SGS Fimko has conducted several audits at Innokas Medical in 2014. The most significant audits were a follow-up audit of the ISO9001 and ISO13485 quality system certificates, a USTC audit, and a CMDCAS audit.
SGS Fimko conducted the follow-up audit of the ISO9001 and ISO13485 quality system certificates at Innokas Medical’s different sites. This audit was conducted to monitor Innokas Medical’s operational compliance with the quality system standards, and it assessed all of Innokas Medical’s sites. As expected, the audit went well – it determined that both the ISO9001 and ISO13485 certificates are still in effect.
SGS Fimko conducted a USTC audit at Innokas Medical, as well. This audit was conducted at Innokas’ Kempele and Tallinn sites. The USTC certificate indicates that Innokas Medical manufactures medical devices according to the requirements of North American authorities. The USTC certificate is required for Innokas to be able to manufacture medical devices for the US and Canadian markets at its Kempele and Tallinn factories.
The last audit that was conducted in 2014 was a CMDCAS audit. This audit was conducted in cooperation with SGS Fimko and SGS UK at Innokas Medical’s different sites. During the audit the whole quality system with all its functions at Innokas Medical were gone through.
“The CMDCAS audit lasted 9½ days and it was a success. We did get some minor remarks, and corrective actions have already been implemented, so Innokas will be granted the CMDCAS certificate,” Tiina Kotipalo, Innokas Medical’s Director in Quality and Regulatory Affairs, says.
SGS Fimko and SGS UK will grant Innokas Medical the Canada 13485 quality system certificate. This certificate is required of medical device manufacturers and distributors before they can sell and market their medical devices in Canada. The Canada 13485 certificate indicates that Innokas Medical operates according to the regulatory requirements of Canadian authorities.
In addition to SGS Fimko, various customers have also conducted many audits at Innokas Medical during the past year.
For more information, please contact:
Tiina Kotipalo, Director, Quality and Regulatory Affairs
+358 44 5623 131
tiina.kotipalo@innokasmedical.fi
