Record

Records are evidence, so they are kept as created and generally are not revised like procedures. The risk management file is mostly made of records, and auditors trace requirements through them.

document stating results achieved or providing evidence of activities performed Note 1 to entry: Records can be used, for example, to formalize traceability and to provide evidence of verification, preventive action and corrective action. Note 2 to entry: Generally records need not be under revision control. [SOURCE: ISO 9000:2015, 3.8.10]

ISO 14971:2019, clause 3.16