Many companies keep putting it off: anyone who has to write a quality manual thinks of thick folders that nobody reads. It does not have to be that way. This guide shows whether a manual is required at all, which contents have proved their worth in practice and how to build the whole body of documentation so that it is used in everyday work. We give references to ISO 9001 in substance, with the clause number of the 2015 edition (check the numbering in your edition); the text of the standard itself is protected and is not reproduced here.
Does it have to be a manual?
In short: a quality management manual is not prescribed as a document type in ISO 9001:2015. This is shown, for example, by the overview from a certification body (see Sources), which lists all the clauses of the 2015 edition in which documented information is required: a “manual” does not appear in it. What is required is individual contents, not a particular document. The paper of the ISO 9001 Auditing Practices Group on the context of the organisation also mentions the quality manual only for the case where the organisation chooses to have one.
Even so, a manual is useful in practice (practice, not normative). It serves as a signpost: new employees, customers and auditors find in one place how the company organises quality and where the details are. What matters is that it stays short and refers to the procedures instead of repeating them.
A note on the edition: the overview mentioned relates to the 2015 edition. Since 16 September 2026 the new edition ISO 9001:2026 has been available. A certification body describes changes mainly in clauses 4 to 6 and 10 and mentions minor adjustments in other clauses from 4 to 10 without listing them individually. You should therefore check the requirements for documented information in your copy of the edition against which you will be audited. You can read more about the new edition in the guide on the ISO 9001 revision.
What the standard requires in terms of documentation
The 2015 edition distinguishes two kinds of documented information. Put simply: “maintain” applies to specifications that you keep up to date (practice: roughly the former “documents”), “retain” applies to evidence that you keep as proof (practice: roughly the former “records”). According to this overview, documented information is required in these clauses, among others:
| Topic | Clause (2015 edition) | In practice in an SME |
|---|---|---|
| Scope of the system | 4.3 | Section in the manual |
| Processes and their support | 4.4 | Process map, process descriptions |
| Quality policy | 5.2 | Separate document, known to everyone |
| Quality objectives | 6.2 | List of objectives with metrics |
| Competence | 7.2 | Records of education and training |
| Monitoring and measuring resources | 7.1.5 | Inspection records |
| Internal audits | 9.2 | Audit programme and reports |
| Management review | 9.3 | Minutes with decisions |
| Nonconformities and corrective actions | 10.2 | Reports, list of actions |
The list is not complete; the overview lists further clauses in the operations part (clause 8), for example on the review of customer requirements, the release of products and the control of nonconforming outputs. How much documented information is needed is for the company itself to decide, to the extent that it can rely on the effectiveness of its system; the standard does not prescribe form, medium or content (ISO 9001 Auditing Practices Group, whose papers are not formally endorsed by ISO and IAF). The principle is: as much as necessary, as little as possible.
What belongs in a lean manual
A well-tried structure has six short chapters (practice, not normative; the clause numbers come from the 2015 edition):
- Purpose and company. Who are we, what do we provide, which sites are there?
- Scope. For which services and sites does the system apply? Give reasons for exclusions (clause 4.3).
- Process map. A picture of the management, core and support processes with a reference to the process descriptions (clause 4.4).
- Policy and objectives. A reference to the quality policy and the measurable objectives (clauses 5.2 and 6.2).
- Roles and responsibilities. Who is responsible for what? An organisation chart is often enough (clause 5.3).
- Reference list. Which procedures, work instructions and forms exist, with number and title.
Everything that changes continually does not belong in the manual but in separate documents: process details, checklists, forms. That way the manual rarely has to be changed.
The document structure: from policy to record
The manual is the top level. Below it lie documents with increasing detail:
- Manual and policy: purpose, scope, principles.
- Process descriptions and procedures: what happens in which order, who is responsible?
- Work instructions: how is an individual task carried out?
- Forms and checklists: templates you work with.
- Records: completed forms, reports, minutes. They prove that you worked according to the specifications.
In addition there are external documents such as laws, standards or customer specifications, which you must know and keep up to date. How to control these documents is shown in the guide on document control under ISO 9001.
Common mistakes (practice, not normative)
- The manual repeats the standard. Auditors know the standard. Describe how your company works, not what the standard says.
- Too many documents. Every document has to be maintained, reviewed and read. Before each new document, ask which error it prevents.
- Outdated versions in circulation. When copies circulate on drives, in e-mails and in the folder, soon nobody knows what applies.
- Nobody feels responsible. Every document needs a responsible person and a date for the next review.
- Everything is finished at once. It is better to have a lean manual that you add to in the first year on the basis of experience from internal audits.
Practical example: Muster Elektro GmbH
Muster Elektro GmbH in Musterhausen, a fictitious installation company with twelve employees, wants to be certified to ISO 9001. So far, arrangements have been made verbally and there are many folders on a server. The managing director decides on a manual of around twelve pages, supplemented by short procedures and a few work instructions.
| Number | Document type | Title |
|---|---|---|
| HB-001 | Manual | Management manual |
| PO-001 | Policy | Quality policy |
| PB-001 | Process description | Quotation and clarification of orders |
| VA-001 | Procedure | Document control |
| VA-002 | Procedure | Handling complaints |
| AA-001 | Work instruction | Acceptance of an installation |
| FO-001 | Form | Complaint report |
| CL-001 | Checklist | Handover to the customer |
| EX-001 | External document | Installation regulations (publisher and source) |
| NW-001 | Record | Training record for document control |
The manual states the purpose, the scope (electrical installations in the Canton of Muster, with design excluded and a justification given), the process map and the reference list. The quality policy is a separate document because it is displayed publicly. Three weeks later the managing director has captured the ten documents. The site manager reviews them, the office manager approves them; that way a second person always reads against the author. Each document is given a review interval of twelve months, and the manual and the policy are distributed to all twelve employees. The manual is valid as soon as it has been approved with a valid-from date.
Step by step to the manual
- Clarify the scope. Which services and sites do you cover?
- Define the processes. Draw the process map and determine who is responsible.
- Formulate policy and objectives. Short, understandable, verifiable.
- Write procedures and work instructions. Only where it prevents errors or the standard requires it.
- Set the numbering system. Each document type gets an abbreviation, each document a number.
- Review and approve. A second person reads before the document applies.
- Distribute and have reading confirmed. Who knows the new version?
- Set a review date. A document that is never reviewed becomes outdated.
Checklist
- Scope recorded in writing, exclusions justified
- Process map with responsible persons in place
- Quality policy as a separate, known document
- Quality objectives with metrics and due dates
- Manual no longer than someone will actually read
- Reference list with number and title of all procedures
- Numbering system set by document type
- Review and approval by a second person regulated
- Review interval set for each document
- Requirements for documented information cross-checked against the valid edition of the standard
How KMU | base helps
QMS | base comes with the structure you would otherwise build by hand.
1. Starter pack. Under “QMS settings” you load the starter pack with one click: clause framework, process map with sample flows, document drafts, context, interested parties, roles and standard mapping, in German, French, Italian or English as you prefer. The starter documents arrive as drafts and only apply after your review and approval; the program never overwrites existing numbers. The manual in the starter pack is a concise framework with placeholders that you fill in. It replaces neither your professional review nor the adaptation to your company.
2. Nine document types. Manual, policy, process description, procedure, work instruction, form, checklist, external document and record automatically receive the next number, for example VA- or AA-; if you wish, you can assign your own. You write the documents directly in QMS | base, with headings, lists and bold type. Files such as plans, contracts or certificates are stored in Docu.
3. Management manual as a PDF. QMS | base prints the valid versions of the manual, policy and procedures with company header and table of contents as a single PDF. You will find the button “Print management manual (PDF)” in the “Management system” group under “Reports and certification status”.
You will find the way to the documents in the “Day to day” group under “Documents”. People with edit rights in the QMS can see the “Management system” group.
If you would like to try it yourself, take a look at the demo or open a trial account. If you have questions, we will be glad to help via the contact page.
Sources
- Kiwa ZertPunkt: Mindestanforderungen der DIN EN ISO 9001:2015 an zu dokumentierende Informationen, overview of the clauses with documented information (2015 edition, in German), accessed 27.10.2026.
- ISO 9001 Auditing Practices Group: Guidance on Processes, Edition 2, 19.07.2020; the APG is an informal group and its papers are not formally endorsed by ISO and IAF; accessed 27.10.2026.
- ISO 9001 Auditing Practices Group: Guidance on Context of the organization, 13.01.2016, accessed 27.10.2026.
- ISO: ISO 9001:2026 Quality management systems – Requirements, standard page, accessed 27.10.2026.
- DNV: ISO 9001:2026 Standard Revision, changes by clause, accessed 27.10.2026.
This guide does not replace legal or tax advice. Information as at 27 October 2026.