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Scope of ISO 13485 certificate

akp060

Involved In Discussions
#1
Looking for clarifications on some questions related to the following query

I design my product and the production, assembly is done by a contract manufacturer. The contract manufacturer has an ISO 13485 certificate which does not include "Packaging" and however the process is done at their end. and the assembled product is sent to us for QA and distribution. I am implementing the QMS. Three questions:

a. Who is responsible for the process "packaging" here?
b. Should packaging come in my scope or should my contract manufacturer have it included in their scope?
c. If it is done through a quality agreement between me and the contract manufacturer is it fine if later my ISO certificate includes it given that the process actually takes place at the latter's premises? This is because of the inference of Clause 7.5.1. (e) of ISO 13485:2016 it seems to fall under production and in my case production is done by the contract manufacturer
 
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somashekar

Staff member
Super Moderator
#2
Looking for clarifications on some questions related to the following query

I design my product and the production, assembly is done by a contract manufacturer. The contract manufacturer has an ISO 13485 certificate which does not include "Packaging" and however the process is done at their end. and the assembled product is sent to us for QA and distribution. I am implementing the QMS. Three questions:

a. Who is responsible for the process "packaging" here?
b. Should packaging come in my scope or should my contract manufacturer have it included in their scope?
c. If it is done through a quality agreement between me and the contract manufacturer is it fine if later my ISO certificate includes it given that the process actually takes place at the latter's premises? This is because of the inference of Clause 7.5.1. (e) of ISO 13485:2016 it seems to fall under production and in my case production is done by the contract manufacturer
a. You are responsible for design, manufacturing and distribution. Packaging is an activity in the manufacturing.
b. See a.
c. What you are not doing by yourself, you are outsourcing. See the Clause 4.1.5

The contract manufacturer's scope would be like ... The contract manufacturing of >>>. Your quality agreement can spell out the details very clearly about the manufacturing activity.

Help us with your Scope statement for more clarity. Thanks
 
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