The ISO 9001 Quality Manual: Optional Since 2015, Still Worth Having

If you have been told you need a quality manual for ISO 9001, that was true until 2015 and has not been since. The 2015 revision removed the requirement, and the 2026 edition does not bring it back. What the standard requires is documented information for specific things: your scope, your quality policy, your objectives, your processes, and a set of records. Whether you gather those into one document called a manual is up to you.

Most small businesses still do, and for good reasons. This guide explains what a quality manual is for now that it is optional, what to put in it, what to leave out, and when you are better off without one. The template below is the one we use with clients.

Download the free quality manual template (Word)

The template follows the clause 4 to 10 structure described in this article, with example wording in every section and tables for issues, interested parties, scope, roles and resources ready to fill in. It is marked optional for the reason this article explains. Replace the placeholders, delete the sections that do not apply, and keep it to what the business needs. No sign-up needed.

Why it stopped being mandatory

The 2008 edition of ISO 9001 required a quality manual that described the scope, the documented procedures and the interaction of the processes. In practice that produced a lot of manuals that restated the standard clause by clause, said nothing about the business, and were read by nobody except the auditor. The 2015 revision replaced the requirement with the more flexible “documented information”, so each organisation could decide how to document its system.

The standard’s own guidance is that the amount of documentation should depend on the size and type of the organisation, the complexity of its processes, and the competence of its people. A manual that helps is fine. A manual written only because the standard asked for one is what the revision removed.

What you still have to document

Whether or not you have a manual, these have to exist as documented information:

• The scope of the QMS (clause 4.3)
• The quality policy (5.2)
• The quality objectives (6.2)
• Whatever is needed to support the operation of your processes (4.4), which in practice means process descriptions or procedures for the parts of the business that matter
• Records: competence, calibration, order reviews, design, supplier evaluations, production and release, non-conformances, audits, management reviews, corrective actions

Our ISO 9001 clauses guide lists what each clause asks for. The manual is a way of organising the first four items, not a fifth requirement.

Reasons to have one anyway

It gives the auditor a map. A certification auditor arriving at a small business with no manual has to find the scope, the policy, the process map and the roles one at a time. A manual that points to all of them saves half a morning at stage 1 and sets the tone for the rest of the audit.

It gives new staff a map. The same document tells a new starter how the business works and where the procedures are.

It answers customer questionnaires. Larger customers often ask for “a copy of your quality manual” in supplier due diligence. Sending one is quicker than explaining that the standard no longer requires it.

It forces you to decide the scope and the process map. Writing the manual is usually where a business first commits to paper what the QMS covers and how its processes connect. That thinking has to happen somewhere.

Reasons not to

• You are a very small business (under ten people) where the policy, scope and a one-page process map on the wall do the same job.
• You already keep the system on an intranet or wiki where each element is a page and the manual would duplicate it.
• You would be tempted to copy the standard into it. A manual that restates ISO 9001 adds nothing and has to be maintained.

What goes in a good quality manual

Keep it to the things that do not change often. Procedures, forms and registers live elsewhere and are referenced, not copied. A workable structure, following the clauses so it can be read alongside the standard:

The template above runs to about 25 pages with every section written out and example tables in place; most small businesses end up shorter once the sections that do not apply are removed. The page count is not what matters. What matters is that every section describes your business rather than the standard, and that a reader can get from the manual to the procedure or register they need in one step. A manual that keeps growing is usually one where procedures have crept in.

What to leave out

• The text of the standard. Reference the clause, do not reproduce it.
• Procedures and work instructions. Point to them.
• Forms and registers. Point to them.
• Anything that changes monthly: objectives values, audit dates, names of individual staff. Put those in the registers the manual points to.
• A history of the company. One paragraph of context is enough.

Keeping it current

The manual is documented information and has to be controlled under clause 7.5: a version number, an owner, an approval, and a review date. Review it at management review once a year and whenever the scope, the process map or the organisation changes. A manual that still names a director who left two years ago is a finding waiting to happen.

What changed in ISO 9001:2026

Nothing on the manual itself; it stays optional. If you keep one, the sections that need updating for 2026 are leadership (quality culture and ethical behaviour, clause 5.1), planning (risks and opportunities now treated separately, clause 6.1), support (organisational knowledge expanded, clause 7.1) and management review inputs (clause 9.3). Our ISO 9001:2026 changes article lists them all.

Where to go next

The template is one of the 32 documents in the free ISO 9001 toolkit, which has the procedures and registers the manual points to. If you are deciding what to document, start with the ISO 9001 clauses guide. The quality policy is the one document every manual contains, so write that first. If you would rather have someone build the system with you, our ISO 9001 consultancy programme produces the manual, policy and process map in the first two workshops.

Frequently asked questions