 

Certification of QM systems according to ISO 13485

ISO 13485 is the worldwide recognized standard for quality management systems in the medical devices sector. It contains almost all requirements of ISO 9001, but puts the main focus on product safety.

With a certification according to ISO 13485 you not only prove the safety of your products, but also communicate the quality standards of your company.

SLG is a Notified Body according to the Medical Device Regulation (EU) 2017/745. We test active medical devices and certify quality management systems according to ISO 13485.

Certification procedure

1. Briefing
Our auditors work out a schedule with you and discuss open issues regarding the certification.

2. Site inspection / check of your QM documentation
We evaluate on-site whether your company is ready for certification and check the existing QM documents for their conformity with ISO 13485.

3. Audit in your company
Our auditors assess the practical implementation of your QM system in your company and document the audit results and hints for potential improvements in an audit report.

4. Certification
After the successful completion of the audit, we issue a certificate showing the conformity of your QM system with ISO 13485. In addition, your company will receive our ISO 13485 mark for advertising purposes.

5. Annual surveillance
During the validity period of your certificate, our auditors check annually whether your QM system is maintained and further improved.

6. Re-certification
A re-certification not later than three years after the initial certification verifies the continuous improvement of the processes in your company. 

Dipl.-Ing. (FH)

Dirk Eisentraut

+49 3722 7323-839