Integrated Management Systems (IMS)

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We integrate ISO 13485, ISO 9001, ISO 27001, ISO 42001, and other standards into an efficient system – applicable to all markets, devices, and locations

Multiple certifications often lead to multiple costs

As a managing director or QM lead, you know the drill: redundant processes, duplicate documentation, parallel audits – your manage­ment systems resemble a patchwork quilt of different standards.

The result: skyrocketing costs, frustrated employees, and the constant risk of failing audits.

Without integration, you're not only wasting resources –you're risking your competi­tive­ness and regulatory compliance.

Significantly reduce your costs with an integrated management system

Unique Regulatory Competence

As a trainer of notified bodies and authorities, we are familiar with all regulatory requirements for all markets and devices. You gain the certainty of full compliance, without any unpleasant sur­prises during audits.

Significantly Lower Efforts and Costs

By eliminating redundancies and unnecessary efforts, you can drastically reduce your running costs. Less documentation, more efficient processes, and reduced audit efforts will ultimately economize on your budget.

Professional Change Management

We ensure acceptance among all stakeholders and reduce resistance. Through a uniform understanding and clear communication, you can implement your project faster and more successfully.

Objective Outside Expertise

Benefit from neutral experts who develop the best solution for your company without internal politics. That means no suboptimal compro­mises, but a stable basis for successful projects.

Customized Templates

Instead of generic specification documents, you receive specific, action-oriented documents for your company. That reduces training require­ments, accelerates implementation, and shortens the time-to-market for your devices.

Active Project Management

We don't just observe – we actively drive your project forward. With realistic planning, consistent implementation, and professional project management, you will achieve your objectives without any detours.

Presentation by an Expert

Our proven three-step approach

  1. Module 1: Develop a strategy for an integrated management system

    We analyze your existing management systems (QMS, ISMS, KI-MS), processes, and certificates. In structured workshops, we work with you to develop several target visions for your integrated management system. With clear evaluation criteria (time, costs, personnel and structural resources, regulatory risks), we help you select the optimal solution.

    Your benefit: Clarity about scope, necessary certificates, and the best structure for your company – no costly mistakes in decision-making.

  2. Module 2: Project planning

    Our experts will create a detailed project plan for your selected target vision, inclu­ding a work breakdown structure, realistic cost estimates, resource allocation, mile­stones, and a clear project organization.

    Your benefit: Planning reliability, realistic schedules, and transparent costs – no unpleasant surprises during implemen­tation.

  3. Module 3: Project implementation

    We actively support you throughout the entire implementation process: project management, gap analyses, revision of specification documents, training, internal audits, and support for external audits. Our hotline support is available to you at any time.

    Your benefit: Fast, successful implemen­tation without detours – and the certainty of meeting all regulatory requirements.

Start your QM integration now

Contact us now to learn how you can efficiently integrate your management systems and save costs in the process.

 

Contact us, we're happy to help!
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+49 7531 94500 20

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Further support for your management systems

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. 

 

Development/Optimization ISMS

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

 

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