A manufacturer must designate the standards or essential requirements to be applied for regarding the product he wants to design and produce. These standards or essential requirements must be defined by a party independent from the manufacturer.
The applicant has to draw up and sign a Declaration of Conformity, stating that the product will be designed in conformance with the standards or essential requirements listed on the declaration (this is the designation).
Next to that the applicant has to draw up and sign a Declaration of Conformity to Design stating that the products produced will be equal to the product designed.
If more (different) types of products are designed and produced then for every product type a Declaration of Conformity and a Declaration of Conformity to Design is needed.
The Declaration of Conformity is the link between the quality system – guaranteeing all products designed and produced are equal – and the designated standards or essential requirements. This is the way to ensure all designed and produced products are compliant with the standards or essential requirements, designated by the applicant.
This FQA is, in fact, a conformity assessment procedure. It is part of several product certification schemes that have a continued compliance program. For example Radio Equipment Directive (RED) (2014/53/EC). When the FQA is part of a product certification scheme, the designation of the standards or essential requirements is defined in the product certifications scheme.
When the FQA is used independent from any product certification scheme, the product certification scheme is not the point of departure, but the designation in the form of the Declaration of Conformity.
This conformity assessment procedure is also known as Module H and as FQA (Full Quality Assurance).