The certification of a QM system serves as a proof of adoption and maintenance conforming to standards of the quality management system of a company. A certified quality assurance is compulsory for manufacturers of medical devices (except for those of class I). Basically, depending on the conformity class the outsourced quality assurance (verification according to annex IV of Directive 93/42/EEC) can be chosen or – in case the manufacturer adopted an autonomous QM system – one out of three conformity assessment procedures in the field of QM certification has to be chosen, which are:

• quality-assured final inspection (annex IV)
• quality-assured manufacture and final inspection (annex V)
• a full quality management system which comprises design, manufacture and final inspection (annex II)

If a manufacturer of medical devices adopted and maintains his own quality management system it must conform to EN ISO 13485. A certification according to EN ISO 13485 does not only have its advantages on the European market, but also worldwide. A certification is already a precondition for the entry into the market of other countries (e. g.: Canada, Japan, Taiwan, …).
It should be noted that in comparison to the full QM system (see above) there are restrictions regarding the requirements of the standard depending on the chosen procedure. The standard defines the organizational demands on the design and the manufacture of medical devices. Although the standards EN ISO 13485 and EN ISO 9001 have overlapping requirements they partially differ in their concept and specific requirements.
Basically the EN ISO 13485 standard is divided into five parts namely:
 

• QM system
• management responsibility
• resource management
• product realization
• measurement, analysis and improvement

The procedure of first-time certification of customers by the PMG can be divided into three stages namely an application stage, a preparation stage and the stage of the audit procedure. The audit program comprises a two-stage first audit, a supervision audit in the first and in the second year and a re-certification audit in the third year. Within the scope of the first audit the management documents (such as quality manual, quality system procedures and operating procedures, …) are examined for the fulfillment of the requirements of the standards in the first stage.
In the second stage the realization of the customers QM system is examined on site.

Detailed information on the European Testing Center of Medical Devices and on the certification procedure of quality management systems is available for download.
The PMG will gladly submit an individual offer. Please attach the completed customer questionnaire to your inquiry. Contact: pmgnoSpam@tugraz.at Documents (only available in German)