Compliance

• Compliance with the “Essential Requirements” of a Directive can be achieved in several different ways.
• For most products, third-party certification is not mandatory, and the manufacturer is allowed to self-declare conformity with the relevant Directives.
• The various methods of compliance available to manufacturers are outlined in each particular Directive, and are known as “Conformity Assessment Modules”.
• Depending on the type of product and the associated hazards, it may be necessary to involve a European third-party Certification Body to carry out what is known as EC Type testing and examination, or to check the quality system.
• European Certification Bodies or Test Houses are commonly referred to as “Notified Bodies”.
• European Notified Bodies may contract out testing and evaluation work to other non-European Certification/Testing Organizations (such as QPS).

Conformity Assessment Modules

• Module A: Self declaration, with internal production control
• Module Aa1 and Aa2: Self declaration, with limited involvement by a Notified Body
• Module B: Type examination by a Notified Body. This Module may not be used alone to CE mark a product. It must be used in combination with module C, D, E or F
• Module C: Declaration of conformity to type
• Module D: Production Quality Assurance (EN 29002/ISO 9002)
• Module E: Product Quality Assurance (EN 29003/ISO 9003)
• Module F: Product Verification
• Module G: Unit Verification
• Module H: Full Quality Assurance (EN 29001/ISO 9001)