Outsourced Audit

As a manufacturer of medical devices, you need to ensure that you have an effective internal audit system in place. This is not always easy, and can put a strain on your organization. If your organization is finding it difficult to find the resources to complete these audits, then outsourced audit may be the solution. Quality-Audit can do so on your behalf.

Quality-Audit will:

  • Develop an Internal Audit Program based on your company’s needs. The starting point is IAF MD9 and/or MDSAPs criteria for determining audit duration. We then consider previous audit results, your management system, and the standards and regulations to which you are certified.
  • Cover risk-based audits of suppliers and outsourced activities if you wish that, thereby further reducing the load on your internal resources.
  • Carry out Internal Audits, handling all audit preparation, planning & reporting, and issue any findings in accordance with your system.
  • Verify all corrective actions taken against audit nonconformities, including analysis of data and trends
  • Provide input to management review meeting(s) summarizing all internal audit activities, their outcomes, and any trends.

All audits carried out by Quality-Audit are by auditors with Notified Body and MDSAP experience, or specialized knowledge about, e.g., Clinical Trials or Software Design.

Benefits of outsourced audit

When you outsource your audit activities then Quality-Audit provides:

  • A fully managed internal audit system in conformance with your certified management system
  • Evidence to a certification body of effective audits being delivered that provides them with a high level of assurance that you are managing your system successfully.
  • Certainty that you do not need to worry about investing in qualifying internal auditors and maintaining their competences.

For further information about how Quality-Audit can help you with your current medical device compliance challenges:

Please use the contact form, or call for an informal discussion on +45 31 44 40 24.