International

8.5  Actions to address risks and opportunities (Option A)

8.5.1 

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.

8.5.2 

The laboratory shall plan:

a)  actions to address these risks and opportunities;

b)  how to:

—  integrate and implement these actions into its management system;

—  evaluate the effectiveness of these actions.

NOTE 

Although  this  document  specifies  that  the  laboratory  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.

8.5.3 

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.