Correction

A correction is action that fixes a nonconformity you have found: you rework the batch, remove the account, roll back the faulty release. It deals with this instance only. Removing the cause so it does not happen again is corrective action, and a good record keeps the two apart.

Clauses
ISO 27001:2022 10.2 · ISO 9001:2015 10.2 · ISO 13485:2016 8.3 · ISO 42001:2023 10.2

Where the term appears

ISO 27001:2022 10.2, ISO 9001:2015 10.2 and ISO 42001:2023 10.2 open the same way: when a nonconformity occurs, you control it, correct it and deal with its consequences, then decide whether the cause needs action. For medical devices, ISO 13485:2016 8.3 sets out corrections for nonconforming product: identify and segregate it, then decide its fate by rework, concession or scrap, with records of who authorised what. The ISO vocabulary notes that a correction can come before, alongside or after the corrective action.

Containment, correction, then the cause

Containment stops the problem spreading, for example by quarantining stock. Correction fixes what is already wrong. An auditor checks that each has a date and an owner, that the record did not close at the correction, and that the decision on corrective action is written down even when the answer is that none is needed.

How Sted uses it

  • Sted’s knowledge base includes a Corrective and Preventive Actions record template, under its Corrective and Preventive Action Procedure.
  • Records are part of the Full Management System plan.
  • The Corrective and Preventive Actions record keeps containment and corrections in their own section, apart from the corrective actions that remove the cause.
  • Records are part of the Full Management System plan.