Introduction to Quality Management System .pdf
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This document provides an overview of quality management systems and ISO 15189 requirements for medical laboratories. It discusses key aspects of a quality management system including documentation requirements for policies, procedures, manuals, SOPs and forms. It outlines the 15 managerial clauses of ISO 15189 which focus on documentation and quality system development. These clauses cover topics like organization, document control, management reviews and audits. It also summarizes the 10 technical clauses related to operations, which include requirements for personnel management, equipment management, examination procedures and reporting of results. The goal of ISO 15189 is to help laboratories develop quality systems and assess their competence.
Introduction to Quality Management System .pdf
- 1. Introduction to Quality Management System (QMS)
- 2. Learning Objectives • What is Quality? • What is our Quality policy? • ISO standard? • Scope of Test • ISO Clauses • ISO Manuals
- 3. Quality • Doing the right thing right, the first time and every time. • A service which is free of deficiencies and meet customer needs • It is in visible when GOOD and impossible to ignore when it is BAD
- 4. Quality Policy • Chughtais Lahore Lab (CLL) serves to its customers with accurate, reliable and quality results in a timely manner.
- 5. ISO 15189:2012 • This International Standard is for use by medical laboratories in developing their quality management systems and assessing their own competence. • Laboratory customers, regulating authorities and accreditation bodies may also use it for confirming or recognizing the competence of medical laboratories.
- 6. What is the purpose of ISO 15189? • Primarily, it is for use by medical laboratories in developing their systems for managing quality and in assessing their competence. • Secondarily, it may be used by Accreditation Bodies in confirming or recognising the competence of medical laboratories.
- 7. Scope of Test • In Chemistry : Albumin, Cortisol • In Histopathology: Biopsy • In hematology: Hb • In PCR: Hep C quantitative
- 8. ISO 15189:2012 Clauses • Managerial Clauses ⮚Total 15 requirements ⮚Focus on “Documentation” • Technical Clauses ⮚Total 10 requirements ⮚Focus on “Operations”
- 9. Management Clauses • 4.1 to 4.15 • Documentation is the key.
- 10. Continued… • 4.1 Organization and management ⮚ Document of legal lab existence ⮚ Hierarchy Chart • 4.2 Quality Management System ⮚ The qualitymanagement system shall provide for the integrationof all processes required to fulfill its qualitypolicy and objective and meet the needs and requirements of the users.
- 11. 4.2 QMS • Policies • Procedures • Test methods/SOPs • Kits literatures • Forms and records • Scope of test • Quality policy • Quality system manual • Calibration of equipments and reagents
- 12. 4.3 Document Control • Procedures for document and control record • List of laboratory folder of documents, files • List of external documents
- 13. Level of Documentation Policies, Manuals, JDs Quality System Procedures SOPs, Work Instructions Forms, Tables
- 14. Policies • 7 Policies ⮚ Quality Policy ⮚ Complaint Resolution Policy ⮚ Sample Rejection Policy ⮚ Reporting of Result ⮚ Undue Pressure ⮚ Lab Access Policy ⮚ Selection of Personal
- 15. Procedures • 16 Procedures ⮚ Procedure for document and control ⮚ Procedure for personal management ⮚ Procedure for corrective and preventive action ⮚ Procedure for feedbacks and complaints ⮚ Procedure for evaluation and audits ⮚ Procedure for accommodation and environmental conditions ⮚ Procedure for non-conforming work ⮚ Procedure for lab equipment
- 16. ⮚ Procedure for management review ⮚ Procedure for uncertainty management ⮚ Procedure for ensuring quality of examination results ⮚ Procedure for establishment of service agreement ⮚ Procedure for external services and supplies ⮚ Procedure for release of results ⮚ Procedure for lab information system ⮚ Procedure for examination of referral lab
- 17. Management Clauses Continued… • 4.4 Establishment of services agreement • 4.5 Examination by referral laboratories • 4.6 External services and supplies • 4.7 Advisory service • 4.8 Resolution of complaint
- 18. • 4.9, 4.10, 4.11 Identification and control of Non-conformities,corrective and preventive action • 4.12 Continual improvement • 4.13 Control of record • 4.14 Evaluation and Audit • 4.15 Management review
- 19. Technical Clauses • 5.1 to 5.10 • 5.1 Personal Management ⮚ Policy for selection of personal ⮚ JDs ⮚ Training plan
- 20. 5.1 Personal Management Training Need Assessment Training Feedback form Training Completion Form Training Evaluation Training Sign in Sheet Training Plan Lab Authorization Permit
- 21. Technical Clauses • 5.2 Accommodation and Environmental condition ⮚ Lab access policy ⮚ QWI for cleaning of bench surfaces ⮚ Temperature monitoring forms • 5.3 Laboratory equipment ⮚ Procedures for lab equipments ⮚ QWI for equipments ⮚ Equipment log book, installation/validation/calibration record
- 22. Technical Clauses • 5.4 Pre-Examination procedures • 5.5 Examination Procedures • 5.6 Assuring Quality of Examination Procedure ⮚ Internal Quality Control ⮚ Intra Lab Comparison ⮚ External Quality Control
- 23. Technical Clauses • 5.7 Post Examination Procedures • 5.8, 5.9 Release of Results ⮚ Result reporting Policy ⮚ Critical Alerts and record • 5.10 Laboratory Information System
- 24. Manuals • 2 Manuals • 1. Quality Manual • 2. Occupational safety Manual ⮚SOP of Needle stick injury ⮚QWI’s of NSI • Primary and secondary sample collection Manual (Departmental)