Laboratory Manual

Analytical laboratory quality manual complies with Clinical Laboratory Improvement Amendments (CLIA), 42 CFR Part 493.

1. Responsibility for quality compliance begins with each analyst and ultimately resides with management.
2. This document is intended for use by employees and Customers of (Your Co) to provide a working knowledge of Policies and Standard Operating Procedures (SOP's) used to control the quality of work performed in the laboratory.
3. The primary goal of the laboratory quality assurance system is accuracy, consistency, and defensibility of results.
4. Analytical methods performed by the laboratory shall be documented in Standard Operating Procedures (SOP) , which will be synonymous with (Your Co) Laboratory Procedures (LP).

It Provides information on:

1. QUALITY GOALS AND OBJECTIVES
2. QUALITY POLICIES
3. QUALITY PLANNING
4. QUALITY IN PROCUREMENT
5. CHAIN-OF-CUSTODY PROCEDURES
6. ANALYTICAL QUALITY CONTROL
7. DATA VALIDATION
8. STATISTICAL METHODS
9. NONCONFORMITY
10. QUALITY AUDITS