Production Quality Assurance (Module D)

What's production quality assurance?
It consists of the verification of the quality assurance system applied by the Manufacturer for the production, inspection and testing during fabrication and on the finished equipment in order to obtain the reasonable presumption that the marketed equipment conform to the type described in the applicable EC Type Examination Certificate (Module B) and satisfy the requirements of the applicable international standards.
Once the quality assurance system is assessed and found compliant to MED requirements, the relevant Module D certificate is issued with a three year validity period.
The maintenance of Module D is subjected to the satisfactory outcome of the three-years surveillance cycle consisting of the following audits:

• Annual audits of the quality assurance system
• Six-monthly audit of the production line(s) of product(s) certified. These audits are required only for complex or critical products, as decided on a case-by-case basis
• renewal audits of the quality assurance system at the start of a new three-year period.

How to proceed?
The procedure consists of the following main steps:

• Manufacturer's application
• Examination of the EC Type Examination Certificate and the associated technical documentation
• Examination of quality system documentation (including procedures and instructions)
• Execution of initial surveillance audit at Manufacturer premises
• Issuance of the Marine Equipment EC Production Quality Certificate (Module D)
• Execution of periodical surveillance Manufacturer premises.