Information Security Manage­ment System (ISMS)

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Customized develop­ment and integration of your information security management system according to ISO 27001

Clarity and Compe­tence in the Company

Your team and executives know exactly what is required by law, what information needs to be protected in the company, and how they can implement the necessary steps in practice without unnecessary effort.

Certainty for Upcoming Audits

Our team ensures that your (integrated) Information Security Management System meets all relevant legal requirements – and you are then ready for certifi­cation. This will reduce your stress levels in the future and lower the risk of non-conformities in upcoming audits. 

Minimal Effort and Costs

With our help, your ISMS will be implemented as leanly and simply as possible in your com­pany. To do this, we define efficient processes and integrate them into your existing quality and risk management system where it makes sense. This helps you avoid redundancies and unnecessary duplicate work and audits.

Confidentiality, Data Protection, and Integrity

We will show you how your ISMS can serve as an effective tool for infor­mation and security in the future. This means fewer problems for you, such as critical data loss, reportable incidents, and damage to your company's image.

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Effectively protecting data: When an ISMS makes sense for your company

The topic of information security and ISO 27001 triggers numerous uncertainties in many people:

  • For which medical devices is there a legal obligation to implement an ISMS in the company?
  • In which cases could it be helpful regard­less?
  • How can it be implemented, and who is responsible for it?
  • How can the ISMS be combined with quality and risk management?

Our team of experts will show you how a comp­liant ISMS can help protect your data regarding confidentiality, integrity, and availability and how to implement it in your company with little effort and cost. 

Customized solutions for medical and IVD medical device manufac­turers that work and help your company succeed

Development and Establishment of an ISMS

​​​We help you develop and establish an ISMS that is tailored to your company and works in practice – whether you are a start-up or a large corpo­ration. We are also happy to use a digital tool of your choice. 

Implementation/Consoli­dation of Several Manage­ment Systems

We can create integrated manage­ment systems on request or help you to merge different manage­ment systems. For example, we can extend your quality manage­ment system to ISO 27001 by implementing relevant SOPs.

Takeover of Project Management and Training

We ensure that the project runs smoothly and you achieve defined objectives on time. We also train your teams to understand the require­ments, implement the new processes success­fully, and develop them further in the future. 

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With us, your manage­ment system will be a success factor for productive and legally compliant work without audit stress

  1. Experienced and Competent Auditors       
    Our team consists not only of experienced field experts and auditors but also of members of standards bodies who help develop the regulatory require­ments themselves and can, therefore, best prepare you for audits.

  2. Worldwide Conformity 
    We not only have an ISO 27001 certification in mind but also other requirements such as ISO 13485 or the FDA requirements. This way, you ensure that your manage­ment system meets all requirements worldwide – without unnecessary additional effort.  

  3. Broad Expertise 
    Our comprehensive expertise extends far beyond infor­mation security and quality management - from approval to clinical strategies and biological safety to artificial intelligence. This means we can also help you meet any other regulatory requirements.

  4. Proven Templates
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    Our experts provide templates that have proven themselves in countless audits. This saves time and money and gives you extra regulatory safety. You don't always have to start from scratch. 

  5. Looking to the Future 
    At the Johner Institute, we have a clear vision for modern management systems. This means you are perfectly prepared for tomorrow  digital transformation included. Simply fit-for-future. 

Contact us right away to discuss the best strategy for your (integrated) information security management system. 

 

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Further support for your management systems and software devices

Audits and Audit Support

We check your management system from an expert and external perspective. If we find any problems, we help you eliminate them in a targeted manner. You will then be ready for audits by authorities and notified bodies. 

 

Development/Optimization QMS

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

 

Integrated Management System

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

Software Develop­ment/Approval

We can help you optimize your develop­ment process, classify your software, and create all the necessary approval docu­ments.   

 

Cybersecurity File

Our expert team will help you quickly and safely pass the approval, audits, and reviews with a legally compliant cyber­security file.   

 

Penetration Testing

Our IT security team detects security vulnerabilities in your software devices early and fixes them so you can launch them quickly and safely.  

 

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