Using of risk-oriented thinking in testing laboratories

Abstract

A new version of ISO/IEC 17025:2017 released in November 2017, and a new version of GOST ISO/IEC 17025 developed on the basis of this document which is to appear in 2019 are discussed. An emphasis is made on the concept of management and operation of testing industrial laboratories (IL) in quality assurance, including application of the process approach and risk management which are considered the main tools of the quality management system (QMS) of testing laboratories. The goal of the article is to provide practical assistance in ensuring a smooth transition of IL from meeting the requirements of the current GOST ISO/IEC 17025-2009 standard to the new version based on the aforementioned process approach and risk-based thinking, the main focus being on the embodiment of risk management requirements. We consider the stages and objectives of the risk management process and options for a systematic approach to risk management, taking into account the initial and subsequent stages of further improvement of the process. Specific recommendations for risk management implementation in IL with a description of the risk management process in the laboratory within the life cycle of the laboratory products or the main business process are proposed. Examples of risk assessment in IL using effective tools: “brainstorm” and “matrix of consequences and probabilities” are presented. The guidelines of improving risk management and subsequent the transition to a more detailed assessment and management of risks are specified and exemplified in the framework of the IL activity. The directions of further developing the QMS of IL regard-ing setting goals and objectives are outlined taking into account risk assessment and risk management both within the internal context of the laboratory and the enterprise, and with allowance for the external environmental impact.