Transcription of Risk Management Guide - College of American Pathologists
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Risk Management Guide - College of American Pathologists
Risk Management Guide ISO 15189 Accreditation Program 2 December 2015 CAP 15189 CAP 15189 BackgroundThe ISO 15189:2012 standard includes a clause regarding risk Management ( ). The text reads: The laboratory shall evaluate the impact of work processes and potential failures on examination results as they affect patient safety, and shall modify processes to reduce or eliminate the identified risks and document decisions and actions taken. To clarify the laboratory s responsibility and the CAP s assessment standards, the CAP has developed this Guidance SummaryISO 15189 assessors from the CAP will ask to see risk assessments of any new or significantly revised processes implemented in the laboratory.
• ISO 31000:2009, Risk management—Principles and guidelines • CLSI EP23-A, Laboratory Quality Control Based on Risk Management; Approved Guideline References 1. ISO 14971:2007, Medical devices—Application of risk management to medical devices; specifically Annex H, Guidance on risk management for in vitro diagnostic medical devices 2.
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