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 ‘In-process goods”. During the manufacturing process, the manufacturer wants to make sure that the product is being produced as per the specification laid down during the design stages. 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.