Master - OLA Guidance For Lab Quality Manuals

Master - OLA Guidance For Lab Quality Manuals
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    QUALITY MANAGEMENT PROGRAM – LABORATORY SERVICES (QMP–LS) Ontario Laboratory Accreditation Division (OLA) Guidance for Laboratory   Quality Manuals   Quality Management Program – Laboratory Services (QMP–LS) October 2011  Version 4.1 Prepared by J Coffey Issued by L Crawford Ontario Laboratory Accreditation Division Suite 1500 • 393 University Avenue Phone 416.323.9540 • Fax 416.323.9324 OLA Ontario Medical Association  OLA GUIDANCE FOR LABORATORY QUALITY MANUALS OCTOBER 2011 Version 4.1 Page 1 of 27 Table of Contents SECTION PAGE   Introduction 2 Glossary of Terms 3 Quality Manual Basics 5 International Organization for Standardization (ISO) 6 ISO Definition of a Quality Manual 6 Structure and Contents of the Quality Manual 7 Table 1: Quality Manual as Described in Clause 4.2.4 of ISO 15189 9 Table 2: Quality Manual Based on the Structure of ISO 15189 10  Table 3: CLSI Style Quality Manual Table of Contents 11 Table 4: OLA Style Quality Manual Table of Contents 12 Table 5: ISO 9001:2008 Style Quality Manual 13   The Introduction 14 The Quality Policy Statement 15 Document Control 16 Example Headers and Footers 17 Maintaining the Manual 18 Review of Laboratory Quality Manual 19 Table 5: Self- Assessment of Laboratory Quality Manual  20 The Assessment Visit 22 Frequently Asked Questions 23 Sample Quality Manuals 25 Resources 25  OLA GUIDANCE FOR LABORATORY QUALITY MANUALS OCTOBER 2011 Version 4.1 Page 2 of 27 Introduction  An essential requirement of the Ontario Laboratory Accreditation (OLA) program is the design and implementation of a quality management system. Central to an effective quality management system is the creation of a laboratory quality manual, the top tier of a facility’s quality system documentation.  This guide will help laboratories write a quality manual that meets the criteria defined by the OLA Program Requirements.  The guide:    Provides necessary information on the structure and content of the quality manual    Provides guidance on document control of the quality manual    Includes sample tables of contents to illustrate how a quality manual can be organized    Presents OLA criteria for participant self-assessment of their quality manual    Clarifies what assessors will evaluate during an assessment visit    Provides Internet links to examples of quality manuals    Suggests resources for those needing further information  OLA GUIDANCE FOR LABORATORY QUALITY MANUALS OCTOBER 2011 Version 4.1 Page 3 of 27 Glossary of Terms Document  Any information that provides direction (e.g. instructions including policy statements, textbooks, reference intervals and their srcins, procedures, specifications, calibration tables, charts, posters, notices, memoranda, plans, software, drawings, regulations and standards). Document Control  A system to regulate the handling and management (including archiving, storing and destruction) of documents containing information that communicates policies, processes, procedures as well as records. Usually pertains to documents that are part of the quality management system. ISO International Organization for Standardization. A network of standards institutes from 140 countries  working in partnership with international organizations, governments, industry, business and consumer representation. The source of more than 13,000 international standards for business, government and society. CLSI Clinical and Laboratory Standards Institute. A global, voluntary organization that develops and disseminates consensus standards, guidelines and best practices. Formerly known as the National Committee for Clinical Laboratory Standards (NCCLS). Non-Conforming Examinations Non-fulfillment of any requirement in the performance of a laboratory examination or test. Identified from many sources, including audits, quality control, staff comments and clinician complaints. Policy Statement describing what is done and why. Process Series of inter-related steps involved in an activity or examination that uses resources and is managed to transform inputs into outputs. Procedure  Written work instructions that specify a way to carry out an examination or step in a process.


May 1, 2018


May 1, 2018
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