An ISO 13485 certificate proves your commitment to the quality of medical devices. It enables you to demonstrate that your quality management system has been assessed and found compliant in order to meet regulatory requirements and customer needs.
Medical devices and IVDD (In Vitro Diagnostic devices) is an increasingly important health care area in relation to their impact on health and health care expenditure. The sector covers a large range of products, from simple bandages, through life maintaining implantable devices, equipment to screen and diagnose disease and health conditions, to the most sophisticated diagnostic imaging and minimal invasive surgery equipment.
ISO 13485:2003 – “Medical devices – Quality management systems – Requirements for regulatory purposes” is the internationally recognised standard for quality management system in the medical device industry. It specifies requirements for a quality management system where an organisation need to demonstrate its ability to provide medical devices and that related services consistently meet customer requirements and applicable regulatory requirements. It is designed and intended for use by organisations for the design and development, production, installation, servicing and sales of medical devices.
As this is a highly regulated sector across the world, the primary objective of ISO 13485 is to facilitate harmonised medical device regulatory requirements for quality management systems. ISO 13485 is a standalone standard. It is largely based on the structure of ISO 9001, but includes some particular requirements for medical devices such as risk analysis, sterile manufacturing and traceability and excludes some of the requirements of ISO 9001 that are not necessary as regulatory requirements. Because of these exclusions, organisations being certified to ISO 13485 can not claim conformity to ISO 9001.
Connection with national requirements for approval of medical devices
Legal access to markets for products is essential for manufacturers of medical devices. ISO 13485 is often referred to and required by national regulations as part of the approval process for medical devices, e.g. for the EU directive on medical devices (Medical Device Directive 93/42/EEC, In Vitro Diagnostic Directive 98/79/EC , Active Implantable Medical Devices 90/385/EEC). DNV is also appointed as a notified body to carry out conformity assessment according to Annex II, IV and V of the Medical Device Directive 93/42/EEC. Manufacturers certified according to ISO 13485:2003 fulfil all the quality management requirements for any class of devices under this directive.
Related documents
ISO 14969:2005 - This standard provides guidance for the application of the requirements for quality management systems contained in ISO 13485:2003. This guidance can be used to better understand the requirements of ISO 13485 as it helps illustrate some of the variety of methods and approaches available for meeting the requirements of ISO 13485:2003.
ISO 14971:2007 - This standard specifies a procedure by which a manufacturer can identify the hazards associated with medical devices and their accessories. It also specifies a procedure to estimate and evaluate the identified risks, control these risks and monitor the effectiveness of the control.
Where do I go from here?
For third party certification, you need to implement an effective management system complying with the requirements of the standard. The first step is to get on the road to certification.