Annex X of the new Machinery Directive places very high demands on the quality management systems of companies that develop and manufacture machinery safety components. The requirements go far beyond the familiar DIN EN ISO 9000ff. – and anyone who meets them can develop and market directive-compliant products that are listed in Annex IV of the MD. For the Schmersal Group this particularly involves the "Logic units for safety functions" described under no. 21 and the "Protective systems for personnel detection" described under no. 19.
The Schmersal Group can now develop and manufacture these functional safety products in accordance with Article 12 Para. 3c and Para. 4b without involving a Notified Body. Those responsible for QM at Schmersal addressed the quality requirements of Annex X of MD 2006/42/EC at an early stage, expanded the quality management system accordingly and commissioned TÜV Rheinland to audit and certify the system.
The result: in November 2009 – following a thorough audit – the appropriate certificate was issued for the development and production sites in Wuppertal and Wettenberg. Regular local audits will ensure that the system is being used properly and developed further.
Even though the Schmersal Group is now in a position to subject products to comprehensive quality assurance in accordance with the conformity assessment procedure, for series products it will continue to commission a Notified Body to subject its own results to external verification.
