ISO 13485 implementation - Product realization is done at the 3rd party site

PPcricket

Starting to get Involved
#1
We are looking at implementing ISO13485 in the near future, we will be using a 3rd party manufacturer to make our products (we will be the licence holder). Can anyone advise on what aspects can need to be included for implementation, i.e. most of the product realization is done at the 3rd party site, hence can this be excluded from our Quality Manual or do we reference to the 3rd party site? They are already certified and experienced, we would essentially be the virtual company with the licence....
Thanks, P
 
Elsmar Forum Sponsor
R

Roland Cooke

#2
Re: ISO 13485 implementation

You can't exclude those things because you are still responsible. If you are directing what your supplier makes, and possibly how he makes it, you will need to show strong controls over outsourcing.

If you buying finished / near-finished product, out of a "catalogue", there is less (but not zero) onus on you, especially if the supplier is also certified.

The attached GHTF guidance may be of assistance.
 

Attachments

PPcricket

Starting to get Involved
#3
Re: ISO 13485 implementation

Thanks Roland, I thought that this would be the case, so i guess we can make references to our supplier/3rd base controls etc...when it comes product relisation but we would still create all the relevant requirements. Thanks for the document, will have a good read of this...P
 
M

MIREGMGR

#4
You mention being a license holder. Who is marketing the product? Are you having the product contract manufactured and then provided to you for marketing, or are you licensing a product design or some other form of intellectual property to another company that will make the product and then market it themselves?

In the latter case, you are not a manufacturer/marketer, and don't have any of the associated responsibilities.

In the former case:

If your product's realization by the contract manufacturer cannot be effectively 100% verified by you upon product receipt to meet your specifications, and/or if your product requires validated processes for which 100% verification is not an acceptable substitute, you will be responsible for control of your contract manufacturer's process validations.

You will be responsible for incorporation of product-realization-caused product hazards, and their control/mitigation, into your risk management.

If your contract manufacturer provides design services, you will be responsible for their conformance. Your product's Technical File will be your responsibility, even if you arrange for your Contract Manufacturer to construct and maintain it. You will be responsible for your product's labels/labeling.
 

PPcricket

Starting to get Involved
#5
Yes we will be the licence holder and marketing the product, we understand that the technical file is our responsibility (we will construct this) even though alot of the work is done at the 3rd party.
Thanks for the constructive comments.

Just wondering are there any sample/example 13485 manuals out to reference against what we are constructing? Any information would be helpful, regards, P
 

jkuil

Quite Involved in Discussions
#6
You will have to define how you ae monitoring and controlling the manufacturing of the product you are putting on the market.
  • You should be in control of all specification; inspection methods; acceptance criteria
  • you must have assured that (if needed) clean room validation and sterilization validation is appropiate
  • non-conformities during manufacturing should be reported/monitored for risk managment purpose
  • You must be able to put products on quality hold
 
Thread starter Similar threads Forum Replies Date
R ISO 13485 QMS Implementation Training ISO 13485:2016 - Medical Device Quality Management Systems 7
R ISO 13485 QMS sequence of implementation ISO 13485:2016 - Medical Device Quality Management Systems 4
M Startup Company - Implementation of ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 19
gunnyshore ISO 13485:2016 Implementation Plan ISO 13485:2016 - Medical Device Quality Management Systems 5
S Suggest a book that clearly demonstrates ISO 13485 Implementation Book, Video, Blog and Web Site Reviews and Recommendations 1
J ISO 13485 and ISO9001 Quality Management Implementation Start ISO 13485:2016 - Medical Device Quality Management Systems 6
N Survey for Masters Project - ISO 13485 and its implementation ISO 13485:2016 - Medical Device Quality Management Systems 5
N Survey for Master's Project - ISO 13485 and Implementation practices ISO 13485:2016 - Medical Device Quality Management Systems 3
M Advice and counsel on ISO 13485 Implementation and Certification ISO 13485:2016 - Medical Device Quality Management Systems 6
W ISO 13485 implementation - Other required standards and guides ISO 13485:2016 - Medical Device Quality Management Systems 13
J Need step-by-step ISO 13485 implementation help ISO 13485:2016 - Medical Device Quality Management Systems 8
V ISO 13485 Implementation - Medical Equipment Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 5
S Concurrent Manufacturing and ISO 13485 Implementation ISO 13485:2016 - Medical Device Quality Management Systems 11
M ISO 13485 training - Understanding of intent and implementation of risk management Training - Internal, External, Online and Distance Learning 1
K Software validation question - Contract Manufacturer - ISO 13485 implementation ISO 13485:2016 - Medical Device Quality Management Systems 2
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 13485 & CE Certification for Surgical Gloves CE Marking (Conformité Européene) / CB Scheme 0
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 2
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
M Scope for ISO 13485 Certification of a Translation Service Provider ISO 13485:2016 - Medical Device Quality Management Systems 17
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
A ISO 13485 Certification for Resin Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
A ISO 13485 Sterilization Clause Applicability ISO 13485:2016 - Medical Device Quality Management Systems 7
K ISO 13485 and compliance of electronic signature ISO 13485:2016 - Medical Device Quality Management Systems 5
T ISO 13485 - Assembly instructions written vs. online ISO 13485:2016 - Medical Device Quality Management Systems 5
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 5
N 93/42/EEC certification without ISO 13485 EU Medical Device Regulations 3
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
0 ISO 13485:2016 Chapter 8 Integration of the subsections ISO 13485:2016 - Medical Device Quality Management Systems 3
M Change in Constitution / Ownership of firm -------ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
E ISO 13485 QMS certification as a Supplier ISO 13485:2016 - Medical Device Quality Management Systems 8
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
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 6
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
J New Job Position - Achieving ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 5
A Scope of ISO 13485 certificate ISO 13485:2016 - Medical Device Quality Management Systems 1
A ASL requirement when the supplier is certified for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
M ISO 13485-2016 online certification ISO 13485:2016 - Medical Device Quality Management Systems 3
S Thoughts on managing ISO 9001, 13485, IATF 16949 and 17025 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
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
J Possible to get ISO 13485 certified with only OEM Product? ISO 13485:2016 - Medical Device Quality Management Systems 4
D Definition of equipment for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1

Similar threads

Top Bottom