Implementing Quality in Laboratory Policies and Processes (inbunden)
Inbunden (Hardback)
Antal sidor
CRC Press Inc
Houck, Max M. (series ed.)
6; 275 Tables, black and white; 31 Illustrations, black and white
254 x 180 x 69 mm
2633 g
Antal komponenter
Implementing Quality in Laboratory Policies and Processes (inbunden)

Implementing Quality in Laboratory Policies and Processes

Using Templates, Project Management, and Six Sigma

Inbunden Engelska, 2009-11-20
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In order to gain accreditation, every laboratory must have a superior quality assurance program. The keys to a successful program are the operational and technical manuals and associated documents which define the program and its various components. Written by experts with global experience in setting up laboratories, Implementing Quality in Laboratory Policies and Processes: Using Templates, Project Management, and Six Sigma provides templates for the various policies, procedures, and forms that should be contained in the quality assurance, operational, and technical manuals of a laboratory seeking accreditation. Templates for the entire project life cycle The book begins with a general introduction and overview of quality assurance and then moves on to cover implementation strategies. It contains best practices and templates for the project management of the design and implementation of the laboratory operational and technical manuals required to establish a quality assurance program. The templates span the entire project life cycle, from initiation, to planning, to execution, to monitoring, and finally, to closure. The book also examines how Six Sigma concepts can be used to optimize laboratories, and contains templates that cover administrative issues, quality assurance, sample control, and health and safety issues. In addition, there is a section of criteria files that relate the individual document templates to specific accreditation criterion. Addresses the standards of ISO 17025 The results of any laboratory examination have the potential to be presented in court and can ultimately affect the life and liberty of the parties involved. Therefore, a stringent quality assurance program, including well-documented policies and a procedure manual, is essential. Ensuring that laboratories meet the standards of ISO 17025, this volume is a critical component of any laboratory's accreditation process.
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...The authors do deserve applause for preventing repetitions, which are the norm, rather than exceptions, in books of this kind ... it is an important book which describes how quality has to be managed in any laboratory... -Puneet Setia and Avneesh Gupta, in Anil Aggrawal's Internet Journal of Forensic Medicine and Toxicology, Volume 11, Number 2, July - December 2010

Övrig information

Professional Business Solutions, O'Fallon, Missouri, USA Professional Business Solutions, O'Fallon, Missouri, USA


Section I: Establishing the Need Introduction What Manuals? Application A Manual by Any Other Name Manual Categories Manual Components Overview of Quality Assurance What Is Quality Assurance Quality Assurance Program Components Responsibilities Quality Assurance Benefits Quality Assurance Cost Cost of NO Quality Assurance Quality Control Quality Assurance Documentation Summary Section II: Implementation Strategies Project Management Overview What Is Project Management? What Is a Project? What Are the Phases of a Project? Project Initiation Project Planning Project Execution Project Monitoring and Control Project Closure Overview of Six Sigma Overview Six Sigma Foundation-DMAIC Define Measure Analyze Improve Control Conclusion Outsourcing Quality Assurance Programs Introduction Services Benefits Conclusion Section III: Policy Manual Development Content and Format Manual Types Manual Categories Manual Components Content Format Operational Manuals Definitions Administrative Manual Quality Manual Health and Safety Manual Sample Control Manual Technical Methods Manuals Training Manuals (TM) Analytical Procedures Quality Assurance Procedures Documentation Requirements Inventories Criteria Files Section IV: Appendices Definitions Administrative Policy Document Templates Administrative Policy Manual Template Quality Policy Document Templates Quality Policy Manual Template Safety Policy Document Templates Safety Manual Template Sample Control Document Templates Sample Control Manual Template Technical Manual Template ISO 17025 Criteria File ASCLD/LAB (Legacy) Criteria File Policy/Procedure Association Templates Project Management Templates Index