Quality is our job

To develop products and to bring them to market maturity is one thing. Optimum quality, upon which you can rely on, is the other. Therefore, quality control has the highest priority here at SAMAPLAST AG. We continue to optimise and develop our efficient company structures on a constant basis. The result: a perfect organisation, which is certified to ISO 9001 and ISO 13485. The benefit: You can fully rely on the adherence to and optimisation of these standards. Both today and in the future.

Risk management that really works

Globalisation creates tremendous opportunities for a globally active company like SAMAPLAST AG, but also risks which need to be taken into account. Bad investments, losses in sales, product recalls, catastrophes and a number of other items could prove fatal for a business, damage its reputation or threaten its existence. In addition, the risks are on the side of the user or patient at home should our reliability falter. Therefore, a functional risk management based upon EN ISO 14971 which prevents such an outcome is a central task of company management. We accept our responsibilities. For our customers, for our staff, for our business.

Evidence of suitability through process validation

That which we develop and manufacture, must also function. Therefore, it is part of our task to provide evidence of suitability by means of a process validation. Within this validation, we need to demonstrate that our main and secondary facilities are qualified for production.

For the implementation of qualification and validation at SAMAPLAST AG apply:

  • Qualification master plan (QMP)
  • Validation master plan (VMP) 

Precision is measurable

A component in our quality work and quality assurance is precise measurement in all areas and variations. In order to avoid even the smallest errors, we rely on the most diverse measuring techniques and methods which are carried out by our highly qualified and specially trained staff. Since for us applies: trust is good, control is certain.

Measurement methods

  • modern 3D-coordinate measuring machine
  • video measurement system
  • strain / compression testing machine
  • computer tomography (CT) with our partners

Aim of the measurements

  • measurement of complex geometries
  • creation of a variance analysis