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ISO/TSTECHNICALThis is a preview of "ISO/TS 22163:2017". Click here to purchase the full version from the ANSI store.SPECIFICATION22163First edition2017-05Railway applications — Qualitymanagement system — Businessmanagement system requirementsfor rail organizations: ISO 9001:2015and particular requirements forapplication in the rail sectorApplications ferroviaires — Système de management de la qualité —Exigences liées au système de management de l’activité à destinationdes organismes ferroviaires: ISO 9001:2015 et exigences particulièresconcernant les applications dans le secteur ferroviaireReference numberISO/TS 22163:2017(E) ISO 2017

ISO/TS 22163:2017(E) This is a preview of "ISO/TS 22163:2017". Click here to purchase the full version from the ANSI store.COPYRIGHT PROTECTED DOCUMENT ISO 2017, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any formor by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without priorwritten permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country ofthe requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. 41 22 749 01 11Fax 41 22 749 09 47copyright@iso.orgwww.iso.orgii ISO 2017 – All rights reserved

ISO/TS 22163:2017(E) This is a preview of "ISO/TS 22163:2017". Click here to purchase the full version from the ANSI store.Contents PageForeword. vi012345678Introduction. viiScope. 11.1Scope — Supplemental. 1Normative references. 2Terms and definitions. 23.1Terms and definitions for the rail sector. 23.2Abbreviations. 7Context of the organization. 84.1Understanding the organization and its context. 84.2Understanding the needs and expectations of interested parties. 84.3Determining the scope of the quality management system. 94.4Quality management system and its processes. 104.4.3Quality management system and its processes — Supplemental. 10Leadership. 115.1Leadership and commitment. 115.1.1General. 115.1.2Customer focus. 115.2Policy. 125.2.1Establishing the quality policy. 125.2.2Communicating the quality policy. 125.2.3Quality policy — Supplemental. 125.2.4Safety policy. 125.3Organizational roles, responsibilities and authorities. 135.3.1Organizational roles, responsibilities and authorities — Supplemental. 135.3.2Responsibilities and authorities of process owners. 13Planning. 146.1Actions to address risks and opportunities. 146.1.3Actions to address risks and opportunities — Supplemental. 146.1.4Contingency planning. 156.2Quality objectives and planning to achieve them. 156.3Planning of changes. 166.4Business planning. 16Support. 177.1Resources. 177.1.1General. 177.1.2People. 177.1.3Infrastructure. 187.1.4Environment for the operation of processes. 187.1.5Monitoring and measuring resources. 187.1.6Organizational knowledge. 207.2Competence. 217.2.1Competence — Supplemental. 217.3Awareness. 227.3.1Awareness — Supplemental. 227.4Communication. 227.5Documented information. 237.5.1General. 237.5.2Creating and updating. 237.5.3Control of documented information. 24Operation. 25 ISO 2017 – All rights reserved iii

ISO/TS 22163:2017(E) This is a preview of "ISO/TS 22163:2017". Click here to purchase the full version from the ANSI store. planning and control. 258.1.1Planning for the outsourcing or transfer of processes. 258.1.2Tender management. 268.1.3Project management. 268.1.4Configuration management. 308.1.5Change management. 31Requirements for products and services. 338.2.1Customer communication. 338.2.2Determining the requirements related to products and services. 338.2.3Review of requirements related to products and services. 348.2.4Changes to requirements for products and services. 348.2.5Requirements for products and services — Supplemental. 34Design and development of products and services. 358.3.1General. 358.3.2Design and development planning. 368.3.3Design and development inputs. 378.3.4Design and development controls. 388.3.5Design and development outputs. 408.3.6Design and development changes. 41Control of externally provided processes, products and services. 418.4.1General. 418.4.2Type and extent of control. 448.4.3Information for external providers. 468.4.4Supply chain management. 47Production and service provision. 488.5.1Control of production and service provision. 488.5.2Identification and traceability. 518.5.3Property belonging to customers or external providers. 528.5.4Preservation. 528.5.5Post-delivery activities. 538.5.6Control of changes. 548.5.7Production scheduling. 54Release of products and services. 558.6.1Release of products and services — Supplemental. 55Control of nonconforming outputs. 568.7.3Control of nonconforming outputs — Supplemental. 56RAMS / LCC. 57First article inspection. 58Obsolescence management. 58Innovation management. 59Performance evaluation.599.1Monitoring, measurement, analysis and evaluation. 599.1.1General. 599.1.2Customer satisfaction. 619.1.3Analysis and evaluation. 619.2Internal audit. 629.2.3Internal audit — Supplemental. 629.3Management review. 639.3.1General. 639.3.2Management review inputs. 649.3.3Management review outputs. 659.4Process reviews. 65Improvement.6610.1 General. 6610.2 Nonconformity and corrective action. 6710.2.3 Nonconformity and corrective action — Supplemental. 6710.3 Continual improvement. 68 ISO 2017 – All rights reserved

ISO/TS 22163:2017(E) This is a preview of "ISO/TS 22163:2017". Click here to purchase the full version from the ANSI store.Bibliography. 69 ISO 2017 – All rights reserved v

ISO/TS 22163:2017(E) This is a preview of "ISO/TS 22163:2017". Click here to purchase the full version from the ANSI store.ForewordISO (the International Organization for Standardization) is a worldwide federation of national standardsbodies (ISO member bodies). The work of preparing International Standards is normally carried outthrough ISO technical committees. Each member body interested in a subject for which a technicalcommittee has been established has the right to be represented on that committee. Internationalorganizations, 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 ofelectrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance aredescribed in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for thedifferent types of ISO documents should be noted. This document was drafted in accordance with theeditorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).Attention is drawn to the possibility that some of the elements of this document may be the subject ofpatent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details ofany patent rights identified during the development of the document will be in the Introduction and/oron the ISO list of patent declarations received (see www .iso .org/ patents).Any trade name used in this document is information given for the convenience of users and does notconstitute an endorsement.For an explanation on the voluntary nature of standards, the meaning of ISO specific terms andexpressions related to conformity assessment, as well as information about ISO’s adherence to theWorld Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the followingURL: www .iso .org/ iso/ foreword .html.This document was prepared by Technical Committee ISO/TC 269, Railway applications.The aim of this document, which has been prepared by UNIFE, the European Rail Industry Association,is the development and continual improvement of a business management system to ensure productquality and safety in the global rail sector.The content inside the boxed text of this document is ISO 9001:2015 text. The text outside the boxes hasbeen originated by the UNIFE, IRIS Certification working group.Whenever the ISO 9001:2015 text in this document refers to “quality management system”, thisterm is understood hereinafter as “business management system”, not limited to quality, so that itencompasses all business processes of the organization. Therefore, in the supplemental rail sectorspecific requirements, the term “business management system” is used outside the boxed text.Whenever the ISO 9001:2015 text refers to “this International Standard”, this applies to this document,including the text outside the boxes.Whenever this document refers to clause numbers, it is to be understood that all the requirementsunder this clause including sub-clauses are to be considered.Whenever this document refers to “safety”, the term is to be understood as “product safety”, not to beconfused with “occupational safety”.Whenever the ISO 9001:2015 text in this document refers to “quality policy” or “quality objectives”these terms apply to “safety policy” or “safety objectives” accordingly.Whenever this document requires documented processes (e.g. calibration and production), theseprocesses can be defined within a single documented process (e.g. both defined within a “productionmanagement” process).vi ISO 2017 – All rights reserved

ISO/TS 22163:2017(E) This is a preview of "ISO/TS 22163:2017". Click here to purchase the full version from the ANSI store.0Introduction0.1   GeneralISO 9001:2015, Quality management systems — Requirements0.1   GeneralThe adoption of a quality management system is a strategic decision for an organization that canhelp to improve its overall performance and provide a sound basis for sustainable developmentinitiatives.The potential benefits to an organization of implementing a quality management system based onthis International Standard are:a)the ability to consistently provide products and services that meet customer and applicablestatutory and regulatory requirements;c)addressing risks and opportunities associated with its context and objectives;b) facilitating opportunities to enhance customer satisfaction;d) the ability to demonstrate conformity to specified quality management system requirements.This International Standard can be used by internal and external parties.It is not the intent of this International Standard to imply the need for:— uniformity in the structure of different quality management systems;— alignment of documentation to the clause structure of this International Standard;— the use of the specific terminology of this International Standard within the organization.The quality management system requirements specified in this International Standard arecomplementary to requirements for products and services.This International Standard employs the process approach, which incorporates the Plan-Do-CheckAct (PDCA) cycle and risk-based thinking.The process approach enables an organization to plan its processes and their interactions.The PDCA cycle enables an organization to ensure that its processes are adequately resourced andmanaged, and that opportunities for improvement are determined and acted on.Risk-based thinking enables an organization to determine the factors that could cause its processesand its quality management system to deviate from the planned results, to put in place preventivecontrols to minimize negative effects and to make maximum use of opportunities as they arise (seeClause A.4). ISO 2017 – All rights reserved vii

ISO/TS 22163:2017(E) This is a preview of "ISO/TS 22163:2017". Click here to purchase the full version from the ANSI store.Consistently meeting requirements and addressing future needs and expectations poses a challengefor organizations in an increasingly dynamic and complex environment. To achieve this objective, theorganization might find it necessary to adopt various forms of improvement in addition to correctionand continual improvement, such as breakthrough change, innovation and re-organization.In this International Standard, the following verbal forms are used:— “shall” indicates a requirement;— “should” indicates a recommendation;— “may” indicates a permission;— “can” indicates a possibility or a capability.Information marked as “NOTE” is for guidance in understanding or clarifying the associatedrequirement.0.2   Quality management principlesISO 9001:2015, Quality management systems — Requirements0.2   Quality management principlesThis International Standard is based on the quality management principles described in ISO 9000.The descriptions include a statement of each principle, a rationale of why the principle is importantfor the organization, some examples of benefits associated with the principle and examples of typicalactions to improve the organization’s performance when applying the principle.The quality management principles are:— customer focus;— leadership;— engagement of people;— process approach;— improvement;— evidence-based decision making;— relationship management.viii ISO 2017 – All rights reserved

ISO/TS 22163:2017(E) This is a preview of "ISO/TS 22163:2017". Click here to purchase the full version from the ANSI store.0.3   Process approach0.3.1   GeneralISO 9001:2015, Quality management systems — Requirements0.3   Process approach0.3.1   GeneralThis International Standard promotes the adoption of a process approach when developing,implementing and improving the effectiveness of a quality management system, to enhance customersatisfaction by meeting customer requirements. Specific requirements considered essential to theadoption of a process approach are included in 4.4.Understanding and managing interrelated processes as a system contributes to the organization’seffectiveness and efficiency in achieving its intended results. This approach enables the organizationto control the interrelationships and interdependencies among the processes of the system, so thatthe overall performance of the organization can be enhanced.The process approach involves the systematic definition and management of processes, and theirinteractions, so as to achieve the intended results in accordance with the quality policy and strategicdirection of the organization. Management of the processes and the system as a whole can beachieved using the PDCA cycle (see 0.3.2) with an overall focus on risk-based thinking (see 0.3.3)aimed at taking advantage of opportunities and preventing undesirable results.The application of the process approach in a quality management system enables:a)understanding and consistency in meeting requirements;c)the achievement of effective process performance;b) the consideration of processes in terms of added value;d) improvement of processes based on evaluation of data and information.Figure 1 gives a schematic representation of any process and shows the interaction of its elements.The mo

ISO/TS 22163:2017(E) 0 Introduction 0.1eneral G ISO001:2015, Quality management systems — Requirements 9 0.1 General The adoption of a quality management system is a strategic decision for an organization that can

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