Changes for page X0200 - Overview of the CEC Certification Process

Last modified by SuperUwe Trueggelmann on 2025-01-07

From version < 10.2 >

edited by SuperUwe Trueggelmann
on 2024-07-26

To version < 10.1 >

edited by SuperUwe Trueggelmann
on 2024-07-26

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@@ -230,26 +230,6 @@
  |(% colspan="4" %)(((
  == 4.1 Schedule CEC Assessment ==
  )))
--| |The Vendor accepts the date proposed by CEC Administration, or proposes an alternative date.|CEC Administration proposes a date for the CEC Assessment to the Vendor|
--|(% colspan="4" %)(((
--== 4.2 Conduct CEC Assessment ==
--)))
--|CEC Assessment Conference Call|(((
--CEC Assessments are normally conducted as remote audits.
--
--During a Zoom or Teams call, a CEC Assessor reviews the cecAP and the information provided in the cecAP together with the Vendor. The Vendor provides the relevant evidences.
--
--As a rough guidance, a CEC Assessment takes 3 to 4 hours for the first product, and an additional 1 to 2 hours per additional product and additional manufacturing site. Depending on the complexity of the CEC Assessment, multiple calls may be needed.
--
--CEC Administration may offer on a case by case basis, and upon the Vendor's request, conducting CEC Assessments on-site. This will result in additional cost and the price for on-site CEC assessments cannot be automatically determined using the cecAOF.
--)))| |cecAP
--|Create CEC Assessment Report|If requested by the CEC Assessor, the Vendor defines corrective actions using the CAP worksheet contained in the cecAP and submits these to the CEC Assessor.|(((
--The CEC Assessor amends the cecAP to include the CEC Assessor's findings and notes. The CEC Assessor determines compliance levels for each requirements.
--
--In case of findings, the CEC Assessor, using the CAP worksheet in the cecAP, requests the Vendor to define corrective actions.
--)))|
--|Submit CEC Assessment Report to CEC Administration| |The CEC Assessor submits the cecAP, in case of findings with corrective actions defined by the Vendor in the CAP worksheet, to CEC Administration.|
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