Implementing ISO/IEC 17025:2017 , livre ebook

ASQ Quality Press - Bhavan (Bob) Mehta

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Description

The focus of this book is to demystify the requirements delineated within ISO/IEC 17025:2017, while providing a road map for organizations wishing to receive accreditation for their laboratories.
AS9100, ISO 9001:2015, and ISO 13485:2016 are standards that have been created to 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 many diverse industries. Similar to these recognized QMS standards, ISO/IEC 17025:2017 for laboratory accreditation serves a unique purpose. It is not unusual for laboratories to retain dual certification in ISO 9001:2015 and ISO/IEC 17025:2017. However, ISO/IEC 17025:2017 contains requirements specific to the laboratory environment that are not addressed by ISO 9001:2015.
This book highlights those differences between ISO 9001:2015 and ISO/IEC 17025:2017, while providing practical insight and tools needed for laboratories wishing to achieve or sustain accreditation to ISO/IEC 17025:2017. For those currently or formerly accredited to the 2005 version of ISO/IEC 17025, an appendix outlines the changes between the 2005 and 2017 versions of the standard.

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Business

Qualité, hygiène, sécurité, environnement

Techniques

Automatisation et Contrôle

Contrôle des processus

Automatisation

Automate

Organisation internationale de normalisation

QMS

Engineering

International Organization for Standardization

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ISO

Sciences et techniques

Quality Control

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Publié par	ASQ Quality Press
Date de parution	21 février 2019
Nombre de lectures	0
EAN13	9781953079107
Langue	English

Informations légales : prix de location à la page 0,3750€. Cette information est donnée uniquement à titre indicatif conformément à la législation en vigueur.

Extrait

Implementing ISO/IEC 17025:2017
SECOND EDITION
Bob Mehta
ASQ Quality Press
Milwaukee, Wisconsin

American Society for Quality, Quality Press, Milwaukee 53203
© 2019 by ASQ. Printed in 2019.
All rights reserved.
Portions of information contained in this publication/book are printed with permission of Minitab Inc. All such material remains the exclusive property and copyright of Minitab Inc. All rights reserved.
Library of Congress Cataloging-in-Publication Data
Names: Mehta, Bob, 1961– author.
Title: Implementing ISO/IEC 17025:2017 / Bob Mehta.
Other titles: ISO/IEC 17025:2017
Description: 2nd edition. | Milwaukee, Wisconsin : ASQ Quality Press, [2019] | Includes bibliographical references and index.
Identifiers: LCCN 2018051137 | ISBN 9780873899802 (hardcover : alk. paper)
Subjects: LCSH: Laboratories—Accreditation—Standards. | Laboratories—Standards.
Classification: LCC QC100.A2 M44 2019 | DDC 001.402/18—dc23
LC record available at https://lccn.loc.gov/2018051137
No part of this book may be reproduced in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of the publisher.
Publisher: Seiche Sanders
Sr. Creative Services Specialist: Randy L. Benson
ASQ Mission: The American Society for Quality advances individual, organizational, and community excellence worldwide through learning, quality improvement, and knowledge exchange.
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Acknowledgments
First, to my late parents, who both passed away when I was in India. Thank you to my mother for sacrificing her life to give birth to me. Since my mother passed away during childbirth, I depended on my dad until he passed away when I was in college. He taught me to believe in myself, work hard, and stay determined in everything that I do. I kept these values with me when I came to the United States in 1986. Since then, I never looked back. You both are the inspiration for my lifelong passion for learning and for sharing my knowledge with others. Your nurtured love and support make me what I am today.
To my wife for her love and support for over two decades. Your support while I wrote this book after working long hours as a consultant was invaluable to me.
To my son, Jay, for his love and support, including proofreading the manuscript for this book and sharing ideas as a quality professional.
My thanks to Ahmedabad Science College (Ahmedabad, India), where I earned a Bachelor of Science degree in chemistry; to Pepperdine University for helping me develop an understanding of business practices and use my learnings from my MBA degree toward professional goals; and to California State University–Dominguez Hills for helping me increase my competence in the field of quality and use my Master of Science degree in quality assurance to achieve my career aspirations. I would also like to acknowledge the adjunct faculty there, where I teach Master of Science in Quality Assurance classes, for their support and guidance.
And to the American Society for Quality sections around the world, members of the Orange Empire Section, to which I belong, and to all measurement and analysis professionals supporting and/or managing calibration functions.

Introduction
The focus of this book will be to demystify the requirements delineated within ISO/IEC 17025:2017, while providing a road map for organizations wishing to receive accreditation for their laboratories. For those of you who have read my first book, which focused on complying with ISO/IEC 17025:2005, this is essentially a second edition. AS9100, ISO 9001:2015, and ISO 13485:2016 are standards that have been created to 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 many diverse industries. Similar to these recognized QMS standards, ISO/IEC 17025:2017 for laboratory accreditation serves a unique purpose. It is not unusual for laboratories to retain dual certification in ISO 9001:2015 and ISO/IEC 17025:2017. However, ISO/IEC 17025:2017 does contain requirements specific to the laboratory environment that are not addressed by ISO 9001:2015. This book will highlight the differences between ISO 9001:2015 and ISO/IEC 17025:2017, while providing practical insight and tools needed for laboratories wishing to achieve or sustain accreditation to ISO/IEC 17025:2017.

1
Scope
The scope of ISO/IEC 17025:2017 is essentially the creating of a sound functional platform for laboratories to operate in an environment that supports laboratory competency, impartiality, and consistency. Irrespective of a laboratory’s size and the number of supporting personnel, the standard discussed in this book is deemed to be relevant. Not only can ISO/IEC 17025:2017 be employed to create the foundation for a laboratory, it can be used to assist customers, regulators, and other interested parties in their performance of assessment activities.

2
Normative References
There are two documents that are identified within ISO/IEC 17025:2017 that have content considered to be germane to any discussion associated with the understanding of this standard. According to ISO/IEC 17012:2017, these two documents are identified as: (a) ISO/IEC 17000 (Conformity assessment—Vocabulary and general principles) and (b) ISO/IEC Guide 99 (International vocabulary of metrology—Basic and general concepts and associated terms).

3
Terms and Definitions
According to ISO/IEC 17025:2017, the terms and definitions associated with ISO/IEC 17000 and ISO/IEC Guide 99 are applicable for this standard. However, ISO and IEC do maintain terminological databases that can be used in support of standardization. These two databases can be located at: ISO’s Online Browsing Platform, https://www.iso.org/obp IEC’s Electropedia: The World’s Online Electrotechnical Vocabulary, http://www.electropedia.org/
Key terms and definitions referenced within the standard include:
Complaint: An expression of dissatisfaction by any person or organization to a laboratory, relating to the activities or results of that laboratory, where a response is expected.
Decision Rule: A rule that describes how measurement uncertainty is accounted for when starting conformity with a specified requirement.
Impartiality: The presence of objectivity.
Interlaboratory Comparison: The organization, performance, and evaluation of measurements or tests, on the same or similar items, by two or more laboratories in accordance with predetermined conditions.
Intralaboratory Comparison: The organization, performance, and evaluation of measurements or tests, on the same or similar items within the same laboratory in accordance with predetermined conditions.
Laboratory: A body that performs one or more of the following activities: (a) testing, (b) calibration, and (c) sampling associated with subsequent testing or calibration.
Proficiency Testing: The evaluation of participant performance against preestablished criteria by means of interlaboratory comparisons.
Reference Standard: A reference standard is a highly characterized, standardized, and validated reference material. It enables the measurement of the sensitivity, specificity, and accuracy of your assay or workflow.
Validation: The verification where the specified requirements are adequate for its intended use.
Verification: The provision of objective evidence that a given item fulfills specified requirements.

4
General Requirements
INTRODUCTION
It is imperative that laboratories complying with ISO/IEC 17025:2017 adhere to two fundamental concepts: (a) impartiality and (b) confidentiality. Not unlike a person’s relationship with their family doctor or that inopportune time when a person ends up in traffic court, the expectation is that regardless of outcome, impartiality and confidentiality are appropriately maintained. Laboratories are required to adhere with those same principles. Because of the brevity of clause 4.1 (Impartiality) and clause 4.2 (Confidentiality) of ISO/IEC 17025:2017, both clauses will be reviewed in this initial chapter.

SUMMARY OF ISO/IEC 17025:2017 REQUIREMENT—4.1 (IMPARTIALITY) Laboratory activities must be carried out in a manner to ensure impartiality is maintained. Management shall be fully committed to the concept of impartiality. Commercial, fiscal, or other operational pressures should not influence impartiality. Laboratories are expected to review and identify potential risks to sustaining impartiality. When risks to impartiality have been identified, the laboratory is required to mitigate those risks.

SUMMARY OF ISO/IEC 17025:2017 REQUIREMENT—4.2 (CONFIDENTIALITY) Laboratories are to be responsible for carefully managing information with which they have been entrusted. If the information is not deemed to be public knowledge, then appropriate permission shall be in place to protect the confidentiality of information. When a laboratory is required by law to release confidential information, then this agreement must be defined within a contract. Confidential information shared between a laboratory and its clients, regardless of source, is still to be treated as confidential. Individuals acting on behalf of a laboratory (e.g., consultant) shall maintain the integrity of confidential agreements.
EFFECTIVE TOOLS FOR IMPLEMENTATION AND COMPLIANCE
Clause 4.1 and clause 4.2 are essentially c