ISO 13485 Audits for Medical Device companies

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ISO 13485 is a quality standard based on the ISO 9001 standard with a focus on medical devices and compliance with this standard is requirement in most countries.

ISO 13485 certification is an important milestone for a medical device company.
The certification is granted after passing an initial audit by an accredited external party.
Companies interested in pursuing a CE Mark are advised to combine the ISO 13485 audit with a CE audit, performed by a notified body.

The purpose of this audit is to ensure the Quality Management System is compliant with the regulations.
During the audit, the auditor conducts a thorough review of the company’s current quality and regulatory documentation through a sampling method.
In order to maintain ISO 13485 certification, annual surveillance audits are performed, the scope of which varies to ensure that the entire quality system is covered. A renewal audit is performed every 3 years that covers the entire quality system.
At the end of each audit, the auditor issues a report summarizing the audit findings and any non-conformities found. After receiving the non-conformity report, the company needs to establish and present a Corrective and Preventive Action (CAPA) plan to address and close the non-conformities.

How can we help?

Li-Med’s experts have more than 20 years of experience in establishing and maintaining quality systems according to applicable regulatory requirements.
Li-Med can help clients by preparing for, participating in and serving as management representative in external ISO 13485 audits performed by various notified bodies and standards institutes

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