Measuring and monitoring of product

ISO 13485-2016

7.5.1 Control of production and service provision

Production and service provision shall be planned, carried out, monitored and controlled to ensure that product conforms to specification. As appropriate, production controls shall include but are not limited to:

a) documentation of procedures and methods for the control of production (see 4.2.4);

b) qualification of infrastructure;

c) implementation of monitoring and measurement of process parameters and product characteristics;

d) availability and use of monitoring and measuring equipment;

e) implementation of defined operations for labelling and packaging;

f) implementation of product release, delivery and post-delivery activities.

The organization shall establish and maintain a record (see 4.2.5) for each medical device or batch of medical devices that provides traceability to the extent specified in 7.5.9 and identifies the amount manufactured and amount approved for distribution. The record shall be verified and approved.