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Is a quality manual still required by ISO 9001?
Short answer: no — and the 2026 edition did not bring it back. Here is what to keep instead.
Updated 13 November 2026 · 5 min read · Written for working labs and quality teams
Short answer
No. ISO 9001:2015 removed the explicit requirement for a quality manual, and ISO 9001:2026 (published 16 September 2026) did not bring it back. What the standard requires is documented information: documents needed for the operation of processes, and records needed to have confidence that processes are being carried out as planned (clause 7.5). You may keep a manual if customers, tenders or your own organisation want one — but it is not an audit requirement.
On this page
What the standard actually asks for
In practice many organisations replace the manual with a short QMS map: scope and exclusions, the process sequence and interactions, who owns each process, which documents and records support it, and where to find them. That single page does more for an auditor than a 60-page manual copied from a template.
- Documented information to be maintained (7.5.2 / 7.5.3): the quality policy (5.2), quality objectives (6.2), and the information you determine is necessary for the operation of processes and for confidence that they are carried out as planned — scope, process interactions, criteria for control, responsibilities.
- Documented information to be retained (records): evidence of results — monitoring and measurement, competence, contract review, design and development, external-provider evaluation, nonconformities, internal-audit results, management-review outputs and corrective actions.
- Control of it (7.5.3): availability and suitability for use where and when needed, protection, version/change control, retention periods and disposition. The 2026 edition puts more weight on information being available and used, rather than merely retained.
- The quality policy is still a defined document (5.2), and the scope of the QMS must be available as documented information (4.3). Neither requires a bound manual.
So why do people still ask for one?
| Who asks | Why | What to do |
|---|---|---|
| A customer or tender portal | Its supplier questionnaire still lists 'quality manual' from the 2008 era | Provide the QMS map plus a short cover note mapping their requested sections to your documents |
| A certification auditor | Wants to understand scope, processes and interactions quickly | Have the scope, process map and document index ready; there is no clause requiring a manual |
| An internal legacy procedure | The document-control list still names QM-001 | Retire or re-label it as a QMS overview — do not keep a dead mandatory document |
| A multi-site or integrated system | One place to state how 9001 / 14001 / 45001 fit together | An integrated-system overview is genuinely useful; just do not call it a mandatory standard requirement |
Practical note. A transition to ISO 9001:2026 is not a reason to rewrite a manual. Start with the clause-by-clause gap list (5.1, 5.2, 6.1, 6.3, 7.1.6, 7.3, 8.2, 9.2, 9.3) and revise only the documents and records that actually change.
What about ISO/IEC 17025:2017?
ISO/IEC 17025:2017 does not mandate a document called a quality manual either. It offers two routes: option A, where the laboratory addresses the management-system requirements in clauses 8.2–8.9 directly, or option B, where a laboratory that already operates a management system in accordance with ISO 9001 can use it, provided it also meets the technical competence requirements of clauses 4–7. Many accreditation bodies' own documents still use the term "quality manual" informally — follow the current document list of your own body, and note that Global ACI replaced IAF and ILAC on 1 January 2026 and is republishing guidance under new numbering.
Where this goes wrong in practice
Buying a generic quality-manual template as the first step of a 2026 transition — it adds documents to control and changes no behaviour.
Deleting every overview document because "manuals are no longer required", then being unable to show scope, process interactions or where records live.
Answering a customer questionnaire with "not applicable, standard does not require it" instead of mapping their requested section to the document you do have.
Confusing a quality policy (required, 5.2) with a quality manual (not required).
Frequently asked
Will an auditor raise a nonconformity if we have no quality manual?
Not against ISO 9001:2015 or ISO 9001:2026 — neither requires one. You do need the documented information the standard specifies (scope, policy, objectives, information necessary for process operation, and records of results) and control over it.
Can we keep our existing quality manual?
Yes. Nothing prohibits it. Just make sure it is controlled, current, reflects the 2026 edition's terminology and is genuinely used — an out-of-date manual that contradicts current practice is a liability, not a defence.
Is a quality manual required for ISO/IEC 17025 accreditation?
No. ISO/IEC 17025:2017 uses option A or option B for the management system and does not mandate a manual by name. Some accreditation bodies' application checklists still ask for an equivalent overview document; follow your own body's current requirements.
What should we hand a customer who insists on a manual?
A short QMS overview (scope, process map, responsibilities, document/record index) plus a cross-reference from each section of their questionnaire to the controlled document that covers it. It satisfies the request without inventing a document the standard does not require.
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LabKitPro guides are written from published standards and accreditation-body documents — references, clause numbers and paraphrased intent only, never verbatim standard text. They are for preparation and study, not a certification or accreditation decision, and not legal advice. ISO standards are trademarks of ISO; IATF 16949 is published by the International Automotive Task Force and is not an ISO standard. The current laboratory standard is ISO/IEC 17025:2017; there is no 2025 edition. Global ACI replaced IAF and ILAC on 1 January 2026.
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