INTERNATIONAL ISO This Is A Preview Of ISO 9001:2015 .

ISOINTERNATIONALThis is a preview of "ISO 9001:2015". Click here to purchase the full version from the ANSI store.STANDARD9001Fifth edition2015-09-15Quality management systems —RequirementsSystèmes de management de la qualité — ExigencesReference numberISO 9001:2015(E) ISO 2015

ISO 9001:2015(E) This is a preview of "ISO 9001:2015". Click here to purchase the full version from the ANSI store.COPYRIGHT PROTECTED DOCUMENT ISO 2015, 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 2015 – All rights reserved

ISO 9001:2015(E) This is a preview of "ISO 9001:2015". Click here to purchase the full version from the ANSI store.Contents PageForeword.vIntroduction. vi12345678Scope. 1Normative references. 1Terms and definitions. 1Context of the organization. 14.1Understanding the organization and its context. 1Understanding the needs and expectations of interested parties. 24.24.3Determining the scope of the quality management system. 24.4Quality management system and its processes. 2Leadership. 35.1Leadership and commitment. 35.1.1General. 35.1.2Customer focus. 3Policy. 45.25.2.1Establishing the quality policy. 4Communicating the quality policy. 45.2.25.3Organizational roles, responsibilities and authorities. 4Planning. 4Actions to address risks and opportunities. 46.16.2Quality objectives and planning to achieve them. 56.3Planning of changes. 5Support. 6Resources. 67.17.1.1General. 67.1.2People. 6Infrastructure. 67.1.37.1.4Environment for the operation of processes. 6Monitoring and measuring resources. 77.1.57.1.6Organizational knowledge. 77.2Competence. 8Awareness. 87.37.4Communication. 8Documented information. 87.57.5.1General. 87.5.2Creating and updating. 97.5.3Control of documented information. 9Operation. 98.1Operational planning and control. 98.2Requirements for products and services. 108.2.1Customer communication. 108.2.2Determining the requirements for products and services. 108.2.3Review of the requirements for products and services. 108.2.4Changes to requirements for products and services. 118.3Design and development of products and services. 118.3.1General. 118.3.2Design and development planning. 118.3.3Design and development inputs. 118.3.4Design and development controls. 128.3.5Design and development outputs. 128.3.6Design and development changes. 12 ISO 2015 – All rights reserved iii

ISO 9001:2015(E) This is a preview of "ISO 9001:2015". Click here to purchase the full version from the ANSI store.8.48.59108.68.7Control of externally provided processes, products and services. 138.4.1General. 138.4.2Type and extent of control. 138.4.3Information for external providers. 13Production and service provision. 14Control of production and service provision. 148.5.18.5.2Identification and traceability. 148.5.3Property belonging to customers or external providers. 158.5.4Preservation. 158.5.5Post-delivery activities. 15Control of changes. 158.5.6Release of products and services. 15Control of nonconforming outputs. 16Performance evaluation.16Monitoring, measurement, analysis and evaluation. 169.19.1.1General. 169.1.2Customer satisfaction. 179.1.3Analysis and evaluation. 179.2Internal audit. 17Management review. 189.39.3.1General. 189.3.2Management review inputs. 189.3.3Management review outputs. 18Improvement.1910.1 General. 1910.2 Nonconformity and corrective action. 1910.3 Continual improvement. 19Annex A (informative) Clarification of new structure, terminology and concepts.21Annex B (informative) Other International Standards on quality management and qualitymanagement systems developed by ISO/TC 176.25Bibliography. 28iv ISO 2015 – All rights reserved

ISO 9001:2015(E) This is a preview of "ISO 9001:2015". 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 meaning of ISO specific terms and expressions related to conformity assessment,as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in theTechnical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.The committee responsible for this document is Technical Committee ISO/TC 176, Quality managementand quality assurance, Subcommittee SC 2, Quality systems.This fifth edition cancels and replaces the fourth edition (ISO 9001:2008), which has been technicallyrevised, through the adoption of a revised clause sequence and the adaptation of the revised qualitymanagement principles and of new concepts. It also cancels and replaces the Technical CorrigendumISO 9001:2008/Cor.1:2009. ISO 2015 – All rights reserved v

ISO 9001:2015(E) This is a preview of "ISO 9001:2015". Click here to purchase the full version from the ANSI store.Introduction0.1   GeneralThe adoption of a quality management system is a strategic decision for an organization that can helpto improve its overall performance and provide a sound basis for sustainable development initiatives.The potential benefits to an organization of implementing a quality management system based on thisInternational 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-Check-Act(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 i

ISO 9001:2015(E) Foreword ISO (the International Organization 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