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Quality assurance

MPS has implemented a quality management system across its entire organisation, which complies with different quality, safety and environmental protection standards. The MPS quality department monitors the company's certifications:

  • Certification according to ISO 9001: 2015: quality management system
  • Certification according to ISO 13485: 2016: medical devices - quality management system
  • Certification according to ISO 14001: 2015: environmental management system

 


Control & validation

Each MPS entity has its own management systems developed in accordance with the guidelines of the groups' quality management team. For each project, and based on customer specifications, all production resources are validated, suppliers are qualified, and products are certified by MPS. As a result, we can guarantee a high level of quality through the implementation of strict and regular inspections, which are conducted, for example, in a controlled environment (temperature and humidity). All production monitoring is managed by an SPC (Statistical Process Control) system.


Special needs of the medical field

In the medical field, we guarantee the quality of our products by complying with legal and regulatory requirements through the continuous improvement of our quality systems. Our quality assurance experts ensure that we provide Class I and IIa medical devices for the CE zone or Class I for the FDA zone to our customers.

We prepare the necessary documents for certification and marketing of these medical devices. Our quality management system is certified by the Swiss Association for Quality and Management Systems (SQS) and meets all the requirements of ISO 13485:2012.

  • ISO 13485 certificate registration number: 40115
  • EU certificate registration number: 41653
  • US FDA registration number: 3010045785

Needs for turning processes

Statistical process control: MPS Décolletage is one of the first turning companies to have introduced the SPC method (Statistical Process Control). Periodic inspections are performed throughout the manufacturing process to ensure full product traceability. Thus, MPS Décolletage can provide the customer, with each delivery, a detailed manufacturing inspection protocol, as well as the different material, treatment and coating certificates.

A clear competitive advantage enabling the company to to eliminate incoming goods inspections and to ensure supply chain security for its customers.


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