Is it okay to store the design files (device drawings) at contract manufacturer location?

S.Rajesh

Registered
Dear members,

Is it okay to store the design files (device drawings) at contract manufacturer location if the scope of ISO13485 Certificate says scope as "Design,development,manufacturing,distribution and service of opticsl diagnostic systems for the area of ophthalmology"?

Appreciate,your valuable feedback.

Regards,
S.Rajesh
 

yodon

Leader
Super Moderator
You, as the 'manufacturer of record' are ultimately responsible. If they have the controls in place to ensure the documents / records are controlled / retained per the requirements then you can certainly authorize them to do that.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
As the main site (you) is ultimately responsible for what happens, I would add that arrangements should be made carefully to address the risk of the contract manufacturer using obsolete versions and/or losing control of sensitive information. This is a reasonable part of supplier control.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Its ok as long as you are not defining something in more than 1 place. There should be only one location for official documents and "copies" everywhere else.
 
S

snoopy2017

The specific obligations should be clearly spelled out in a quality agreement. Also consider the risks involved.
 

William55401

Quite Involved in Discussions
I agree it is OK to store the design files at the CM. As the customer, you need to be clear (yes, in a Quality Agreement) that you are the Design Authority and must approve all changes to the design files. In the past, Notified Bodies liked this language in Quality Agreements. The CM is providing manufacturing services for you and also providing document control services by maintaining your design documents. Good luck.
 
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