Module
BASICS OF THE QUALITY
SYSTEM CONCEPT
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Content Overview
• Understanding importance of high quality
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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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Importance
of High Quality Laboratory Service
Accurate, reliable and timely
laboratory results are essential to all
aspects of health care
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Mission of Health Laboratory Services
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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
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How Do We Achieve Excellent
Performance in the Laboratory?
Importance of Quality Systems
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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
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1947
Worldwide federation of national standards
bodies
Develops voluntary consensus standards (and
other types of document)
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ISO 9000 Family
• Guidance for quality in manufacturing and
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service industries
Has broad applicability, many kinds of
organizations can use
ISO 9001:2000, Quality management system –
Requirements
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ISO Documents - Laboratory
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
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ISO 15189:2007: Content
Management Requirement
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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
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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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National Committee
for Clinical
Laboratory
Standards (NCCLS)
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A committed forum for laboratory improvement
through consensus, guidelines, and
standardization.
International in scope and participation
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in 2005
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World Health Organization Collaborating Centre
Secretariat – ISO Technical Committee 212
Ten area committees addressing the full range
of laboratory activities.
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CLSI Quality Standards
Guideline No.
Title
HS1-A2
A Quality Management System Model for
Health Care
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GP 26-A3
Describes quality system model, 12 essentials
Applicable to all health care systems,
Applies quality design consistent with ISO 9000 series
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
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laboratories
Contain costs
Ensure customer satisfaction
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Who Is Responsible
for Quality in the Laboratory?
EVERYONE!
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Key Messages
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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
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