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Questionnaire for your ISO 13485 certification

Please fill out the following information in the ISO 13485 questionnaire so that we can provide you with a customized offer for your certification.
Our experts will then contact you and guide you through the entire process.

Additional downloads for the ISO 13485 questionnaire

If your company has multiple locations, please download the “ISO 13485 list of locations” document from the attachment, fill it out, and then upload it in the online form.

Downloads

Appendix 1: Information on company locations and branches

ISO 13485 list of locations
PDF
83 . 74 KB
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Fields marked with an asterisk (*) must be filled in.

In order to receive a quote

Please fill out the following information so that we can provide you with a quote for ISO 13485.

Note for planning a (re-)certification or extension audit: Documents to be made available to the auditor or the audit team in advance

  • Extract from a professional or commercial register (or comparable evidence, if applicable)
  • Management system documentation (e.g.: Table of contents or presentation of the structure of the management system documentation) Organisational chart/evidence of the organisational structure
  • Corporate policy
  • Management review (e.g.: cover sheet or table of contents with date and signature)
  • Current annual planning of internal audits and evidence of audit report(s) (e.g.: cover sheet with date and signature)
  • As applicable: List of critical suppliers, certificates, quality agreements and evidence for supplier evaluation
  • Standard-specific documents, if applicable
  • Procedural instructions in German or English language

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