Labels

• Audit

  Internal/external audit records
• CAPA

  Corrective and preventive actions
• Change

  Implementation of a Change Request
• Change Request

  Proposed QMS-level change needing review or approval
• Improvement

  General improvement actions not requiring CAPA
• Management Review

  Management review records and outputs
• Nonconformance

  Record of non-fulfilment of a requirement
• Objective

  Quality objectives and performance tracking
• Opportunity

  Positive improvement opportunities
• Risk

  Risk identification, evaluation, and mitigation