Quality manual and procedures writing
Fewer documents, each one controlled, each one followed.
We write the documented information an ISO 9001 system needs, and the document control procedure that keeps it current: procedures, work instructions, forms and a master list with one live revision of everything. For plants, labs and offices whose documents grew faster than anyone could read them.
- Document master list
- Quality policy
- Scope statement
- Process map
- Work instruction
- Nonconformance report
- Supplier evaluation form
- Calibration register
The problem we are hired for
The shared drive called FINAL_v7
If your document control lives in a shared drive called FINAL_v7, we start there.Where most document jobs begin
The pattern is always the same. A folder of 300 files, a third of them duplicates. Three versions of the incoming inspection procedure, one of them printed and laminated at goods-in and none of them matching. A 140-page quality manual bought off the internet that nobody on the floor has read, with clause references to a standard that was withdrawn in 2018.
Clause 7.5.3 does not ask for a lot. It asks that documents are available where needed, protected, and that changes are controlled so nobody works to an obsolete revision. That is the whole job. It is harder than it sounds because it has to survive the day someone saves a copy to their desktop.
What we write
Documented information, sized to the processes you run
ISO 9001 asks for six documented procedures fewer than most manuals contain. It asks for evidence you follow the ones you keep.
The 2008 edition required six mandatory procedures. The 2015 edition dropped them. What remains is a short list of things you must maintain, such as scope, policy and objectives, and a longer list of records you must retain: calibration, competence, design outputs, supplier evaluation, nonconforming output, audit results, management review and corrective action. Everything else is your call, based on 7.5.1 b, whatever you need for the system to be effective.
The quality manual
It is optional under 9001:2015. We usually write one anyway, eight to twelve pages, because a certification body auditor reads it first and a short one saves you an hour of explaining. It holds the scope, the process map, the interactions, and pointers to where each clause is met. It does not restate the standard. If your manual paraphrases clause 8.4 for three pages, it is padding.
Procedures and work instructions
A procedure says who does what across departments. A work instruction says how one task is done at one station, ideally on one page with photographs from your own floor. We interview the person who does the job, watch them do it, and write what they do. Then we read it back to them. If they would do it differently, the document is wrong, not the operator.
We will not write a procedure for a process you do not run. Design control is the classic case. If you build to customer drawings and never design anything, 8.3 is excluded with a justification in the scope, not covered by a fictional procedure.
Forms and records
A form is a document until someone fills it in. Then it is a record and gets retained, not revised. Most shared-drive confusion comes from mixing the two in one folder. We separate them, number the blanks, and set retention periods that match your customer and regulatory requirements. Where a customer contract says ten years, the form carries ten years.
Format example Not a client register
The master list is the whole of document control
One register. Every controlled document on it, with its number, owner, live revision, approval date and where the controlled copies sit. If it is not on the list, it is not controlled.
| Number | Title | Owner | Rev | Approved | Controlled copies |
|---|---|---|---|---|---|
| QM-01 | Quality manual | Quality lead | C | 2024-11-04 | Electronic only |
| QP-03 | Control of documented information | Quality lead | B | 2024-11-04 | Electronic only |
| QP-07 | Purchasing and supplier evaluation | Purchasing | A | 2024-09-18 | Purchasing office |
| WI-14 | Press cell set-up | Production | D | 2025-01-22 | Press cell, laminated, 1 copy |
| F-22 | Nonconformance report | Quality lead | B | 2024-10-02 | Blank pad at goods-in |
Revision control
Five rules that stop the second version
- Every controlled document carries a revision block at the foot: rev letter, date, a line saying what changed, and the approver's initials.
- One person approves each document type. Not a committee. A named role on the master list.
- Printed copies are counted. When rev D is issued, rev C is collected from the press cell, not left in a drawer.
- Obsolete revisions kept for reference are marked superseded and moved out of the working folder.
- The shared drive gets one read-only folder for live documents. Drafts live somewhere else. Nobody saves over the live copy.
Process
How a document set gets written
A set of 8 to 15 procedures for one site usually runs six to ten weeks, most of it waiting for the people we need to watch.
- Wk 1
Review what exists
You send the drive, all of it. We sort keep, merge and retire, then quote the set.
- Wk 2
Numbering and master list
The register is built first, so every new document has a number and an owner before it has a word.
- Wk 2 to 7
Interview, observe, draft
One process at a time. Drafts go back to the person who does the work for a read-through.
- Wk 8
Approve and issue
Owners approve, rev A is issued, old copies collected. We check the floor for strays.
- Wk 10
First use check
A short visit to see which documents people used and which they worked around. Fix those.
Objections
Questions about rewriting what you already have
Not for: anyone wanting a boxed set of forty generic procedures by Friday. Plenty of sites sell those. The 140-page manuals they produce are what we get hired to cut down.
Can you just edit our existing manual?
Sometimes. If the processes described are the ones you run, editing is cheaper and we quote it that way. If the manual was bought from a template, it is usually quicker to start from the process map.
Do we need QMS software?
No. A controlled folder and a spreadsheet master list meet clause 7.5 for most sites under 200 people. If you already pay for software, we write into it.
Will the documents be accepted by our certification body?
We write them against the clauses and cite them. Whether they are accepted depends on whether your people follow them, which is what the auditor tests. A mock audit checks that before the real one.
We have nothing at all yet. Is this the right service?
Probably not on its own. Documents are one part of a system. Start with a gap assessment, or go straight to ISO 9001 implementation, which includes the document set.
Send us the drive.
Tell us roughly how many documents you have and the standard. We review, then quote the document set in writing.
- Phone(206) 464-3067
- Email[email protected]
- Studio1325 6TH AVE, SEATTLE, WA 98101