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1、 Reference number ISO 10576-1:2003(E) ISO 2003 INTERNATIONAL STANDARD ISO 10576-1 First edition 2003-03-01 Statistical methods Guidelines for the evaluation of conformity with specified requirements Part 1: General principles Mthodes statistiques Lignes directrices pour lvaluation de la conformit de
2、s exigences spcifiques Partie 1: Principes gnraux Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 03:16:42 MDTNo reproduction or networking permitted without license from IHS -,-
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6、ess given below. ISO 2003 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs
7、 member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2003 All rights reserved Copyright International Organization for Standardization
8、Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 03:16:42 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 10576-1:2003(E) ISO 2003 All rights reserved iii Contents Page Forewordiv Introduction v 1 Scope1 2
9、Normative references .1 3 Terms and definitions.2 4 Specification of requirements3 5 Uncertainty of results.5 6 Assessing conformity to requirements5 7 Reporting the result of the conformity assessment9 Annex A (informative) Examples of entities and quantifiable characteristics .10 Annex B (informat
10、ive) Examples.11 Bibliography .15 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 03:16:42 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 10576-1:2
11、003(E) iv ISO 2003 All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member bod
12、y interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrote
13、chnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by
14、 the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rig
15、hts. ISO shall not be held responsible for identifying any or all such patent rights. ISO 10576-1 was prepared by Technical Committee ISO/TC 69, Applications of statistical methods, Subcommittee SC 6, Measurement methods and results. Copyright International Organization for Standardization Provided
16、by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 03:16:42 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 10576-1:2003(E) ISO 2003 All rights reserved v Introduction Conformity testing is a systematic examination of
17、 the extent to which an entity conforms to a specified criterion. The objective is to provide assurance of conformity, either in the form of a suppliers declaration, or of a third party certification (see ISO/IEC Guide 2, 1996). A specification is usually formulated as a single limiting value, LV, o
18、r as a set of (upper and lower) limiting values for a measurable characteristic. When the specification refers, e.g. to health-related characteristics, the limiting values are sometimes termed threshold limit value TLV, or permissible exposure limits, PEL. Whenever conformity testing involves measur
19、ement or sampling uncertainty, it is common practice to invoke elements from the theory of statistical hypothesis testing to provide a formal procedure. With the knowledge of the measurement procedure and of its behaviour with regard to the uncertainty of its outcomes it is possible to estimate and
20、minimize the risk of making erroneous declarations of conformity or non-conformity to the specifications. An operational way of formulating requirements of assurance is to require that whenever an entity has been declared to be conforming, this status should not be altered by subsequent measurements
21、 on the entity, even using more precise measurements (e.g. a better measurement method or technology). Or, in terms of risks, the risk of (erroneously) declaring a non-conforming entity to be conforming shall be small. Consequently, it is necessary to tolerate a (large) risk that an entity, which on
22、ly marginally conforms, will fail to be declared as conforming. Applying a two-stage procedure instead of a one-stage procedure will in general decrease this risk. When a test for non-conformity is performed, similar considerations are valid. In this part of ISO 10576, this issue is addressed in res
23、pect of the construction of specifications and the testing of output from production or service processes for conformity and non-conformity with specifications. The problems of how to determine the relevant components of uncertainty and how to estimate them will be addressed in a future ISO 10576-2.
24、 Because of the apparent similarity to acceptance sampling procedures, it is sometimes seen that acceptance sampling plans are used in conformity testing activities. Acceptance sampling and conformity testing activities both utilize elements of hypothesis testing (see e.g. ISO 28542). It is, however
25、, important to realise that the objectives of the two activities are fundamentally different and in particular the two activities imply different approaches to the risk involved (see ISO 28542 and Holst9). Copyright International Organization for Standardization Provided by IHS under license with IS
26、O Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 03:16:42 MDTNo reproduction or networking permitted without license from IHS -,-,- Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/997254500
27、1 Not for Resale, 04/19/2007 03:16:42 MDTNo reproduction or networking permitted without license from IHS -,-,- INTERNATIONAL STANDARD ISO 10576-1:2003(E) ISO 2003 All rights reserved 1 Statistical methods Guidelines for the evaluation of conformity with specified requirements Part 1: General princi
28、ples 1 Scope This part of ISO 10576 sets out guidelines: a) for drafting requirements that may be formulated as limiting values for a quantifiable characteristic; b) for checking conformity to such requirements when the test or measurement result is subject to uncertainty. This part of ISO 10576 is
29、applicable whenever the uncertainty may be quantified according to the principles laid down in GUM. The term uncertainty is thus a descriptor for all elements of variation in the measurement result, including uncertainty due to sampling. It is outside the scope of this part of ISO 10576 to give rule
30、s for how to act when an inconclusive result of a conformity test has been obtained. NOTE Neither on the nature of the entity subject to the requirements nor on the quantifiable characteristic are there limitations. Examples of entities together with quantifiable characteristics are given in Table A
31、.1. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 3534-1:1993, Stati
32、stics Vocabulary and symbols Part 1: Probability and general statistical terms ISO 3534-2:1993, Statistics Vocabulary and symbols Part 2: Statistical quality control ISO 5725-1:1994, Accuracy (trueness and precision) of measurement methods and results Part 1: General principles and definitions ISO 5
33、725-2:1994, Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method ISO 5725-3:1994, Accuracy (trueness and precision) of measurement methods and results Part 3: Intermediate
34、 measures of the precision of a standard measurement method ISO 5725-4:1994, Accuracy (trueness and precision) of measurement methods and results Part 4: Basic methods for the determination of the trueness of a standard measurement method Copyright International Organization for Standardization Prov
35、ided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 03:16:42 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 10576-1:2003(E) 2 ISO 2003 All rights reserved ISO 5725-5:1998, Accuracy (trueness and precision) of mea
36、surement methods and results Part 5: Alternative methods for the determination of the precision of a standard measurement method ISO 5725-6:1994, Accuracy (trueness and precision) of measurement methods and results Part 6: Use in practice of accuracy values Guide to the expression of uncertainty in
37、measurement (GUM):19931), BIPM/IEC/IFCC/ISO/IUPAC/IUPAP/ OIML 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 3534-1, ISO 3534-2 and the following apply. 3.1 limiting values specification limits L specified values of the characteristic giving upper a
38、nd/or lower bounds of the permissible values ISO 3534-2:1993, 1.4.3 3.2 lower specification limit LSL lower bound of the permissible values of the characteristic 3.3 upper specification limit USL upper bound of the permissible values of the characteristic 3.4 conformity test systematic evaluation by
39、 means of testing of the extent to which a product, process or service fulfils specified requirements 3.5 region of permissible values interval or intervals of all permissible values of the characteristic NOTE Unless otherwise stated in the specification, the limiting values belong to the region of
40、permissible values. 3.6 region of non-permissible values interval or intervals of all values of the characteristic that are not permissible NOTE Figure 1 displays various possibilities for the partitioning of the region of possible values of the characteristic in regions of permissible and non-permi
41、ssible values. 1) Published in 1993 but corrected and reprinted in 1995. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 03:16:42 MDTNo reproduction or networking permitted witho
42、ut license from IHS -,-,- ISO 10576-1:2003(E) ISO 2003 All rights reserved 3 3.7 uncertainty interval interval derived from the actual measurement of the characteristic and its uncertainty, covering the values that could reasonably be attributed to this characteristic NOTE 1 An uncertainty interval
43、may be the symmetric interval around the measurement result as defined in 6.2.1 of GUM:1993. NOTE 2 When the uncertainty has been obtained only by Type A evaluations of uncertainty components, the uncertainty interval may be in the form of a confidence interval for the value of the characteristic (s
44、ee e.g., 2.57 of ISO 3534-1:1993 and G.3 of GUM:1993). 3.8 two-sided confidence interval when T1 and T2 are two functions of the observed values such that, being a population parameter to be estimated, the probability Pr(T1 u u T2) is at least equal to (1) where (1) is a fixed number, positive and l
45、ess than 1, the interval between T1 and T2 is a two-sided (1) confidence interval for ISO 3534-1:1993, 2.57 3.9 confidence coefficient confidence level the value (1) of the probability associated with a confidence interval or a statistical coverage interval ISO 3534-1:1993, 2.59 4 Specification of r
46、equirements 4.1 Requirements for definition of limiting values 4.1.1 The entity shall be clearly and unambiguously specified. 4.1.2 The quantifiable characteristic of the entity shall be clearly and unambiguously specified. The value of the characteristic shall be determined by means of a measuremen
47、t or test procedure that enables an assessment of the uncertainty of the measurement to be made. 4.1.3 The measurement or test procedure should be a standardized procedure. 4.1.4 The uncertainty of the measurement shall neither explicitly nor implicitly be referred to in the designation of the limit
48、ing values. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 03:16:42 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 10576-1:2003(E) 4 ISO 2003 All rights reserved NOTE RPV denotes Region of permissible values while RNV denotes Region of