Documented information

documents and records in ISO 9001

ISO 9001:2015 uses “documented information” for both documents (to be maintained, such as procedures and instructions) and records (to be retained as evidence). It removed the mandatory quality manual and the list of required procedures.

The organisation decides how much documentation it needs, depending on size, complexity, competence of people and the risk of errors.

Calculate it

ISO 9001 Internal Audit: Clause 4 to 10 checklist with minor / major findings, actions and PDF.

Related terms

• QMS: quality management system
• Traceability: following a product through its history