ISO 13485
Is a three-day internal audit enough for our ISO 13485 scope?
Often, yes, for a focused operation such as kitting, distribution or a single production line. Audit length should follow the number of processes and their risk, not headcount alone.
We confirm the number of days after reviewing your quality manual, process map and your last certification body report, and we tell you if three days is too few before you commit. For one healthcare logistics client with a focused kitting process, three days covered the full scope because the documents were reviewed remotely first.
What to have ready
- Your quality manual or QMS overview
- A process map or list of processes in scope
- Your last certification body or gap assessment report
- Sites and shifts in scope
- Your target certification date
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Senior Lead Auditors across ISO 9001, 27001, 14001, 13485, IATF 16949, AS9100 and VDA 6.3
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Related answers
Audit planning
Can you review our documents before coming on site?
Yes, and we recommend it.
Read the answerAudit planning
Can you be with us during the certification audit?
Yes, as an option.
Read the answerIntegrated audits
Can we combine ISO 27001 and ISO 13485 audits?
Yes. Both standards share a management system structure.
Read the answerGet in touch
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