Clinical laboratory quality manual

POLICIES AND PROCEDURES MANUAL CLIA #01D Sharon P. Massingale, Ph.D., HCLD (ABB) Laboratory Director Prepared by: Bureau of Clinical Laboratories Quality Management Division December ALABAMA COUNTY HEALTH DEPARTMENT LABORATORY SYSTEMS (ACHDLS) Table of Contents. It is based on training sessions and modules provided by CDC and WHO in more than 25 countries, and on guidelines for implementation of ISO in diagnostic laboratories developed by CLSI that are essential for quality management of a public health or clinical laboratory. THE CILM’S LABORATORY QUALITY MANUAL VERSION ACRONYMS AND TERMINOLOGY BSL Biosafety Level CILM Center Infectiology Lao-Christophe Mérieux CDC Centres for Disease Control and Prevention, USA CISI Clinical and Laboratory Standards Institute, Wayne, Pennsylvania, USA EQA External Quality Assessment.

This handbook is intended to provide a comprehensive reference on Laboratory Quality Management System for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. The laboratory complies with the requirements of this Quality Manual. The Quality Manual is intentionally numerically aligned with ISO requirements to provide a standard format. Manual is to define and document our facility’s quality management system. The Quality Manual communicates the structure and detail of our organization’s quality management and documentation systems to our own personnel, customers, and external assessors. The key quality elements used in the Department of Pathology and Laboratory Medicine’s Quality Manual are the following: 1. Organization 2. Personnel Resources 3. Equipment 4.

Feb The policies and procedures of the Quality Manual are applicable to all testing performed in the laboratory, unless superseded by a project or. It has been compiled to meet the requirements of The International Standard ISO 'Medical Laboratories – Requirements for Quality and Competence' . define, implement and monitor standards of performance and quality improvement of the medical laboratory service or services. Quality Manual that.