ISO 13485 Calibration Supplier Evaluation Requirements question

M

mech2008

#1
Dear experts,
For ISO 13485 requirement, do you know if the suppliers of equipment calibration must be evaluated and listed in "approved vendor list" in accordance with clause 7.4.1? As I know, just material/component and subcontractor need to do this.
But the auditor of NB said "Yes" when he audited for ISO 13485.
Thank you for kindly comment.
 
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mdurivage

Quite Involved in Discussions
#2

The short answer is yes.

7.4.1 Purchasing process
The type and extent of control applied to the supplier and the purchased product shall be dependent upon theeffect of the purchased product on subsequent product realization or the final product.

and

Sec. 820.50 Purchasing controls
Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.
Anything that is purchased that has a quality system impact (goods, services, consultants) must be on the ASL. The requirements to place the supplier on the list and the controls to maintain them should be risk based.



 

medwise

Involved In Discussions
#3
In simple terms, if any step or process which is outsourced and can impact the quality of the final product should be evaluated and monitored. For e.g. if you are sterilising the product and if your thermocouple is not calibrated then your sterilisation process may not be valid. Other e.g. if your pressure gauge (magnehelic) which is used to monitor the pressure differential of your clean room area is not calibrated then how will you know that your clean room is clean. Therefore, as a manufacturer you are required to identify your critical supplier and monitor them periodically.

P.S - Not an expert though an obedient student of ISO 13485:2003.:tg:
 
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