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Since 1 June 2017 DEKRA Certification GmbH has been accredited by the German Accreditation Body (Deutsche Akkreditierungsgesellschaft, DAkkS) in accordance with DIN EN ISO 13485:2016 and is therefore authorised to conduct certifications of quality management systems based on this standard revision and to issue the relevant certificates.
In 2016 the quality management standard DIN EN ISO was extensively revised. This included, among other things, the integration of additional requirements in the standard, e.g. in the labelling requirement and the technical documentation. We have compiled the most important changes for you.