ISO 13485 Certification
ISO 13485:2016
ISO 13485 Certification helps organizations establish, implement, maintain and continually improve a Quality Management System for medical devices. It provides a structured framework for managing quality, meeting applicable regulatory requirements and consistently providing medical devices and related services that meet customer and regulatory requirements.
What is ISO 13485?
ISO 13485 is an internationally recognized standard for Quality Management Systems specifically designed for organizations involved in the medical device industry.
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
The standard is designed for organizations involved in different stages of the medical device life cycle, including design, development, production, installation and servicing.
Why is ISO 13485 Certification Important?
Medical devices are subject to specific quality and regulatory requirements because their performance and safety can directly affect patients and users. ISO 13485 provides a structured quality management framework tailored to the needs of the medical device industry.
The standard helps organizations establish controlled processes, manage risks, maintain appropriate documentation and demonstrate their ability to consistently meet customer and applicable regulatory requirements.
Benefits of ISO 13485 Certification
Who Can Obtain ISO 13485 Certification?
ISO 13485 is intended for organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be relevant to suppliers and external parties that provide products or quality management system-related services to medical device organizations.
ISO 13485 certification may be relevant for:
- Medical device manufacturers
- Medical equipment manufacturers
- Medical device designers and developers
- Medical device component suppliers
- Contract manufacturers
- Medical device distributors
- Organizations providing installation services
- Organizations providing servicing and maintenance of medical devices
- Packaging and sterilization service providers
- Testing and laboratory service organizations
- Other suppliers supporting the medical device supply chain
Key Elements of ISO 13485
ISO 13485 establishes requirements for a Quality Management System specifically addressing the characteristics and regulatory needs of the medical device industry.
ISO 13485:2016 – Medical Devices Quality Management System
ISO 13485:2016 is the current published edition of the Medical devices – Quality management systems – Requirements for regulatory purposes standard.
The standard was designed to respond to developments in medical device technology and changes in regulatory requirements and expectations. It places particular emphasis on regulatory requirements, risk management and controls throughout the medical device supply chain.
ISO 13485:2016 remains the current edition following its most recent systematic review and confirmation in 2025.
ISO 13485 and Medical Device Risk Management
Risk management is an important element of quality management for medical devices. Organizations should establish processes appropriate to their activities for identifying and controlling risks associated with medical devices and related processes.
Effective risk-based processes can help organizations address potential problems throughout relevant stages of the medical device life cycle and support product safety and performance.
ISO 13485 and Regulatory Requirements
ISO 13485 is specifically designed around the quality management needs of the medical device industry and places greater emphasis on regulatory requirements than general quality management standards.
Organizations should identify and maintain applicable regulatory requirements for the markets and jurisdictions in which their medical devices and related services are supplied.
Certification to ISO 13485 does not by itself constitute regulatory approval of a medical device. Regulatory approval or authorization requirements depend on the applicable laws and regulations of the relevant market.
ISO 13485 Certification Process
The certification process generally involves several stages to assess whether an organization's Quality Management System meets the applicable ISO 13485 requirements.
The organization submits an application for ISO 13485 certification.
The organization's activities, products, services and QMS scope are reviewed.
The organization's readiness and documented quality management system are assessed.
The implementation and effectiveness of the QMS are evaluated.
Identified nonconformities are addressed by the organization.
The certification decision is completed based on the audit results.
Where applicable certification requirements are met, the organization receives its ISO 13485 certificate.
Ongoing surveillance activities may be conducted according to the applicable certification scheme.
ISO 13485 Certification Requirements
Organizations seeking ISO 13485 certification should establish and maintain a Quality Management System appropriate to their medical device activities, products, services and applicable regulatory requirements.
Important areas include:
- Defining the scope of the Quality Management System
- Understanding applicable regulatory requirements
- Establishing a quality policy and quality objectives
- Defining responsibilities and authorities
- Managing competence, training and awareness
- Maintaining appropriate infrastructure and work environment controls
- Managing medical device design and development where applicable
- Managing purchasing and supplier controls
- Controlling production and service activities
- Maintaining appropriate identification and traceability where required
- Managing customer-related and regulatory requirements
- Monitoring and measuring processes and products
- Managing complaints and feedback where applicable
- Managing nonconformities and corrective actions
- Conducting internal audits and management reviews
- Continually improving the Quality Management System
ISO 13485 and Medical Device Supply Chains
Medical device manufacturers often rely on suppliers and external service providers for components, materials, manufacturing processes, testing, sterilization, distribution and other activities.
ISO 13485 provides requirements for appropriate control of externally provided processes and products according to their impact on the quality management system and medical device requirements.
Effective supplier controls can help organizations maintain consistent quality and meet applicable customer and regulatory requirements throughout the supply chain.
Why Choose BMG Certification?
BMG Certification provides certification-related services for organizations seeking to demonstrate conformity with applicable management system standards.
Our approach focuses on understanding the organization's Quality Management System, assessing conformity against applicable ISO 13485 requirements and supporting a structured certification process.
Organizations can use ISO 13485 certification to demonstrate their commitment to medical device quality management, applicable regulatory requirements and continual improvement.
ISO 13485 Certification FAQs
What is ISO 13485 certification?
ISO 13485 certification demonstrates that an organization's Quality Management System for medical devices has been assessed against the applicable requirements of ISO 13485 by a certification body.
What is the current version of ISO 13485?
ISO 13485:2016 is the current published edition. ISO confirmed the standard as current following its 2025 systematic review.
Who should use ISO 13485?
ISO 13485 is intended for organizations involved in the design, production, installation and servicing of medical devices and related services. It can also benefit suppliers and external parties supporting medical device organizations.
Is ISO 13485 the same as ISO 9001?
No. ISO 9001 is a general Quality Management System standard applicable across many sectors, while ISO 13485 is specifically tailored to medical devices and their regulatory and safety requirements.
Does ISO 13485 certification mean a medical device is approved?
No. ISO 13485 certification relates to the organization's Quality Management System. Medical device regulatory approval or authorization is governed by the applicable requirements of the relevant market.
Is ISO 13485 certification mandatory?
ISO 13485 certification itself is not universally mandatory. However, applicable regulations, customers, contracts or market-access requirements may make certification relevant to an organization.
Get ISO 13485 Certification
Establish a structured Quality Management System for medical devices and demonstrate your organization's commitment to quality, regulatory requirements, risk management and continual improvement.
Contact BMG Certification to learn more about the ISO 13485 certification process.
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