The Laboratory Quality Assurance System

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.

Both the 17025:1999 standard and especially ANSI/ISO/ASQ,9001-2000 standard require that a laboratory document its procedures for obtaining reliable results. The Laboratory Quality Assurance Manual details to the user how to a prepare a new laboratory quality assurance manual, which will be appropriate to use as a procedures manual for a particular laboratory, a sales tool to attract potential customers, a document that can be to answer regulatory questions, and ultimately a tool to become a registered ISO 9001/2000 Lab and gain related certifications based on the standard. The Laboratory Quality Assurance Manual:
 
-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.

Preface.
 
PART 1: LABORATORY QUALITY SYSTEM ELEMENTS.
 
Introduction.
 
Title Page.
 
Letter of Promulgation.
 
Quality Policies.
 
Quality Objectives.
 
Management of the Quality Manual.
 
Control of Quality Documentation and Records.
 
Customer Focus.
 
Quality System Planning.
 
Organization for Quality.
 
Communications.
 
Management Review.
 
Human Resources.
 
Laboratory Infrastructure.
 
Work Environment.
 
Quality in Procurement.
 
Sample Handling, Identification, Storage, and Shipping.
 
Chain-of-Custody Procedures.
 
Laboratory Testing and Control: Intra-and Interlaboratory Proficiency Testing.
 
Design and Development (Excluded).
 
Customer Property (Excluded).
 
Control of Measuring and Test Equipment.
 
Preventive Maintenance.
 
Estimate of Uncertainty of Measurement.
 
Reference Standards and Standard Reference Materials.
 
Data Validation.
 
Measurement, Analysis, and Improvement of the Quality System.
 
Statistical Methods.
 
Subcontracting Services and Supplies.
 
Quality Audits.
 
Nonconformity.
 
Customer Satisfaction and Complaints.
 
Corrective and Preventive Action.
 
Method Validation.
 
Reliability.
 
Quality Cost Reporting.
 
PART 2: HOW TO WRITE A LABORATORY QUALITY ASSURANCE MANUAL.
 
Introduction.
 
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.
 
Index.

Lieferung vom Verlag mit leichten Qualitätsmängeln möglich