What is ISO 9001?
In short
ISO 9001 is the international standard for a quality management system: the way an organisation documents, carries out, measures and improves its processes so customers get what was agreed. An independent certification body can check whether an organisation meets the standard.
What does ISO 9001 require?
ISO 9001 does not prescribe how you do your work, but it does require that you control it. Among other things, the standard asks that an organisation:
- knows what customers and other stakeholders expect;
- describes its processes, with who is responsible for what;
- maps risks and opportunities;
- measures whether it achieves its objectives, with internal audits and a management review;
- records nonconformities and complaints, tackles the cause and keeps improving.
Which version applies?
The familiar version is ISO 9001:2015, with a small amendment from 2024 on climate change. A revised version, ISO 9001:2026, was scheduled for September 2026. According to the certification body LRQA, a transition period of three years is expected, during which certificates to the 2015 version remain valid.
What does a certificate say?
A certification body, accredited in the Netherlands by the Dutch Accreditation Council (RvA), uses audits to check whether the organisation meets the standard. Customers and clients often ask for it, for example in tenders. The certificate says something about how well controlled an organisation's work is, not about the quality of a single product.
How does software help?
A quality system produces many documents and actions: procedures, work instructions, audit reports, complaints and improvement actions. Quality management software tracks what is outstanding and whose turn it is, and stores documents with version control like a DMS. It often combines with information security under ISO 27001, which has the same structure.
Which software helps with this?
Quality management software records procedures, nonconformities, audits and improvement actions and tracks who has to do what. Many organisations start with documents in a DMS and switch when the number of actions and audits grows.
Compare in the category
Including Zenya Software, Metaware platform and ISO2HANDLE.