Quality System Manual - Exclusions from ISO 13485 Clause 7.5

D

danush

#1
Hello all,

i am new to the site but already found a lot of valuable information. my company develops a medical device that will be manufactured by an outsourcing manufacturer. does it mean that clause 7.5 "production and service provision" can be fully excluded from our QMS or we should still address some sub-clauses like validation, sterilization ect?

thanks.
 
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pkost

Trusted Information Resource
#2
Re: Quality System Manual -exclusions from ISO 13485

You cannot exclude 7.5 due to the following clause in 1.2:

The processes required by this International Standard, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system [see 4.1 a)].
 

somashekar

Staff member
Super Moderator
#3
Re: Quality System Manual -exclusions from ISO 13485

Hello all,

i am new to the site but already found a lot of valuable information. my company develops a medical device that will be manufactured by an outsourcing manufacturer. does it mean that clause 7.5 "production and service provision" can be fully excluded from our QMS or we should still address some sub-clauses like validation, sterilization ect?

thanks.
Hello Danush ~~~
Welcome to the cove and it is good to note you have liked this place.
Your question is a very common business process model which many medical devices manufacturers adopt. Depending on your medical device manufactured all OR applicable clauses of 7.5 are INCLUSIONS., and these are directly mapped with requirements as in 4.1 about control of outsourced process.
 
Last edited:
D

danush

#4
Re: Quality System Manual -exclusions from ISO 13485

thanks for drawing my attention to 4.1 Does it mean that I need to review and have on file all relevant procedures of manufacturer? basically, we provide the product specifications and some manufacturing instructions but mostly using their standard procedures, including sterilization, packaging ect.
 

somashekar

Staff member
Super Moderator
#5
Re: Quality System Manual -exclusions from ISO 13485

thanks for drawing my attention to 4.1 Does it mean that I need to review and have on file all relevant procedures of manufacturer? basically, we provide the product specifications and some manufacturing instructions but mostly using their standard procedures, including sterilization, packaging ect.
No. It means you have a method of dynamic control that assures your product is manufactured and tested per your product specifications and manufacturing instructions, and that their standard procedures, including sterilization, packaging etc, are approved by you in meeting your products safety and effectiveness of performance. If processes of your outsourcing manufacturer needs validations, then it must be so done and you are aware of it and its proper application.
In short have your outsourced manufacturer qualified to ISO 13485 requirements. That in itself will do a lot good as a major control exercised.
 
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