Why is quality assessment procedure required?
According to “Directions Governing Type Verification of Machinery, Equipment and Tools” stipulated by Ministry of Labor, quality assessment procedure are required to inspect and ensure manufacturing capability of factories. The working principles and requirement for quality assessment follow “Regulations Governing the Surveillance of Machinery, Equipment and Appliances”. Note that practical methods to conduct quality assessment depends on the operational procedures made by type verification institutes.
Is the quality assessment procedure by ITRI equal to so-called the factory
audit as in regular certification scheme?
Most certification procedures and schemes (e.g, IECEx or ATEX) require factory audit. In ITRI Type Verification Approval scheme, factory audit is not always necessary and several alternative options are provided for applicants to fulfill ITRI quality assessment procedure.
How does ITRI conduct quality assessment for foreign manufacturers?
Foreign manufacturers can provide valid IECEx QAR, ATEX QAN or other relevant documents that indicates the conformity in manufacturing quality procedure and system. Alternatively, foreign CBs can conduct factory audit on behalf of ITRI in overseas locations. If the above factory visits are not available, product batch inspection or testing could be required.