Overview
ISO 13485 focuses on consistent design, production, installation and servicing of medical devices and related services. It emphasizes risk management, documented controls, traceability, validation and regulatory requirements.
Business benefits
- Greater control over regulated medical-device processes
- Improved traceability and documentation
- Stronger supplier and outsourced-process controls
- Systematic complaint and feedback management
- Enhanced customer and regulatory confidence
Key assessment focus
01
Regulatory and customer requirements
02
Risk management throughout product realization
03
Design and development controls, where applicable
04
Process validation, cleanliness and traceability
05
Complaint handling, reporting and corrective action
Typical information required
- Organization profile, products and regulatory markets
- Quality-system documentation and procedures
- Risk-management and product-realization records
- Validation, traceability and supplier records
- Internal audit, management review and corrective actions
Certification process
Application
Scope, sites, employees, shifts and process details.
Stage 1
Readiness, system design and audit planning review.
Stage 2
Evaluation of implementation and effectiveness.
Decision
Independent review followed by surveillance planning.
Frequently asked questions
Medical-device manufacturers and relevant suppliers or service providers may apply according to their activities and certification scope.
No. Management-system certification does not itself authorize a medical device for sale; regulatory product approvals remain separate.
Applicability depends on the organization’s role, activities and regulatory framework and must be properly justified.