CLSI QMS11 : 2015(R2019)
Current
The latest, up-to-date edition.
Nonconforming Event Management
Hardcopy , PDF
English
01-09-2019
This guideline is intended for use by individuals in a laboratory to facilitate establishment and maintenance of an internal nonconforming event (NCE) management program that includes: Responding to an event that does not conform to the laboratory’s established policies, processes, and/or procedures Responding to an event that does not follow established QMS policies, processes, and/or procedures Monitoring events through the data assessment, management review, and continual improvement (CI) connected processes This guideline is intended to supplement, but not replace, an organization’s established risk management or patient safety program.
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