An Inspection/Quality Plan lays out a programme of inspections at points of failure during the life-cycle of a medical device, in order to ensure that the process is in compliance with required specifications. Inspection/Quality Plans are used to comply with the requirements of the ISO 13485 standard related to control of production and service provision.
A common point of failure is ‘Incoming Goods”. In order to be sure that the incoming material complies with the documented specification, the manufacturer has to be sure that the supplied material is delivered as per the specification. If non-conforming material is delivered the same shall be returned to the supplier. This template contains provisions for test method, sampling quantity, test specification, test frequency etc.
This template is written specifically for early-stage medical device companies and is audit ready and is written by highly experienced professionals. Click below to get a preview of this template.