FPC system, AVCP classes and the CE marking

5/11/2013

Author: Martti Blomberg

Translated: Deborah Johansson

The confirmation of product compliance is a prerequisite for the CE marking. Ensuring the compliance with the requirements can change between different products, mainly dependent on how critical a product is from the viewpoint of safety and health or concerning other essential requirements defined in the directive, such as energy efficiency. Attestation of the compliance to the requirements and when notified bodies are participating are defined based on a product’s ACVP class.

CE marking always requires an FPC manual

A requirement for all ACVP classes is a factory internal quality control. Factory internal quality control is also defined in the FPC manual (Factory Production Control), also called the handbook for factory production supervision. It is a written description of how a company ensures its products’ compliance with the requirements. The FPC manual consists of production process descriptions, written instructions, planned regular inspections, and the records showing fulfillment of the standards, such as auditing reports and control of deviating products.

FPC manual and the ISO 9001 quality system

Usually the ISO 9001 quality system is accepted as the quality control system required for the CE marking, as long as the requirements in the product and referenced standards are considered in it. The maintenance and realization of the FPC manual is a lot easier if it is part of a quality system that covers the whole business.

When implementing the CE marking, companies may already have an existing quality system which is based on the ISO 9001 standard, and the requirements for an FPC system can be met by completing the quality system according to the requirements of a harmonized quality standard.

When there is no quality system, the implementation will start with the FPC requirements first. The processes that affect product features for the part required for the CE marking will be described and defined first.

In practice, this means the definition and description of the following processes:

 

  • registering of personnel competence and authority
  • product design (including preliminary testing and other product testing)
  • purchase (material and production subcontracting)
  • production (work instructions, monitoring, measuring, auditing, machines and equipment, calibration)
  • logistics (storing and transportation) and installation processes


These same requirements are the basic prerequisites for the ISO 9001 quality control standard, so the FPC system can work as the basis for implementing the ISO 9001 system. On a longer timescale, a company should aim for a quality system that meets both the ISO 9001 standard requirements as well as the FPC requirements.

Confused already?

Don't worry: these things take a little orientation. You can find more information in our free quick guide here, discussing the establishment of the FPC system.