I want to outsource the quality control manager position. Is this possible and reasonable with regards to my notified body? My company is small and we have no need for a full-time quality control manager. How can I do it?
Nex’Quality enables you to outsource quality control management to Nexialist and we provide you with:
- A quality control management expert who sets up and/or takes over your existing certification procedure and verifies consistency between your organisation and current quality control system.
- Support to guide your company through the specific tools (i.e., management review, process and indicators).
- The ability to have internal and external audits conducted by a certified auditor.
- The opportunity to present the decisions and choices your company make to the notified body and appropriate authorities in a more organised manner.
- An external liaison that facilitates acceptance by your company employees.
- An interdisciplinary team at your disposal to ensure your needs are indeed satisfied.
What are the risks associated with poorly managed quality control?
- With the stringent standards and regulatory requirements that are in place, it has become impossible for a single manager to handle everything that quality control of medical devices entails.
- The risk of missing important new requirements and critical non-conformities that arise during the audit.
- If your sub-contractors’ audits are inadequate, you will not be able to address recurrent problems and this will create uncertainty in your management and notified body about the competency of your sub-contractor.