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The Laboratory Quality Assurance System
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THE LABOMTORY QUALITY ASSURANCE SYSTEM Third Edition A Manual of Quality Procedures and Forms SYSTEM ELEMENTS / 1 Introduction / 1 Title Page / 1 Letter of Promulgation / 1 Quality Policies / 1 Quality Objectives / 2 Management of the Quality Manual / 2 Control of Quality Documentation and Records / 2 Customer Focus / 4 Quality System Planning / 4 Organization for Quality / 5 Communications / 6 Management Review / 6 Human Resources / 6 Laboratory Infrastructure / 8 Work Environment / 8 Quality in Procurement / 8 Sample Handling, Identification, Storage,and Shipping / 9 Chain-of-Custody Procedures / 10 Laboratory Testing and Control: IntraandInterlaboratory Proficiency Testing /11 Design and Development (Excluded) /14 Customer Property (Excluded) / 14 Control of Measuring and Test Equipment / 14 Preventive Maintenance / 17 Estimate of Uncertainty of Measurement / 18 Reference Standards and Standard Reference Materials / 18 Data Validation / 19 Measurement, Analysis, and Improvement of the Quality System / 20 Statistical Methods / 21 Subcontracting Services and Supplies /24 Quality Audits / 24 Nonconformity / 25 Customer Satisfaction and Complaints / 26 Corrective and Preventive Action / 27 Method Validation / 28 Reliability / 28 Quality Cost Reporting / 3 1 PART 2: HOW TO WRITE A LABORATORY QUALITY ASSURANCE MANUAL / 33 Introduction / 33 Organizing for Preparation of the Manual / 33 Establishing Objectives and Priorities /33 Collection and Review of Existing Procedures / 34 Preparation of a Flowchart / 34 Identification of Program Requirements / 36 Identification of Shortfalls and the Assignment of Priorities / 36 Writing the Manual / 36 PART 3: XYZ LABORATORY QUALITY ASSURANCE MANUAL / 37 PART 4: SAMPLE QUALITY ASSURANCE FORMS / 181[ Last edited by 1949stone on 2014-1-3 at 12:26 ] |
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