Calibration Handbook of Measuring Instruments excerpt

Jan 6, 2018 - Notes to Technical Requirements on Document Management According to FDA 21 ... management system of instruments and measurements.
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Alessandro Brunelli

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FIRST EDITION Notice The information presented in this publication is for the general education of the reader. Because neither the author nor the publisher has any control over the use of the information by the reader, both the author and the publisher disclaim any and all liability of any kind arising out of such use. The reader is expected to exercise sound professional judgment in using any of the information presented in a particular application. Additionally, neither the author nor the publisher has investigated or considered the effect of any patents on the ability of the reader to use any of the information in a particular application. The reader is responsible for reviewing any possible patents that may affect any particular use of the information presented. Any references to commercial products in the work are cited as examples only. Neither the author nor the publisher endorses any referenced commercial product. Any trademarks or tradenames referenced belong to the respective owner of the mark or name. Neither the author nor the publisher makes any representation regarding the availability of any referenced commercial product at any time. The manufacturer’s instructions on the use of any commercial product must be followed at all times, even if in conflict with the information in this publication. Copyright © 2017 International Society of Automation (ISA) All rights reserved. Printed in the United States of America. 10 9 8 7 6 5 4 3 2 ISBN: 978-1-945541-57-5 No part of this work may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior written permission of the publisher. ISA 67 T. W. Alexander Drive P.O. Box 12277 Research Triangle Park, NC 27709 Library of Congress Cataloging-in-Publication Data in process

Disclaimer: Neither the Author nor the Publisher are responsible for the results obtained by the use or possible misuse of the spreadsheets used in this handbook or on the CD. The literary property and all rights of the series of ISA Publications are reserved to the Publisher. The graphical structure, the editorial content, and illustrations in this volume cannot be reported, translated, or stored, even partially, without the permission of the Publisher.

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Part I – Requirements and General Guidelines for Management of Instruments and Measurements


1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12.

International System of Units (SI) International Calibration System (ILAC) European Calibration System (EA) Traceability and Compatibility of the Measures Measurement Uncertainty Calibration of Measuring Instruments Requirements in the Quality Management Systems ISO 9001, 14001, 16949, and EN 9100 Requirements in the Measurement Management Systems ISO 10012 Criteria for Instrument Selection in Relation to the Measurement Requirements Criteria for Conformity Evaluation of the Measuring Instrument Notes to Legislative Requirements for Initial and Periodic Calibration Checks Notes to Technical Requirements on Document Management According to FDA 21 CFR Part 11

9 15 17 21 23 29 35 39 49 53 59 65

Part II – Requirements and Criteria for the Management and Calibration of Measuring Instruments




Physical Quantities 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8





Pressure Flow Level Temperature Humidity Viscosity Dens