to cover ISO 9001:2008 and 13485:2003 Supplier Quality Assurance and other Supplier Issues 1
T I'm seeking ISO 13485:2003 Supplier Audit Checklist Supplier Quality Assurance and other Supplier Issues 1
D Supplier Certification for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 7
S Medical Device/IVD Manufacturer Supplier Requirements - Compliant to ISO 13485?? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Trusting ISO 13485 Certification of a Supplier... A Sad Story ISO 13485:2016 - Medical Device Quality Management Systems 117
P Approved Suppliers - ISO 13485 Normal Supplier Qualification Process Requirements ISO 13485:2016 - Medical Device Quality Management Systems 9
H ISO 13485 Sec 7.4 - Supplier Selection, Evaluation and Re-evaluation ISO 13485:2016 - Medical Device Quality Management Systems 20
T AVL (Approved Vendor List) Supplier Listing - ISO 13485 Requirements ISO 13485:2016 - Medical Device Quality Management Systems 6
F Vendor (supplier) for ISO 13485 Medical Devices Co. minimum QA System ISO 13485:2016 - Medical Device Quality Management Systems 3
M Approved Supplier List ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 43
LostLouie DHF linked to ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 4
B ISO 13485 Certificate Location / Scope ISO 13485:2016 - Medical Device Quality Management Systems 9
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

Similar threads

Top Bottom