Auditing services

We develop effective yearly audit plans that turn auditing into an effective tool, not just a mandatory requirement.

Internal audits

Internal audits are part of the continuous improvement of the Quality Management System (QMS) and are mandatory. They identify gaps and the effectiveness of your QMS. Internal audits give you confidence that the requirements across the relevant regulations and standards are accurately implemented in your processes. We view internal audits not only as a means to ensure compliance, but also as an opportunity to enhance the effectiveness of your QMS.

Examples include:

• Full ISO 13485 QMS audit
• Partial ISO 13485 audit, such as only management responsibility
• Full or partial ISO 9001 audit
• Full or partial ISO 13485 + 9001 audit
• Full or partial ISO 13485 audit + MDR/IVDR 
• Full or partial ISO 13485 audit with emphasis on applicable standards such as IEC 62304 or IEC 62366.
• FDA QMSR audit
• Full or partial ISO 15189 audit

Medical Device Single Audit Program (MDSAP) mock audits

MDSAP is a program where up to 5 country QMS requirements for Australia, Brazil, Canada, Japan and USA can be satisfied with a single audit. The MDSAP requirements are based on ISO 13485 and complemented with country-specific requirements. Canada accepts only MDSAP QMS certificates. We perform mock audits, which will determine your readiness for an actual MDSAP audit or annual internal MDSAP audits.

Supplier audits

The quality of the materials or components you use in your medical device is a prerequisite for the quality of your product. A control method for the suppliers is needed to ensure their operations are at the desired level. A supplier audit is the most effective way to ensure that your suppliers comply with applicable standards and regulations, as well as your needs. We can audit your candidate suppliers before you approve them and also take care of the periodical follow-up audits.

An auditor provides new insights into your QMS and we can cover: 

• ISO 13485:2016
• ISO 9001:2015
• MDR 2017/745
• IVDR 2017/746
• FDA QMSR
• MDSAP
• ISO 15189:2022
• ISO 27001:2022
• Additional weightings for standards