ISO 9001 consultant, Seattle
A working ISO 9001 system in 16 to 26 weeks, built from the processes you already run
For organizations in Washington with no quality management system, or one that exists only as a template. WAC maps what you do, writes the documented information the standard actually requires, trains the owners and runs the first internal audit and management review. Then an independent certification body audits you. Fixed fee, agreed after a scoping call.
01 The job
What ISO 9001 implementation includes
ISO 9001 asks for six documented procedures fewer than most manuals contain. It asks for evidence you follow the ones you keep. That sentence is the whole method. The 2015 revision dropped the six mandatory procedures of the 2008 edition, so the question for every process is no longer "which procedure covers this" but "what would an auditor need to see to believe it is controlled".
We start at the whiteboard, not the template. Each process owner walks us through their work: receiving, quoting, production, inspection, shipping, complaints. We draw it, agree the inputs, outputs, risks and measures, and only then decide whether it needs a written procedure, a one-page work instruction, a form, or nothing more than a trained person and a record. A 30-person machine shop typically ends with 8 to 14 controlled documents, not 60.
What most clients get wrong is timing. Records cannot be written after the fact, and an auditor at stage 2 will want to see the system has run: at least one internal audit cycle, one management review, corrective actions opened and closed, calibration and training current. That is why forms go live in the first month and why we will not agree a stage 2 date less than three months after the system starts producing records.
The certificate is not in this price. You contract a certification body directly, and its audit days are set under IAF MD 5 according to your headcount and complexity. We tell you what to ask it; audit readiness covers the choice in more detail.
02 Clause by clause
Clauses 4 to 10, and what we build for each
Clauses 1 to 3 are scope, references and definitions. The requirements start at 4. The tags under each clause are the records an auditor will ask to see.
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4
Context of the organization
Internal and external issues, interested parties and their requirements, and the scope statement. The scope is where people trip: every exclusion under 4.3 has to be justified, and "we don't do design" only works if you genuinely don't. We draw the process map here, which becomes the spine of everything after.
4.3 Scope4.4 Process map -
5
Leadership
A quality policy of five or six sentences that someone in the building could repeat, and clear roles. The stage 2 auditor will interview your top manager. We prepare them for that conversation. We do not script it.
5.2 Quality policy5.3 Roles -
6
Planning
Risks and opportunities, measurable quality objectives and a plan for each. We keep the risk register short and tied to processes. Twenty generic risks copied from a template tell an auditor you did not think about your own.
6.2 Quality objectives6.1 Risk register -
7
Support
Resources, calibrated measuring equipment, competence, awareness, communication and the control of documented information. This is where the calibration register and training records live, and where document control is set up so obsolete copies come off the floor. See documented information if this is the part you mainly need.
7.1.5 Calibration7.2 Competence7.5 Document control -
8
Operation
The biggest clause and the one closest to your actual work: contract review, design if you do it, supplier control, production, identification and traceability, release, and nonconforming output. Most of our on-site hours go here, standing at benches and in storage bays, not in the conference room.
8.2.3 Contract review8.4 Supplier evaluation8.6 Release8.7 Nonconforming output -
9
Performance evaluation
Monitoring and measurement, customer satisfaction, the internal audit programme and management review. We run your first internal audit cycle and the first review with you, inside the records window, so both exist when the auditor arrives. Later cycles can go to internal audit and management review, or to your own trained people.
9.1 Monitoring results9.2 Audit programme9.3 Review minutes -
10
Improvement
Nonconformity and corrective action, and continual improvement. Most nonconformities we find sit in clause 10.2. The corrective action was opened in March and nobody closed it. We set up the log so each action has a root cause, an owner, a date and an effectiveness check, and we close the first ones with you.
10.2 Corrective action log
03 Required by the standard
The mandatory documented information, in full
This is the list ISO 9001:2015 explicitly requires you to maintain or retain. Everything else you document is your choice. A quality manual is not on it.
Some items only apply if the activity exists: design records under 8.3 disappear if design is legitimately excluded under 4.3.
| Clause | Documented information | Type |
|---|---|---|
| 4.3 | Scope of the quality management system | Maintain |
| 5.2 | Quality policy | Maintain |
| 6.2 | Quality objectives | Maintain |
| 7.1.5 | Evidence of fitness of monitoring and measuring resources; calibration basis | Retain |
| 7.2 | Evidence of competence | Retain |
| 8.2.3 | Results of review of requirements for products and services | Retain |
| 8.3 | Design and development inputs, controls, outputs and changes | Retain |
| 8.4.1 | Supplier evaluation, selection and re-evaluation | Retain |
| 8.5.2 | Traceability, where it is a requirement | Retain |
| 8.5.6 | Review of changes to production or service provision | Retain |
| 8.6 | Release of products and services, with authorising person | Retain |
| 8.7.2 | Nonconforming outputs and actions taken | Retain |
| 9.1.1 | Monitoring and measurement results | Retain |
| 9.2.2 | Audit programme and audit results | Retain |
| 9.3.3 | Results of management reviews | Retain |
| 10.2.2 | Nature of nonconformities, actions taken, results of corrective action | Retain |
04 Sequence
The 16 to 26 week sequence to stage 2
Sixteen weeks is a single site with fast reviewers and management that turns up. Twenty-six is more typical once holidays, a second site or a slow approval chain are in the picture.
- Week 0
Scoping call and fixed fee
45 minutes on headcount, sites, products and target date. You get a written fixed fee and an engagement letter naming deliverables and site days.
- Weeks 1 to 2
Gap walk and scope
Two days on site. Findings ledger, draft scope statement, list of processes and owners. Exclusions under 4.3 decided here.
- Weeks 3 to 6
Process mapping and policy
Whiteboard sessions with each owner, 90 minutes each. Quality policy, objectives, risk register. The first forms go live on the floor.
- Weeks 5 to 10
Documented information
Procedures and work instructions written, reviewed by owners within 5 working days, approved and issued on a master list. Calibration register and training matrix set up.
- Weeks 8 to 20
Records run, minimum 3 months
The system operates. We visit every two to three weeks to check records are being made and corrective actions are closing. Internal auditors trained.
- Weeks 14 to 22
Internal audit and management review
A full cycle of internal audit against all clauses, then a management review covering every 9.3.2 input. Findings logged under 10.2.
- Weeks 16 to 26
Stage 1, mock stage 2, stage 2
Your certification body runs stage 1. We run a mock stage 2 against its report and close what it finds. Then stage 2 is between you and the auditor.
05 Objections
What owners ask before they sign
We will not write a procedure for a process you do not run.
Our customer wants a certificate in 8 weeks. Can you do it?
Not from zero, and neither can anyone honest. Three months of records is the floor. What we can do in 8 weeks is get the system running and give you a written plan with dates, which many customers will accept as evidence you are underway.
Why not just buy a template kit?
You can. The 140-page manual bought off the internet is the thing we most often end up removing. The documents are rarely wrong in themselves. They just describe a company that is not yours, and the auditor finds that out by asking the first operator they meet.
How much of our staff time does this take?
A management representative for about 4 hours a week. Each process owner for one 90-minute mapping session and a document review. Top management for the policy, objectives and the management review. If nobody can give that time, postpone; the system will not survive stage 2 otherwise.
Who is implementation not right for?
If you already have a running system with records, you probably need a gap assessment or audit readiness, which cost a fraction of this. The comparison ledger sets the five side by side.
Send us headcount, sites and the date your customer is pushing for. You get a fixed fee back in writing.
Request a scope