Risk Analysis for a Subcontractor

[gprasadhc]

Request some help from cove members "Risk analysis procedure" development for a subcontractor ,

(Who is Not responsible Product Design ,product safety Labeling .Installation and servicing is not our responsibility )

Regards
Gprasadhc

 

[DannyK]

ISO 13485 requirements in 7.1 requires the company to address risk management throughout product realization.

Product realization is clause 7 in ISO 13485:2003. Go through each clause in 7 and come up with situations which may cause failures or defects.

For example- clause 7.4- long lead items can mean missed deliveries or critical suppliers not meeting quality requirements, etc..

It probably would be helpful to refer to ISO 14971 which provides an excellent framework for risk management.

Danny