IFA certification body for QA systems

According to the European regulation 2016/425, personal protective equipment (PPE) that provides protection against mortal hazards or serious and irreversible health damage (risk category III) 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 this regulation, two alternative procedures are available for the PPE manufacturer to choose from:

• EC quality assurance for the end product (according to Module C2):
  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 Module D):
  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 the certification body of the notified body is recommended.

The IFA was notified 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 Module D of regulation 2016/425.