Feature deep-dive · Compliance

ISO 9001, baked into the build flow.

Every clause of ISO 9001. And its industry-specific siblings AS9100, IATF 16949, ISO 13485. Comes back to a handful of questions: who wrote the work instruction, what version was on the floor, who approved the deviation, how do you know nothing was changed after the fact. Ignite Lean answers each of those questions automatically. Not because we sell to QMS managers, but because the only way to run an SMB floor without a binder is to capture the data anyway.

Clause 7.5 · Documented information

Controlled, current, available. Without a binder

Clause 7.5 is the most-flagged finding in SMB ISO 9001 audits. It asks for documented information that is controlled (you know what's authoritative), current (the latest revision is on the floor), and available (operators can actually find and use it). A binder system technically meets the words but rarely the spirit; revision letters drift, the floor copy stays at rev D after engineering moved to rev F, and the auditor finds it in five minutes. Ignite Lean's WI versioning answers all three at once: the database row is authoritative, the kiosk reads the row, every save bumps the version and stamps the editor.

  • 7.5.2 Creating and updating: every save stamps the editor + timestamp
  • 7.5.3 Control: kiosk always serves the latest published version
  • 7.5.3.2 a) Distribution: instant. No print-and-distribute cycle
  • 7.5.3.2 b) Prevention of obsolete use: structurally impossible
  • 7.5.3.2 d) Identification of changes: full version history per WI
  • No "rev letter on the master, different rev letter on the floor copy"
Version history current v4
  • v4
    Eric Flint current
    May 17, 2026 · 2:22 PM · changed torque to 12 ft-lb
  • v3
    Maya Rodriguez
    May 14, 2026 · 9:48 AM · updated bolt callouts
  • v2
    Jorge Lee
    May 09, 2026 · 11:04 AM · added rotor close-up photo
  • v1
    Eric Flint
    May 05, 2026 · 4:15 PM · initial publish
Clause 8.5.1 · Control of production

Records that prove every build followed the plan

Clause 8.5.1 asks you to plan and control production: defined operations, monitoring activities, suitable workforce, and evidence that all of that happened on each unit. Most SMBs have the plan; the proof is what fails the audit. Ignite Lean captures the proof as a side-effect of the build flow: every unit gets a build record stamped with the operator, the workstation, every component consumed, the cycle time, and any photos the operator took. The auditor asks "show me unit BC-260517-0023" and you click. One row, one record, ten minutes saved per sampled unit.

  • Build record per unit: operator, workstation, start/finish, components, photos
  • Defined operations enforced by the kiosk's step sequence
  • Monitoring: target vs. actual cycle time captured automatically
  • Workforce: each step attributed to the badge-in operator (no shared accounts)
  • Search by serial, by date, by operator, by workstation. Sub-second
  • Records are append-only. Corrections are new events, not edits
Clause 8.7 · Non-conforming output

Defects flagged, dispositioned, attributed

When an operator flags an out-of-tolerance bore at the caliper-machining station, the unit drops into the supervisor approval queue with the operator's photo attached. The supervisor either ships as-is (with a reason that goes into the record), reworks (sends back to a prior station), or scrapps. That decision is attributed to the supervisor. Name, user id, timestamp, reason text. No more "I think Pat approved it on the third shift". Clause 8.7 specifically requires this attribution; most SMBs rebuild it from sticky notes during the audit.

  • Operator flag in the kiosk → unit drops into the supervisor approval queue
  • Three dispositions: ship as-is, rework, scrap. Each requires a reason
  • Photo captured at the flag stays attached through the decision
  • Decision attributed to the supervisor (name + user id + timestamp)
  • The non-conformance record is immutable once committed
  • Searchable by reason / station / date for clause 9.1 trend analysis
Clause 9.2 · Internal audit prep

Stop dreading the 90-day audit window

Clause 9.2 internal audits exist to prove your system actually works between external audits. For most SMBs this means a panicked binder-gathering sprint every quarter. Ignite Lean turns that into a 30-minute walkthrough: the build history page filters by date and operator, the NC list filters by reason, the WI version history shows every revision since the last audit. The auditor (internal or external) sees a system being used in real time, not a binder reconstructed last week.

  • Build history. Every unit, filterable by date, station, operator, serial
  • WI version history per work instruction. Every save, every editor
  • Non-conformance log with three-disposition + reason on every entry
  • Downtime log with reason categorisation for clause 10 improvement cycles
  • KPI dashboard with target vs. actual + defect pareto for management review
  • Roles + RLS prove access control at the database level, not in app code
AS9100 · IATF 16949 · ISO 13485

The same engine, the tighter clauses

AS9100 (aerospace), IATF 16949 (automotive), and ISO 13485 (medical devices) all extend ISO 9001 with sector-specific tightening. The clauses that change. Risk-based controls, FAI / PPAP records, design history files. Rest on the same foundation: controlled work instructions, attributed records, traceability, attributed approvals. Ignite Lean doesn't pretend to be a certified PPAP module. It gives you the build- execution backbone those modules sit on top of, without the seven-figure price tag.

  • AS9100: WI revision control + FAI traceability backbone
  • IATF 16949: WI controls + sub-supplier serial traceability + downtime pareto
  • ISO 13485: WI controls + design-history-file integration via build records
  • Designed-for-audit posture without the per-clause certification overhead
  • Pairs with existing PPAP / FAI / DHF tools. We own the floor, not the form
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