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Quality Manual

QM-001 · v3.2ApprovedOwner · Sarah Chen
QM-001Quality Manualv3.2 — Apr 2026

4Context of the OrganizationISO 9001 §4AS9100D §4

ACME Robotics maintains a quality management system aligned with ISO 9001:2015 and AS9100D. This section establishes the scope, internal and external context, and the needs of relevant interested parties.

4.1Understanding the organizationISO 9001 §4.1

The organization determines external and internal issues relevant to its purpose and strategic direction, reviewed quarterly through the Management Review process (see QMS-P-013 ↗).

AI suggestionThis section could also map to IATF 16949 §4.3.2 — add mapping?
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Compliance map · ISO 9001:201587% covered
§4
Context of the Organization
6 headings
100%
§5
Leadership
8 headings
100%
§6
Planning
5 headings
80%
§7
Support
12 headings
92%
§8
Operation
24 headings
75%
§9
Performance evaluation
10 headings
60%
§10
Improvement
4 headings
50%
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NCR-2026-0142OPENSeverity · Major
AI drafted from your description
Coating thickness out of spec on Lot #B-2241

QC inspection found 18 of 50 sampled parts below the minimum 0.025mm coating thickness specified in WI-COAT-04. Source: incoming inspection.

5-Why
Why? Coating gun was producing inconsistent spray pattern
Why? Nozzle was partially clogged
Why? Maintenance schedule extended without re-test
Why? PM interval was changed by request, not by data
Why? No requirement to validate PM changes against trend data ← root
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Q2 internal audit · Production · Birmingham3 of 4 auditors live
1
Are calibration records current for all production gauges?
Sarah · ✓ Conforming
2
Is operator training documented for each work cell?
Marco · ⚠ Finding
3
Are NCRs raised within 24h of detection?
Sarah · ✓ Conforming
4
Does the FMEA cover all current process steps?
Priya · in progress
Evidence summary3 PDFs and 1 photo summarized into bullet findings.
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