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2016 renewal audit

In November 2016, a group of auditors of the competent public body carried out the HYB’s quality management system (SVK) and compliance with the MDD 93/42/EEC Medical Directive audit. For the ISO 9001 and ISO 14001 standards, a recertifying audit was carried out; for the ISO 13485 standard and the MDD 93/42/EEC directive, a regular audit was carried out.

The auditors have spotted no important inconsistencies that could affect the currently valid certificates or the issue of new ones for ISO 9001 and ISO 14001.

The HYB’s quality management system is still in accordance with the ISO 9001/13845/14001 standard’s requirements.

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