ISO 13485 Medical Devices Quality Management System Certification
High-performing businesses know that quality management is at the root of their success. ISO 13485 Medical Devices Quality Management System Certification by Bureau Veritas supports your drive to increase efficiency and exceed customer expectations.
To compete effectively and win their customers’ loyalty, companies need to deliver products and services of consistent quality. This demands a rigorous approach to quality management.
The purpose of the ISO 13485 certification process is to help you develop a robust Medical devices Quality Management System (MDQMS) that drives continual improvement. ISO quality standards are globally recognized and trusted. The ISO 13485 standard offers flexibility, enabling you to design your own Quality Management System around your specific products, customer needs and risks. As such, it acts as an essential building block for any company looking to improve risk and quality management. ISO 13485 certification by Bureau Veritas demonstrates a commitment to quality and customer excellence.
• Improve Customer Satisfaction
• Boost Organizational Efficiency
• Empower User and Patient Safety
• Manage Risk Effectively
• Empower Your Employees
• Seal Your Reputation for Quality
HOW DO I CERTIFY
Key steps in our certification process are:
• Definition of certification scope
• Pre-audit (optional): gap analysis and diagnosis of your current position against standard
• Certification Audit Performed in 2 Stages: -
Stage 1 - Readiness review performed to verify that the organization is ready for certification - Stage 2 - Evaluation of implementation, including the effectiveness of the management system of the organization
• A certificate valid for 3 years is issued upon satisfactory results of stage 2 audit
• Surveillance audits to verify that the management system continues to fulfil the requirements of the standard and monitor the continual improvement
• Re-certification after 3 years to confirm the continued conformance and effectiveness of the management system as a whole
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