DRAFT(S) IN WIDE CIRCULATION. Reference Date MSD 2/T Quality Management Sectional Committee, MSD 2

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1 DRAFT(S) IN WIDE CIRCULATION Reference Date MSD 2/T Quality Management Sectional Committee, MSD 2 All members of Quality Management Sectional Committee, MSD 2, its subcommittee, MSD 2:1 Management and Productivity Sectional Committee, MSD 4 Social Responsibility Sectional Committee, MSD 10 Management and Systems Division Council, MSDC Others interested Dear Sir/Madam, Quality Management Sectional Committee, MSD 2 decided to consider following International Standard for identical adoption as Indian Standards. Accordingly, the following document is enclosed for comments: Doc. No. MSD 2 (12627)C/ ISO 9002: 2016 Title Quality management systems Guidelines for the application of ISO 9001:2015 Kindly examine the above mentioned draft standard and forward your views stating any difficulties which you are likely to experience in your business or profession, if this/these is/are finally adopted as National Standard(s). Last date for comments: 20 June 2018 Comments, if any, may please be made in the format attached and mailed to the undersigned at the above address. Thanking You, Encl : As above Yours truly, (Sneh Lata) Scientist F and Head Management and Systems msd@bis.org.in

2 FORMAT FOR SENDING COMMENTS ON BIS DOCUMENTS [Please use A4 sheet of paper only and type within fields indicated. Comments on each clause/subclause be started on a fresh paper. Information in column 3 should include reasons for the comments and suggestions for modified wording of the clause when the existing text is found not acceptable. Adherence to this format facilities Secretariat s work] NAME OF THE COMMENTATOR/ORGANIZATION DOC. NUMBER MSD 2 (12627)C/ ISO 9002: 2016 TITLE Quality management systems Guidelines for the application of ISO 9001:2015 SL. NO. (1) CLAUSE SUB-CLAUSE PARA NO. COMMENTED (2) COMMENTS (3)

3 प पर ल र भ त त एएड 2/ ट गण त तलए तय प ण ल त तत एएड 3 र : गण प ब त तत, एएड 2 प ब ए त प त तत, एएड 4 त त तत त तत, एएड 10 प ब प ण ल तर ग पर, एएड तप /, प त तल त प प त गण प ब त तत, एएड 2 क क प ल य 1. एमएसड 2 (12627 )/ आई एस ओ 9002: 2016 भ ग णवत त प ब धन प ण ल - आईएसओ 9001: 2015 क उपय ग क ललए द श नन श प स ल प म त ब ह ए र क : क ह ट र प प त ए प ल प ब र प क प म त लग प र प स क प पर तलत प प र म त र त त त : प ल बए ब ट ( प र पलब, लग : पर तलत र, (स नह लत ) वज एफ एव प म ख (प ब ध एव पद तत) टलल/फ क स: म ब इल: ई-मल: msd@bis.org.in

4 DRAFT FOR COMMENTS ONLY Doc : MSD 2 (12627) IS/ ISO 9002 : 2016 May 2018 BUREAU OF INDIAN STANDARDS Draft Indian Standard QUALITY MANAGEMENT SYSTEMS GUIDELINES FOR THE APPLICATION OF ISO 9001:2015 (ICS ) Not to be reproduced without the permission of BIS or used as Standard Last Date for receipt of Comments is 20 June 2018 NATIONAL FOREWORD (Formal Clause will be added later). This document has been developed to assist users to apply the quality management system requirements of ISO 9001:2015 Quality Requirements. This document provides guidance, with a clause by clause correlation to Clauses 4 to 10 of ISO 9001:2015, however it does not provide guidance on ISO 9001:2015, Annexes A and B. Where there is direct correlation between list items (i.e. bullet points) in a clause in ISO 9001:2015 and the guidance, this is indicated within the clause of this document. This document gives examples of what an organization can do, but it does not add new requirements to ISO The examples in this document are not definitive and only represent possibilities, not all of which are necessarily suitable for every organization. ISO 9001 contains requirements that can be objectively audited or evaluated. This document includes examples, descriptions and options that aid both in the implementation of a quality management system and in strengthening its relation to the overall management system of an organization. While the guidelines in this document are consistent with the ISO 9001 quality management system model, they are not intended to provide interpretations of the requirements of ISO 9001 or be used for audit or evaluation purposes. As the requirements of ISO 9001 are generic, this document can be used by organizations of all types, sizes, levels of maturity and in all sectors and geographic locations. However, the way an organization applies the guidance can vary based on factors such as the size or the complexity of the organization, the management model it adopts, the range of the organization s activities and the nature of the risks and opportunities it encounters.

5 Risk is the level of uncertainty inherent in a quality management system. There are risks in all systems, processes and functions. Risk-based thinking ensures these risks are determined, considered and controlled throughout the design and use of the quality management system. Risk-based thinking has been implicit in previous editions of ISO 9001 in such requirements as determining the type and extent of control for external providers based on the effect of the product that is going to be provided, or taking corrective action based on the potential effect of an identified nonconformity. In addition, in previous editions of ISO 9001, a clause on preventive action was included. By using risk-based thinking the consideration of risk is integral. It becomes proactive rather than reactive in preventing or reducing undesired effects through early identification and action. Preventive action is built-in when a management system is risk-based. The text of the ISO 9002 has been approved as suitable for publication as 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. In this standard, normative reference appears to certain International Standard, for which Indian Standard also exists. The corresponding Indian Standard which is to be substituted in its place is listed below along with its degree of equivalence: International Standard ISO 9000:2015 Quality Fundamentals and vocabulary ISO 9001:2015 Quality Requirements Corresponding Indian Standard IS/ISO 9000:2015 Quality Fundamentals and vocabulary IS/ISO 9001:2015 Quality Requirements Degree of Equivalence Identical Identical

6 Note: The technical content of the document is not available on website. For details, please refer the ISO/TS 9002:2016 or kindly contact: Head Management and Systems Department Bureau of Indian Standards Manak Bhawan 9, B.S. Zafar Marg New Delhi Telephone/Fax: