Our commitment to quality is supported by implementation of several international standards. MACHEREY-NAGEL has chosen the TÜV Rheinland as strong and renowned partner for control and maintenance of the quality management system.

Other certificates complement the portfolio of national or international regulations and standards to provide the highest level of quality and service to our customers worldwide.

A commitment to quality

Quality is an integral part of MACHEREY-NAGELs business principles. These principles guide our actions to develop and produce products that are safe, compliant and meet our customers’ expectations. Since 1996 MACHEREY-NAGEL is certified to international standards for quality management. Our performance is monitored and reviewed to ensure, that our high standards are met continuously.

EN ISO 13485

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

You can download the EN ISO 13485 certificate here.

ISO 9001

The ISO 9001 standard sets out the criteria for a quality management system.

You can download the ISO 9001 certificate here.

IvD 98/79/EC

This certificate demonstrates the compliance of the listed products with the In-vitro diagnostic (IVD) directive 98/79/EC.

You can download the IvD 98/79/EC certificate here.

Waste Management Company

MACHEREY-NAGEL is a certified disposal specialist! The corresponding certificate can be downloaded here.

Rapid Tests Products- Brochure