Policy required document Quality
ISO 9001 Quality Policy and Documented Information
ISO 9001:2015 dropped the mandatory quality manual and the six mandatory procedures of earlier editions and replaced them with a single concept: documented information.
The organization must maintain the documented information the standard names (scope, quality policy, quality objectives, and what is needed to operate its processes) and retain the records the standard names (monitoring and measurement results, design reviews, supplier evaluations, nonconformity and corrective action, internal audits, management reviews, and more), and it must control all of it under clause 7.5: identification, format, review and approval, availability, protection, distribution, access, change control, retention and disposition, and prevention of unintended use of obsolete documents.
Most certified organizations still keep a quality manual because customers and auditors find it easier to navigate, and the standard permits it. The quality policy is the one document that must be communicated, understood and applied within the organization and made available to interested parties, which is why auditors ask staff on the floor what it says.
The sixth edition of ISO 9001 is scheduled for publication on September 16, 2026, with a three-year transition, and keeps the documented information model.
Obligation ledger
Who requires it, and what each one says.
| Source | Applies when | What it requires | Status |
|---|---|---|---|
| ISO 9001:2015, documented information Clause 7.5.1 to 7.5.3 | Organization claims conformity to ISO 9001 | Include the documented information required by the standard and what the organization determines necessary; create and update it with identification, format and review and approval for suitability and adequacy; control it for availability, protection, distribution, access, retrieval, use, storage, preservation, change control, retention and disposition; identify and control externally provided documented information; protect retained records from unintended alteration. Standard requirement, contractual via certification. | Implied |
| ISO 9001:2015, quality policy Clause 5.2.1 and 5.2.2 | Always | Top management establishes a quality policy appropriate to the organization's purpose and context, providing a framework for objectives and committing to satisfy requirements and continually improve; it is available as documented information, communicated, understood and applied within the organization, and available to relevant interested parties. Standard requirement. | Implied |
| ISO 9001:2015, competence and awareness Clause 7.2 and 7.3 | Always | Determine competence, ensure it, take action where needed, and retain documented information as evidence of competence; ensure persons are aware of the quality policy, relevant objectives, their contribution, and the implications of nonconformity. Standard requirement. | Implied |
| ISO 9001:2015/Amd 1:2024, climate action changes Amendment 1, clauses 4.1 and 4.2 | Always, from February 2024 | Determine whether climate change is a relevant issue in the context of the organization; note that interested parties can have climate-related requirements. Adds a documented consideration to the context analysis. Standard requirement; certification bodies audit it. | Implied |
| ISO/IEC 17021-1 and IAF mandatory documents Certification body requirements; IAF MD transition arrangements | You hold a certificate | Certification bodies audit the documented information and the control of records at initial, surveillance and recertification audits; transition to a new edition within the IAF-set period (expected three years from Sept 2026 publication). Auditor expectation set by accreditation rules. | Implied |
| Customer quality agreements and supplier requirements Contract-specific | Customer requires ISO 9001 or equivalent | Evidence of a controlled documentation system, often with right to audit. Contractual. | Market |
Required sections
- Scope of the quality management system, with justification for any requirement not applicable (4.3)
- Quality policy (5.2)
- Quality objectives at relevant functions and levels, with plans to achieve them (6.2)
- Documented information the organization determines necessary for the effectiveness of the QMS, typically process descriptions or a quality manual (4.4.2, 7.5.1)
- Document control procedure: identification, format, review and approval, distribution, access, change control, retention and disposition, control of obsolete documents, external documents (7.5.2, 7.5.3)
- Context of the organization analysis including the climate change determination (4.1, 4.2 as amended 2024)
- Records the standard requires to be retained: calibration and traceability (7.1.5), competence evidence (7.2), review of requirements for products and services (8.2.3), design and development inputs, controls, outputs and changes (8.3), supplier evaluation (8.4.1), production and service identification and traceability where required (8.5.2), customer property (8.5.3), change control (8.5.6), release of products and services (8.6), nonconforming outputs (8.7.2), monitoring and measurement results (9.1.1), internal audit program and results (9.2.2), management review outputs (9.3.3), nonconformity and corrective action (10.2.2)
- Operational planning outputs and criteria for processes (8.1)
- Risk and opportunity actions and their evaluation (6.1; documentation not mandated but auditors expect a record)
- Master list or register of documented information with current revision status (not mandated; the common way to evidence 7.5.3)
- Communication plan for the quality policy and awareness (5.2.2, 7.3, 7.4)
What the examiner asks for
What changed
Change log.
Frameworks
Where this document is required.
Who looks at it
Where this document gets checked.
No one certifies a document like this on its own. It is read during the audits and inspections below, and by the agency behind each rule.
| Where it is looked at | Who looks at it |
|---|---|
| ISO 9001 | Accredited certification body (registrar) accredited to ISO/IEC 17021-1 for quality management systems |
Who helps write it
Consultants.
Firms that name these standards in their own material.
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Where it lives
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From the publisher
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Questions
What people ask.
Is a quality manual still required?
Not by name since 2015. You must document the scope, the policy, the objectives and whatever your processes need to run consistently. Most organizations keep a short manual because auditors and customers ask for one and it is the easiest place to show the process map.
What records must we keep?
The standard names them with the phrase retain documented information. The list in the required sections above is the union. Retention periods are yours to set, but they should match contractual and legal requirements, which auditors will check.
What does the climate change amendment require us to write?
A documented determination of whether climate change is relevant to your context and interested parties. For most organizations that is one paragraph in the context analysis with a rationale.
When do we need to move to ISO 9001:2026?
The new edition is scheduled for September 16, 2026, and the IAF is expected to set a three-year transition. Certification bodies will announce their own schedules. Do not update your documentation until the published text is in hand.
Who owns this site?
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Sources
ISO 9001:2015 Quality management systems, Requirements (ISO store)ISO 9001:2015/Amd 1:2024 Climate action changes (ISO store)ISO/TC 176 Auditing Practices Group, auditing climate change issues (PDF)TUV Rheinland, revision of ISO 9001 coming in 2026SGS, ISO 9001:2026 key updates and transition guidance