The Laboratory Quality Assurance System

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.