Built for first-time ISO 9001 certification

The QMS that writes its own audit trail.

Normatic is the Quality Management System for teams pursuing ISO 9001:2015. Every SOP approval, CAPA, and audit finding produces the objective evidence an auditor needs — automatically, and in your Google Drive.

Start free — 14 days See ISO coverageNo credit card · SOC 2 in progress
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ISO clauses mapped
from 4.1 to 10.3
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QMS modules
one integrated system
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click audit export
clause-indexed PDF pack
normatic.app / capa / NCR-0142
Open
Nonconformance · NCR-0142
Out-of-spec batch — line 2
clause 10.2
Severity
Major
Owner
D. Kumar
Due
Nov 12
AI-assisted · 5 Whys
draft · human review required
01Why did the batch fail spec? Viscosity reading was 12% low at QC.
02Why was viscosity low? Mixing vessel undershoot on temperature setpoint.
03Why did temperature undershoot? Jacket sensor drift since last calibration.
Fig. 01
CAPA · clause 10.2
Clause → module traceability

Every requirement
has a home.

An auditor can walk in with the ISO 9001:2015 standard and point to any clause. Normatic will show them where, in your system, that clause is satisfied.

Hover to explore
ISO 9001:2015 · 20 mapped clauses
Module
CAPA & Nonconformance

NCR → root cause → corrective action → verification → closure. AI walks users through 5 Whys and Fishbone.

Satisfies
§8.7 · Nonconforming outputs§10.1 · Improvement§10.2 · Nonconformity & CAPA§10.3 · Continual improvement
Hover any clause to trace it to its module.
Integrated modules

One system. Ten modules.

Each module satisfies specific ISO clauses and shares data with the rest — evidence you collect once shows up everywhere an auditor will look.

§4.4§5.2§7.5
Document Control

SOPs, work instructions, forms. Approval workflows, revision history, distribution acknowledgment, auto-PDF snapshots at approval.

§8.7§10.1§10.2
CAPA & Nonconformance

NCR → root cause → corrective action → verification → closure. AI walks users through 5 Whys and Fishbone.

§9.2
Internal Audit

Annual audit program, checklists tied to ISO clauses, findings auto-create CAPAs, audit reports.

§5.1§9.3
Management Review

Clause 9.3 input package auto-assembled from live QMS data.

§4.1§4.2§6.1
Risk Register

5×5 matrix, treatment plans, re-assessment triggers tied to interested parties.

§5.3§7.1§7.2
Training Matrix

Employee × topic grid, renewals, new-hire induction.

Plus Customer Complaints, Supplier Management, Quality Objectives, and Access Control.
AI assistance

Human-made,
agent-assisted.

Claude helps draft, analyze, and assemble — but it never approves. Every output is a draft a human reviewer edits and signs. Low hallucination because wrong compliance documents fail audits.

How we think about AI
  • AI output is labeled as a draft until a human approves it.
  • Railroaded templates mean the AI cannot skip required fields.
  • Haiku-class models for deterministic, low-hallucination drafts.
  • Every AI action is logged alongside its human reviewer.
01
Document control
Drafts an SOP from a conversation.

Describe the process in plain language. Normatic returns a draft in your approved SOP template — title block, purpose, scope, responsibilities, procedure, records — ready for a human to review and approve.

02
CAPA
Walks you through the 5 Whys.

Asks follow-up questions grounded in your NCR. Suggests root causes; you accept, reject, or rewrite. The decision trail is logged as evidence — the AI’s role and the human’s role are distinguishable in the audit log.

03
Management review
Assembles your 9.3 input package.

Pulls last-period KPIs, CAPA aging, audit findings, complaint trends, supplier scorecards, and risk changes into the management review agenda. You edit, you present.

Trust & security

Evidence, not trust-me-bro.

Row-Level Security at the database, not the application. Export every byte of your data. Read our trust page — it exists.

SOC 2
Type II — in progress
4-tier classification
Public · Internal · Restricted · Confidential
MFA
Required for Restricted & Confidential tiers
Full audit log
Every create, edit, approve, delete
Your Drive
Documents live in your Google Drive
RBAC + SSO
SCIM on Enterprise, SAML on Growth+
Early customers
Sample · placeholder
We went into our Stage 2 audit two weeks after migrating from SharePoint. The auditor asked for objective evidence of competence and I exported it in forty seconds.
Dana K.
Head of Quality, 48-person biotech
Normatic made the 5 Whys feel like a conversation with a senior quality engineer, not a form I was dreading.
Marcus R.
Operations Lead, hardware startup
The clause-to-feature traceability alone saved us two weeks of pre-audit scrambling.
Priya S.
Founder, medical device company
Used by quality teams at
Lumen Biosciences
Axon Robotics
Verdant Therapeutics
Keelson Manufacturing
Northwind Devices
Parallax Motors
vs. legacy QMS

Isolocity. QT9. Q-Hub.
We know.

Legacy QMS tools cost $3k–$20k/year and feel like it. Normatic keeps the parts an auditor insists on, and throws away the ceremony.

Legacy QMS
Normatic
First-time setup
4–8 weeks of vendor services
Self-serve, configured in an afternoon
Document approvals
Emailed Word docs, signatures in PDF
Routed workflow with PDF snapshot on approval
CAPA root cause
Free-text box, usually blank
Guided 5 Whys / Fishbone, drafted with you
Audit trail
Database log the auditor can’t read
Human-readable trail exportable to PDF
Document storage
Proprietary silo, migration is a project
Lives in your Google Drive
AI
Bolt-on chat, hallucination risk
Drafts only — every output is human-reviewed
Annual cost
$3k–$20k + implementation
Starts at $X, no implementation fee
FAQ

The reasonable questions.

Yes. We’ve written importers for the most common exports (CSV, native backups where available). For Drive-based SharePoint setups, we map folder structure to document types in a guided step.
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Get the binder
out of your head.

Start a workspace in two minutes. We’ll tailor your onboarding checklist to your certification timeline.