How Much Documentation Does ISO 9001:2015 Really Need?
A year after publication, the most common question about ISO 9001:2015 is still about documents. The standard asks for less than many organisations keep, and more than some now assume.
Key points
- ISO 9001:2015 no longer requires a quality manual or six mandatory procedures.
- It still requires documented information in specific clauses, and whatever the organisation needs for effective processes.
- The test is practical: could the process run consistently, and could you prove it did, without the document?
What the standard asks for
The 2015 edition uses one term, documented information. Where the standard says “maintain”, it means a document that is kept up to date, such as the scope, the quality policy and the quality objectives. Where it says “retain”, it means a record that provides evidence, such as calibration results, competence, management review and nonconformities.
What the organisation decides
Beyond those clauses, the organisation decides what it needs. The extent depends on its size, the complexity of its processes and the competence of its people. A complex process run by new staff needs more written support than a simple one run by experienced operators.
A sensible approach
- Do not delete documents only because they are no longer mandatory.
- Remove duplicates and procedures that nobody follows.
- Use flowcharts, forms and system screens as documented information.
- Keep the evidence an auditor, and your own managers, need to trust the process.