Laboratory Auditing for Quality and Regulatory Compliance

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Introduction
Quality and Auditing.
Quality Control and Quality Assurance in a Laboratory
The Regulated Industries
Goals of a Laboratory Quality Audit
Audit Tools : Observation, Working Knowledge and Audit Documents
Non-Technical Parameters for Evaluation
Quality Programs, Organizational Structure and Documentation
Personnel
Facility and Environment
Technical Parameters for Evaluation
Sample Control
Instrumentation
Automation of Analytical Process
Acquisition and Processing of Data
Uncertainty of Measurements
Reliability of Measurements
Standards and Standardisation
Supplies Organization
Proficiency Testing
Other Areas to Consider
Customer Satisfaction
Laboratory Health and Safety
Communications and Follow-Up
Closing Conference, Final Report, and Follow-Up
Frequency of Audit
Epiloge
Appendices
Sample Laboratory Quality Audit Document
National Voluntary Laboratory Accreditation Program, NIST Handbook 150 Guide To Quality In Analytical Chemistry (Eurachem/CITAC)
Quality Assurance of Research and Development and Non-routine Analysis (Eurachem/ CITAC)
Accreditation for Microbiological Laboratories (Eurachem/EA)
EPA Manual for Certification of Laboratories Analyzing Drinking Water
Federal Register (FDA): Good Laboratory Practice Regulations for tNonclinical Laboratory Studies
Bibliography
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