Earlier versions of standards for Laboratory Management Systems have
advocated risk management and risk avoidance, but it has been implicit.
The new ISO/IEC 17025:2017 standard explicitly expects organizations
to consider and identify actions to address risks and opportunities
associated with their laboratory operations, processes, and activities,
aimed at and resulting in improved performance.
Besides identifying the risks, the ISO standard expects laboratories to
address opportunities for improvements and corrective actions based on
the risk analysis.
Note that while corrective action is an ISO/IEC 17025:2017 requirement,
the concept of preventive action is expressed through a risk-based
approach where risks are determined and actions to address risks and
opportunities are taken.
The standard does not require you to create a formal risk management
system. However, this risk analysis exercise is intended to outline
several approaches / options for the management of risk for your
laboratory.
To prepare for the change, it is important to understand Risk Based
Thinking and begin to look at your operations, processes, and activities
in terms of risks and opportunities.
Risk is the possibility of an event or activity negatively impacting the
operational or strategic objectives of an organization.