Risk Analysis Guidelines provides an introduction and overview of the guidelines and standards that govern Risk Management practices in the laboratory.
Risk Management is coming to the medical laboratory. CLSI guidelines and ISO standards strongly advocate that medical laboratories implement Risk Management as a way to assure quality in testing processes. While Risk Management is commonplace in other fields, it is new to the medical laboratory, particularly in the US.
This online course will introduce participants to the CLSI guidelines EP18, EP22 (which, while never passed, has had an influence on the approach), and EP23, which provide a general framework for Risk Management in the laboratory, for both manufacturer and customer. The ISO standards 22367, 14971, and 15189 will also be introduced. As ISO accreditation becomes more dominant worldwide and grows in popularity in the US, the ISO requirements for the use of Risk Management are increasingly important.
While this course discusses aspects of CLSI guidelines and ISO standards, the focus is on the actual Risk Analysis Tools themselves - the practical techniques that laboratories can put to use to improve their quality systems:
- FMEA (Failure Mode Effects Analysis)
- Criticality, Hazard scores, and Risk Matrices
- Process Flowcharts
- Sigma-metric QC Decision charts
- Quality Control Plans
Visit the Risk Guidelines course homepage for more details.
[Please Note: this course does not include copies of the CLSI guidelines or ISO standards. Participants who wish to purchase these documents, are encouraged to purchase the relevant guidelines and standards through the respective organizations. For those who do not purchase the documents or standards, this online course provides an overview and introduction to those documents. Participants may be able to use this course to decide which documents apply to their specific situation and make informed decisions.]