ISO 9001 promotes the application of the process approach in the implementation of a QMS, where a process or a system of processes is managed by controlling its inputs, outputs and activities. This approach is fundamentally adopted (in whole) from the Shewhart/Deming Cycle of "Plan-Do-Check-Act". The following is the application of the approach/philosophy/concept/cycle in terms of ISO 9001 clauses:

Plan

  • 5.3 Quality policy
  • 5.4.2 Quality management system planning
  • 7.1 Planning of product realization
  • 7.3.1 Design and development planning
  • 7.5.1 Control of production and service provision
  • 8.1 General (measurement, analysis, and improvement)
Do
  • 4.1 General requirements
  • 4.2.1 General (documentation requirements)
  • 4.2.2 Quality manual
  • 4.2.3 Control of documents
  • 4.2.4 Control of records
  • 5.1 Management commitment
  • 5.2 Customer focus
  • 5.4.1 Quality objectives
  • 5.5.1 Responsibility and authority
  • 5.5.2 Management representative
  • 5.5.3 Internal communication
  • 6.1 Provision of resources
  • 6.2 Human resources
  • 6.3 Infrastructure
  • 6.4 Work environment
  • 7.2.1 Determination of requirements related to the product
  • 7.2.2 Review of requirements related to the product
  • 7.2.3 Customer communication
  • 7.3.2 Design and development inputs
  • 7.3.3 Design and development outputs
  • 7.4 Purchasing
  • 7.5.3 Identification and traceability
  • 7.5.4 Customer property
  • 7.5.5 Preservation of product
  • 7.6 Control of monitoring and measuring devices
  • 8.2.4 Monitoring and measurement of product
  • 8.5.1 Continual improvement.
Check
  • 5.6 Management review
  • 7.3.5 Design and development verification
  • 7.3.6 Design and development validation
  • 7.5.2 Validation of processes for production and service provision
  • 8.2.1 Customer satisfaction
  • 8.2.2 Internal audit
  • 8.4 Analysis of data.
Act
  • 7.3.4 Design and development review
  • 7.3.7 Control of design and development changes
  • 8.2.3 Monitoring and measurement of processes
  • 8.3 Control of nonconforming product
  • 8.5.2 Corrective action
  • 8.5.3 Preventive action