Stage 1 audit

Stage 1 is usually called „Documentation audit“ because auditors what will check are all documentation requirements from the standard fulfilled. SO, you need to prepare all documents from the requirements that are applicable for your company and within the scope. If some of the major documents are missing, it is not possible to access the next step, the initial audit or so-called Stage 2 audit.

For more information regarding the certification process, please see the following articles:

• First-, Second- & Third-Party Audits for medical device manufacturers & suppliers https://advisera.com/13485academy/knowledgebase/first-second-third-party-audits-for-medical-device-manufacturers-suppliers/
• Checklist of ISO 13485 implementation and certification steps https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/
• How to get ISO 13485 certified? https://advisera.com/13485academy/iso-13485-certification/