FAQ's zur ISO 13485 Zertifizierung

ISO 13485 is the international standard for quality management systems in the medical device sector. It is aimed at all organisations along the value chain – from development and manufacturing to storage and distribution of medical devices. The standard forms a central basis for the approval of medical devices in numerous markets worldwide, including Europe with the CE marking.

The certification does not make any judgements about individual products and does not replace product certification or approval. Rather, it confirms that your management system has established the minimum requirements for processes to develop, manufacture and distribute medical devices. The quality management system according to ISO 13485 forms an excellent basis for the creation of high-quality medical devices.

ISO 13485 certification is particularly relevant for:

Manufacturers and suppliers:

• Medical device manufacturers: From imaging procedures to implants and surgical instruments, certification is often essential for all manufacturers of medical devices.
• Suppliers: Companies that supply components for medical devices are increasingly being asked to obtain certification in order to remain in the supply chain.

Service providers and specialist suppliers:

• Medical technology service providers: Service providers for the installation, maintenance and repair of medical devices benefit from structured process design.
• Software developers in the medical field: For software as a medical device or for medical applications, ISO 13485 is a decisive proof of quality.
• Manufacturers and distributors: Organisations that assemble, sterilise, package or distribute medical devices increasingly require certification.

• Market access: Simplified access to international markets for your medical devices, especially in Europe, the USA and Asia, where the standard is recognised as a quality benchmark.
• Legal certainty: Proof of compliance with regulatory requirements for medical devices, thereby improving your legal position vis-à-vis authorities and in the event of damage.
• Customer loyalty: Increased trust among customers, patients and healthcare facilities through demonstrable quality orientation and standardised processes.
• Process optimisation: Structured improvement of internal processes, reduction of error risks and increased efficiency throughout the entire product life cycle.

ISO 13485 certification is based on five key pillars of quality management:

1. A fully documented quality management system
2. Clearly defined management responsibilities
3. Systematic resource management
4. Consistent control of product realisation
5. Continuous measurement, analysis and improvement
6. These requirements for quality management systems apply equally to medical device manufacturers, suppliers, service providers and software developers – wherever medical devices are created or processed.

ISO 13485 differs from ISO 9001 in the following ways:

• Focus on the safety and performance of medical devices rather than general customer orientation
• Risk management as a central, consistent element in quality management
• Stricter requirements for the validation and verification of processes
• Significantly more extensive documentation requirements for medical device manufacturers