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ModuleModule

BASICS OF THE QUALITY BASICS OF THE QUALITY SYSTEM CONCEPTSYSTEM CONCEPT

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Content OverviewContent Overview

• Understanding importance of high quality laboratory service

• ISO 15189 as a quality management standard for medical laboratories

• CLSI guidelines: a complementary role to ISO standards

• The quality system outline

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Accurate, reliable and timely laboratory results are essential to all

aspects of health care

Importance of High Quality Laboratory Service

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Provide high quality services:

• in the right place

• in the right time

• in respect of the needs of• patients• community • health staff

• clinicians • epidemiologists • environmental sanitarians

Mission of Health Laboratory Services

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How Do We Achieve Excellent Performance in the Laboratory?

Importance of Quality Systems

• Different techniques and concepts have been developed to improve product or service quality

• ISO 9000 series of standards • widely used

• outlines the systemic approach to quality

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International Organization for Standardization (ISO)

• Non-governmental organization established in 1947

• Worldwide federation of national standards bodies

• Develops voluntary consensus standards (and other types of document)

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• Guidance for quality in manufacturing and Guidance for quality in manufacturing and service industriesservice industries

• Has broad applicability, many kinds of Has broad applicability, many kinds of organizations can useorganizations can use

ISO 9001:2000, Quality management system – Requirements

ISO 9000 Family

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ISO 15189:2007, Medical laboratories - Particular requirements to quality and competence

• Valuable compilation of statements to assist laboratory specialists in understanding and implementing quality management systems

• Has become the international foundation for medical laboratory accreditation

ISO Documents - Laboratory

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ISO 15189:2007: Content Management Requirement• Organization• Quality management system• Document control• Contract review• Referral laboratories• Supplier review• Advisory services• Complaint resolution• Identification and control of

nonconformities• Corrective actions • Preventive actions• Continual Improvement• Quality and technical records• Internal audits • Management review

Technical Requirements• Personnel authorities and

responsibilities

• Accommodation and environmental conditions

• Laboratory equipment

• Pre-examination procedures

• Examination procedures

• Assuring quality of examination procedures

• Post-Examination procedures

• Reporting of results

Annexes

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• A committed forum for laboratory improvement through consensus, guidelines, and standardization.

• International in scope and participation• World Health Organization Collaborating Centre• Secretariat – ISO Technical Committee 212

• Ten area committees addressing the full range of laboratory activities.

National Committee for Clinical Laboratory Standards (NCCLS) in 2005

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CLSI Quality Standards

Guideline No. Title

HS1-A2 A Quality Management System Model for Health Care Describes quality system model, 12 essentials Applicable to all health care systems, Applies quality design consistent with ISO 9000 series

GP 26-A3 Application of Quality Management System Model for Laboratory Services

• Laboratory application document for quality system

• Describes path of workflow

• Assists lab in improving processes

• Relates to HS1-A

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ISO vs. CLSI

• Complimentary not conflicting roles

• ISO provides broad standard requirements

• CLSI provides detailed best practices, standards and practical guidance for implementation

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Quality System

Organizational structure, resources, processes and procedures needed to implement quality management (ISO, CLSI)

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Quality System Essentials

Set of coordinated activities that function as building blocks for quality management

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Application of a Quality System Approach Helps

• Ensure quality of overall process

• Detect and reduce errors,

• Improve consistency within and between laboratories

• Contain costs

• Ensure customer satisfaction

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Who Is Responsible for Quality in the Laboratory?

EVERYONE!EVERYONE!

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Key Messages

• Accurate, reliable and timely laboratory results are essential to all aspects of health care.

• The ISO 15189 standard is a valuable tool for development of effective quality management in a laboratory

• The CLSI guidelines are tied very closely to the ISO standards and are a way to “translate” ISO standards into laboratory language

• The rationale for applying a quality system approach is to ensure quality of overall process, detect and reduce errors, improve consistency within and between laboratories, contain costs, ensure customer satisfaction.

• Everyone in the laboratory is responsible for quality