Scope of the quality system:
- Describe the quality management system of Plum Safety ApS
- Define responsibilities and competencies relative to activities impacting quality
- Ensuring goals and policies are defined along with planning and implementation of required management follow-up activitie
- Ensuring continuously improving quality and environmental impact through analysis, lessons learned and corrective and preventive actions
- Demonstrating compliance of customer and regulatory requirements
The quality management system is the foundation for Plum Safety ApS’ compliance with regulatory requirements and the following standard:
- ISO 13485 Medical Devices – Quality Management Systems – regulatory purpose requirements
