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UNE-EN ISO 13485 Quality Management System for Health Care Products

Guarantee that the health products that it manufactures, distributes or uses are safe, perfectly suitable for the intended use and comply with the legal requirements.

The UNE-EN ISO 13485:2013 Standard is based on the UNE-EN-ISO 9001:2000 Standard and lists the requirements for a quality management system to be used by an organisation in the design, development, production and installation of health products and the provision of services related to them. Using health products that comply with this standard help enhance the quality of the healthcare provided.

It incorporates additional demands in order to meet the sector's legal requirements in aspects such as: design, control of the records, critical processes, traceability, sterilisation processes and risk management.

It is a Standard harmonised for all health product guidelines.

It is designed to be a tool for maintaining process efficiency and effectiveness, more than a business improvement model, which is why it fully complies with the UNE-EN-ISO 9001.2000 Standard.

There are two complementary standards, the standard UNE-CEN-ISO/TR 14969:2006 Health products. Quality Management Systems. Guide for the application of the ISO 13485:2003 Standard, which provides recommendations for its implementation and use; and the UNE-EN ISO 14971:2012 standard Health products. Application of risk management to health products with recommendations for meeting the risk management requirements.

Related sectors

The certification in accordance with this Standard is applicable to all organisations in any sector that participate, during the useful life of a health product, in the activities of design, manufacturing, packaging, packing, drawing up and/or translating instruction manuals, advertising, sales, distribution or training for its use, installation and maintenance.

Possibility of obtaining comprehensive certification with

The certification in accordance with the UNE-EN-ISO 13485 Standard is compatible with and complementary to the ISO 9001 certification, and can be easily integrated with any other management system such as ISO 14001 and OHSHAS 18001.

What clients obtain

Once the audit process has been successfully completed, if the implemented system meets the requirements of the ISO 13485 standard, the organisation will obtain:

  • The AENOR Certificate of Quality Management Systems for Health Products.
  • A license to use the AENOR Mark of Quality Management Systems for Health Products.
  • The IQNet Certificate, passport for international access of its certification. With it, its AENOR certificate will be recognised by leading certification entities all over the world.
  • A licence to use the IQNet mark.

Furthermore, organisations with management systems certified by AENOR have free access to AENORnet and subscription to the AENOR monthly magazine.

Related logos or marks

AENOR Mark of Quality Management System for Medical Devices
AENOR Mark of Quality Management
for Health Products
IQNet Mark
IQNet Mark

Experience with certification

Since 2007, when the first quality management certificate in accordance with the UNE-EN ISO 13485:2004 Standard was awarded to the organisation IMMUNOSTEP, S.L., more than 20 organisations have turned to AENOR to certify their quality management system for healthcare products.

Contact us

Request detailed information from us today about the complete audit process (reports, timescales, visits, etc.) and an offer adapted to the needs of your organisation.
Tel. (+34) 914 326 000


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