Product-related Factory Production Control (FPC)

Precondition for the certification is the establishment and the operation of a specific product-related FPC, taking into account the elements of EN ISO 9001 and the process of the related production line from the raw material to finished product and storage of the product. The FPC is an integral part of the customer’s quality management system, if any. The empowered Certification Body makes the necessary arrangements with the customers for the initial inspection at the factory and the Initial Type Test (ITT). 

The initial inspection covers the evaluation of the FPC (see above) and normally includes the selection of samples for the ITT. If not specified otherwise in the European standard(s) or KEYMARK Scheme, at least one sample shall be selected. 

The regularly factory inspections include verification of the documentation of the related FPC at least once a year, as well as sampling for tests at least every second year, unless otherwise specified in the European standard(s) or KEYMRK Scheme. If necessary, samples can be taken from the market. With regard to the FPC, particular attention is to be drawn to any changes of product design, materials or methods of production which may affect the conformity as established through the ITT of the product.

For the purpose of surveillance the customers agrees to allow the empowered Certification Body, or bodies acting on its behalf, reasonable access to its premises.

Requirements for Inspection Bodies

All Inspection Bodies, whether internal or external, shall be accredited on the basis of EN ISO/IEC 17021 by a signatory to the relevant Multilateral Accreditation Agreement (ILAC).

There might be further specific requirements and procedures for Inspection Bodies taking part in the specific KEYMARK Scheme Rules to be fulfilled.

Furthermore, all internal or external Inspection Bodies shall:

  • participate in meetings relevant to the operation of the KEYMARK Scheme
  • not receive any financial subsidy to support their inspection activities, in order to avoid unfair competition
  • maintain confidentiality of the information obtained in the course of conformity assessment procedures, unless explicitly agreed upon in writing in advance
  • have a contract with the involved empowered Certification Body to act as sub-contractor