B.PHARMACY (VI SEM)

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)