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Analytical laboratory quality manual complies with Clinical Laboratory Improvement Amendments ( CLIA ), 42 CFR Part 493.
- Provider: Quality-Control-Plan
- Shipping: Available for download - Link will be provided in My ComplianceOnline section
Analytical laboratory quality manual complies with Clinical Laboratory Improvement Amendments (CLIA), 42 CFR Part 493.
- Responsibility for quality compliance begins with each analyst and ultimately resides with management.
- 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.
- The primary goal of the laboratory quality assurance system is accuracy, consistency, and defensibility of results.
- 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:
- QUALITY GOALS AND OBJECTIVES
- QUALITY POLICIES
- QUALITY PLANNING
- QUALITY IN PROCUREMENT
- CHAIN-OF-CUSTODY PROCEDURES
- ANALYTICAL QUALITY CONTROL
- DATA VALIDATION
- STATISTICAL METHODS
- QUALITY AUDITS
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