QM SYSTEM

Your Quality Management System

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EVERYTHING FOR YOUR QM SySTEM

Do you need help in creating or improving your QM system? Or do you need an external expert to put your QM system to the test in the form of a review or internal audit? In any case, we are happy to support you on the way to your audit-ready QM system.

Review

We will do a thorough ISO 13485 compliance check of single documents or your complete quality management system. With our guidance, you will have your documents audit-ready in no time.

Creation

We create your QMS. Individual documents or the entire QMS: our experts work quickly, reliably and ensure the highest quality. Audit-ready documents are created in close consultation with you.

Internal Audit

We conduct internal audits on-premise or remotely. We plan and conduct the mandatory internal audit for you. All non-conformities will be discussed with you and recorded according to ISO 13485.

YOU CREATE - WE REVIEW

Your QMS is out-dated, an audit is coming up, or you are unsure if it is ISO 13485 compliant? Our experts will do a thorough compliance check of single documents or your complete QMS. Our experts will review your documents (especially your QM manual and the top level documents like SOPs) and provide a detailed assessment considering the latest harmonized standards and regulations. With our guidance, you will have your documents audit-ready in no time.

WE CREATE - YOU review

Your company needs a functional quality management system? However, you lack the time and resources to build your own QM system. Then, let our experts support you in reviewing or creating your QM system. Whether individual documents or the entire QM system: our experts work quickly, reliably and ensure the highest quality. Audit-ready documents are created in close consultation with you.

INTERNAL AUDIT

You need to know if the QM system is audit-ready? In this case, we conduct ISO 13485 conform internal audits for you at your company or on your suppliers’ premises. Our qualified auditors prepare all the necessary documentation required for a successful audit: Audit plan, audit agenda and report, and most importantly a sound rationale of why these audits can be carried out remotely, which is of utmost importance in the current pandemic.