Legal & compliance · Skill
ISO 13485 QMS Forcing Questions
Use before an ISO 13485 internal audit or DHF closure.
Open in PhởWhat the skill covers
The sections of its instructions, in order.
- 01 When to Run
- 02 The Six QMS Questions
- 1. Pull three random DHFs. Are design verification + validation evidence complete?
- 2. Show me the last 5 CAPAs with effectiveness verification evidence.
- 3. When was process validation (IQ/OQ/PQ) last revalidated?
- 4. Show me the risk management file for the highest-risk product.
- 5. Show me post-market surveillance evidence — last 6 months.
- 6. Where's the management review evidence covering all Clause 5.6 inputs?
- 03 Workflow
- 04 Output Format
- 05 Routing
- 06 Related
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Frequently asked questions
What does ISO 13485 QMS Forcing Questions do?
Use before an ISO 13485 internal audit or DHF closure.
Is ISO 13485 QMS Forcing Questions free to use?
Yes. ISO 13485 QMS Forcing Questions is published by Alireza Rezvani under the MIT licence, and you can use it with a free Phở account.
How do I use ISO 13485 QMS Forcing Questions in Phở?
Press Open in Phở, then Try to apply it to your next message, or add the Regulatory & compliance audits set so Phở loads it whenever a request matches.
Does ISO 13485 QMS Forcing Questions need other tools?
No. It works in a normal Phở chat with what you type or upload.
Copied unchanged from alirezarezvani/claude-skills at commit c85b17e and credited to Alireza Rezvani, who is not affiliated with Phở. The full instructions and licence text ship with the skill inside Phở.