最新ISO9001中英文.docx

1、最新ISO9001中英文ISO-9001-2022-中英文Quality management systems RequirementsISO 9001:2022(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

2、.3 Determining the 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, re

3、sponsibilities and 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 Monitorin

4、g and measuring resources.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 servi

5、ces.8.2.1 Customer 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 developm

6、ent planning.8.3.3 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 ex

7、ternal providers.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

8、and services.8.7 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 Manageme

9、nt review outputs.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 opportunities for improvement are determined and act

10、ed 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 preventive controls to minimize negative effects and to make maximum use of opportunities as they arise (se

11、e 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 objective, the organization might find it necessary to adopt various forms of improvement in addition t

12、o 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; “should indicates a recommendation; “may indicates a permission; “can indicates a possibility or a

13、capability.Information marked as “NOTE is for guidance in understanding or clarifying the associated requirement.0.2 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

14、 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 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 the adoption of a process approach when developing, im