Quality Management System
Process control, software validation, and documented information/record control
MANAGEMENT SYSTEM CERTIFICATION
ISO Certification
We provide professional and impartial certification services based on international standards.MEDICAL DEVICES QUALITY MANAGEMENT SYSTEM
ISO 13485
Medical Devices Quality Management System
APPLICABLE STANDARDISO 13485
OVERVIEW
An international standard for managing safety and regulatory conformity throughout the medical-device lifecycle
ISO 13485 specifies quality management system requirements tailored to the medical-device industry so that medical devices and related services consistently meet customer and applicable regulatory requirements.
It emphasizes risk-based control and process effectiveness throughout the medical-device lifecycle, from design and development through production, storage, distribution, installation, servicing and disposal.
01
WHO IT IS FOR
Who It Is For
- Organizations that design, develop and manufacture medical devices
- Suppliers of medical-device components, raw materials and services, and organizations performing outsourced processes
- Organizations involved in sterilization, packaging, storage, distribution, installation or maintenance
02
KEY REQUIREMENTS
Key Requirements
Management Responsibility
Quality policy/objectives, responsibilities and authorities, management review and regulatory compliance
Resource Management
Human resources, infrastructure, work environment and contamination control
Product Realization
Risk management, design and development, purchasing, production, traceability and sterilization-process control
Measurement, Analysis & Improvement
Feedback, complaints, regulatory reporting, internal audit, nonconforming product and corrective action
03
EXPECTED BENEFITS
Expected Benefits
Consistent medical-device safety and quality
A stronger foundation for country-specific regulatory requirements
Improved product/process risk and supply-chain management
Support for exports and global market access
Greater confidence among customers, regulators and interested parties
04
PREPARATION GUIDE
Preparation Guide
CERTIFICATION INQUIRY
Certification inquiry →
ISO 13485 Are you preparing for certification?
We review your organization and certification scope and guide you through the required process.