BS EN ISO 22367:2020 PDF

What is ISO 22367 about?

ISO 22367 discusses risk management for medical laboratories. ISO 22367 outlines a process for a medical laboratory to identify and manage the risks to patients, laboratory workers, and service providers associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling, and monitoring the risks. The requirements in ISO 22367 apply to all aspects of the examinations and services of a medical laboratory, including the pre-examination and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record, and other technical and management processes described in ISO 15189 . Note 1: ISO 22367 does not specify acceptable levels of risk. Note 2: ISO 22367 does not apply to risks from post-examination clinical decisions made by healthcare providers. Note 3: ISO 22367 does not apply to the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulator...