Changes for page X0200 - Overview of the CEC Certification Process
Last modified by SuperUwe Trueggelmann on 2025-01-07
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... ... @@ -230,6 +230,26 @@ 230 230 |(% colspan="4" %)((( 231 231 == 4.1 Schedule CEC Assessment == 232 232 ))) 233 -|(% colspan="4" %) 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| 234 +|(% colspan="4" %)((( 235 +== 4.2 Conduct CEC Assessment == 236 +))) 237 +|CEC Assessment Conference Call|((( 238 +CEC Assessments are normally conducted as remote audits. 234 234 240 +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 +|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.| 252 +| | | | 253 +| | | | 254 + 235 235