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A prerequisite for a medical laboratory to become accredited is to have a documented quality management system. The usual contents of the quality manual follow the suggested format of the ISO 15189 standard. This is as follows:
1. Introduction:
a. Laboratory Background,
b. Purpose of Quality Manual,
c. Distribution List,
d. Scope of Quality Management System,
e. Terms and Definitions
2. Description of the Laboratory:
a. Legal Identity,
b. Resources,
c. Main Duties,
d. Laboratory Management
3. Quality Policy
4. Staff Education and Training
5. Quality Assurance
6. Document Control
7. Records, Maintenance, and Archiving
8. Accommodation and Environment
9. Instruments
10. Reagents and Consumable Management
11. Validation of Examination Procedures
12. Safety
13. Environmental Management:
a. Transportation,
b. Consumables,
c. Waste Disposal,
d. Equipment
14. Research and Development (if appropriate)
15. List of Examination Procedures
16. Pre-Examination
17. Validation of Results
18. Quality Control (including interlaboratory comparisons)
19. Remedial Actions and Handling of Complaints
20. Communications
21. Internal Audits
22. Laboratory Information System
23. Ethics
★ Corrective and Preventative Action (CAPA)
★ ISO 15189 Quality Manual Template
1. Introduction:
a. Laboratory Background,
b. Purpose of Quality Manual,
c. Distribution List,
d. Scope of Quality Management System,
e. Terms and Definitions
2. Description of the Laboratory:
a. Legal Identity,
b. Resources,
c. Main Duties,
d. Laboratory Management
3. Quality Policy
4. Staff Education and Training
5. Quality Assurance
6. Document Control
7. Records, Maintenance, and Archiving
8. Accommodation and Environment
9. Instruments
10. Reagents and Consumable Management
11. Validation of Examination Procedures
12. Safety
13. Environmental Management:
a. Transportation,
b. Consumables,
c. Waste Disposal,
d. Equipment
14. Research and Development (if appropriate)
15. List of Examination Procedures
16. Pre-Examination
17. Validation of Results
18. Quality Control (including interlaboratory comparisons)
19. Remedial Actions and Handling of Complaints
20. Communications
21. Internal Audits
22. Laboratory Information System
23. Ethics
| Contents |
| See also |
| External Links |
See also
★ Corrective and Preventative Action (CAPA)
External Links
★ ISO 15189 Quality Manual Template
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