ISO 9001 consultant, SeattleConsulting, not certification
Ready for the certification audit.Not a certificate for sale.
WAC is a small quality management system consultant at 1325 6th Ave in Seattle. We build and repair ISO 9001 systems for plants, labs and offices in Washington, and get them ready for the stage 2 audit a certification body will run. Gap assessment, implementation, documents, internal audit. Each engagement is quoted on a stated basis before anyone signs.
- 4Context of the organization
- 5Leadership
- 6Planning
- 7Support
- 8Operation
- 9Performance evaluation
- 10Improvement
01 Impartiality
We don't certify you.
We do not issue certificates. A certification body does, and it cannot also be your consultant.
That line comes from ISO/IEC 17021-1, the standard accredited certification bodies are held to. A body that helped write your system cannot turn around and audit it, because it would be marking its own homework. So when someone offers you consulting and the certificate in one package, one of two things is true. Either the certificate is not from an accredited body, or the consulting is going to be very light.
We sit on the other side of the table. We read your processes against the clauses, write down what is missing, help your people fix it, and run the internal audit the standard asks for. Then an auditor we have no commercial tie to walks in and decides. That separation is what makes the certificate worth anything to the customer who asked you for it.
Most nonconformities we find sit in clause 10.2. The corrective action was opened in March and nobody closed it.Our most common finding, by some distance
What a certification body does
Plans audit days under IAF MD 5, runs stage 1 and stage 2, grades nonconformities, issues and suspends the certificate, returns for surveillance.
What WAC does
Gap assessment, the documents, training process owners, the internal audit and management review, and the closure of whatever the auditor raises.
02 Five engagements
What a quality management system consultant is actually hired for
Most clients need one of these, not all five. Each has a price basis written on it. None of them includes the certificate, which you buy from the certification body separately.
Not sure which one? The comparison ledger lays out duration basis, deliverables and what you supply for each.
Compare all five03 How it is priced
A quote depends on four things, and we tell you which
We do not publish a day rate on a web page and then add travel, report writing and "project management" later. Every engagement is quoted in writing after a scoping call, on the basis shown on its tile, and the engagement letter names the deliverables and the number of days on site.
What moves the number: people in scope, number of sites, what already exists, and which standard. A 20-person machine shop with one building and no system at all is a very different job from a 300-person medical device plant with three sites and a lapsed ISO 13485 certificate. The first mostly needs writing. The second mostly needs records rebuilt and a mock audit that is not polite.
The scope builder runs that arithmetic in the open. For ISO 9001 implementation it starts at 14 consulting days and multiplies by headcount, sites, starting point and standard. A 20-person single site starting from nothing comes out at 17.5 days. That is an estimate for scoping, not a quote, and it covers our days only. Audit days are set by the certification body under IAF MD 5 and invoiced by them.
- Implementation
- Fixed fee agreed after a scoping call
- Gap assessment
- Fixed fee per site
- Audit readiness
- Day rate for an agreed number of days
- Documented information
- Per document set, quoted after review
- Internal audit
- Per audit cycle
- Certificate
- Not sold here. Contracted directly with a certification body of your choosing.
- 10.2Corrective action log
- 7.1.5Calibration register
- 9.3Management review minutes
- 8.4Supplier evaluation
- 7.2Training records
- 7.5Document master list
04 The ledger
Every finding is one line you can act on
Clause, evidence seen, gap, owner, date. No paragraphs of "opportunities for improvement". This is the exact format you receive after a gap assessment or an internal audit.
| Clause | Evidence seen | Gap | Owner | Due | Rating |
|---|---|---|---|---|---|
| 10.2.2 | CA log, 14 entries opened since January | 9 of 14 have no root cause or effectiveness check recorded | Quality lead | Wk 3 | Red |
| 7.1.5.2 | Torque wrench on line 2, tag expired 4 months | Tool in use; no assessment of product checked since expiry | Maintenance | Wk 1 | Red |
| 7.5.3 | Three versions of the packing instruction on the floor | No master list; obsolete copies not withdrawn | Ops manager | Wk 4 | Amber |
| 9.3.2 | Management review minutes, one meeting, last year | Inputs c), e) and f) not covered; no decisions recorded | General manager | Wk 6 | Amber |
| 8.4.1 | Approved supplier list, 22 suppliers, criteria defined | Criteria applied; re-evaluation dates set and met | Purchasing | None | Green |
A green line stays in the ledger. An auditor will sample that area too, and you should know what the evidence is before they ask.
What you keep after we leave
Everything is yours, in formats your team can edit without us. We do not hold documents hostage in a portal with a subscription.
- The findings ledger, as a spreadsheet and a signed PDF, with every line owned and dated.
- A process map of how work actually moves through your site, drawn with the people who do it.
- Controlled documents in Word and Excel, each with a revision block and a line on the master list.
- An internal audit programme for the next 12 months, with the first cycle already complete.
- Management review minutes that cover every input listed in 9.3.2 and record decisions, not attendance.
- A corrective action log with nothing left open that could have been closed.
05 First call to stage 2
What happens, in order
The weeks below are for a full ISO 9001 implementation. A gap assessment alone ends at step two.
- Day 1
Scoping call, 45 minutes
Standard, people in scope, sites, what exists, and the date a customer or tender is pushing you toward. We tell you if the date is not realistic.
- Week 1 to 2
Written quote, then the gap walk
Engagement letter with basis and deliverables. Two days on site. You get the ledger and a plan built from its red lines.
- Week 3 to 10
Map, write, train
Process owners describe what they do; we write it down short. Forms go on the floor as soon as they exist, because records start the day the form does.
- Week 10 to 22
Records run
At least three months of the system working before stage 2. Internal audit and management review happen inside this window, not the week before.
- Week 20 to 26
Stage 1, mock audit, stage 2
The certification body you contracted runs stage 1. We run a mock stage 2 against its report, then step back. We are not in the room for the real one unless you ask.
06 Before you call
The questions buyers ask first
We will not write a procedure for a process you do not run. Most of what follows comes back to that.
Can you guarantee we pass the certification audit?
No. The certification body decides, and anyone who promises a pass either does not understand the process or is selling a certificate from a body you should not trust. What we can say is which clauses are weak before its auditor does, and that the records will exist when the auditor samples them.
Do you pick the certification body for us?
We explain how to check accreditation, how audit days are calculated and what to ask about auditor availability. The choice and the contract are yours. We take no referral fee from any certification body.
We already bought a quality manual template. Can you use it?
Usually we cut it down. The 140-page manual bought off the internet is the failure we see most, sitting beside a corrective action log with nothing closed in it. Auditors do not score page count. They pick a record and ask who filled it in.
Can this be done remotely?
Document drafting and review, yes. Gap assessments, process mapping and mock audits happen on site, because the evidence is on the floor and in the drawers, not in the shared drive.
Who is this not for?
Anyone who needs a certificate in four weeks with no records behind it. An accredited body will not issue one, and we will not pretend otherwise. Also anyone who wants procedures written for processes that exist only on paper.
Do you work on standards other than ISO 9001?
Yes, on the same Annex SL structure: ISO 14001:2015 for environmental systems, ISO 45001:2018 for health and safety, ISO 13485:2016 for medical devices, and documentation support for ISO/IEC 27001:2022. The scope builder shows the difference in days for each.
Tell us the standard and the date
A person reads every inquiry. You get a reply with questions or a scoping call slot, not an automated brochure.
- Studio1325 6TH AVE, SEATTLE, WA 98101
- Phone(206) 464-3067
- Email[email protected]