CSA ISO 22367:21

CSA Preface

This is the first edition of CSA ISO 22367, Medical laboratories — Application of risk management to medical laboratories, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 22367 (first edition, 2020-02).

CSA Group acknowledges that the development of this Standard was made possible, in part, by the financial support of governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Ontario, Prince Edward Island, Québec, Saskatchewan, and Yukon, as administered by the Canadian Agency for Drugs and Technologies in Health (CADTH).

This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.

Scope

This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks.

The requirements of this document are applicable 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.

This document does not specify acceptable levels of risk.

This document does not apply to risks from post-examination clinical decisions made by healthcare providers.

This document does not apply to the management of risks affecting medical laboratory enterprises that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.