Rose Gmbh - Sterilization Quality Management

Quality Management

The department quality management begins with the contact to the customer from the very beginning of the estimation of the medical products.

In pretests their presumable behaviour in an ethylene oxide sterilization process can be tested. On the basis of emipirical data a fitting sterilization process might also directly be predictable.

The assignment of medical products to a sterilization process is done by a test process with defined course (validation). Its

  • execution,
  • evaluation,
  • documentation,

are also made by the quality management.

The continuation of the contact to the customer after the first assignment of his medical products is shown in routine operations as well as in regularly plannable recurring appointments. In periodical audits, a customer can perform checks of his medical products’ sterilization processes at Rose GmbH.

Parallel to building and keeping of customer-contacts the quality management also works on the continuous application of relevant statutory provisions.

First worth mentioning should be Rose GmbH’s first certification according ISO 9001, which already took place  in 1993.

A list with current prescriptions and certifications can be found on the right.

Relevant prescriptions:

  • DIN EN ISO 9000: 2005
  • DIN EN ISO 9001: 2008
  • DIN EN ISO 10993-7: 2008
  • DIN EN 556-1: 2001

Relevant prescriptions with certification:

  • DIN EN ISO 11135: 2020
  • DIN EN ISO 13485: 2016

Foreign national administrations: registrations:

  • USA: Food and Drug Administration
  • Japan: Ministry of Health and Welfare: accreditation according to Ordinance No. 169