ISO 13458 Certification is the globally recognized standard for Quality Management Systems (QMS) in the medical device industry. It ensures that organizations involved in the design, production, installation, and servicing of medical devices meet stringent regulatory and customer requirements. Achieving ISO 13485 certification demonstrates a commitment to quality, safety, and compliance with international medical device regulations.
At ICV Assessments, we provide comprehensive ISO 13485 certification services, helping businesses enhance product reliability, improve risk management, and streamline operational processes. This certification is crucial for manufacturers, suppliers, and distributors looking to gain market trust and meet legal requirements in various countries.
✔ Ensures compliance with global medical device regulations.
✔ Enhances product safety and quality.
✔ Strengthens risk management and process efficiency.
✔ Boosts market access and competitive advantage.
✔ Increases customer confidence and credibility.
The following is a list of prerequisites for ISO 13485 certification:
Establish a documented QMS with defined scope and objectives
Implement risk-based thinking across processes
Maintain control of documents and records
Define a quality policy and objectives
Assign roles, responsibilities, and authorities
Conduct regular management reviews
Provide trained personnel with documented competencies
Maintain a safe and suitable work environment
Ensure infrastructure supports regulatory compliance
Identify customer and regulatory requirements
Establish design and development controls
Implement supplier evaluations and purchasing controls
Maintain product identification, traceability, and cleanliness
Implement risk-based approaches (ISO 14971)
Conduct internal audits and corrective actions
Establish non-conformance handling procedures
Monitor customer feedback and post-market surveillance