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Module BASICS OF THE QUALITY SYSTEM CONCEPT

Module BASICS OF THE QUALITY SYSTEM CONCEPT. Content 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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Module BASICS OF THE QUALITY SYSTEM CONCEPT

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  1. ModuleBASICS OF THE QUALITY SYSTEM CONCEPT

  2. Content 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

  3. Accurate, reliable and timely laboratory results are essential to all aspects of health care Importance of High Quality Laboratory Service

  4. Mission of Health Laboratory Services 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

  5. How Do We Achieve Excellent Performance in the Laboratory? • 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 Importance of Quality Systems

  6. 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)

  7. ISO 9000 Family • Guidance for quality in manufacturing and service industries • Has broad applicability, many kinds of organizations can use ISO 9001:2000, Quality management system – Requirements

  8. ISO 15189:2007, Medical laboratories - Particular requirements to quality and competence ISO Documents - Laboratory • Valuable compilation of statements to assist laboratory specialists in understanding and implementing quality management systems • Has become the international foundation for medical laboratory accreditation

  9. 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 ISO 15189:2007: Content Annexes

  10. National Committee for Clinical Laboratory Standards (NCCLS) in 2005 • 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.

  11. CLSI Quality Standards

  12. ISO vs. CLSI • Complimentary not conflicting roles • ISO provides broad standard requirements • CLSI provides detailed best practices, standards and practical guidance for implementation

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

  14. Quality System Essentials Set of coordinated activities that function as building blocks for quality management

  15. 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

  16. Who Is Responsible for Quality in the Laboratory? EVERYONE!

  17. 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

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