supplementtothelaboratoryquality.docVIP

SUPPLEMENT TO THE LABORATORY QUALITY MANAGEMENT SYSTEM TRAINING TOOLKIT, Module 16 - Documents and records QUALITY MANUAL Version 2013 Name of the laboratory Address Director name Contact details… Written by Reviewed by Authorized by Date: Date: Date: Preface This quality manual template provides guidance for public health and clinical laboratories on writing policies and procedures that support a quality management system. It is based on both ISO 15189 Standard for Medical laboratories - Medical laboratories — Particular requirements for quality and competence - and CLSI GP26-A4 documents - Quality Management System: A Model for Laboratory Services; Approved guideline 4th edition - , and provides information and examples to assist with writing a quality manual that addresses all quality system essentials (QSE) that are critical for quality management. The template is organized following the framework developed by CLSI and the “12 Quality System Essentials”, as described in greater detail in the Laboratory Quality Management System (LQMS) Training Toolkit . Furthermore, additional resources (e.g. glossary) can also be found in the LQMS Training Toolkit and Handbook. A quality manual is required for implementing a quality management system. Such a system aims primarily at achieving customer satisfaction by meeting customer requirements through application of the system, continuous improvement of the system, and prevention of the occurrence of nonconformities. This quality manual template is based on internationally-accepted standards and focuses on good quality principles and best practices. Information noted in red in this template is provided as example, by no means complete, or as instruction. The individual laboratories are required to customize the text of the template to the local situation. The watermark “template” is to be removed before finalization. The resulting quality manual will need to be reviewe