Auditing

Auditing is critical for improvements in your Quality Management System. We help you to perform it when your internal people are not enough, or when you see a need for independent external expertise.

In many companies auditing becomes a heavy load with low value. We help you to make auditing value adding by assuring compliance and supporting continuous improvements in your organization. Do you want a "mean auditor” to play the bad guy or do you want an auditor that also supports improvement of your or your suppliers Quality Management System? We can provide both. We are RABQSA certified auditors for ISO 13485 (and QSR).

We can help you with:

 

• Internal audits
• Supplier audits on behalf of you
• Risk management audits
• Software audits
• Project audits
• QSIT- inspections (FDA mock inspections)
• Preparation for FDA-inspections
• Support during and after an FDA inspection
• Developing your auditing program