The Laboratory Quality Assurance System – A Manual of Quality Procedures and Forms 3e
A Manual of Quality Procedures and Forms
Paperback Engels 2003 3e druk 9780471269182Samenvatting
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.
Specificaties
Lezersrecensies
Inhoudsopgave
<p>PART 1: LABORATORY QUALITY SYSTEM ELEMENTS.</p>
<p>Introduction.</p>
<p>Title Page.</p>
<p>Letter of Promulgation.</p>
<p>Quality Policies.</p>
<p>Quality Objectives.</p>
<p>Management of the Quality Manual.</p>
<p>Control of Quality Documentation and Records.</p>
<p>Customer Focus.</p>
<p>Quality System Planning.</p>
<p>Organization for Quality.</p>
<p>Communications.</p>
<p>Management Review.</p>
<p>Human Resources.</p>
<p>Laboratory Infrastructure.</p>
<p>Work Environment.</p>
<p>Quality in Procurement.</p>
<p>Sample Handling, Identification, Storage, and Shipping.</p>
<p>Chain–of–Custody Procedures.</p>
<p>Laboratory Testing and Control: Intra–and Interlaboratory Proficiency Testing.</p>
<p>Design and Development (Excluded).</p>
<p>Customer Property (Excluded).</p>
<p>Control of Measuring and Test Equipment.</p>
<p>Preventive Maintenance.</p>
<p>Estimate of Uncertainty of Measurement.</p>
<p>Reference Standards and Standard Reference Materials.</p>
<p>Data Validation.</p>
<p>Measurement, Analysis, and Improvement of the Quality System.</p>
<p>Statistical Methods. </p>
<p>Subcontracting Services and Supplies.</p>
<p>Quality Audits.</p>
<p>Nonconformity.</p>
<p>Customer Satisfaction and Complaints.</p>
<p>Corrective and Preventive Action.</p>
<p>Method Validation.</p>
<p>Reliability.</p>
<p>Quality Cost Reporting.</p>
<p>PART 2: HOW TO WRITE A LABORATORY QUALITY ASSURANCE MANUAL.</p>
<p>Introduction.</p>
<p>Organizing for Preparation of the Manual.</p>
<p>Establishing Objectives and Priorities.</p>
<p>Collection and Review of Existing Procedures.</p>
<p>Preparation of a Flowchart.</p>
<p>Identification of Program Requirements.</p>
<p>Identification of Shortfalls and the Assignment of Priorities.</p>
<p>Writing the Manual.</p>
<p>PART 3: XYZ LABORATORY QUALITY ASSURANCE MANUAL.</p>
<p>PART 4: SAMPLE QUALITY ASSURANCE FORMS.</p>
<p>Index.</p>
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