The documents that will comprise the quality manual will be inclusive of those discussed in Documentation of Quality Management: policies, processes, procedures, and forms.
A quality manual will be constructed of a policy, process, and procedure for each of the QSE's established for the laboratory. Appropriate personnel such as laboratory director, managers, and other supervisory personnel are typically the key team members in the establishment and compilation of a quality manual.
Various templates may be employed but the structure of specific documents is institution-specific. The components for each template will vary and be compliant so long as the document includes all data and information required by a specific compliance agency.
A policy document is a basic statement of intent.
Example: The laboratory will perform quality control testing as per manufacturer's instructions; federal, state, and local regulatory requirements; and accreditation agency requirements.
Process and procedure are most often stated in a single document. See the table summarizing the components of a CLSI procedure as per Clinical Laboratory Standards Institute. Some of the components for these documents will not apply to non-technical processes.
| Section | Description |
| Intended Use | Description statement of the process |
| Summary and Explanation | What the specific process is expected to accomplish and, if appropriate, an explanation of the purpose for performing the test method and technology of the specific test |
| Principle | A brief explanation of the steps involved in completing the process and what purpose each step serves. Brief description of the interpretation of test results, if appropriate. |
| Reagents and Material Supplied | All materials/reagents required to perform the process, if appropriate |
| Warnings and Precautions | Precautionary information for completing the process |
| Storage and Stability | Manufacturer requirements for storage to guarantee maximum stability, if appropriate |
| Quality Control | Quality control as per manufacturer and regulatory requirements for test methods |
| Test Procedure | Specific steps to be completed to complete the process |
| Interpretation of Results | Description of how to interpret the final outcome of the process when all of the specific procedural steps are complete |
| Expected Values | Description of the possible outcomes at the completion of the process |
| Performance Characteristics | Optional: Appropriate for test methodologies but not appropriate for some non-technical processes. How the process will perform when properly completed |
| References | Reference material that is applicable to the process |
Forms are for recording data and information. Forms take many formats and may be on paper or electronic. These forms may be created by staff within the laboratory, purchased, shared from other sources, or provided by commercial manufacturers.
Forms may be directly incorporated into the quality manual or may be stand-alone and stored separately.
The quality manual is reviewed periodically as required for compliance and revised as appropriate for current operations and to maintain compliance with all appropriate agencies. When documents are revised, the original document is retained in a location separate from the manual for a minimum period of time as required for compliance. Following the required storage time for document retention for compliance, the retired document may be retired.
All completed forms and additional records are retained as required for compliance in a specific location designated for document storage. All document storage may be on paper or electronic.
