Certification EN ISO 13485

EN ISO 13485 is similar in scope and intention to ISO 9001, but it contains additional requirements for medical devices and excludes certain provisions of ISO 9001. For this reason, in most countries certification to ISO 9001 is not an acceptable substitute for certification to EN ISO 13485.

Based on a functioning management system, individual company structures can be precisely tailored to the specific needs and specifications of the individual customer. Operational procedures can be designed so as to be flexible, and everybody benefits.  

The manufacturer places Class I products on the market on his own responsibility. For products of Classes Im, Is, Ir, IIa, IIb and III, a conformity assessment procedure with the involvement of a Notified Body is needed. TÜV NORD CERT is a Notified Body as per Regulation (EU) 2017/745 on medical devices.

- Continual improvement

- Prevention of nonconformity

- Control of the supply chain

- Identification and monitoring of quality-related key indicators

- Product safety

- Determination of customer satisfaction

- Product and process development are considered separately

- Interdisciplinary cooperation

- Implementation and monitoring of a QM system for medical devices including components and the original raw materials used in manufacture, along with any related services.

A QM system according to EN ISO 13485 provides the ideal basis for modern organizations of every size to demonstrate competence and efficiency at home and abroad. Internal work processes, responsibilities and authorities are taken fully into account, as is the regulation of processes for interaction with customers and business partners.