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1、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 the scope of t
2、he 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 and authoritie
3、s6 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 resources.7.1
4、.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 Customer communicat
5、ion.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.8.3.3 Design and
6、 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.8.5 Producti
7、on 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 Control of n
8、onconforming 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.10 Improvem
9、ent.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 176.Bibliog
10、raphy.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 implementing a quality
11、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 opportunities associa
12、ted 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 in the struc
13、ture 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 Stand
14、ard 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 interactions.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 factor
