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Notified body certification is not permanent. Article 44 provides for periodic reassessment, and the notified body may conduct unannounced audits. Annex VII points 5.1 through 5.3 require ongoing surveillance: QMS compliance verification, premises access, and periodic audits with possible additional testing.

Changes to the system that constitute substantial modifications under Article 3(23) may trigger a supplementary assessment. The Conformity Assessment Coordinator maintains a change notification log, submitting notifications to the notified body when changes to the QMS or the system list occur. The notified body then decides whether reassessment is needed.

Organisations must maintain the same documentation discipline and evidence currency after certification as during the initial assessment. A certification that was hard-won through a rigorous assessment process can be lost through post-certification complacency. The continuous assessment model provides the framework for maintaining certification-grade compliance on an ongoing basis.

Key outputs

  • Periodic reassessment and unannounced audit readiness
  • Change notification log submitted to the notified body
  • Post-certification documentation discipline maintained
  • Continuous assessment model as certification maintenance framework
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