ISO 9001 中英文.docx

1、ISO 9001 中英文Quality management systems RequirementsISO 9001:2015(E)Introduction.1 Scope.2 Normative references.3 Terms and definitions.4 Context of the organization.4.1 Understanding the organization and its context.4.2 Understanding the needs and expectations of interested parties4.3 Determining th

2、e scope of the quality management system.4.4 Quality management system and its processes.5 Leadership.5.1 Leadership and commitment.5.1.1 General.5.1.2 Customer focus.5.2 Policy.5.2.1 Establishing the quality policy.5.2.2 Communicating the quality policy.5.3 Organizational roles, responsibilities an

3、d authorities6 Planning.6.1 Actions to address risks and opportunities.6.2 Quality objectives and planning to achieve them.6.3 Planning of changes.7 Support.7.1 Resources.7.1.1 General.7.1.2 People.7.1.3 Infrastructure.7.1.4 Environment for the operation of processes.7.1.5 Monitoring and measuring r

4、esources.7.1.6 Organizational knowledge.7.2 Competence.7.3 Awareness.7.4 Communication.7.5 Documented information.7.5.1 General.7.5.2 Creating and updating.7.5.3 Control of documented information8 Operation.8.1 Operational planning and control.8.2 Requirements for products and services.8.2.1 Custome

5、r communication.8.2.2 Determining the requirements for products and services.8.2.3 Review of the requirements for products and services.8.2.4 Changes to requirements for products and services.8.3 Design and development of products and services.8.3.1 General.8.3.2 Design and development planning.8.3.

6、3 Design and development inputs.8.3.4 Design and development controls.8.3.5 Design and development outputs.8.3.6 Design and development changes.8.4 Control of externally provided processes, products and services.8.4.1 General.8.4.2 Type and extent of control.8.4.3 Information for external providers.

7、8.5 Production and service provision.8.5.1 Control of production and service provision.8.5.2 Identification and traceability.8.5.3 Property belonging to customers or external providers8.5.4 Preservation.8.5.5 Post-delivery activities.8.5.6 Control of changes.8.6 Release of products and services.8.7

8、Control of nonconforming outputs.9 Performance evaluation.9.1 Monitoring, measurement, analysis and evaluation.9.1.1 General.9.1.2 Customer satisfaction.9.1.3 Analysis and evaluation.9.2 Internal audit.9.3 Management review.9.3.1 General.9.3.2 Management review inputs.9.3.3 Management review outputs

9、.10 Improvement.10.1 General.10.2 Nonconformity and corrective action.10.3 Continual improvement.Annex A (informative) Clarification of new structure, terminology and concepts.Annex B (informative) Other International Standards on quality management and quality management systems developed by ISO/TC

10、 176.Bibliography.Introduction0.1 GeneralThe adoption of a quality management 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 implementin

11、g a quality management system based on this International Standard are:a) the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements;b) facilitating opportunities to enhance customer satisfaction;c) addressing risks and opportuni

12、ties associated with its context and objectives;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

13、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 Interna

14、tional Standard are complementary 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 interaction

15、s.The PDCA cycle enables an organization to ensure that its processes 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 managemen

16、t system to deviate from the planned results, to put in place preventive 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

17、 an increasingly dynamic and complex environment. To achieve this objective, 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,

18、 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 associated requirement.0.2 Quality m

19、anagement 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 important for the organization, some examples of benefits associated with the principle and

20、 examples of typical actions to improve the 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

21、GeneralThis International Standard promotes 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 o

22、f a process approach are included in 4.4.Understanding 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

23、 the processes of the system, so that the overall 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 dir

24、ection of the organization. Management of the 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 app

25、roach in a quality management system enables: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

26、 schematic representation of any process and 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.Figure 1 Schematic representation of the elements of a single proc

27、ess0.3.2 Plan-Do-Check-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

28、Representation of the structure of this International Standard in the PDCA cycleThe 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 organizati

29、ons 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: take actions

30、 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, carr

31、ying out preventive action to eliminate potential nonconformities, analyzing 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 International Standard, an organization needs to plan and implement actions to ad