Quality Manual and Quality Procedures for ANSI/Iso/iec 17025 PDF Download

Author: Michael E. Deen
Publisher: CreateSpace
ISBN: 9781450552899
Category : Business & Economics
Languages : en
Pages : 88

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Book Description
The Laboratory quality management system is based on the requirements of ISO/IEC 17025:2005 and performs all testing and calibration activities in a manner to meet the requirements of that international standard. Content is intended as an example of a quality manual format and associated quality procedures that may be used as assistance in the achievement of accreditation to the international quality standard ANSI/ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories.

Author: National Conference of Standards Laboratories, Inc.
Publisher:
ISBN: 9781584640356
Category :
Languages : en
Pages :

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Author: Bhavan "Bob" Mehta
Publisher: Quality Press
ISBN: 0873898540
Category : Science
Languages : en
Pages : 225

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Book Description
The purpose of this book is to demystify the requirements delineated within ISO/IEC 17025:2005 while providing a road map for organizations that wish to receive/maintain accreditation for their laboratories. AS9100, ISO 9001, and ISO 13485 are standards that support the development and implementation of effective approaches to quality management and are recognized blueprints for the establishment of a quality management system (QMS) for diverse industries. Although similar to these recognized QMS standards, ISO/IEC 17025 serves a unique purpose: laboratory accreditation. It is not unusual for laboratories to retain dual certification to ISO 9001 and ISO/IEC 17025.

Author: Jay L. Bucher
Publisher: Quality Press
ISBN: 9780873897044
Category : Business & Economics
Languages : en
Pages : 216

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Book Description
If a business expects to be a player in their market segment, their product(s) must have the quality expected by their customers. This can only be accomplished with test equipment that produces repeatable, accurate, and traceable measurements and/or outputs. Without a quality calibration system in place, this cannot and will not happen. This book is about how to design, implement, maintain, and continuously improve a quality calibration system, with all the required documentation, traceability, and known uncertainty for each and every item of test equipment owned and used by any company, large or small. It will benefit companies that want to implement a program and also those that already have one in place. Some industries have tighter requirements than others on how they treat calibration; some are more specific about how their standards are read, while being vague about what is needed to meet calibration. Is there one tried-and-true quality calibration system that every organization can use as a foundation for its personalized program? There certainly is, and The Quality Calibration Handbook describes it. By using the quality calibration system outlined and demonstrated, any organization can put together its own version to meet its specific requirements and/or regulations. Quality calibration systems are the very foundation for improving research and development (R&D), production, and quality assurance arenas through accurate, reliable, and traceable calibrations of their test equipment. By ensuring the calibration of test equipment used in the production of genetic identity kits used by law enforcement at crime scenes, the guilty are often caught and the innocent exonerated. Calibrated test equipment used in support of the airline and automotive industries helps prevent disasters. At pharmaceutical companies, calibration technicians quietly lay the foundation for quality treatments that help keep us healthy, cure diseases, and sometimes prevent death. This book explains why a quality calibration system can be the difference between life and death, success and failure, andmost important to shareholders and boards of directorsprofit and loss. COMMENTS FROM OTHER CUSTOMERS Average Customer Rating (5 of 5 based on 4 reviews) "This book offers me the information I need to upgrade the quality of the service I provide to customers. It makes the quantum leap between the theory and practice in calibration. I needed this applicable and practical information a long time ago." A reader in Anchorage, Alaska "This book is a great and simple reference guide for developing a world class calibration system. If you are thinking about revamping your calibration system or developing one, this book is a must. This book is written by a person sharing his practical experience to less experienced people." A reader in Austin, Texas "Excellent reference for setting up a calibration program or improving your current operations. This book is a must read for anyone working in the metrology field." A reader in Springboro, Ohio "This book is for anyone who wants to learn more about the requirements of a good calibration program. It gives easy to understand guidelines and practical advice to help you make your calibration program world class." A reader in Putnam, Connecticut

Author:
Publisher:
ISBN:
Category :
Languages : it
Pages : 0

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Author: Satinder Ahuja
Publisher: Elsevier
ISBN: 0080554199
Category : Medical
Languages : en
Pages : 533

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Book Description
High pressure, or high performance, liquid chromatography (HPLC) is the method of choice for checking purity of new drug candidates, monitoring changes during scale up or revision of synthetic procedures, evaluating new formulations, and running control/assurance of the final drug product. HPLC Method Development for Pharmaceuticals provides an extensive overview of modern HPLC method development that addresses these unique concerns. Includes a review and update of the current state of the art and science of HPLC, including theory, modes of HPLC, column chemistry, retention mechanisms, chiral separations, modern instrumentation (including ultrahigh-pressure systems), and sample preparation. Emphasis has been placed on implementation in a pharmaceutical setting and on providing a practical perspective. HPLC Method Development for Pharmaceuticals is intended to be particularly useful for both novice and experienced HPLC method development chemists in the pharmaceutical industry and for managers who are seeking to update their knowledge. Covers the requirements for HPLC in a pharmaceutical setting including strategies for software and hardware validation to allow for use in a regulated laboratory Provides an overview of the pharmaceutical development process (clinical phases, chemical and pharmaceutical development activities) Discusses how HPLC is used in each phase of pharmaceutical development and how methods are developed to support activities in each phase

Author: James Agalloco
Publisher: CRC Press
ISBN: 1000436012
Category : Medical
Languages : en
Pages : 1062

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Book Description
Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals. Key Features: Provides an in-depth discussion of recent advances in sterilization Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture

Author: Heather A. Wade
Publisher: Quality Press
ISBN: 1636940218
Category : Mathematics
Languages : en
Pages : 553

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Book Description
The ever-changing fields of science and technology have made huge leaps, thanks in part to improvements in measurements. Without metrology, these areas may not have experienced exponential growth. Developed by experts in the field as a comprehensive and practical reference, The ASQ Metrology Handbook, Third Edition provides a foundation for understanding metrology as well as calibration principles and practices. This handbook is ideal for not only metrology professionals, but also calibration professionals including calibration technicians and technologists, quality professionals, workers in testing laboratories, consultants, and instructors. Whether you are entering a new phase of your career field, investing in your own continuous improvement journey, training your fellow calibration practitioners, or preparing for ASQ’s Certified Calibration Technician (CCT) exam, this handbook provides the information, guidance, and knowledge to help you achieve your goals. New to this Third Edition: • A thorough explanation of ISO/IEC 17025:2017 • The 2019 Redefinition of the International System of Units • Updated and expanded chapters, including information about training and competency, software validation, statistics, decision rules and risk, uncertainty in measurement, mass and weighing, force, and chemical and biological measurements and uncertainties

Author: John J. Barbara
Publisher: Springer Science & Business Media
ISBN: 1597455776
Category : Social Science
Languages : en
Pages : 147

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Book Description
This volume presents an overview of computer forensics perfect for beginners. A distinguished group of specialist authors have crafted chapters rich with detail yet accessible for readers who are not experts in the field. Tying together topics as diverse as applicable laws on search and seizure, investigating cybercrime, and preparation for courtroom testimony, Handbook of Digital and Multimedia Evidence is an ideal overall reference for this multi-faceted discipline.

Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 0470248475
Category : Medical
Languages : en
Pages : 1346

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Book Description
A clear, straightforward resource to guide you through preclinical drug development Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic, comprehensive reference to prioritizing and optimizing leads, dose formulation, ADME, pharmacokinetics, modeling, and regulations. This authoritative, easy-to-use resource covers all the issues that need to be considered and provides detailed instructions for current methods and techniques. Each chapter is written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and testing, give you the tools needed to apply an effective multidisciplinary approach. The editor has carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. Among the key topics covered are: * Modeling and informatics in drug design * Bioanalytical chemistry * Absorption of drugs after oral administration * Transporter interactions in the ADME pathway of drugs * Metabolism kinetics * Mechanisms and consequences of drug-drug interactions Each chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage. This publication should be readily accessible to all pharmaceutical scientists involved in preclinical testing, enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin.