point, step or procedure at which control can be applied and is essential to prevent or eliminate a hazard (3.32) or reduce it to an acceptable level

systematic methodology that recognizes and reviews the hazards (3.32) throughout a process and identifies critical control points (3.16) where preventative measures or set-points can be established and controlled to ensure product quality

point in the rotation loop at which the information for the calculation is gathered

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

process intended to ensure consistency between a life cycle assessment and the principles and requirements of the International Standards on life cycle assessment

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

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

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

process intended to ensure conformity (3.1.16) of a life cycle assessment (3.6.2) or an eco-efficiency (3.6.48) assessment to the principles and requirements (3.1.15) of the relevant International Standards

process intended to ensure consistency between a life cycle assessment and the principles and requirements of the International Standards on life cycle assessment