CLSI has released a new standard, EP23, titled “Laboratory Quality Control Based on Risk Management; Approved Guideline.” The document, available through Document Center Inc., provides guidance based on risk management for laboratories to develop quality control plans tailored to the particular combination of measuring system, laboratory setting, and clinical application of the test.
CLSI, formerly known as NCCLS, is a global, nonprofit, standards-developing organization that promotes the development and use of voluntary consensus standards and guidelines within the health care community.
The new guideline EP23 compliments the ISO 14971, “Medical devices — Application of risk management to medical devices,” ISO 10993-1, “Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process,” and ISO 20993, “Biological evaluation of medical devices — Guidance on a risk-management process.” It shows the increasing emphasis on risk management as a component of quality control in the health care industry.
All standards mentioned can be purchased from Document Center Inc. through our website, www.document-center.com. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We can assist you in the challenge of compiling and maintaining your standards documentation.