Management established this policy in alignment with ISO 13485: the safety and efficacy of medical devices, and compliance with the regulations that apply. Risk is named early. Corrective and preventive action is taken while the file is still ours to fix.
Objectives
- 01Deliver work that meets regulatory and client-specific requirements for safe, effective devices
- 02Reduce the risks that sit in development and use
- 03Review quality objectives and performance so the system improves
How the system is built
- 01Quality requirements are identified, documented, and evaluated against ISO 13485
- 02Risk management is written to meet the issues a device can raise
- 03People are trained so the culture of the file is the culture of the desk
Review
The policy is reviewed annually at management review. It is available to stakeholders. Employees take part in the procedures of the Integrated Management System. Compliance is obligatory for the organisation.