ISO 9001:2015 Standard (clause-by-clause)

NOTE: This chapter provides an index of standard requirement for the reader to acknowledge on each of clause of ISO 9001:2015. The input of the content is just extracted from the header or sub-header of the element addressed by the standard.

The user is just only need to click on the respective clause and the requirement of the standard will appear by opening with new window.

Anyway, the full sets of requirement can be referred through this LINK.

 

4. context of the organization

4.1 Understanding the organization and its context

4.2 Understanding the needs and expectations of interested parties

4.3 Determining the scope of the quality management system

4.4 Quality management system and its processes

• 4.4.1 System establishment..

• 4.4.2 Necessity..

5. Leadership

5.1 Leadership and Commitment

• 5.1.1 General

• 5.1.2 Customer focus

5.2 Policy

• 5.2.1 Developing the quality policy

• 5.2.2 Communicating the quality policy

5.3 Organizational Roles, Responsibility and Authorities

6. Planning

6.1 Action to address risks and opportunities

• 6.1.1 When planning for the quality management system, the organization shall..

• 6.1.2 The organization shall plan..

6.2 Quality Objectives and planning to achieve them

• 6.2.1 The organization shall establish..

• 6.2.2 When planning how to achieve..

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

• 7.1.6 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 information

8. Operation

8.1 Operational planning and control

8.2. Requirement for products and services

• 8.2.1 Customer communication

• 8.2.2 Determining the requirements related to products and services

• 8.2.3 Review of requirements related to 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 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 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 providers

• 8.5.4 Preservation

• 8.5.5 Post-delivery activities

• 8.5.6 Control of changes

8.6 Release of products and services

8.7 Control of nonconforming outputs

• 8.7.1 The organization shall ensure that outputs that do not conform..

• 8.7.2 Retain documented information

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

• 9.2.1 Performing an internal audit..

• 9.2.2 Execution of internal audit

9.3 Management Review

• 9.3.1 General

• 9.3.2 Management review inputs

• 9.3.3 Management review outputs

10. Improvement

10.1 General

10.2 Nonconformity and corrective action

• 10.2.1 When a nonconformities occurs..

• 10.2.2 Retain documented information

10.3 Continual Improvement