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Glossary · ISO 9001 clause 4.4

Process approach in ISO 9001

The process approach views a company as a network of interrelated processes rather than a collection of departments. ISO 9001 clause 4.4 requires you to determine the processes needed for the QMS, their inputs and outputs, sequence and interactions, criteria, resources, responsibilities, risks and opportunities, and to evaluate and improve them.

  • ISO 9001 clause 4.4
  • Processes, not departments
  • Based on PDCA
Updated 13 October 20262 min read

The building blocks

  • Process map: shows management, core and support processes and how they connect.
  • Process owners: one person per process responsible for results and improvement.
  • Inputs and outputs: what goes into a process and what comes out, including at interfaces with other processes.
  • Criteria and metrics: how you can tell the process is effective.
  • Risks and opportunities: what can threaten or improve the process.

A compact way to describe all building blocks of a process on one page is the turtle diagram.

An example

The core process “order to delivery” starts with the customer enquiry and ends with delivery. It touches sales, planning, purchasing, production and shipping. Department thinking optimises each area on its own; the process approach asks how long the whole flow takes and where information gets lost at interfaces. A process owner sees the whole and steers through metrics such as lead time and on-time delivery.

Common mistakes

  • The process map mirrors the org chart instead of value creation.
  • Too many, too small processes nobody can keep track of.
  • Processes without metrics, so their effectiveness cannot be evaluated.
  • Interfaces are described but nobody is responsible for them.

Why the approach pays off

Most errors do not arise within one department but at handovers: incomplete orders from sales, missing information for purchasing, unclear inspection requirements for production. The process approach makes these handovers visible and assigns responsibility for them. It also helps put resources where they do the most for the overall result.

Implementing it in docxpert

In process management you create processes with owners and link them to their documents. The “Process map and interactions” template from the template library helps with the description. Traceability shows which requirements a process covers.

Frequently asked questions

How many processes should an SME have?

Ten to twenty processes are often enough. What matters is that each process has an owner and measurable criteria.

Do I have to describe every process?

ISO 9001 requires documented information to the extent necessary to support the operation of processes. Not every process needs a detailed procedure.

What is the difference between a process and a procedure?

A process describes what happens and with what result. A procedure is the specified way to carry out a process or activity.

How does the process approach relate to PDCA?

Each process is planned, operated, evaluated and improved according to the [PDCA cycle](content:term-pdca).

Free checklist

ISO 9001 internal audit checklist

Audit questions for clauses 4 to 10 – to tick off and download as PDF.