ISO/DIS 9001:2015, Clause 0.3

ISO 9001:2008 states that it promotes the adoption of a process approach, but it seems to be more an encouragement than a requirement. Clause 0.3 of the draft ISO 9001:2015 standard now refers to specific requirements that are essential for a process approach.

Process Approach

  • Consistent and predictable results are achieved more effectively and efficiently when:
    • Activities are understood
    • Managed as interrelated processes
    • Function as a coherent system
  • ISO 9001 promotes use of the process approach to develop, implement, and improve the effectiveness of the system
  • Clause 4.4 includes requirements “essential” for the adoption of a process approach

Definitions
A process is defined as a set of interrelated or interacting activities which transforms inputs into outputs.
The process approach applies systematic definition and management of processes and their interactions to achieve the intended results in accordance with the quality policy and strategic direction of the organization.

PDCA Methodology

Management of the processes and the system as a whole can be achieved using the PDCA methodology. Clause 0.3 refers the reader to clause 0.4, Plan-Do-Check-Act Cycle, for more information.

Risk-Based Thinking

Management of the processes and the system as a whole should focus on risk-based thinking to prevent undesirable outcomes. Clause 0.3 refers the reader to clause 0.5, Risk-Based Thinking, for more details.

Benefits

Use of the process approach helps:

  • Understand and consistently meet requirements
  • Consider processes in terms of added value
  • Achieve effective process performance
  • Improve processes based on data evaluation

Process Model
The Process Model from ISO 9001:2008 has been revised as Figure 1 in clause 0.3 of the draft ISO 9001:2015 standard. The diagram now shows the process linkages to the requirement clauses and uses the new terminology:

5. Leadership replaces Management Responsibility
6. Planning replaces Resource Management
8. Operations replaces Product Realization
9. Performance Evaluation replaces Measurement, Analysis, and Improvement

Clause 7, Support Processes, has been added to the diagram as the foundation for the whole quality management system. Continual Improvement was a concept on the ISO 9001:2008 process model, but it is now shown as requirement clause 10.