Auditing

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Enter your next external audit with confidence and peace of mind

From now on, you know exactly what to do: Benefit from our expertise for audi­ting your manage­ment systems

Are you stuck when it comes to auditing your management systems? Do you feel over­whelmed by the complexity of the tasks, do you simply lack the time, or do you have difficulty convincing your colleagues or superiors of the necessity of specific processes? 

Implementing and maintaining management systems can be challenging, especially if there is a risk of negative consequences, such as devia­tions in external audits, which could even result in the loss of certification. 

Optimal preparation through internal ISO audits and custo­mized audit plans

Carrying out System Audits

We check your entire manage­ment system and the respective specifi­cation docu­ments as part of an internal or mock audit.​​​​​​

Procedure/Process/Supplier Audits

We check certain parts of your management system in the form of a pro­ce­dure or process audit.  We are also happy to carry out an audit of your suppliers.

Creation of Audit Plans

We provide you with tailor-made audit plans based on your internal audit criteria.

Writing and Reviewing Audit Reports

We're happy to provide you with templates for audit reports, help you write them, or check your reports as part of a gap analysis.

Stress-free external audits thanks to experienced experts at your side

Support in External Audits

We accompany you during your upcoming system or process audit by a notified or certi­fication body and ensure that everything runs smoothly.

Support with Audit Follow-up

Even after an external audit, we support you in analyzing the causes and formulating targeted measures to solve the problems sustainably and to the auditors' satisfaction.

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With us, you will establish a manage­ment system that not only fulfills its function but is also accepted within the company

  1. Comprehensive Expertise in all Devices and Manage­ment Systems
    ​​​​​​​We are familiar with all devices, techno­logies, and management systems in the medical technology sector. We can carry out audits and reviews based on a wide range of regulations and standards. These include, for example, ISO 13485, ISO 9001, ISO 15189, ISO 27001, MDSAP, and 820 CFR.
     
  2. Experienced and Competent Auditors 
    Our experts have not only successfully set up several hundred manage­ment systems from a wide range of manufacturers and their suppliers and guided them safely through the certifi­cation process. Our team consists of many experienced auditors who regularly train employees of notified bodies, and some of whom are even active in standardization committees themselves. 
     
  3. Fast and Clear Results
    We will show you exactly what needs to be done in the shortest possible time: Concrete recommendations for action and step-by-step instructions, for example, to rectify identified deficits as quickly as possible and on time for the audit date.
     
  4. Culture of Transparency and Solution Orientation
    We provide you with an external view of your management system and help ensure that it and all associated processes are accepted and appre­ciated within the company.
     
  5. Professional Consulting Service and Individual Support
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    Our team of experts advises and supports you in all your tasks relating to your manage­ment system – from planning an internal or external audit to conducting or accompa­nying it and following it up. We provide you with tailor-made solutions for your individual challenges. 

Get in touch to find out how we can best support you in a joint meeting.

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

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Further support for management systems

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.

 

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.

External QMR

As your external quality management representative (QMR), we handle much of the QM work for you, which gives you continuity and regulatory safety. 

 

QM Legal Manufacturer

Save yourself the trouble of having your own QM system and slip under our umbrella. We also act as your legal manufacturer. This will get your devices into the market as quickly as possible.

 

E-Learning/Seminars/Workshops

Want to gain more knowledge? Our custo­mized e-learning courses, seminars, and workshops are the key.

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