The ISO 13485 management system is designed for organizations that design, develop, produce, or supply medical devices and services. Learn more about ISO 13485 certification below.
ISO 13485 is an international standard specifically aimed at medical devices and services. It sets requirements for the quality management system used in the development, production, and distribution of medical devices to ensure they meet customer and regulatory requirements. Achieving ISO 13485 certification is an important step in building trust and credibility within the medical device industry.
Nordic Certification meets the requirements of ISO 17021, the management system for certification bodies, and is accredited for certifications in medical technology ISO 13485 by Swedac.
The ISO 13485 encompasses several key elements that organizations in the medical technology field must follow to establish and maintain their quality management systems. These include:
Quality Policy: Organizations must develop and communicate a quality policy that outlines their commitment to meeting customer requirements and applicable regulations in medical technology. This policy serves as the foundation for the organization’s quality objectives.
Planning: Careful planning is required to identify risks related to medical devices, establish quality objectives, and develop action plans to achieve these goals. This includes ensuring that the products are safe and effective.
Implementation and Operation: Organizations must implement their quality management system and provide resources, training, and communication to ensure the system’s effectiveness. This includes following processes for product development, manufacturing, and delivery according to the standard’s requirements.
Monitoring and Measurement: Regular monitoring and measurement of product quality and performance are essential to ensure the quality management system operates effectively. This means organizations should conduct internal audits and collect data to identify areas for continuous improvement.
Improved Quality and Risk Management:
- Provides more effective control over product quality, processes, and risks, reducing costs associated with errors and deviations.
Increased Awareness and Engagement Among Staff:
- Through training and involvement, staff gain a deeper understanding of quality requirements, increasing motivation and accountability in their work.
Compliance with Regulatory Requirements:
- ISO 13485 certification helps organizations meet the stringent regulations in medical technology, enhancing competitiveness and trust among customers and regulatory bodies.
Systematic Approach and Documentation:
- A well-defined quality management system provides structure and documentation, creating order and facilitating traceability.
Market Advantages:
- An ISO 13485 certificate can be a clear competitive advantage, especially in an industry where safety and quality are crucial for market trust.
Trust from Customers and Partners:
- Certification to ISO 13485 instills confidence among customers and partners by demonstrating that the organization adheres to global standards for quality management in medical technology.
Read more about ISO Certification.
The duration depends on the organization’s circumstances. Typically, the process takes between 6–12 months, from implementing the quality management system to completing the certification audit.
Yes, ISO 13485 can be integrated with other management systems, such as ISO 9001 (quality), ISO 14001 (environment), and ISO 45001 (occupational health and safety). By combining the standards, you achieve a more comprehensive system that effectively manages quality, safety, and regulatory compliance. This also simplifies audits and makes them more cost-efficient.
Yes, we can take over from another certification body and guide you through the entire certification cycle – from initial contact to surveillance audits and recertification.
Our auditors at Svensk Certifiering have extensive experience assisting organizations in achieving this standard and establishing an effective quality and safety management system. Contact us today to find out how we can help you secure your processes and products and get your organization certified to ISO 13485.
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Svensk Certifiering Norden AB is accredited by SWEDAC to perform audits and certifications of management systems according to ISO 9001, ISO 14001, ISO 45001, ISO 27001, and ISO 13485.
Svensk Certifiering Norden AB is accredited by SWEDAC for personnel certification according to the specification Authorized Fire Alarm Engineer SBF 1007:5.
