The certificate issued by an independent accredited certification body guarantees that the quality management system of a supplier and manufacturer of medical devices has been established, documented, used and maintained in accordance with the requirements of ISO 13485:2003 standard.
As more stringent quality management system demands are placed on suppliers and manufacturers of medical devices, ISO 13485/13488:2001 standard has been developed, extending the requirements of ISO 9001 standard (sterilization, technical documentation requirements, traceability, etc.).
In 2003, ISO 13485:2003 standard was published as a revised standard, with structure corresponding to ISO 9001:2000 and containing criteria for the whole range of the quality management system for medical devices. The certificate according to ISO 13485:2003 standard applies to the whole management system of an organization manufacturing or supplying medical devices and related services.
The certification process consists of 3 basic phases:
1) Elaboration of documentation
2) Putting QMS into practice
3) Certification by an accredited certification body
The times of elaboration of documentation and putting the system into practice are individual (it usually takes several months).
During the three year validity period of the certificate, a surveillance audit takes place once a year. One of the following is issued depending on the surveillance findings
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