|
This broadly based, single source volume provides guidance for the quality auditing of a chemical
or biological testing laboratory. It will help the reader develop or improve quality control and
quality assurance programs in order to meet certification standards or pass external-source audits. The
six appendices, which comprise the bulk of the book, offer valuable specific information on a variety
of regulations, standard practices, and the like.
From the Preface: “...A laboratory can exist for the purpose of analyzing samples and nothing
more. Or, a laboratory can be a site of investigation, creativity and development, achievement, training
and education, as well as a trusted analytical testing site. A combined effort by management,
employees, and customers is necessary to ensure that the product is of the highest quality. Indeed, a
laboratory must meet the expectations of each customer in order to assure continued existence...”
Target Audience: Laboratory managers and administrators responsible for quality control and
quality assurance in the health care field and at analytical and microbiological testing facilities;
laboratory quality auditors; and upper-level students in these disciplines.
Table of Contents:
The Need for Quality Control and Quality Assurance in a Laboratory
The Regulated Industries
Goals of a Laboratory Quality Audit
Working Knowledge and Audit Documents
Parameters for Evaluation
Laboratory Instrumentation: Calibration and Preventative Maintenance
Closing Conference, Final Report, and Follow-Up
Frequency of Audit
Epilog
Appendices:
Comparison of Domestic Laboratory Standards (FDA, EPA, and HCFA)
Sample Laboratory Quality Audit Document
The OECD Principles of Good Laboratory Practice
State of Illinois Rules and Regulations: EPA Rules for Environmental Laboratories
Federal Register (FDA): Good Laboratory Practice Regulations for Nonclinical Laboratory Studies
Proposed Revision of the Clinical Laboratory Regulations for Medicare, Medicaid, and Clinical
Laboratories Improvement Act of 1967 (HCFA)
Bibliography
Index
|
