Changes for page X0200 - Overview of the CEC Certification Process

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231	231	== 4.1 Schedule CEC Assessment ==
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	233	+| |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|
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	235	+== 4.2 Conduct CEC Assessment ==
	236	+)))
	237	+|CEC Assessment Conference Call|(((
	238	+CEC Assessments are normally conducted as remote audits.
	239	+
	240	+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.
	241	+
	242	+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.
	243	+
	244	+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.
	245	+)))| |cecAP
	246	+|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.|(((
	247	+The CEC Assessor amends the cecAP to include the CEC Assessor's findings and notes. The CEC Assessor determines compliance levels for each requirements.
	248	+
	249	+In case of findings, the CEC Assessor, using the CAP worksheet in the cecAP, requests the Vendor to define corrective actions.
	250	+)))|
	251	+|Complete corrective actions|(((
	252	+To qualify for Validation, the cecAP must show a conformity at the Program Level of 100%.
	253	+
	254	+If the CEC Assessor determines Non-Conformities at the Program Level, then the Vendor must complete the related corrective actions and provide supporting evidences before the cecAP can be submitted to the CEC Administration for Validation and Certification.
	255	+)))| |
	256	+|Submit CEC Assessment Report to CEC Administration| |The CEC Assessor submits the cecAP to CEC Administration for Validation.|
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