19 resultaten gevonden voor 'configuration control board'

configuration control board

person or a group of persons with assigned responsibility and authority to make decisions on the configuration (3.10.6)

control procedure

set of operations at the point of use, described specifically, intended to monitor the performance characteristics of an IVD medical device and fulfil requirements for quality

configuration authority

person or a group of persons with assigned responsibility and authority to make decisions on the configuration (3.10.6)

configuration baseline

approved product configuration information (3.6.8) that establishes the characteristics (3.10.1) of a product (3.7.6) or service (3.7.7) at a point in time that serves as reference for activities throughout the life cycle of the product or service

change control

<configuration management> activities for control of the output (3.7.5) after formal approval of its product configuration information (3.6.8)

control material

substance, material or article intended by its manufacturer to be used to verify the performance characteristics of an IVD medical device

performance control

comparison between performance (3.1.78.1)(3.1.78.2) and defined requirements

configuration management

coordinated activities to direct and control configuration (3.10.6)

configuration object

object (3.6.1)

within a configuration (3.10.6) that satisfies an end-use function