Laboratory Auditing For Quality And Regulatory Compliance

Download or read book Laboratory Auditing for Quality and Regulatory Compliance written by Donald C Singer and published by CRC Press. This book was released on 2019-08-30 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Laboratory Auditing for Quality and Regulatory Compliance written by Donald C. Singer and published by CRC Press. This book was released on 2005-07-25 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Guidelines for Laboratory Quality Auditing written by Singer and published by CRC Press. This book was released on 1992-11-23 with total page 434 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Implementing Quality in Laboratory Policies and Processes written by Donnell R. Christian, Jr. and published by CRC Press. This book was released on 2009-11-24 with total page 1434 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 Labora

Download or read book The Regulatory Compliance Almanac written by Les Schnoll and published by Paton Professional. This book was released on 2008 with total page 564 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Laboratory Quality Management System written by World Health Organization and published by . This book was released on 2011 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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".

Download or read book A Laboratory Quality Handbook of Best Practices written by Donald C. Singer and published by Quality Press. This book was released on 2001-09-25 with total page 401 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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