ISO Certification Services
What is ISO 13485 Quality Management System?
ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system.
ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.
Benefits of ISO 13485 certification in Kuwait
ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.
- Outline how to review and improve processes
- Increase efficiency, cut costs and monitor performance
- Demonstrate that you produce safer medical devices
- Meet regulatory requirements and customer expectations
- For independent assessment
- Show an ability to meet customer requirements
- Demonstrate your reliability and high quality of service
- Opens your organization up to key markets who require certification
- Measurable level of effectiveness and culture of continual improvement
BWA has helped organizations around the kuwait achieve ISO 13485 certification smoothly and cost effectively. We provide more than just a certificate: we have given them the tools to manage their Quality management systems more efficiently