1st Edition

Laboratory Auditing for Quality and Regulatory Compliance

    496 Pages
    by CRC Press

    496 Pages 9 B/W Illustrations
    by CRC Press

    Identifying current tools, techniques, and approaches for the evaluation of laboratory operations, this reference reviews the latest regulatory standards and auditing practices to test laboratory safety, quality, and performance.

    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 Nonclinical Laboratory Studies. Bibliography


    Singer, Donald C.; Stefan, Raluca-Ioana; van Staden, Jacobus F.