Management Systems

Employees Looking at a Laptop Together

Maximum productivity and mini­mal stress during audits – with lean and legally compliant management systems

We support medical device manufacturers, their service providers, and laboratories in setting up, continuously improving, and integrating management systems. This ensures that they are well-prepared for upcoming audits.

Development/Optimization QMS

Our experts help you to achieve a lean and ISO 13485-compliant quality management system without bureau­cratic frustration.

 

Development/Optimization ISMS

Our team helps you to effectively protect your data with a lean information security management system and to meet the requirements of ISO 27001.

 

Auditing and Audit Support

We review your management system with a trained external perspective. We help you eliminate any problems we find in a targe­ted manner. You will then be ready for audits by authorities and notified bodies.

 

Integrated Management Systems

We help you efficiently integrate your management systems, such as those in accordance with ISO 13485, ISO 9001, or ISO 27001, thereby saving costs.

We are always there for our customers

Feedback of our Customers

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At the beginning of September, we had our first maintenance audit and passed with flying colors! Thank you and Mr. Wittorf for your support in this matter as well!
Lisa Hopp, SuPSmed
With the practical help of Prof. Johner and his team, we were able to establish a “workable” QM system for our company in just a few months and success­fully certify it according to ISO 13485. We greatly appreciate the pleasant cooperation and the fact that we were able to complete the project within the planned time frame and budget.
Dominik Blei, Gesellschaft für Patientenhilfe DGP mbH
We had two really good audit days and Mr. [NB auditor] praised our company highly. Thank you very much again for your good work and guidance. Without you, we would probably have failed. We made a big impression with the develop­ment plan :-).
Björn Maucher, Health Information Management GmbH
Our audit is complete and we have “passed.” There were no non-conformities and only a few suggestions for improvement. The (auditor) team particularly praised the technical basis of the QM system. On behalf of myself and the entire team, I would like to express my sincere thanks to you for your excellent support!
Klaus Mueller, TWT Digital Health GmbH
The Johner Institute provided us with customized consulting services as a supplier to the medical technology industry. Our problems were identified in online conferences. An in-house workshop was developed together with JI, and our docu­ments and requests were taken into account in the planning. The workshop took place in a consistently pleasant and productive atmosphere. We were particularly impressed by the modular concept. It enabled a presentation that was tailored to our individual needs. The tutors were able to respond to further questions and com­ments as they arose. After the workshop, we received our customized presentation and documentation within one day. We are delighted and would like to thank you for your compre­hensive support.
Nick Rittich, ME-Meßsysteme GmbH
I particularly appreciate two things about working with JI. Excellent project planning combined with outstanding expert knowledge. The pilot concept allowed me to familia­rize myself with the topic under guidance and clarify any ques­tions I had through an indivi­dual correction loop. I can only recommend working with JI.
Reviderm AG Team
Yesterday and today, we had the initial audit according to ISO 13485 with TÜV. They did not find any non-conformities and had only a few comments for improvement. The risk manage­ment and usability files were praised in particular and des­cribed as exemplary by the auditors. We will therefore receive our certificate in the near future. On behalf of the entire team, I would like to take this opportunity to thank you all very much. We found the colla­bo­ration with you to be very productive and appreciative.
Raimund Oberhammer, World-Direct eBusiness solutions GmbH
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