–Incoporates changes to ANSI/ISO/ASQ 9001–2000 pertaining to laboratories.
–Provides blank forms used in preparing a quality manual.
–Provides information on the interrelationship of ANSI/ISO 17025:1999 and ANSI/ISO/ASQ 9001–2000.
PART 1: LABORATORY QUALITY SYSTEM ELEMENTS.
Letter of Promulgation.
Management of the Quality Manual.
Control of Quality Documentation and Records.
Quality System Planning.
Organization for Quality.
Quality in Procurement.
Sample Handling, Identification, Storage, and Shipping.
Laboratory Testing and Control: Intra–and Interlaboratory Proficiency Testing.
Design and Development (Excluded).
Customer Property (Excluded).
Control of Measuring and Test Equipment.
Estimate of Uncertainty of Measurement.
Reference Standards and Standard Reference Materials.
Measurement, Analysis, and Improvement of the Quality System.
Subcontracting Services and Supplies.
Customer Satisfaction and Complaints.
Corrective and Preventive Action.
Quality Cost Reporting.
PART 2: HOW TO WRITE A LABORATORY QUALITY ASSURANCE MANUAL.
Organizing for Preparation of the Manual.
Establishing Objectives and Priorities.
Collection and Review of Existing Procedures.
Preparation of a Flowchart.
Identification of Program Requirements.
Identification of Shortfalls and the Assignment of Priorities.
Writing the Manual.
PART 3: XYZ LABORATORY QUALITY ASSURANCE MANUAL.
PART 4: SAMPLE QUALITY ASSURANCE FORMS.
Tom Ratilff has been a consultant in the field of Quality Control since 1970. He has taught the course "Industrial Hygiene Laboratory Quality Control" since 1973 for the Mine Safety and Health Administration, and the National Institute for Occupational Safety and Health. He is a Fellow, American Society for Quality, Biomedical, Service Industry & Health Divisions of the American Society of Quality Control.