ISO 13485
ISO 13485 Medical Devices Quality Management
Quality management for the design and manufacture of medical devices.
ISO 13485 specifies the requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
It applies across the life cycle of a medical device, from design and development to production, storage, distribution, installation and servicing, and it places strong emphasis on risk management and on meeting regulatory requirements.
Key requirements
What ISO 13485 asks for
Quality management system
General requirements, documentation and the quality manual, with documented procedures and records.
Management responsibility
Management commitment, customer focus, quality policy, planning and management review.
Resource management
Human resources, infrastructure and a work environment suitable for the product, including contamination control.
Product realization
Planning, design and development, purchasing, production, sterile device controls and traceability.
Measurement, analysis and improvement
Feedback, complaint handling, regulatory reporting, internal audit, and corrective and preventive action.
Benefits
Why organisations use it
- A recognised basis for regulatory submissions
- Risk management across the device life cycle
- Traceability and controlled records
- Confidence for hospitals, distributors and regulators
- Access to markets that expect a quality system
Who it is for
Typical organisations
ANAP accreditation
How ANAP accredits ISO 13485 certification bodies
Certification bodies auditing ISO 13485 are assessed against ISO/IEC 17021-1, with the competence needed to audit medical device organisations.
FAQ
Frequently asked questions
Is ISO 13485 the same as ISO 9001?+
No. ISO 13485 is based on quality management principles but is more prescriptive and puts regulatory requirements and risk management at its centre.
Does ISO 13485 mean a device is approved for sale?+
No. It certifies the quality management system. Market approval depends on the regulations of each country, although many regulators accept or require the system.