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The ISO 15189 Quality Manual Template allows medical laboratories to document their Quality Management System with confidence and speed.
Reduce the work! Get your documentation right the first time!
What you get:
1. Electronic templates to create your Quality Manual and Quality Management System SOPs (MS Word files with interactive macros).
2. A User's Guide explaining each step in customizing the electronic templates.
3. 9 standard operating procedures for the quality management system.
Download Sample if you would like to review the sample selection from the ISO 15189 Quality Manual Template.
No other template on the market like this one. See the Table of Contents below:
Table of Contents:
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
Standard Operating Procedures:
Control of nonconformances
Corrective actions
Preventive actions
Contract review
Document control
Control of records
Purchasing
Complaints
Internal quality audit