Aerospace and medical
ISO 13485: Medical devices, quality management systems, requirements for regulatory purposes
The QMS standard for medical device manufacturers and their critical suppliers.
Reference noteThis page is an independent plain-language summary written by QUALITAS TR. It does not reproduce the standard. Always work from the current official edition, available from ISO, the International Organization for Standardization, and national standards bodies such as TSE in Turkey (official page). QUALITAS TR supports organisations against this standard; it does not certify them.
01Purpose
ISO 13485 specifies QMS requirements for organisations involved in one or more stages of the medical device lifecycle, with a focus on meeting customer and regulatory requirements.
02Scope
Applies to manufacturers and suppliers of medical devices, components and services such as sterilisation.
03Main requirements
- Risk based approach across processes
- Design and development controls
- Process validation where output cannot be verified
- Supplier evaluation and controls proportional to risk
- Traceability and identification
- Cleanliness and contamination control
- Feedback, complaint handling and regulatory reporting
04Typical applications and industries
Required by many regulators and medical device customers for suppliers of critical components.
05Audit and inspection considerations
- Are special processes validated?
- Are changes notified to the customer?
- Is traceability complete?
06Common nonconformities
- Process validation missing or incomplete
- Supplier controls not risk based
- Cleanliness requirements not monitored
07How QUALITAS TR can support
We perform ISO 13485 structured supplier audits of Turkish medical device suppliers.