IS 16179 : Part 1 : 2014/ISO 10576-1 : 2003 : Statistical Methods - Guidelines for the Evaluation of Conformity With Specified Requirements Part 1 General Principles

ICS 03.120.30 MSD 3

Reaffirmed 2023

NATIONAL FOREWORD

This Indian Standard (Part 1) which is identical with ISO 10576-1 : 2003 'Statistical methods - Guidelines for the evaluation of conformity with specified requirements - Part 1: General principles' issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Statistical Methods for Quality and Reliability Sectional Committee and approval of the Management and Systems Division Council.

Conformity testing is a systematic examination of 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 supplier's declaration, or of a third party certification. A specification is usually formulated as a single limitingvalue, LV, or as set of (upper and lower) limiting values for a measurable characteristic. When the specification refers, for example, to health-related characteristics, the limiting values are sometimestermed threshold limit value, TLV, or permissible exposure limits, PEL.

Whenever conformity testing involves measurement 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 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 on the entity, even using more precise measurements (for example, 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 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 standard, this issue is addressed in respect of the construction of specifications and the testing of output from production or service processes for conformity and non-conformity with specifications.

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. It is, however, 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.

The text of ISO Standard has been approved as suitable for publication as an Indian Standard without deviations. Certain conventions are, however, not identical to those used in Indian Standards. Attention is particularly drawn to the following:

a) Wherever the words 'International Standard' appear, referring to this standard, they should be read as 'Indian Standard'.

b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker.