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Audit-ready · Consulting

ISO 9001, nothing written down.

A tender or a key customer asks for ISO 9001, and the business runs on experience. We write the procedures with the people who do the work and get you ready.

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What it looked like

  • Procedures exist only in people's heads.
  • Complaints and defects are fixed but never analysed.
  • Quality records are scattered or missing.

ManufacturingHealthcare

02 · What we did, stage by stage

What we did, stage by stage

  1. Assess

    A gap assessment against ISO 9001 clauses 4–10, with a realistic plan.

  2. Map

    We map core processes with the people who run them, including handoffs and checks.

  3. Mature

    SOPs, a quality manual sized to your company, a complaint and corrective action loop, and internal audit.

  4. Run

    We run internal audits and management reviews until your team can run them alone.

03 · The process

Complaint to root cause analysis

Every complaint is fixed for the customer, tagged by cause, and repeated causes go to an owner who changes the SOP.

What changed

  • Audit preparation6 weeks3 daysExample
  • Complaint to root cause2 months10 daysExample
Complaint to root cause analysisComplaint to root cause: 2 months → 10 days · Example

Complaint to root cause analysis

  1. Complaint arrives
  2. Tag the cause
  3. Logged in CRM
  4. Serious or repeat customer?
  5. Fix for the customer
  6. Weekly cause report
  7. Same cause three times?
  8. Owner finds root cause
  9. SOP or control updated
  10. Cause removed for good
  11. Complaint to root cause: 2 months → 10 days (Example)

05 · Questions

Questions

  • Will ISO 9001 bury us in paperwork?

    Not if it is sized right: Devvion writes short SOPs around how the work already runs, and only adds records the standard requires or that you will use.

  • Do you certify us?

    No, Devvion gets you ready; an accredited certification body audits and certifies you.

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06 · Contact

Book the assessment.

Tell us what is slowing the business down. We'll confirm the scope and the dates on a first call.