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Assessment modules PDF Print E-mail

Conformity assessment flow chart

Module Title Description
A Internal Production Control Internal conformity assessment and production control by the manufacturer himself who draws up a written declaration of conformity containing the information given in Annex XV.
Aa Internal Production Control plus Tests This is module A, plus tests carried out by the manufacturer under the responsibility of the notified body, which issues anexamination report.
 B EC-Type Examination Covers EC-Type Examination; the notified body issues an EC type-examination certificate for a representative production sample which it has assessed in accordance with the Essential Requirements. This module applies only to the design phase and must be followed up by the manufacturer applying a module providing for assessment in the production phase.
C Conformity to Type Covers the manufacturer’s declaration on the basis of conformity to type, approved by the notified body (Module B above)
D Production Quality Assurance Supplements Module B. Derives from Quality Assurance standard EN ISO 9002 with the notified body responsible for approving and controlling the quality system for production, final product inspection and testing set up by the manufacturer.
E Product Quality Assurance Supplements Module B. Derives from Quality Assurance standard EN ISO 9003 with the notified body responsible for approving and controlling the quality system for final product inspection and testing set up by the manufacturer.
F Product Verification Supplements Module B. Covers product verification at the production phase, with the involvement of a notified body, which controls conformity to type and issues the certificate of conformity.
G Unit Verification Covers unit verification of the design and production phase of each product controlled by a notified body, which issues a certificate of conformity.
H Full Quality Assurance Derives from the quality assurance standard EN ISO 9001 with the intervention of a notified body responsible for approving and controlling the quality system for design, production, final product inspection and testing set up by the manufacturer.
 
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