The laboratory shall consider the risks and opportunities associated with the laboratory activities in order to:
a) give assurance that the management system achieves its intended results;
b) enhance opportunities to achieve the purpose and objectives of the laboratory;
c) prevent, or reduce, undesired impacts and potential failures in the laboratory activities;
d) achieve improvement.
The laboratory shall plan:
a) actions to address these risks and opportunities;
b) how to:
— integrate and implement the actions into its management system;
— evaluate the effectiveness of these actions.
NOTE Although this document specifies that the organization plans actions to address risks, there is no requirement for formal methods for risk management or a documented risk management process. Laboratories can decide whether or not to develop a more extensive risk management methodology than is required by this document, e.g. through the application of other guidance or standards.
Actions taken to address risks and opportunities shall be proportional to the potential impact on the validity of laboratory results.
NOTE 1 Options to address risks can include identifying and avoiding threats, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.
NOTE 2 Opportunities can lead to expanding the scope of the laboratory activities, addressing new customers, using new technology and other possibilities to address customer needs.