SANS 10576-1-2009 Statistical methods - Guidelines for the evaluation of conformity with specified requirements Part 1 General principles《统计方法 符合特定要求的评估标准 第1部分 一般原则》.pdf

1、 Collection of SANS standards in electronic format (PDF) 1. Copyright This standard is available to staff members of companies that have subscribed to the complete collection of SANS standards in accordance with a formal copyright agreement. This document may reside on a CENTRAL FILE SERVER or INTRA

2、NET SYSTEM only. Unless specific permission has been granted, this document MAY NOT be sent or given to staff members from other companies or organizations. Doing so would constitute a VIOLATION of SABS copyright rules. 2. Indemnity The South African Bureau of Standards accepts no liability for any

3、damage whatsoever than may result from the use of this material or the information contain therein, irrespective of the cause and quantum thereof. ISBN 978-0-626-23519-2 SANS 10576-1:2009Edition 1ISO 10576-1:2003Edition 1SOUTH AFRICAN NATIONAL STANDARD Statistical methods Guidelines for the evaluati

4、on of conformity with specified requirements Part 1: General principles This national standard is the identical implementation of ISO 10576-1:2003 and is adopted with the permission of the International Organization for Standardization. Published by SABS Standards Division 1 Dr Lategan Road Groenklo

5、of Private Bag X191 Pretoria 0001Tel: +27 12 428 7911 Fax: +27 12 344 1568 www.sabs.co.za SABS SANS 10576-1:2009 Edition 1 ISO 10576-1:2003 Edition 1 Table of changes Change No. Date Scope National foreword This South African standard was approved by National Committee SABS TC 169, Applications of s

6、tatistical methods, in accordance with procedures of the SABS Standards Division, in compliance with annex 3 of the WTO/TBT agreement. This SANS document was published in October 2009. Reference numberISO 10576-1:2003(E)ISO 2003INTERNATIONAL STANDARD ISO10576-1First edition2003-03-01Statistical meth

7、ods Guidelines for the evaluation of conformity with specified requirements Part 1: General principles Mthodes statistiques Lignes directrices pour lvaluation de la conformit des exigences spcifiques Partie 1: Principes gnraux SANS 10576-1:2009This s tandard may only be used and printed by approved

8、subscription and freemailing clients of the SABS .ISO 10576-1:2003(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and instal

9、led on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobes licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software produc

10、ts used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, pl

11、ease inform the Central Secretariat at the address 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 writi

12、ng from either ISO at the address below or ISOs 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 reservedSANS 10576-

13、1:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 10576-1:2003(E) ISO 2003 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 2 4 Specification of requirements

14、 3 5 Uncertainty of results . 5 6 Assessing conformity to requirements 5 7 Reporting the result of the conformity assessment 9 Annex A (informative) Examples of entities and quantifiable characteristics . 10 Annex B (informative) Examples. 11 Bibliography . 15 SANS 10576-1:2009This s tandard may onl

15、y be used and printed by approved subscription and freemailing clients of the SABS .ISO 10576-1:2003(E) iv ISO 2003 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing I

16、nternational Standards is normally carried out through ISO technical committees. Each member body 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

17、 with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical 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 tech

18、nical committees is to prepare International Standards. Draft International Standards adopted by 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 draw

19、n to the possibility that some of the elements of this document may be the subject of patent rights. 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, Mea

20、surement methods and results. SANS 10576-1:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 10576-1:2003(E) ISO 2003 All rights reserved vIntroduction Conformity testing is a systematic examination of the extent to which an entity conf

21、orms 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, or as a set of (upper and lower) lim

22、iting 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 measurement or sampling uncertainty, it i

23、s 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 minimize the risk of making erroneo

24、us 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 on the entity, even using more pre

25、cise 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 only marginally conforms, will fail t

26、o 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 respect of the construction of specifi

27、cations 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. Because of the apparent similarity

28、 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, important to realise that the obj

29、ectives of the two activities are fundamentally different and in particular the two activities imply different approaches to the risk involved (see ISO 28542and Holst9). SANS 10576-1:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .SANS 10

30、576-1:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .INTERNATIONAL STANDARD ISO 10576-1:2003(E) ISO 2003 All rights reserved 1Statistical methods Guidelines for the evaluation of conformity with specified requirements Part 1: General pri

31、nciples 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

32、is 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 r

33、ules 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 Tabl

34、e A.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, St

35、atistics 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 IS

36、O 5725-2:1994, 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: Intermedi

37、ate 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 SANS 10576-1:2009This s tandard may only be used and print

38、ed by approved subscription and freemailing clients of the SABS .ISO 10576-1:2003(E) 2 ISO 2003 All rights reservedISO 5725-5:1998, Accuracy (trueness and precision) of measurement methods and results Part 5: Alternative methods for the determination of the precision of a standard measurement method

39、 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 measurement (GUM):19931), BIPM/IEC/IFCC/ISO/IUPAC/IUPAP/ OIML 3 Terms and definitions For the purposes of this document, the ter

40、ms 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 and/or lower bounds of the permissible values ISO 3534-2:1993, 1.4.3 3.2 lower specification limit LSLlower bound of the permissi

41、ble values of the characteristic 3.3 upper specification limit USLupper bound of the permissible values of the characteristic 3.4 conformity test systematic evaluation by means of testing of the extent to which a product, process or service fulfils specified requirements 3.5 region of permissible va

42、lues 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 permissible values. 3.6 region of non-permissible values interval or intervals of all values of the characteristic that are not pe

43、rmissible NOTE Figure 1 displays various possibilities for the partitioning of the region of possible values of the characteristic in regions of permissible and non-permissible values. 1) Published in 1993 but corrected and reprinted in 1995. SANS 10576-1:2009This s tandard may only be used and prin

44、ted by approved subscription and freemailing clients of the SABS .ISO 10576-1:2003(E) ISO 2003 All rights reserved 33.7 uncertainty interval interval derived from the actual measurement of the characteristic and its uncertainty, covering the values that could reasonably be attributed to this charact

45、eristic NOTE 1 An uncertainty interval 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

46、 for the value of the characteristic (see e.g., 2.57 of ISO 3534-1:1993 and G.3 of GUM:1993). 3.8 two-sided confidence interval when T1and T2are two functions of the observed values such that, being a population parameter to be estimated, the probability Pr(T1u u T2) is at least equal to (1) where (

47、1) is a fixed number, positive and less than 1, the interval between T1and T2is 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

48、-1:1993, 2.59 4 Specification of requirements 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 d

49、etermined by means of a measurement 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 limiting values. SANS 10576-1:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 10576-1:2003(E)