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CE Marking

 

1. General Information
  2. Directives
  3. Compliance Options
  4. How Can QPS Help?

Compliance Options

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)
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