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Certification EN ISO 13485

EN ISO 13485: A clearly defined quality standard in international business

Nowadays, fulfilment of clearly defined quality standards in business – and particularly in international business – is becoming ever more important. Part of this is the ability to adapt to changing markets and customer requirements and constantly develop new learning and improvement processes.

EN ISO 13485, as a quality management system for medical devices, describes requirements for regulatory purposes and describes the development, implementation and maintenance of a quality management system for medical device manufacturers and suppliers.

The standard contains detailed requirements for a quality management system which fulfils both customer requirements and the requirements for all life cycle stages of a medical device, including its components and the original raw materials used in manufacture, along with any related services.

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Benefits of EN ISO 13485 certification

  • Sustainable quality assurance
  • Identification of possible cost savings and potentials for improvement
  • High level of customer satisfaction
  • Image enhancement
  • Risk minimisation
  • Improved economic efficiency through process improvement
  • Greater competitive strength
  • Fulfilment of specific customer requirements  

EN ISO 13485 certification procedure

TÜV NORD CERT accreditation and registration

We are accredited by the German Accreditation Body (DAkkS) as a certifier of management systems for medical devices according to EN ISO 13485. TÜV NORD CERT is also a Notified Body (Registration No. 0044) for active and non-active medical devices, appointed by the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG).

FAQs on EN ISO 13485

Why is EN ISO 9001 not sufficient?

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.  

Is EN ISO 13485 certification sufficient for a manufacturer to bring products onto the European market?

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.

Who can benefit from certification?

A QM system according to EN ISO 13485 provides the ideal basis for modern organisations 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.  

 

What are the main aspects of certification to EN ISO 13485?
  • 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.
Conversion of certificates to EN ISO 13485:2021-12

At the end of 2021, the German Institute for Standardization (DIN) published the new edition of EN ISO 13485 as the German version of EN ISO 13485:2016 + AC:2018 + A11:2021. 

On 12.04.2022, in a special announcement, the German Accreditation Body (DAkkS) informed us of the updated requirements for certifications of quality management systems for medical devices and the required changeover at the certification bodies.

Conversion process

  • Accredited bodies active in this area must have their accreditation changed in order to convert their certificates to the new standard.
  • New certificates or changed certificates that have been issued  in accordance with EN ISO 13485:2016 in the meantime, shall be time-limited up to 26.05.2024. A note will be made on the certificate regarding  the extension of the term to the maximum validity period (3 years) after switching to the new edition of EN ISO 13485.
  • Customers who have installed and certified a QM system according to EN ISO 13485 must apply the requirements of the new standard and convert their certificates by 26.05.2024.
  • The conversion of certificates (customers) to the new version of EN ISO 13485:2021-12 takes place within the regular surveillance process.

Significant changes

  • Integration of amendment A11:2021 of the European Standard, Edition EN ISO 13485:2016, with adaptation of the Z-Annexes to the MDR and IVDR
  • With its publication in the Official Journal of the EU, underlying standard EN ISO 13485:2016 + AC:2018 + A11:2021 is harmonized with the MDR and IVDR.

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