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1949stone

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[资源] The Laboratory Quality Assurance System

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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很实用,一直在找这样的指导性的文件来整顿实验室,感谢分享!
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