Expertise.
ISO Audit Consulting.
Compliant?
Efficient?
processes and ensure that all audit criteria are met.
Secure?
ISO Audit Consulting.
ISO audits are a crucial step in ensuring compliance with international quality standards such as ISO 9001, ISO 13485 (for medical technology and IVD), ISO 14001 and ISO 27001. Our experts will guide you through the entire audit process - from the preparation phase to successful certification. We provide tailor-made solutions to help you optimize your processes, create documentation and implement a robust quality management system.
Our services include:
- Audit preparation & strategy development: We create individual audit strategies and prepare you optimally for upcoming certifications in medical technology and IVD.
- Conducting internal audits: Our experts conduct internal audits to evaluate your processes and identify necessary improvements.
- Follow-up & continuous improvement: We support you in the implementation of corrective measures and the continuous optimization of your quality management system, especially in medical technology and IVD.
Ensure your ISO conformity and auditability.
Discover our expertise in ISO audits for medical technology and IVD.
Our ISO audit consulting for medical technology and IVD covers various ISO standards and offers you customized solutions to improve your processes and ensure certification.
ISO 9001 audits.
- Conducting ISO 9001 audits to ensure a robust quality management system
- Support with the implementation of a process-oriented management system
- Preparation for external ISO 9001 certification audits
ISO 13485 audits.
- Support in complying with ISO 13485 standards for quality management
- Advice on implementing a QMS and preparing for certifications
- Conducting audits to verify compliance with regulatory requirements
ISO 27001 audits.
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Review and improvement of information security
management systems in accordance with ISO 27001 - Preparation for certification audits by external auditors
- Training employees on the requirements of the ISO 27001 standard
Successful ISO audit projects.
Challenge.
A medium-sized medical technology company was faced with the challenge of improving its existing processes to ensure compliance with ISO 13485 standards and to renew its certification.
Measures.
- Conducting a comprehensive internal audit to evaluate the existing quality management processes
- Development of a plan to improve documentation and process monitoring
- Training of employees to ensure that the new requirements are fully understood and implemented
Results.
- Successful renewal of ISO 13485 certification without any significant objections
- Improvement of internal process documentation by 30%, resulting in better traceability
Success.
The company was able to optimize its internal processes and ensure that all ISO 13485 requirements were met, resulting in successful recertification.
Secure your ISO certification.
Our ISO Audit Consulting Portfolio.
Our ISO audit consultancy offers you customized solutions for the preparation, implementation and follow-up of audits to ensure conformity with various ISO standards.
The use of modern technologies such as big data, advanced analytics and artificial intelligence (AI) significantly improves the efficiency of ISO audits. These technologies enable the precise analysis of large amounts of data and the early identification of deviations. You can find more information on technology-based audits in the ISO standards.
Many companies rely on integrated management systems that combine quality, environmental and safety management. We offer comprehensive support in the auditing and implementation of such systems to ensure seamless certification. Further information can be found on our Integrated Management Systems page.
Remote audits offer companies the opportunity to monitor compliance remotely. Our consulting services include preparation for digital audits and the implementation of cloud-based quality management systems (QMS). Visit the remote audits page to learn more about digital solutions.
By using IoT technologies, production processes can be monitored in real time. Our experts can help you integrate these technologies to ensure continuous compliance with ISO standards and optimize audit processes.
We support you in implementing a process-oriented management system and preparing for ISO 9001 certification. Our internal audits identify weak points and help you to optimally prepare for external certifications. Further information can be found in the ISO 9001 guidelines.
Our focus is on compliance with ISO 13485 requirements for quality management systems in medical technology and IVD. We support you in the preparation, implementation and follow-up of audits to ensure the conformity of your processes.
For companies wishing to have their information security management systems certified, we offer comprehensive advice on compliance with ISO 27001. Our experts support you in preparing for certification audits and optimizing your information security processes.
