ABSTRACT
The goal of monitoring, measurement, analysis, and the evaluation is to provide decision makers an understanding through a situation report concerning the performance of processes. Measurement, analysis, and improvement include supportive processes, operations, and activities that require inputs, resources, knowledge, and infrastructures and provide important outputs necessary for the progress of the realization. Regulatory requirements or applicable standards might require the implementation and use of certain statistical methods or techniques throughout the measurement and analysis processes. The standard requires the maintenance of a documented procedure describing the method of the audit. The documentation of adverse event should contain enough information to allow its proper review: investigation of the product failure and the evaluation of the effect on the patient or user. Planning and executing the audit must include and specify the activities necessary for organizing and conducting the audit and describing the required resources for the audit.
