List the current processes and documentation in place for ISO 13485 which are applicable to ISO 17025, and then list the additional required by or needing customisation for ISO 17025. I suggest you do a gap assessment of what is in place for ISO 13485. Examples a document control and dealing with complaints and nonconforming work.
It is however, unnecessary to reinvent the wheel, so use the current process and strategies already implemented in 13485 for common ISO 17025 activities, wherever possible. Otherwise if you try and do this upfront, it could slow down the adoption of ISO 17025. Die ISO 13485:2016 beschreibt allgemeine Anforderungen an ein Qualitätsmanagementsystem und dementsprechend werden nicht alle spezifischen Anforderungen der MDR bzw.
If you have different people responsible for the different standards implementation and maintenance, then keep them separate, at least to start with and then integrate to a practical extent later. In my experience it all depends on the management structure of the laboratory. Would it be best practice to integrate the ISO17025 requirements in the ISO13485 QMS or make a separate ISO17025 QMS for the labs? Lorsqu'une exigence dfinie l'Article 6, 7 ou 8 de l'ISO 13485:2016 ne peut tre applique en raison des activits entreprises par l'organisme ou de la nature du dispositif mdical auquel s'applique le systme de management de la qualit, l'organisme n'est pas tenu d'inclure cette exigence dans son systme de management de la qualit.
