ISO 13485:2016 is a globally recognized standard for Quality Management Systems (QMS) in the medical device industry, suitable for organizations of all sizes involved in the design, production, and servicing of medical devices. It provides a structured framework to establish, implement, maintain, and continually improve a QMS that ensures consistent delivery of safe and effective medical devices aligned with regulatory and customer requirements. Based on industry best practices, ISO 13485 supports risk management, process control, and regulatory compliance throughout the product lifecycle.
The latest version emphasizes risk-based thinking and proactive quality assurance to identify and mitigate potential issues before they affect product safety or performance. It promotes continual improvement, objective measurement, and effective documentation. Structured according to ISO’s High Level Structure (HLS), ISO 13485 is designed for seamless integration with other management systems such as ISO 9001, ISO 14971, and ISO 27001, enabling organizations to adopt a unified, strategic approach to quality, compliance, and operational excellence.
At KBS, we offer comprehensive certification services to help medical device organizations achieve and maintain ISO 13485:2016 certification. Our approach delivers thorough, independent, and structured evaluations of your Quality Management System (QMS), ensuring compliance with international standards for medical device safety, quality, and regulatory requirements.
KBS Certification is a globally recognized and trusted certification body providing ISO 13485:2016 certification for medical device quality management systems. We operate across multiple countries, including India, Bangladesh, Bahrain, Brunei, Egypt, Indonesia, Italy, Republic of Korea, Malaysia, Oman, Papua New Guinea, Qatar, Saudi Arabia, Singapore, Thailand, Turkey, United Arab Emirates, and Vietnam.
With a portfolio of over 7,000 clients, KBS has extensive experience in certifying leading organizations across the medical device and healthcare sectors. Leveraging extensive expertise in quality management and regulatory compliance, our experienced auditors deliver reliable, objective, and value-driven certification services that help clients ensure product safety, meet global regulatory requirements, and achieve operational excellence.
Improved Product Safety and Quality: Demonstrates your commitment to consistently delivering safe, effective medical devices that meet customer and regulatory expectations.
Regulatory Compliance: Helps you comply with international regulations such as the EU MDR and FDA QSR, reducing risk and facilitating market access worldwide.
Enhanced Operational Efficiency: Drives process standardization, risk management, and traceability across the product lifecycle, minimizing errors and boosting productivity.
Global Recognition and Market Access: ISO 13485 certification enhances your organization’s credibility and opens doors to new markets, partnerships, and business opportunities.
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