ISO Standards
ISO 13485
What is ISO 13485 Certification?
ISO 13485 is a globally recognized Quality Management System (QMS) designed for medical device and component manufacturers
- Applicable to organizations involved in the design, production, installation, or servicing of medical devices and components
- Ensures product conformity in the complex international supply chains of the medical device industry
- Latest version: ISO 13485:2016
Why ISO 13485 Certification?
ISO 13485 certification helps manufacturers meet industry requirements and regulations. As a trusted standard of medical device quality, it:
- Opens access to global markets
- Ensures compliance with international best practices and safety protocols
- Positions your organization as a leader in quality and safety
Key Features of ISO 13485 Certification
1. Standardizing Quality and Safety
- ISO 13485 ensures consistent quality in medical device manufacturing.
- Builds trust with consumers by delivering safe and effective products
- Creates a foundation for regulatory compliance (e.g., FDA, MDD, CE)
2. Improved Processes
- ISO 13485 enhances manufacturing efficiency.
- Streamlines day-to-day operations for increased productivity and cost savings.
- Creates a foundation for regulatory compliance (e.g., FDA, MDD, CE)
3. Global Market Access
- Certification aligns your organization with international standards, expanding market opportunities
Benefits of ISO 13485 Certification
Achieving ISO 13485 certification with Qualitas Elit offers a wide range of advantages:
1. Effective Risk Management
- Provides tools to manage risks and ensure consistency in delivering safe, reliable products
2. QMS for Safe and Effective Medical Devices
- Establishes protocols for quality control, ensuring medical devices meet critical safety and performance requirements
3. Regulatory Compliance
Acts as a foundation for compliance with global regulations, such as:
- FDA Quality System Regulation (21 CFR 820)
- Medical Device Directive (MDD)
- CE Marking in the EU
- Aligns with global regulatory standards based on ISO 9001 and ISO 13485
4. Improved Operational Processes
- Promotes efficiency through regular monitoring and evaluation.
- Streamlines systems for optimized productivity.
5. New Business Opportunities
- Certification is recognized worldwide, enabling you to engage with new customers and enter broader markets.
Certification Process
Certification requires:
- Implementing ISO 13485 QMS practices
- Undergoing an audit by a third-party registrar
- Engaging all team members in the process.
To learn more about achieving ISO 13485 certification, contact Qualitas Elit or download our free guide
Let Qualitas Elit help you build a safer and more efficient business!
