ISO 13485:2016 MDQMS
What is ISO 13485 Certification?
ISO 13485 is an internationally recognized standard that specifies requirements for a quality management system (QMS) specific to the medical device industry. It ensures that organizations consistently meet customer and regulatory requirements while prioritizing the safety and performance of medical devices throughout their entire life cycle.
The latest version, ISO 13485:2016, serves as well as its European adoption EN ISO 13485, forms the foundation for certification of quality management systems for companies involved in the design, development, production, installation, distribution, and servicing of medical devices.
Why is ISO 13485 Important?
In the medical device sector, two aspects are non-negotiable:
- Consistent product quality
- Patient and user safety
Regulatory authorities worldwide demand stringent control over the entire life cycle of medical devices. Achieving ISO 13485:2016 certification demonstrates that your organization has implemented a robust QMS capable of meeting these rigorous standards.
If you are looking for expert guidance and end-to-end support to achieve ISO 13485 certification, get in touch with Accredix Certifications Pvt Ltd today and start your certification journey.
Key Benefits of ISO 13485 Certification
- Enhances company credibility and brand image
- Promotes evidence-based decision making
- Drives continual improvement in processes and product quality
- Increases employee engagement and accountability
- Boosts customer satisfaction and trust
Who Can Apply for ISO 13485 Certification?
ISO 13485 applies to any organization involved in the medical device life cycle, including:
- Medical Device Manufacturers (from startups to multinational corporations)
- Suppliers, Distributors, and Distributors in the medical device supply chain
- Contract Manufacturers and OEMs
- Service Providers (installation, maintenance, calibration, sterilization, etc.)
- Regulatory Consultants and Notified Body support organizations
Eligibility & Requirements for ISO 13485 Certification in India
Your organization must implement and maintain a QMS that complies with all clauses of the ISO 13485:2016 standard. Key requirements include:
- Adopting a risk-based approach throughout product realization
- Developing a comprehensive QMS manual, procedures, processes, and records
- Establishing and maintaining a Medical Device File (Technical Documentation)
- Validating processes where output cannot be fully verified
Stages of the ISO 13485 Certification Process
- Quality System Planning – Develop your QMS using the Plan-Do-Check-Act (PDCA) cycle and document quality objectives and plans.
- Regulatory Compliance Mapping – Align your QMS with applicable regulations (e.g., MDR/IVDR in EU, 21 CFR 820 in the US, CDSCO requirements in India, etc.).
- Documentation, Training & Record-Keeping – Create mandatory documents, train staff, and establish records as objective evidence.
- Management Review & Internal Audit
- Conduct at least one full management review with all required inputs.
- Perform a complete internal audit using a process and risk-based approach.
- Certification Audit (Stage 1 & Stage 2)
- Stage 1: Documentation review and readiness assessment.
- Stage 2: On-site audit verifying effective implementation, regulatory compliance, risk management, and technical documentation.
Upon successful closure of any findings, the certification body issues the ISO 13485 certificate (valid for 3 years, with annual surveillance audits).