ISO 9001 Quality Manual: What Changed in 2026?
The ISO 9001 quality manual is no longer a mandatory document. ISO 9001:2015 removed the explicit requirement for a quality manual that had existed since the 1987 edition. ISO 9001:2026 continues this approach — there is no "shall maintain a quality manual" requirement in the standard.
However, many organizations still maintain a quality manual because it provides a useful overview of the QMS, helps new employees understand the system, and is expected by some customers and certification bodies as a reference document.
Is a Quality Manual Required for ISO 9001:2026 Certification?
No — a quality manual is not required for ISO 9001:2026 certification. The standard requires "documented information" to support the operation of processes and to provide evidence of results, but it does not specify that this information must be organized into a document called a "quality manual."
What IS required as documented information in ISO 9001:2026:
| Clause | Required documented information |
|---|---|
| 4.3 | QMS scope |
| 5.2 | Quality policy |
| 6.2 | Quality objectives |
| 7.1.5 | Calibration records |
| 7.2 | Competence records |
| 8.1 | Operational planning results |
| 8.2.3 | Contract review records |
| 8.4.1 | External provider evaluation records |
| 8.5.1 | Production/service provision controls |
| 8.6 | Release records |
| 8.7 | Nonconforming output records |
| 9.1 | Monitoring and measurement results |
| 9.2 | Internal audit programme and results |
| 9.3 | Management review results |
| 10.2 | Nonconformity and corrective action records |
None of these requirements specifies a quality manual. They can be met through a combination of procedures, work instructions, forms, databases, and records.
Why Many Organizations Still Write a Quality Manual
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Despite not being required, a quality manual remains useful for several reasons:
Customer requirements: Many large customers, particularly in defence, aerospace, and automotive sectors, require suppliers to provide a quality manual as part of their supplier qualification process.
Certification body expectations: While no accredited certification body can require a quality manual (the standard doesn't), many auditors find it helpful as a navigation document for the QMS. A well-written quality manual can make Stage 1 and Stage 2 audits more efficient.
Employee onboarding: A quality manual provides new employees with a structured overview of how the organization manages quality — what processes exist, how they interact, and where to find detailed procedures.
ISO 9001:2026 transition: Organizations transitioning from ISO 9001:2015 often update their existing quality manual to reflect the three new requirements (quality culture, opportunities register, climate change) rather than abandoning the document entirely.
What to Include in an ISO 9001 Quality Manual
If you choose to maintain a quality manual, a well-structured document typically includes:
1. Scope of the QMS
Define which products, services, locations, and organizational units are covered. Document any exclusions from ISO 9001:2026 and justify them.
2. Organizational context
Brief description of the organization, its products/services, and the key internal and external issues that affect the QMS (Clause 4.1). Reference to the interested parties register (Clause 4.2).
3. Quality policy
The full quality policy text (Clause 5.2), or a reference to where it is maintained.
4. Process overview
A process map or list of QMS processes showing their sequence and interaction (Clause 4.4). This is the most valuable section of a quality manual — it gives auditors and employees a clear picture of how the QMS operates.
5. Responsibilities
An organizational chart or responsibility matrix showing who is responsible for QMS-related functions (Clause 5.3).
6. Document and record control
Reference to the document control procedure (Clause 7.5) — how documents are created, approved, updated, and controlled.
7. Reference to procedures
A list of or links to the detailed procedures that support each QMS process. The quality manual does not need to contain the procedures themselves — it can reference them.
New in ISO 9001:2026 — consider adding:
- Quality culture statement (Clause 5.1.1) — how top management promotes quality culture and ethical behaviour
- Opportunities register reference (Clause 6.1.3) — where improvement opportunities are identified and tracked
- Climate change consideration (Clause 4.1) — how climate change is considered in the organizational context
ISO 9001 Quality Manual Template: Recommended Structure
A typical ISO 9001:2026 quality manual follows this structure:
Section 1: Introduction — purpose and scope, organizational background, document control
Section 2: Organizational Context (Clause 4) — internal and external issues, interested parties, QMS scope, QMS processes
Section 3: Leadership (Clause 5) — management commitment, quality culture and ethics [NEW 2026], quality policy, roles and responsibilities
Section 4: Planning (Clause 6) — risk and opportunity management, opportunities register [NEW 2026], quality objectives
Section 5: Support (Clause 7) — resources, competence and training, documented information
Section 6: Operations (Clause 8) — process overview, customer requirements, external providers
Section 7: Performance Evaluation (Clause 9) — monitoring and measurement, internal audit, management review
Section 8: Improvement (Clause 10) — nonconformity and corrective action, continual improvement
Appendices — process map, document register, organizational chart
How Long Should an ISO 9001 Quality Manual Be?
There is no required length. Effective quality manuals range from 5 pages (a lean overview document) to 50+ pages (a comprehensive reference document). The trend since ISO 9001:2015 has been toward shorter, more focused manuals that reference detailed procedures rather than reproducing them.
A quality manual that is too long is rarely read. A quality manual that is too short may not provide sufficient context for auditors and new employees. Aim for 10–20 pages for most organizations.
ISO 9001:2026 Quality Manual vs ISO 9001:2015 Quality Manual
The main differences when updating a quality manual from ISO 9001:2015 to ISO 9001:2026:
| Section | ISO 9001:2015 | ISO 9001:2026 change |
|---|---|---|
| Clause 4.1 | Internal/external issues | Add climate change consideration |
| Clause 5.1.1 | Leadership commitment | Add quality culture and ethical behaviour |
| Clause 6.1 | Risk and opportunity management | Add separate opportunities register (6.1.3) |
| All clauses | Same requirements | No other structural changes |
The update is straightforward — add three new sections or paragraphs to the existing quality manual addressing quality culture, opportunities, and climate change.
Frequently Asked Questions
Do I need a quality manual to get ISO 9001:2026 certified?
No. ISO 9001:2026 does not require a quality manual. You need documented information covering the specific requirements listed in the standard, but these do not need to be organized into a document called a quality manual.
Can I use my existing ISO 9001:2015 quality manual for the transition?
Yes, with updates. Add sections covering the three new requirements: quality culture promotion (Clause 5.1.1), opportunities register (Clause 6.1.3), and climate change consideration (Clause 4.1). Update the version number and revision date.
What format should a quality manual be in?
Any format that works for your organization — Word document, PDF, SharePoint page, or integrated into your QMS software. The format is not specified by ISO 9001:2026.
Do I need to share my quality manual with customers?
Only if your customers require it. Some customers, particularly in regulated industries, request a copy of the quality manual as part of supplier qualification. In that case, you may want to maintain a customer-facing version that omits sensitive internal information.
Is a quality manual the same as a QMS manual?
Yes — "quality manual" and "QMS manual" are used interchangeably. Some organizations call it a "quality management system manual" or "management system manual" (particularly if it covers multiple standards like ISO 9001 and ISO 14001 together).
Related Resources
- ISO 9001:2026 Compliance ChecklistISO 9001:2026 Compliance Checklist/resources/compliance-checklist — 43 requirements with status checkboxes
- ISO 9001:2026 Gap Analysis TemplateISO 9001:2026 Gap Analysis Template/resources/gap-analysis-template — assess your current QMS documentation
- ISO 9001:2026 Documented Information RequirementsISO 9001:2026 Documented Information Requirements/article/iso-9001-2026-documented-information-requirements — full list of required records
- ISO 9001 Certification Process GuideISO 9001 Certification Process Guide/article/iso-9001-certification-process-guide — step-by-step from documentation to certificate
- ISO 9001:2026 Key ChangesISO 9001:2026 Key Changes/article/iso-9001-2026-key-changes — all three new requirements explained