Quality management systems – Requirements and certification according to EN ISO 13485

In order for your medical devices to be approved in important markets, proven quality management for the design and manufacture of your product is essential. For this, EN ISO 13485 sets requirements for regulatory purposes.

Accordingly, the standard deals with requirements that you as a manufacturer must fulfil in order to meet the quality requirements in the development and implementation of management systems for medical devices. EN ISO 13485 was first developed in 1996.

In the meantime, several standards have been combined under it, including ISO 13488. Certification according to ISO 13485 is carried out by accredited certification bodies, such as DQS or TÜV.

Requirements according to EN ISO 13485

ISO 13485 defines four process areas. Each of these areas contains several processes that you as a manufacturer of medical devices must define. This can be done, for example, in the form of a process instruction. With such an instruction, companies define specific processes, e.g. for product development or services.

The four process areas according to EN ISO 13485 are:

Management responsibility
Resource management
Product realisation and service provision
Measurement, analysis and improvement

Certification according to EN ISO 13485

In order to obtain certification according to EN ISO 13485, it is first necessary that you select a notified body or certifier that is accredited for such certification. According to the German accreditation body DaKKs, there are currently 17 certifiers in Germany.

Did you know …?

… that certified bodies are only allowed to carry out certification according to EN ISO 13485 for a certain type of medical devices? For in-vitro diagnostics, for example, these are Medcert, TÜV Rheinland, TÜV Süd, mdc and Dekra.

In order to obtain certification from the body you have chosen, you invite them to an audit in which their quality management system is examined. After successful audit and certification, you are authorised to place your medical devices on the market.

In order to apply for an audit, you must not only establish and define your quality management system, but already act according to the specifications of this system.

This includes, for example, that you have already created a technical documentation of your medical device. This is where the BAYOOSOFT Risk Manager supports you.

The validated approval accelerator is certified according to EN ISO 13485 and is thus the optimal supplement for your quality management system. In addition, the BAYOOSOFT Risk Manager supports you in generating flawless technical documentation and thus accelerates the process.

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Quality management systems – Requirements and certification according to EN ISO 13485

Requirements according to EN ISO 13485

Certification according to EN ISO 13485

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