Since the MDR , DIN EN ISO 13485 auch bei Klasse I Hersteller*innen ganz oben auf der to-do-Liste.
A quality management system (QMS) is no longer just a matter of good manners but is now also a legal obligation in the Class I area. If you want to do it right from the start, you have to use this standard. Many aid manufacturers are affected by this.
Ein Grund mehr für uns Änderungen, die mit der letzten Aktualisierung aus Dezember 2021 kamen, näher zu betrachten. Für Hersteller*innen von Medizinprodukten und In-Vitro-Diagnostika sowie Berater*innen stellt sich die Frage, was sich konkret geändert hat.
Looking at the revised standard, it is noticeable that it has roughly the same scope as the superseded version. If the viewer skims the table of contents, it looks exactly the same as before. After that, however, it becomes interesting for readers and organizations that have implemented a QMS in accordance with this standard or will have to implement one in the future or are in the process of doing so.
There were a total of 1213 changes compared to the 2016 version:
- 364 replacements
- 243 insertions
- 112 deletions
- 367 formatting changes and
- 127 annotations
An initial classification:
The tables previously located at the end of the standard have been placed in front of the actual standard chapters and explanations of terms.And the relationships between the standard and the requirements in accordance with Regulation (EU-MDR) 2017/745 Art. 10 and Regulation (EU-MDR) 2017/746 Art. 10 are each presented using this clear table.
The chapters and paragraphs of Article 10 of the Regulation(s) are compared – step by step – with the sections of the standard and explanations make it easy to understand which chapters and paragraphs of the Regulation(s) cover the sections of the standard and which do not.
Two further tables have then been added to clarify the relationship between the standard and the requirements of Annex IX and Annex XI of the regulation(s). Thus, the aspects of the conformity assessment procedures based on a QMS and technical documentation as well as on the basis of a product conformity test are taken up and considered in a differentiated manner. The comments and notes should not be ignored.
There are many additional explanations in this document that clarify the translation from English in particular, so that there should be fewer misunderstandings in multi-lingual documentation.The wording always plays a significant role in FDAaudits, for example.
Conclusion: A complete quality management system that meets the regulatory requirements is not automatically given if the tables function as "checklists". In our opinion, they are a suitable tool for the structured realization/implementation of a QMS or its adaptation in accordance with DIN EN ISO 13485:2021-12.
This makes it easier to check the requirements for the QMS taking into account the standard AND the regulation.
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