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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