Quality-Safe AI
Adopt AI without risking your certification
Worried that using AI will jeopardise your ISO 9001 — or your 13485, IATF 16949, GxP, SOC 2, GDPR, or EU AI Act position? It's a reasonable worry. The good news: used carefully, AI can make your quality documentation stronger. We'll show you exactly how, one controlled step at a time — without touching your audit trail.
Who this is for
Regulated and certified SMEs
Precision manufacturing, medical devices, automotive, pharma — anywhere an auditor can ask 'show me the process.'
If a failed audit would hurt more than a missed efficiency, start here. We don't compete on price, because the thing we protect — your certification, your customer contracts, your reputation — is worth far more than the fee.
The standards we work within
We fit AI to your system — not the other way round
ISO 9001
Quality Management
ISO 13485
Medical Devices QMS
IATF 16949
Automotive QMS
GxP
Good Practice (GMP/GLP/GCP)
SOC 2
Trust Services Controls
GDPR / UK GDPR
Data protection
EU AI Act
Reg. 2024/1689
We map each AI step to its impact on your quality system, keep a human accountable for every controlled decision, and produce the documentation an auditor expects.
Pricing
A failed audit costs more than this — by a wide margin
Quality-Safe AI implementation is a fixed-scope engagement. We anchor against the cost of getting it wrong: a lost certification, a failed audit, a contract you can no longer hold.
Fixed scope Every plan is reviewed and stamped by a named expert.
Proof
Every claim sourced, every plan human-verified
Drafted with AI, verified by a named human. That's the standard.
Our verified manufacturing case study leads here once signed off. In the meantime: every claim on this page is sourced, and every plan is reviewed by a named expert before you rely on it.
Common questions
The questions regulated businesses actually ask
- Will using AI break my ISO 9001 certification?
- Not if it's adopted as a controlled process. Auditors care about documented, controlled, repeatable processes — used carefully, AI can make your quality documentation stronger. We map each AI step to its impact on your quality system and keep a human accountable for every controlled decision.
- Who is Quality-Safe AI for?
- Regulated and certified SMEs — precision manufacturing, medical devices, automotive, pharma, and any business where an auditor can ask 'show me the process.' If a failed audit would hurt more than a missed efficiency, start here.
- How do you protect my audit trail?
- We don't touch it. We produce the documentation an auditor expects, and our hash-chained record of what changed and who approved it doubles as audit evidence.
- How is this priced?
- Quality-Safe AI implementation is a fixed-scope engagement. We anchor against the cost of getting it wrong — a lost certification, a failed audit, a contract you can no longer hold — never against software.
Not ready to book?
Send us a line instead
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Two honest next steps
Talk it through, or get a plan first
If a failed audit would cost more than a missed efficiency, a conversation is worth the half hour. Not ready? Get a tailored plan — free.