PCT International Search and Preliminary Examination Guidelines
21.11 Each Authority should establish its own risk-based practices to enable the Authority to determine the factors that could cause its operational processes and its quality management system to deviate from requirements or planned results, to put in place preventive controls to minimize negative effects, and to make use of opportunities as they arise.
21.12 It is open to each Authority to set up its own arrangements to determine the effect of uncertainty on objectives, but the following is proposed as a guide to the basic components of risk-based practices as an element of the QMS. There is no requirement for formal methods of risk management or a documented risk management process.
(i) understanding the Authority’s context (external and internal issues that affect its ability to achieve the intended results of the QMS) and understanding the needs and expectations of interested parties.
(ii) identification of risks and opportunities related to the performance of the QMS, as a basis for planning;
(iii) planning and implementation of actions to address risks and opportunities;
(iv) checking the effectiveness of the actions taken; and
(v) continuously updating risks and opportunities.
21.14 All processes of the QMS present differing levels of risk in terms of the Authority’s ability to meet its objectives, and the effects of uncertainty are not the same for all Authorities. Each Authority is responsible for the actions it decides to take to address risks and opportunities.