Quality manual template

Overview

The quality manual template is a supplement to the laboratory quality management system training toolkit, Module 16 - Documents and records.

This quality manual template is based on internationally-accepted standards, and provides guidance for public health and clinical laboratories on writing policies and procedures that support a quality management system. It comprises a main document providing information and examples to assist with writing a laboratory quality manual, and 24 appendices (examples of standard operating procedures, forms, and processes). All documents are in Word format because they are meant to serve as templates and are thus modifiable. The individual laboratories are required to customize the text of the template to the local situation.

Quality manual template

Appendices:

• 1. Meeting management
• 2. Safe manipulation
• 3. Equipment installation process
• 4. Equipment repair process
• 5. Decontamination of laboratory equipment
• 6. Equipment decommission
• 7. General sampling conditions
• 8. Sample labelling
• 9. Sample rejection or acceptance
• 10. Sample transport
• 11. Results validation
• 12. Critical results reporting
• 13. Internal audit
• 14. Orientation checklist form
• 15. Internal training
• 16. Competency assessment
• 17. Customer survey
• 18. Customer complaint
• 19. Nonconforming event management
• 20. Internal documents management
• 21. SOP management
• 22. Document management
• 23. Short term archiving
• 24. Document control