Laboratory Auditing for Quality and Regulatory Compliance reviews the latest regulatory standards and auditing practices to test laboratory safety, quality, and performance.

Features:

• Assists in the assessment of laboratory procedures in preparation for an external auditor
• Reflects the impact of computers and information technologies on data generation, analysis, and storage
• Offers a global perspective on laboratory management and quality control
• Serves as a comprehensive guide to the design of an effective audit for enhanced laboratory operation

Contents

• 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

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 Nonclinical Laboratory Studies

Index

click here to see books • videos • cd-roms of related interest