Audit

As a Medical Device Manufacturer, you are obliged, according to ISO 13485, to audit your Quality Management System, QMS, on a regular basis.

These Internal Audits are evaluations of the effectiveness of your company's QMS that makes sure that it complies with the requirements. Audits can be conducted internally (self inspection) or externally (by subcontractors) depending on the company’s demands. 

The consultants at Orderly People have a solid experience with internal auditing and can offer you a transparent process to ensure compliance towards ISO 13485, leading to an approval by the contracted Notified Body. Orderly People can also support you in your processes with suppliers and subcontractors. 

Orderly People can support you with:

• Handling of Internal as well as supplier/subcontractor Audits

• MDSAP Audits

• Handling Audits from Notified Bodies and Competent Authorities

• Evaluate your QMS towards ISO 13487 and MDR or IVD/IVDR

• Support in handling of Audit findings