To receive a customized offer for your certification, please fill out the following information in the ISO 13485 questionnaire. One of our experts will then contact you to guide you through the entire process.
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