QUALITY MANAGEMENT SYSTEMS STANDARDS IN HEALTH LABORATORIES Edwin Kibet The Aga Khan University Hospital, Nairobi

OBJECTIVES To review the laboratory quality management systems To explain the role of standards in quality management systems To review requirements from different accreditation agencies based on 12 QSEs

QUALITY DEFINITION: ISO 8406 The totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs

QUALITY SYSTEMS MANAGEMENT QUALITY POLICY = ROAD MAP QUALITY MANAGEMENT = DRIVER QUALITY SYSTEM = VEHICLE QUALITY MANAGEMENT SYSTEM = DRIVING

QUALITY MANAGEMENT SYSTEMS TQM Accreditation CAP- KEMRI/WRP Kericho ISO 15189:2007- KEMRI/CDC, The Aga Khan Hospital and Pathcare COLA CPA JCIA or JCAHO- The Aga Khan Hospital GCLP- KEMRI/Welcome Trust Kilifi 17025:2005- Lancet

QUALITY MANAGEMENT SYSTEM Continual improvement of the Quality management system Management responsibility Customers Customers Measurement, analysis and improvement Resource management Satisfaction Requirements The ISO 9001:2000 Requirements: Scope General Application Normative reference Terms and definitions Quality management system General requirements Documentation requirements Quality manual Control of documents Control of records Management responsibility Management commitment Customer focus Quality policy Planning Quality objectives Quality management system planning Output Input Product realization Product Information flow Value-adding activities Reference: ISO 9001:2008

PRINCIPLES OF QMS The Short Version: Writing down what you do. Doing what you write down. Provide visible evidence that you are doing what you wrote down (quality records). Identify errors in the process and opportunities to improve process. Use a preventive action method to identify additional essential processes.

QUALITY MANAGEMENT SYSTEM General requirements Processes, interaction, improvement The focus is on looking at: What we do. Who we are doing it for. Improving how we provide service.

QUALITY SYSTEM ESSENTIALS NCCLS document: A Quality System Model for Health Care (GP26-A2) Model uses 12 essentials, based on the 20 quality system elements in ISO 9001 Simplifies, uses language more familiar to laboratories

METHOLOGY Reviewed existing common QMS Identified requirements Classified required QMS in accordance with 12 QSEs-Looked at the most appropriate QSE for a QMS requirement Tabulated QMS requirements with the most appropriate QSE

ORGANIZATION STANDARD REQUIREMENTS Quality Management CAP Quality Management ISO 15189:2007 Organization and management/QMS ISO 17025:2005 JCIA Management and Leadership GCLP Organization and Personnel CPA Organization and QMS COLA Organization

PROCESS CONTROL STANDARD REQUIREMENTS CAP Quality Control /Test Method Validation ISO 15189:2007 Examination/ Assuring Quality of Examination Procedures 17025:2005 Test and Calibration Methods / Method validation JCIA Quality Control Processes GCLP Conduct of the Work/Quality Control CPA Examination Process COLA Analytic - General Requirements/Maintenance

PERSONNEL STANDARD REQUIREMENTS CAP Quality Management. Other Different Clauses* ISO 15189:2007 Personnel ISO 17025:2005 JCIA Resource Management and Laboratory Environment (RSM) GCLP Organization and Personnel CPA COLA

EQUIPMENT STANDARD REQUIREMENTS CAP Laboratory Computer Services and Test Method Validation ISO 15189:2007 Laboratory equipment ISO 17025:2005 Equipment JCIA Resource Management and Laboratory Environment (RSM) GCLP Equipment, Materials and Reagents CPA Equipment, Information System and Materials COLA Facility and other Clauses*

DOCUMENTS AND RECORDS STANDARD REQUIREMENTS CAP Quality Management and other clauses* ISO 15189:2007 Document Control/Quality and technical records ISO 17025:2005 Document Control/Control of Records/Technical Records JCIA Development and Control of Policies and Procedures (DCP) GCLP Equipment, Materials and Reagents CPA Organization and Quality Management System/Other Clauses* COLA Appropriate Clauses*

ASSESSMENTS CAP Quality Management and other clauses* ISO 15189:2007 STANDARD REQUIREMENTS CAP Quality Management and other clauses* ISO 15189:2007 Internal audits ISO 17025:2005 JCIA Management and Leadership GCLP Quality Audit CPA Organization and Quality Management System COLA Organization

FACILITIES AND SAFETY CAP Physical Facilities/ Laboratory Safety STANDARD REQUIREMENTS CAP Physical Facilities/ Laboratory Safety ISO 15189:2007 Accommodation and Environmental Conditions ISO 17025:2005 JCIA Resource Management and Laboratory Environment (RSM) GCLP Facilities CPA Premises and Environment COLA Facility

INFORMATION MANAGEMENT STANDARD REQUIREMENTS CAP Laboratory Computer Services and Other Clauses* ISO 15189:2007 Laboratory information systems (LIS) ISO 17025:2005 Technical Records and other clauses* JCIA Resource Management and Laboratory Environment (RSM) GCLP Conduct of the Work CPA Organization and QMS/Other Clauses* COLA Laboratory Information systems and Other Clauses*

PURCHASING AND INVENTORY STANDARD REQUIREMENTS CAP Physical Facilities ISO 15189:2007 External Services and Supplies ISO 17025:2005 Purchasing Services and Supplies JCIA Resource Management and Laboratory Environment (RSM) GCLP Equipment, Materials and Reagents CPA Equipment, Information System and Reagents COLA Facility and Other Clauses*

CUSTOMER SATISFACTION AND SERVICE STANDARD REQUIREMENTS CAP Quality Management ISO 15189:2007 Resolution of Complaints and Review of Contracts ISO 17025:2005 Service to the Customer, Complaints and Review Contracts JCIA Management and Leadership GCLP Planning of Work and Reporting of results CPA Evaluation and Quality Assurance COLA General assessment and Other Clauses*

PROCESS IMPROVEMENT STANDARD REQUIREMENTS CAP Quality Management ISO 15189:2007 Continual improvement ISO 17025:2005 Improvement JCIA Management and Leadership (MGT) GCLP Organization and Personnel CPA Evaluation and Quality Assurance COLA Quality Assessment

OCCURRENCE MANAGEMENT STANDARD REQUIREMENTS CAP Quality Management ISO 15189:2007 Control of Nonconforming Testing and CAPA ISO 17025:2005 Control of Nonconforming Testing and/or Calibration Work and CAPA JCIA Management and Leadership (MGT) GCLP Organization and Personnel CPA Evaluation and Quality Assurance COLA Quality Assessment

TQM AND THE 12 QSEs

EXAMPLE: ISO 15189:2007 NC BASED ON 12 QSEs

PERCENTAGE ACHIEVEMENT BASED ON 12 QSES.

Professionalism means consistency of quality. CONCLUSION Professionalism means consistency of quality. Frank Tyger