ISO 9001 gap assessment · Seattle and on site
Two days on your floor, one ledger line for every gap we find.
An ISO 9001 gap assessment for plants, labs and offices that want to know how far they are from a certification audit. We check clauses 4 to 10 against the records you actually keep, score each finding red, amber or green, and hand over the ledger.
- 4.3 Scope
- 6.1 Risks and opportunities
- 7.1.5 Calibration
- 7.2 Competence
- 8.4 Suppliers
- 8.7 Nonconforming output
- 9.2 Internal audit
- 10.2 Corrective action
What you are buying
A gap assessment against named clauses, not an opinion
A gap assessment is two days on site and a ledger of findings, clause by clause. You keep the ledger.
We arrive with the standard, a clipboard and no template manual to sell you. The first morning goes on context and leadership: the scope statement under 4.3, the quality policy under 5.2, the objectives under 6.2 and whoever owns them. Then we go where the product is made. Most of what matters sits on the floor, in the calibration cage, in the goods-in bay and in the drawer where nonconformance tags end up.
Each finding is written as one ledger line. Clause. Evidence seen. Gap. Owner. Due. No paragraph of commentary, no maturity score out of a hundred, no traffic-light dashboard with no evidence behind it. If we cannot point to what we saw, it does not go in the ledger.
Day one
Opening meeting at 8:30 with whoever runs the site and whoever will own the system. Two hours on clauses 4 to 6 with the documents you have, whatever state they are in. After lunch a floor walk following one order from contract review under 8.2 through to release under 8.6. We pull records as we go: a training matrix, a calibration register, three purchase orders and the supplier files behind them.
Day two
Clause 7 support and clause 9 performance evaluation. We sample the internal audit programme, the last management review minutes if there are any, and the corrective action log. Clause 10.2 gets its own hour because that is where the finding count usually climbs. At 15:00 a closing meeting where every red line is read out, so nobody learns about it first from the report.
What the report is and is not
The report is the ledger, a one-page summary of red, amber and green counts by clause, and a sequencing note that says which reds to fix first. It is not a certificate, a pre-audit opinion from a certification body, or a promise that a stage 2 auditor will see what we saw. Auditors sample differently. We say so in the report itself.
Format example Not a client record
The findings ledger, as you receive it
Five lines of the kind we write on a typical day two. The format is exact. The details are invented for illustration and belong to no client.
| Clause | Evidence seen | Gap | Score | Owner | Due |
|---|---|---|---|---|---|
| 10.2.1 | Corrective action log, 11 entries opened since March | No entry closed; no root cause recorded on any line | Red | Quality lead | Wk 3 |
| 7.1.5.2 | Torque wrench on line 2, calibration tag expired | No recall of product checked since expiry date | Red | Maintenance | Wk 1 |
| 8.4.1 | Approved supplier list, 23 suppliers | Criteria for evaluation not defined; 4 files empty | Amber | Purchasing | Wk 6 |
| 7.5.3 | Work instruction WI-14 at press cell, rev B | Shared drive holds rev D; two versions in use | Amber | Production | Wk 4 |
| 7.2 | Training matrix, sampled 6 operators | All 6 matched to signed records | Green | HR | None |
Scoring
Red, amber, green, and what each one means
- Red. The requirement is absent, or what we saw would likely be written up as a major nonconformity at stage 2. A stopped corrective action process. An uncalibrated gauge used for release. No internal audit at all.
- Amber. Something exists but the evidence is thin or not followed. A procedure nobody on the floor recognised. A supplier list with no criteria behind it. These are the minors that pile up.
- Green. We sampled it and it held. We still write the line, with what we sampled, so you know the green was earned and not assumed.
- Not seen. Clauses we could not reach in two days, marked plainly. Usually 8.3 design where design is done at another site. We do not score what we did not look at.
Process
From first call to ledger in hand
- Call, 30 min
Scoping call
Standard, sites, headcount, whether anything is written. We confirm the fixed fee per site by email the same week.
- Before arrival
Document request
We ask for whatever exists: scope, policy, org chart, any procedures. A blank folder is an acceptable answer.
- Day 1
Clauses 4 to 6 and the floor walk
One order traced from contract review to release. Records pulled as we go.
- Day 2
Clauses 7, 9 and 10, closing meeting
Every red line read aloud at 15:00, with the evidence, so there are no surprises in writing.
- After
Ledger issued
Spreadsheet and PDF. You own both. Use them yourself, hand them to another consultant, or ask us to build the system from them.
Straight answers
Before you book two days
Who this is not for: a company that wants a certificate in six weeks without changing anything. We will tell you on the scoping call and save you the fee.
Will the gap assessment tell us whether we will pass?
No. It tells you where your system stands against each clause on the two days we were there. Only the certification body decides a recommendation, and we will not predict it. If you want a rehearsal of the audit itself, that is audit readiness, which runs a mock stage 2.
Do we need anything written before you come?
No. A site with nothing written still gets a useful ledger. It will simply be mostly red, which tells you the size of the job. If the reds are mostly documents, documented information is the next step.
Can you assess ISO 14001, 45001 or 13485 the same way?
Yes. The ledger format is the same. ISO 13485 takes longer because it asks for more documented procedures and more records, so the scope builder adds days for it.
What does the fixed fee depend on?
The number of sites, the number of people in scope and the standard. The fee is per site and agreed in writing before we travel. It does not grow if we find more reds than expected.
Book the two days.
Tell us the standard, the sites and roughly how many people work inside the scope. We reply with a fixed fee per site.
- Phone(206) 464-3067
- Email[email protected]
- Studio1325 6TH AVE, SEATTLE, WA 98101