ANSI ANS 9001-2015 Quality management systems - Requirements.pdf

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1、AMERICAN NATIONAL STANDARDOCTOBER 2015ASQ/ANSI/ISO 9001:2015Quality management systems RequirementsThis standard is an identical adoption of ISO 9001:2015AMERICAN NATIONAL STANDARD Quality management systems Requirements Approved as an American National Standard onOctober 21, 2015 American National

2、Standards: An American National Standard implies a consensus of those substantially concerned with its scope and provisions. An American National Standard is intended as a guide to aid the manufacturer, the consumer, and the general public. The existence of an American National Standard does not in

3、any respect preclude anyone, whether he or she has approved the standard or not, from manufacturing, purchasing, or using products, processes, or procedures not conforming to the standard. American National Standards are subject to periodic review and users are cautioned to obtain the latest edition

4、. Caution Notice: This American National Standard may be revised or withdrawn at any time. The procedures of the American National Standards Institute require that action be taken to reaffirm, revise, or withdraw this standard no later than five years from the date of publication. Purchasers of Amer

5、ican National Standards may receive current information on all standards by calling of writing the American National Standards Institute. ASQ/ANSI/ISO 9001:2015i 2015 by ASQCopyright Protection Notice for the ASQ/ANSI/ISO 9001:2015 Standard. This standard is subject to copyright claims of ISO, ANSI,

6、 and ASQ. Not for resale. No part of this publication may be reproduced in any form, including an electronic retrieval system, without the prior written permission of ASQ. All requests pertaining to the ASQ/ANSI/ISO 9001:2015Standard should be submitted to ASQ.Note: As used in this document, the ter

7、m “International Standard” refers to the American National Standard adoption of this and other International Standards.ASQ will consider requests for change and information on the submittal of such requests regarding this Standard. All requests should be in writing to the attention of the Standards

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11、tomers. In the unlikely event that a problem relating to it is found, please inform ASQ at the address below.ASQ/ANSI/ISO 9001:2015iiASQ/ANSI/ISO 9001:2015 Foreword vIntroduction vi1 Scope .12 Normative references 13 Terms and definitions .14 Context of the organization .14.1 Understanding the organ

12、ization and its context .14.2 Understanding the needs and expectations of interested parties 24.3 Determining the scope of the quality management system .24.4 Quality management system and its processes 25 Leadership 35.1 Leadership and commitment .35.1.1 General35.1.2 Customer focus 35.2 Policy .45

13、.2.1 Establishing the quality policy .45.2.2 Communicating the quality policy 45.3 Organizational roles, responsibilities and authorities46 Planning .46.1 Actions to address risks and opportunities .46.2 Quality objectives and planning to achieve them 56.3 Planning of changes 57 Support .67.1 Resour

14、ces .67.1.1 General67.1.2 People 67.1.3 Infrastructure .67.1.4 Environment for the operation of processes .67.1.5 Monitoring and measuring resources .77.1.6 Organizational knowledge .77.2 Competence .87.3 Awareness .87.4 Communication 87.5 Documented information .87.5.1 General87.5.2 Creating and up

15、dating .97.5.3 Control of documented information .98 Operation .98.1 Operational planning and control 98.2 Requirements for products and services 108.2.1 Customer communication .108.2.2 Determining the requirements for products and services .108.2.3 Review of the requirements for products and servic

16、es 108.2.4 Changes to requirements for products and services .118.3 Design and development of products and services 118.3.1 General.118.3.2 Design and development planning 118.3.3 Design and development inputs 118.3.4 Design and development controls .128.3.5 Design and development outputs 128.3.6 De

17、sign and development changes 12iiiContents PageASQ/ANSI/ISO 9001:20158.4 Control of externally provided processes, products and services .138.4.1 General.138.4.2 Type and extent of control 138.4.3 Information for external providers .138.5 Production and service provision 148.5.1 Control of productio

18、n and service provision 148.5.2 Identification and traceability .148.5.3 Property belonging to customers or external providers 158.5.4 Preservation 158.5.5 Post-delivery activities 158.5.6 Control of changes .158.6 Release of products and services .158.7 Control of nonconforming outputs .169 Perform

19、ance evaluation 169.1 Monitoring, measurement, analysis and evaluation 169.1.1 General.169.1.2 Customer satisfaction .179.1.3 Analysis and evaluation 179.2 Internal audit .179.3 Management review 189.3.1 General.189.3.2 Management review inputs .189.3.3 Management review outputs .1810 Improvement .1

20、910.1 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 quality management systems developed by ISO/TC 176 .

21、25Bibliography .28iv ForewordISO (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 s

22、ubject for which a technical committee has been established 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

23、(IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should b

24、e noted. This document was drafted in accordance with the editorial 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 of patent rights. ISO shall not be held responsible for identif

25、ying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenienc

26、e of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the fo

27、llowing URL: www.iso.org/iso/foreword.html.The committee responsible for this document is Technical Committee ISO/TC 176, Quality management and quality assurance, Subcommittee SC 2, Quality systems.This fifth edition cancels and replaces the fourth edition (ISO 9001:2008), which has been technicall

28、y revised, through the adoption of a revised clause sequence and the adaptation of the revised quality management principles and of new concepts. It also cancels and replaces the Technical Corrigendum ISO 9001:2008/Cor.1:2009.ASQ/ANSI/ISO 9001:2015 vIntroduction0.1 GeneralThe adoption of a quality m

29、anagement system is a strategic decision for an organization that can help to 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 this International Standard a

30、re:a) the ability to consistently provide products and services that meet customer and applicablestatutory and regulatory requirements;b) facilitating opportunities to enhance customer satisfaction;c) addressing risks and opportunities associated with its context and objectives;d) the ability to dem

31、onstrate 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 o

32、f 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 are complementary to requirements for products and se

33、rvices.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

34、 are adequately resourced and managed, and that opportunities for improvement are determined and acted on.Risk-based thinking enables an organization to determine the factors that could cause its processes and its quality management system to deviate from the planned results, to put in place prevent

35、ive controls to minimize negative effects and to make maximum use of opportunities as they arise (see Clause A.4).Consistently meeting requirements and addressing future needs and expectations poses a challenge for organizations in an increasingly dynamic and complex environment. To achieve this obj

36、ective, the organization might find it necessary to adopt various forms of improvement in addition to correction and continual improvement, such as breakthrough change, innovation and re-organization.In this International Standard, the following verbal forms are used: “shall” indicates a requirement

37、; “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 associated requirement.ASQ/ANSI/ISO 9001:2015vi 0.2 Quality management principlesThis International Stand

38、ard 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 important for the organization, some examples of benefits associated with the principle and examples of typical actions to improve the

39、organizations 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.0.3 Process approach0.3.1 GeneralThis International Standard promotes

40、the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements. Specific requirements considered essential to the adoption of a process approach are included in 4.4.Und

41、erstanding and managing interrelated processes as a system contributes to the organizations effectiveness and efficiency in achieving its intended results. This approach enables the organization to control the interrelationships and interdependencies among the processes of the system, so that the ov

42、erall performance of the organization can be enhanced.The process approach involves the systematic definition and management of processes, and their interactions, so as to achieve the intended results in accordance with the quality policy and strategic direction of the organization. Management of th

43、e processes and the system as a whole can be achieved 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

44、:a) understanding and consistency in meeting requirements;b) the consideration of processes in terms of added value;c) the achievement of effective process performance;d) improvement of processes based on evaluation of data and information.Figure 1 gives a schematic representation of any process and

45、 shows the interaction of its elements. The monitoring and measuring check points, which are necessary for control, are specific to each process and will vary depending on the related risks.ASQ/ANSI/ISO 9001:2015 viiFigure 1 Schematic representation of the elements of a single process0.3.2 Plan-Do-C

46、heck-Act cycleThe PDCA cycle can be applied to all processes and to the quality management system as a whole. Figure 2 illustrates how Clauses 4 to 10 can be grouped in relation to the PDCA cycle.NOTE Numbers in brackets refer to the clauses in this International Standard.Figure 2 Representation of

47、the structure of this International Standard in the PDCA cycleASQ/ANSI/ISO 9001:2015viii The PDCA cycle can be briefly described as follows: Plan: establish the objectives of the system and its processes, and the resources needed to deliver results in accordance with customers requirements and the o

48、rganizations policies, and identify and address risks and opportunities; Do: implement what was planned; Check: monitor and (where applicable) measure processes and the resulting products and services against policies, objectives, requirements and planned activities, and report the results; Act: tak

49、e actions to improve performance, as necessary.0.3.3 Risk-based thinkingRisk-based thinking (see Clause A.4) is essential for achieving an effective quality management system. The concept of risk-based thinking has been implicit in previous editions of this International Standard including, for example, carrying out preventive action to eliminate potential nonconformities, analysing any nonconformities that do occur, and taking action to prevent recurrence that is appropriate for the effects of the nonconformity.To conform to the requirements of this Inte