Are you ready for your ISO 13485 audit?
Answer up to 48 short questions about your quality system in about 15 minutes. The questions follow what the auditor will ask to see. You get your score and your three most serious gaps at once, and you can order a full report with a plan to close every gap before the audit.
Not relevant to us
No
Yes, with evidence
See my result
Answer every question to see your result.
No critical or important gaps. Well done.
Partly
How to close it
Prepared for
Why it is a common finding
Start again
{done} of {total} answered
Checked on
Every gap, with how to close it
Your plan
Book a 30-minute call
No, we don't design devices
At risk
Score by area
Audit
What helps
Print or save as PDF
Audit readiness report
until
I can run a mock audit with your team and help close the gaps before the auditor arrives.
Yes, we design devices
This is a self-assessment based on your own answers. It is not an audit, a certification or a promise of any audit outcome, and the decisions remain your company's responsibility.
Your three most serious gaps
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Full name
Your answer
Clause
Closed since your previous check
This report opens once the payment is confirmed.
Critical gaps
Important gaps
Basic gaps and a dry run
Check again (included until {date})
Weight
Order the full report
Calculating…
Want me to check it with you?
If not, the design questions are left out.
Ready
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The report opens as soon as the payment is confirmed, and the link is sent to your email.
This report was not found.
The report gives a score for each area and lists every gap with its clause, why it is a common finding, what the auditor will ask to see and how to close it. It also includes a plan up to the audit date and links to what helps. A second check within 90 days is included.
You are checking again within 90 days of a paid report, so this report is included.
About your audit
This tool is not available yet.
Change my answers
Needs work
Order the report
What the auditor will ask to see
The full report
Your readiness
A critical question answered "No" keeps the result from showing green.
Country of the company
The plan starts with the most serious gaps. If the audit is less than 90 days away, the plan is compressed to fit the audit date.
In a 30-minute call, you tell me where you stand, and I tell you what I'd do first and whether I'm the right fit.