How long is the certification valid?
The certificate for ISO 13485 is awarded upon successful completion of the certification process. It is valid for three years and must be confirmed every year by a monitoring audit. The interval is thus the same as in the process for certification under the quality management system standard ISO 9001, enabling the two standards to be audited together.
Healthcare equipment is subject to high standards – after all, its quality can have a direct impact on both its effectiveness and the safety of patients and users. Quality management systems are certified in accordance with the international standard EN ISO 13485, with the inspection focusing on quality management in design and development, production, customer service and the assembly of medical devices.
What is ISO 13485?
ISO 13485 is very similar to ISO 9001, but was developed specifically for manufacturers and suppliers of medical devices. As part of the certification procedure – which consists of a document inspection in advance and a subsequent on-site company audit.
The following issues are taken into account alongside the familiar requirements of ISO 9001
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