QM & certifications

The ISO 13485 standard is very similar to ISO 9001 but was developed specifically for manufacturers and suppliers of medical devices. It is based on the EU regulations on medical devices 2017/745 (MDR) and on in vitro diagnostic medical devices 2017/746 (IVDR).

ISO 13485 specifies similar minimum requirements for the quality management system as ISO 9001. However, the specific requirements go well beyond this in some areas. In particular, standard operating procedures (SOPs) are mandatory in many chapters, which is not the case under ISO 9001. The standard also requires applying a clear risk-based approach in all areas of the company that have an influence on the appropriate manufacture and safe use of medical devices.

In the introduction, it is explicitly stated that the standard can also be applied by suppliers of medical device manufacturers. This refers to providers of products and services for organizations that manufacture and/or distribute medical devices. Translations fall into this category of services, especially translations of the so-called “labelling”, which must be considered an integral part of the medical device. This opens up the possibility for a language service provider to be certified in accordance with ISO 13485, which is associated with a number of advantages for the manufacturer of medical devices.

See also: “What our ISO 13485 certification means for our clients”

As part of the ISO 13485 certification procedure, an audit readiness assessment is first carried out (possibly in advance/remotely). The actual audit is then usually carried out on site at the company. In the following two years, annual inspections are carried out by means of surveillance audits. After three years, recertification is required.

This standard specifies requirements for the translation process. In contrast to the ISO 9001 and ISO 13485 standards, it does not prescribe a specific quality management system and the documentation requirements are relatively reduced. The main requirements of the standard are the four-eyes principle and the qualification and competences of the translators, which must be verified by the language service provider. In this way, ISO 17100 creates an industry standard for the professional profile of translators and makes it possible to compare the scope of the “translation” service between different service providers.

The certification procedure prescribes an initial certification audit. In the following two years, annual surveillance audits are carried out. Recertification is then required three years after the initial certification.