ISO 13485 : 2016 Certification

ISO 13485
Certification

Ensuring Quality in Medical Devices

About ISO 13485 Certification​

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.

 

Why ISO 13485 Certification Matters?

ISO 13485 is more than compliance—it’s about building trust and reliability in healthcare.

  • Protects patients by ensuring safe and effective medical devices

  • Meets international regulatory requirements

  • Strengthens credibility with customers and stakeholders

  • Enables entry into global medical device markets

Who Needs ISO 13485?

ISO 13485 is essential for medical device manufacturers, component suppliers, sterilization facilities, testing laboratories, and distributors. Whether you are a startup or an established company, this certification is a key step toward regulatory approval and industry recognition.

Benefits of ISO 13485 Certification:

✔️ Compliance with international healthcare regulations
✔️ Consistent product quality & reduced risks
✔️ Competitive edge in the medical device industry
✔️ Improved operational efficiency
✔️ Access to new global markets
✔️ Boosted trust among customers and partners

ISO 13485:2016 Compliance Checklist

The following is a list of prerequisites for ISO 13485 certification:

1. Quality Management System (QMS)

  • Establish a documented QMS with defined scope and objectives

  • Implement risk-based thinking across processes

  • Maintain control of documents and records

2. Management Responsibility

  • Define a quality policy and objectives

  • Assign roles, responsibilities, and authorities

  • Conduct regular management reviews

3. Resource Management

  • Provide trained personnel with documented competencies

  • Maintain a safe and suitable work environment

  • Ensure infrastructure supports regulatory compliance

4. Product Realization

  • Identify customer and regulatory requirements

  • Establish design and development controls

  • Implement supplier evaluations and purchasing controls

  • Maintain product identification, traceability, and cleanliness

5. Risk Management & Continuous Improvement

    • Implement risk-based approaches (ISO 14971)

    • Conduct internal audits and corrective actions

    • Establish non-conformance handling procedures

    • Monitor customer feedback and post-market surveillance