ISO 22367-2020 pdf download.Medical laboratories – Application of risk management to medical laboratories.
4.4.2 Scope of the plan
The scope of the plan or plans shall be determined by laboratory management. A risk management plan may be created, for example, for technical and management processes, for specific pre- and post-examination aspects, for one or more examinations performed by a particular IVD system, for a particular examination developed by the laboratory, or for all of the examinations performed by the laboratory in which risks could be identified and assessed.
The scope of the plan and the extent of the risk management activities required shall be proportional to the risks associated with the examinations. Factors that should he considered include but are not limited to:
a) relevant quality specifications;
b) medical decision levels and critical values;
c) patient populations;
d) reliability of the measurement system and measurement uncertainty;
e) performance characteristics (precision, bias, specificity, etc.);
f) pre-examination contact with the patient (e.g., phlebotomy); and
g) clinical use of the examination results (e.g., screening, diagnostic, confirmatory tests).
Unless specified otherwise and justified, the risk management plans for medical laboratory examinations shall include pre- and post-examination aspects and the processes that are identified as presenting a risk to patients or other persons.
4.4.3 Contents of the plan
Each risk management plan shall include at least the following:
a) description of the examinations and services, any IVD medical devices involved, and all relevant pre- and post-examination aspects within the scope of the plan;
b) assignment of responsibilities and authorities;
c) requirements for review of risk management activities;
d) criteria for individual and overall risk acceptability, based on the laboratory’s policy for determining acceptable risk;
e) risk control verification and monitoring activities.
NOTE Refer to AnnxC for guidance on risk acceptability considerations, and AnnxB for guidance on establishing risk acceptability criteria.
4.4.4 Revisions to the plan
The plan shall be updated if significant changes occur that could affect the risk assessment. A record of changes to the plan shall he maintained.
NOTE Examples of significant changes that could affect the risk assessment include:
a) modification of laboratory facilities or utilities;
b) introduction of new policies, procedures or work instructions;
c) acquisition, purchase or introduction of new equipment, including laboratory information systems;
d) introduction of new examinations or services, or change in service delivery level;ISO 22367 pdf download.