Experience with ISO quality control in assisted reproductive technology

Capsule:
ISO 9001 is a quality management system, the benefits of which include improved focus on customers, organizational improvement, as well as control of documents, greater efficiency, and mechanisms to allow for continual improvement.

Author:
Michael Alper, M.D.

Volume 100, Issue 6, Pages 1503-1508, December 2013

Abstract:

Assisted reproductive technology (ART) programs are complex organizations requiring the integration of multiple disciplines. ISO 9001:2008 is a quality management system that is readily adaptable to an ART program. The value that ISO brings to the entire organization includes control of documents, clear delineation of responsibilities of staff members, documentation of the numerous processes and procedures, improvement in tracking and reducing errors, and overall better control of systems. A quality ART program sets quality objectives and monitors their progress. ISO provides a sense of transparency within the organization and clearer understanding of how service is provided to patients. Most importantly, ISO provides the framework to allow for continual improvement.

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