Integrated Management Systems for Medical Device Manufacturers
Significantly reduce your costs with an integrated management system
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.
Your benefits with the Johner Institute
Objective Expertise from Outside
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.
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.
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.
Significantly Lower 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.
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.
Our proven three-step approach
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.
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.
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
Find out in a no-obligation meeting how you can efficiently integrate your management systems and save costs in the process.
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