IFA certification body for QA systems

as defined by Article 11B of the EC directive for personal protective equipment (89/686/EEC)

Consultation at a manufacturers office

Informing on the QA system requirements, Source: IFA

IFA-Logo

Certification logo for a QA system according to EC Directive 89/686/EEC, Source: IFA

According to the European directive 89/686/EEC, personal protective equipment (PPE) that provides protection against mortal hazards or serious and irreversible health damage certification category 3 and that is intended for the European common market must be type-tested, and such equipment must also be subjected to monitoring measures. According to Article 11 of this directive, two alternative procedures are available for the PPE manufacturer to choose from:

  • EC quality assurance for the end product (according to Article 11A):
    Representative random sampling test of the product being produced in series is conducted, and has to be repeated at least once a year, by one of the notified bodies in the European economic community.

  • EC quality assurance system with monitoring (according to Article 11B):
    A quality assurance system established by the PPE manufacturer is monitored regularly in the form of an audit by a body appointed by the European Commission. If a manufacturer has had its quality management system already certified according to EN ISO 9001, the evaluation focuses on specific requirements which are essentially related to the manufacture of the product.

After the first audit - the so-called certification audit - two monitoring audits follow at annual intervals before the review audit is conducted after three years. The scope and the costs depend on the integrity of the QA system, the size of the firm, the product diversity, and the travel expenses of the auditors.

The audit is carried out by an expert team consisting of one expert for quality systems and one expert of the particular thematic field. The results are documented in an audit report, and, in positive cases the issuance of a certificate by a notified body is recommended. IFA was notified (PDF, 64 kB) by the Commission of the European Union and registered under the ID number 0121, and is authorised to audit and certify quality assurance systems according to Article 11B of directive 89/686/EEC. Firms whose QA systems have been certified by IFA receive the immediate authorization to advertise the certification with its logo.