Guidelines for Laboratory Quality Auditing PDF Download

Author: Singer
Publisher: CRC Press
ISBN: 1498710522
Category : Technology & Engineering
Languages : en
Pages : 432

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Book Description
This single-source reference provides practical guidance for the quality auditing of a chemical or biological testing laboratory-helping to develop or improve quality control and quality assurance programs in order to meet certification standards or pass external-source audits.

Author: Donald C. Singer
Publisher: Asq Press
ISBN: 9780873891738
Category : Business & Economics
Languages : en
Pages : 411

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Book Description
P This single-source reference provides practical guidance for the quality auditing of a chemical or biological testing laboratory-helping to develop or improve quality control and quality assurance programs in order to meet certification standards or pass external-source audits. /P

Author: Donald C. Singer
Publisher: Quality Press
ISBN: 0873891090
Category : Business & Economics
Languages : en
Pages : 401

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Book Description
Based on the work of a collection of experts from the laboratory science and quality assurance fields, A Laboratory Quality Handbook of Best Practices and Relevant Regulations provides all of the information needed to run a successful laboratory that is in compliance with all regulations. From sample tracking to accurate documentation, training to methods validation, maintenance to calibration, and out-of-spec responses to preparation for audits, a combination of people, instrumentation and documentation must work in sync for high quality results. This handbook provides information that will help a laboratory achieve high quality results and compliance. Contents: Quality Assurance in the Laboratory, History of Regulation, Training in the Laboratory, Laboratory Documentation and Data, Sample Control and LIM Systems, Methods Validation

Author: World Health Organization
Publisher:
ISBN: 9789241548274
Category : Laboratories
Languages : en
Pages : 0

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Book Description
Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. Countries worldwide committed themselves to build national capacities for the detection of, and response to, public health events of international concern when they decided to engage in the International Health Regulations implementation process. Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency. This handbook was developed through collaboration between the WHO Lyon Office for National Epidemic Preparedness and Response, the United States of America Centers for Disease Control and Prevention (CDC) Division of Laboratory Systems, and the Clinical and Laboratory Standards Institute (CLSI). It is based on training sessions and modules provided by the CDC and WHO in more than 25 countries, and on guidelines for implementation of ISO 15189 in diagnostic laboratories, developed by CLSI. This handbook is intended to provide a comprehensive reference on Laboratory Quality Management System for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents. Each topic is discussed in a separate chapter. The chapters follow the framework developed by CLSI and are organized as the "12 Quality System Essentials".

Author: Donald C Singer
Publisher: CRC Press
ISBN: 9780367392468
Category :
Languages : en
Pages : 496

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Book Description
Identifying current tools, techniques, and approaches for the evaluation of laboratory operations, this reference reviews the latest regulatory standards and auditing practices to test laboratory safety, quality, and performance.

Author: Saverio Mannino
Publisher: Springer Nature
ISBN: 3031117247
Category : Technology & Engineering
Languages : en
Pages : 170

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Book Description
This useful and extensive set of guidelines is designed to assist food control laboratories in gaining accreditation from an internationally recognized external body, providing all of the necessary information and practices in an easy-to-read, step-by-step fashion. Authored by an experienced consultant for laboratory accreditation in many different countries, with this text food control lab owners now have all of the up-to-date information they need to gain accreditation in a single source. Guidelines for Laboratory Quality Managers covers the essentials for quality management in the food control laboratory, from testing processes to current quality management systems. The ISO standards for accreditation are extensively explored, including managerial requirements, organizational aspects, complaint handling procedures, internal audits, and sampling. An entire section is dedicated to the implementation of managerial and technical requirements from quality control to program monitoring and evaluation. Analysis selection, preparation, and validation is covered extensively, and an entire section is dedicated to basic statistics from data presentation to distribution. Each section comes with helpful tips for lab managers plus definitions and terms. Comprehensive, easy-to-use and up-to-date, Guidelines for Laboratory Quality Managers is the guide for accreditation for food control laboratories.

Author: Thomas A. Ratliff
Publisher: John Wiley & Sons
ISBN: 0471721662
Category : Technology & Engineering
Languages : en
Pages : 246

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Book Description
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.

Author: David M. Bliesner
Publisher: John Wiley & Sons
ISBN: 047178477X
Category : Science
Languages : en
Pages : 295

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Book Description
The first systematic, hands-on auditing guide for today's pharmaceutical laboratories In today's litigious environment, pharmaceutical laboratories are subject to ever stricter operational guidelines as mandated by the FDA, and must be able to establish and demonstrate sustainable operational practices that ensure compliance with the current good manufacturing practice (CGMP) regulations. David Bliesner's Establishing a CGMP Laboratory Audit System: A Practical Guide is designed to provide laboratory supervisors and personnel with a step-by-step, hands-on audit system that they can rely on to ensure their facility remains compliant with all current and future requirements. Focusing on a "team approach," the author uses detailed flowcharts, checklists, and descriptions of the auditing process to help readers develop a new audit system or upgrade their current system in order to: * Improve current compliance * Demonstrate sustainable compliance * Produce data for federal inspections * Avoid regulatory action Enhanced with detailed checklists and a wealth of practical and flexible auditing tools on CD-ROM, this book provides an ideal resource for new and future laboratory personnel, and an excellent means for keeping existing industry practitioners up to date on the nuances of operating a consistently compliant pharmaceutical laboratory.

Author: Peter Bedson
Publisher: Royal Society of Chemistry
ISBN: 1847559409
Category : Science
Languages : en
Pages : 420

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Book Description
Trace Analysis is a highly practical book which deals with the science rather than the paperwork of quality assurance systems. Produced as part of the UK Valid Analytical Measurement (VAM) initiative, it provides the analyst with a systematic approach across the broad spectrum of trace analysis, offering practical advice and guidance on methodology and techniques. The book is structured to take the analyst step-by-step through the stages of any trace analysis. The approach is general, being broken down only into types of analyte. Additional chapters explain the application of groups of techniques to each analyte type. Each section contains references to published material which will allow the analyst to obtain further information on specific topics. Throughout the book, the analyst is reminded of pitfalls which lead to unreliable results. This new book therefore offers invaluable advice to analysts in all areas and at all levels, providing practical 'expert' advice on methodology. It will prove indispensable as a single, comprehensive bench guide for analysts in university, college and industrial laboratories.

Author: Saverio Mannino
Publisher:
ISBN: 9783031117251
Category :
Languages : en
Pages : 0

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Book Description
This useful and extensive set of guidelines is designed to assist food control laboratories in gainingaccreditation from an internationally recognized external body, providing all of the necessary information and practices in an easy-to-read, step-by-step fashion. Authored by an experienced consultant for laboratory accreditation in many different countries, with this text food control lab owners now have all of the up-to-date information they need to gain accreditation in a single source. Guidelines for Laboratory Quality Managers covers the essentials for quality management in the food control laboratory, from testing processes to current quality management systems. The ISO standards for accreditation are extensively explored, including managerial requirements,organizational aspects, complaint handling procedures, internal audits, and sampling. An entire section is dedicated to the implementation of managerial and technical requirements from quality control to program monitoring and evaluation. Analysis selection, preparation, and validation is covered extensively, and an entire section is dedicated to basic statistics from data presentation todistribution. Each section comes with helpful tips for lab managers plus definitions and terms. Comprehensive, easy-to-use and up-to-date, Guidelines for Laboratory Quality Managers isthe guide for accreditation for food control laboratories. .