MPS has implemented a quality management system across its entire organisation. The company complies with the standards ISO 9001, ISO 13485 and ISO 14001 for quality, safety and environmental protection


Quality

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

Each of MPS's entities has its own management systems developed in accordance with the guidelines of the departments that govern the group's quality systems. Synergies and joint projects between the various entities of the group enable them to take full advantage of their respective contributions in terms of metrology, quality assurance, control and validation. For each project, all means of production are validated, suppliers qualified and products approved by MPS, according to the customer's specifications. MPS guarantees a high level of quality through the planning of strict and regular controls, which are carried out, for example, in a controlled atmosphere (temperature and humidity). All production monitoring is performed by an SPC (Statistical Process Control) system. MPS is able to develop metrology equipment according to the specific needs of a project.


Special needs of the medical field

For projects related to the medical sector, such as traumatology and orthopaedics, we can rely on the regulatory affairs expertise available in our different divisions.

We are committed to satisfying our customers by supplying products and services that fully comply with legal and regulatory requirements, through continuous improvement of our quality systems. Our quality assurance experts are thorough, allowing us to guarantee the high quality level of the products we deliver to our customers, whether they are Class I and IIa medical devices for the EU zone or Class I for the FDA zone (USA).

In order to guarantee the delivery of products that comply with legal requirements, MPS prepares the documentation for certification (European Directives 93/42/EC, 90/385/EEC, 21CFRpart820, etc.) and commercialization of medical devices. MPS has set up a quality management system certified and monitored by SQS (Swiss Association for Quality Management Systems). This system satisfies all the requirements of the ISO 13485:2016 standard on quality management systems for the medical devices industry.

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

Needs for turning processes

The whole inspection procedure is adapted to the specific needs of MPS customers, particularly in the field of turning.

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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