new high-level structure

ISO 9001 includes a new structure, changing from eight clauses to ten clauses in the 2015 revision. This change allows the standard to better align with the strategic direction of the business, become more compatible with other management systems, and incorporate a "plan-do-check-act" approach, as shown below.

  1 Scope

2. Citation Standards

3. Terms and Definitions

  plan:

Set goals and establish the processes necessary to achieve results

4. The 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 process

5. Leadership

5.1 Leadership and Commitment

5.2 Policy

5.3 Organizational roles, responsibilities and authorities

6. Planning

6.1 Responses to risks and opportunities

6.2 Quality objectives and planning for their implementation

6.3 Planning for changes

7. Support

7.1 Resources

7.2 Ability

7.3 Consciousness

7.4 Communication

7.5 Documented information

  implement:

The content of the implementation plan

8. Running

8.1 Operational planning and control

8.2 Product and service requirements

8.3 Design and development of products and services

8.4 Control of externally provided processes, products and services

8.5 Production and service provision

8.6 Release of products and services

8.7 Control of Non-Compliant Outputs

  an examination:

Monitor and measure processes and results against objectives, including effectiveness, efficiency, and risk

9. Performance Evaluation

9.1 Monitoring, measurement, analysis and evaluation

9.2 Internal Audit

9.3 Management Review

  deal with:

Take action to improve results

10. Improvements

10.1 General

10.2 Nonconformities and Corrective Actions

10.3 Continuous Improvement

Notes on Implementation

Organizations are not required to reflect the new ten clause structure and terminology in their quality management system documentation. The purpose of the new structure is to clearly present requirements and is not intended to be a template for forming organizational policy, objectives and process documents.

If an organization's quality system documentation is currently structured in line with previous standards, it is encouraged to consider realigning the documentation with its own value stream. Aligning the QMS with the business structure enables organizations to customize documents according to their unique business needs.

Too many organizations impose structures tied to this standard that are neither natural nor easy to understand within the organization.