1、 Reference number ISO/TR 10017:2003(E) ISO 2003TECHNICAL REPORT ISO/TR 10017 Second edition 2003-05-15 Guidance on statistical techniques for ISO 9001:2000 Lignes directrices pour les techniques statistiques relatives lISO 9001:2000 ISO/TR 10017:2003(E) PDF disclaimer This PDF file may contain embed
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6、se 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 reservedISO/TR 10017:2003(E) ISO 2003 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope 1 2 Normative references
7、. 1 3 Identification of potential needs for statistical techniques 1 4 Descriptions of statistical techniques identified .6 4.1 General. 6 4.2 Descriptive statistics 7 4.3 Design of experiments (DOE) 8 4.4 Hypothesis testing 9 4.5 Measurement analysis 11 4.6 Process capability analysis . 12 4.7 Regr
8、ession analysis . 13 4.8 Reliability analysis 15 4.9 Sampling 16 4.10 Simulation 18 4.11 Statistical process control (SPC) charts 18 4.12 Statistical tolerancing. 20 4.13 Time series analysis . 21 Bibliography . 23 ISO/TR 10017:2003(E) iv ISO 2003 All rights reservedForeword ISO (the International O
9、rganization 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 body interested in a subject for which a technical committee has been estab
10、lished 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 Electrotechnical Commission (IEC) on all matters of electrotechnical standardizat
11、ion. 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 the technical committees are circulated to the member bodies for voting
12、. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. In exceptional circumstances, when a technical committee has collected data of a different kind from that which is normally published as an International Standard (“state of the art”, f
13、or example), it may decide by a simple majority vote of its participating members to publish a Technical Report. A Technical Report is entirely informative in nature and does not have to be reviewed until the data it provides are considered to be no longer valid or useful. Attention is drawn to the
14、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/TR 10017 was prepared by Technical Committee ISO/TC 176, Quality management and quality assurance, Subcommittee SC 3, Suppo
15、rting technologies. This second edition cancels and replaces the first edition (ISO/TR 10017:1999) and is now based on ISO 9001:2000. This Technical Report might be updated to reflect future revisions of ISO 9001. Comments on the contents of this Technical Report may be sent to ISO Central Secretari
16、at for consideration in a future revision. ISO/TR 10017:2003(E) ISO 2003 All rights reserved vIntroduction The purpose of this Technical Report is to assist an organization in identifying statistical techniques that can be useful in developing, implementing, maintaining and improving a quality manag
17、ement system in compliance with the requirements of ISO 9001:2000. In this context, the usefulness of statistical techniques follows from the variability that may be observed in the behaviour and outcome of practically all processes, even under conditions of apparent stability. Such variability can
18、be observed in the quantifiable characteristics of products and processes, and can be seen to exist at various stages over the total life cycle of products, from market research to customer service and final disposal. Statistical techniques can help to measure, describe, analyse, interpret and model
19、 such variability, even with a relatively limited amount of data. Statistical analysis of such data may provide a better understanding of the nature, extent and causes of variability. This could help to solve and even prevent problems that could result from such variability. Statistical techniques c
20、an thus allow better use of available data to assist in decision making, and thereby help to continually improve the quality of products and processes to achieve customer satisfaction. These techniques are applicable to a wide spectrum of activities, such as market research, design, development, pro
21、duction, verification, installation and servicing. This Technical Report is intended to guide and assist an organization in considering and selecting statistical techniques appropriate to the needs of the organization. The criteria for determining the need for statistical techniques, and the appropr
22、iateness of the technique(s) selected, remain the prerogative of the organization. The statistical techniques described in this Technical Report are also applicable to other standards in the ISO 9000 family, in particular ISO 9004:2000. TECHNICAL REPORT ISO/TR 10017:2003(E) ISO 2003 All rights reser
23、ved 1Guidance on statistical techniques for ISO 9001:2000 1 Scope This Technical Report provides guidance on the selection of appropriate statistical techniques that may be useful to an organization in developing, implementing, maintaining and improving a quality management system in compliance with
24、 ISO 9001. This is done by examining those requirements of ISO 9001 that involve the use of quantitative data, and then identifying and describing the statistical techniques that can be useful when applied to such data. The list of statistical techniques cited in this Technical Report is neither com
25、plete nor exhaustive, and does not preclude the use of any other techniques (statistical or otherwise) that are deemed to be beneficial to the organization. Furthermore, this Technical Report does not attempt to prescribe which statistical technique(s) are to be used; nor does it attempt to advise o
26、n how the technique(s) are to be implemented. This Technical Report is not intended for contractual, regulatory or certification/registration purposes. It is not intended to be used as a mandatory checklist for compliance with ISO 9001:2000 requirements. The justification for using statistical techn
27、iques is that their application would help to improve the effectiveness of the quality management system. NOTE 1 The terms “statistical techniques” and “statistical methods” are often used interchangeably. NOTE 2 References in this Technical Report to “product” are applicable to the generic product
28、categories of service, software, hardware and processed materials, or a combination thereof, in accordance with the definition of “product” in ISO 9000:2000. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only t
29、he edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 9001:2000, Quality management systems Requirements 3 Identification of potential needs for statistical techniques The need for quantitative data that may reasonably
30、 be associated with the implementation of the clauses and sub-clauses of ISO 9001 is identified in Table 1. Listed against the need for quantitative data thus identified are one or more statistical techniques that could be of potential benefit to the organization, when appropriately applied to such
31、data. NOTE Statistical techniques can be usefully applied to qualitative data, if such data can be converted into quantitative data. Where no need for quantitative data could be readily associated with a clause or subclause of ISO 9001, no statistical technique is identified. The statistical techniq
32、ues cited in this Technical Report are limited to those that are well known. Likewise, only relatively straightforward applications of statistical techniques are identified here. ISO/TR 10017:2003(E) 2 ISO 2003 All rights reservedEach of the statistical techniques noted below is described briefly in
33、 Clause 4, to assist the organization to assess the relevance and value of the statistical techniques cited, and to help determine whether or not the organization should use them in a specific context. Table 1 Needs involving quantitative data and supporting statistical technique(s) Clause/subclause
34、 of ISO 9001:2000 Needs involving the use of quantitative data Statistical technique(s) 4 Quality management system 4.1 General requirements See Introduction to this Technical Report 4.2 Documentation requirements 4.2.1 General None identified 4.2.2 Quality manual None identified 4.2.3 Control of do
35、cuments None identified 4.2.4 Control of records None identified 5 Management responsibility 5.1 Management commitment None identified 5.2 Customer focus Need to determine customer requirements Need to assess customer satisfaction See 7.2.2 in this table See 8.2.1 in this table 5.3 Quality policy No
36、ne identified 5.4 Planning 5.4.1 Quality objectives None identified 5.4.2 Quality management system planning None identified 5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority None identified None identified 5.5.2 Management representative None identified 5.5.3 Intern
37、al communication None identified 5.6 Management review 5.6.1 General None identified 5.6.2 Review input a) results of audits Need to obtain and evaluate audit dataDescriptive statistics; sampling b) customer feedback Need to obtain and assess customer feedback Descriptive statistics; sampling c) pro
38、cess performance and product conformity Need to assess process performance and product conformity Descriptive statistics; process capability analysis; sampling; SPC charts d) status of preventive and corrective actions Need to obtain and evaluate data from preventive and corrective actions Descripti
39、ve statistics 5.6.3 Review output None identified ISO/TR 10017:2003(E) ISO 2003 All rights reserved 3Clause/subclause of ISO 9001:2000 Needs involving the use of quantitative data Statistical technique(s) 6 Resource management 6.1 Provision of resources None identified 6.2 Human resources 6.2.1 Gene
40、ral None identified 6.2.2 Competence, awareness and training 6.2.2 a) None identified 6.2.2 b) None identified 6.2.2 c) evaluate the effectiveness of the actions taken Need to assess competence, and effectiveness of training Descriptive statistics; sampling 6.2.2 d) None identified 6.2.2 e) None ide
41、ntified 6.3 Infrastructure None identified 6.4 Work environment Need to monitor the work environment Descriptive statistics; SPC charts 7 Product realization 7.1 Planning of product realization None identified 7.2 Customer-related processes 7.2.1 Determination of requirements related to the product
42、None identified 7.2.2 Review of requirements related to the product Need to assess the organizations ability to meet defined requirements Descriptive statistics; measurement analysis; process capability analysis; sampling; statistical tolerancing 7.2.3 Customer communication None identified 7.3 Desi
43、gn and development 7.3.1 Design and development planning None identified 7.3.2 Design and development inputs None identified 7.3.3 Design and development outputs Need to verify that design outputs satisfy input requirements Descriptive statistics; design of experiments; hypothesis testing; measureme
44、nt analysis; regression analysis; reliability analysis; sampling; simulation; time series analysis 7.3.4 Design and development review None identified 7.3.5 Design and development verification Need to verify that design outputs satisfy input requirements Descriptive statistics; design of experiments
45、; hypothesis testing; measurement analysis; process capability analysis; regression analysis; reliability analysis; sampling; simulation; time series analysis 7.3.6 Design and development validation Need to validate that product meets stated use and needs Descriptive statistics; design of experiment
46、s; hypothesis testing; measurement analysis; process capability analysis; regression analysis; reliability analysis; sampling; simulation ISO/TR 10017:2003(E) 4 ISO 2003 All rights reservedClause/subclause of ISO 9001:2000 Needs involving the use of quantitative data Statistical technique(s) 7.3.7 C
47、ontrol of design and development changes Need to evaluate, verify and validate effect of design changes Descriptive statistics; design of experiments; hypothesis testing; measurement analysis; process capability analysis; regression analysis; reliability analysis; sampling; simulation 7.4 Purchasing
48、 7.4.1 Purchasing process Need to ensure that purchased product conforms to specified purchase requirements Need to evaluate suppliers ability to supply product to meet organizations requirements Descriptive statistics; hypothesis testing; measurement analysis; process capability analysis; regressio
49、n analysis; reliability analysis; sampling Descriptive statistics; design of experiments; process capability analysis; regression analysis; sampling 7.4.2 Purchasing information None identified 7.4.3 Verification of purchased product Need to establish and implement inspection and other activities to ensure that purchased product meets specified requirements Descriptive statistics; hypothesis testing; measurement analysis; process capability analysis; reliability analysis; sampling 7.5 Production and service provision 7.5.1 Control of production
