Glossary

Process approach

Treating the organisation as a network of interacting processes — each with defined inputs, outputs, owners, and performance criteria — and managing them as a system.

Source standard: ISO 9001:2015 §0.3, §4.4

The process approach is one of the three pillars of ISO 9001:2015. The 2015 revision elevates it from concept to clause: clause 4.4 requires the organisation to determine the processes needed for the QMS, their sequence and interaction, the criteria and methods to ensure effective operation and control, the resources required, and the responsibilities and authorities for each process.

In practice, this means identifying every process whose output materially affects product or service conformity, then documenting:

• Inputs. What does the process consume?
• Activities. What sequence of work transforms inputs into outputs?
• Outputs. What does the process deliver, and to whom?
• Owner. Who is accountable for the process working as intended?
• Criteria. What must be true for the process output to be acceptable?
• Performance measures. How do we know it is performing?
• Risks and opportunities. What could go wrong; what could be improved?

The process approach is the spine that holds the rest of the standard together. Clause 6.1 risk-based thinking attaches to processes; clause 8 operational controls describe how processes run; clause 9 monitoring measures process performance; clause 10 corrective action restores processes to control when they drift.

A common failure mode is documenting processes once during certification preparation and never revisiting the descriptions as the organisation evolves. Auditors compare the documented process map to how work actually flows; mismatches generate findings.

See: ISO 9001 implementation guide, ISO 9001 quality manual outline, manufacturing SPC inside ISO 9001.

Related terms

• PDCA
• Risk-based thinking
• Process owner
• Quality objective