ISO 9001:2015 and ISO 9001:2026 clause map
What ISO 9001 asks for, and where Obel-MS does it.
No software is ISO 9001 certified. Organisations are, through an accredited certification body. Obel-MS gives you the document control and workflow structure that clause 7.5 and its neighbours ask for, so the evidence is ready when your auditor asks for it.
ISO 9001:2026 was published on 16 September 2026. The clause numbers below apply to both editions: clause 7.5 keeps its place and its intent. Certificates to ISO 9001:2015 stay valid through a three-year transition. See what changed.
| Clause | What it requires | How Obel-MS supports it | Module |
|---|---|---|---|
| 4.4 | Determine the processes your quality management system needs, and how they interact. | External Document Control and Workflow Manager give those processes a home: a register for documents, templates for recurring workflows, and an audit trail across both. | EDC and WFM |
| 7.5.1 | Maintain the documented information your QMS needs, both what the standard requires and what you decide you need. | The EDC Register holds supplier certificates, specifications and statements. Workflow Manager records (Nonconformance, CAPA, Audit, Change Control, Document Review) hold the rest. | EDC and WFM |
| 7.5.2 | Identify documents properly, and review and approve them for suitability before release. | Upload a document, accept, edit or dismiss the AI-suggested metadata, then Approve. Approval moves it into the Register with status Validated. | EDC |
| 7.5.3.1 | Keep documented information available, suitable for use, and adequately protected. | Four roles (Super Admin, Master Admin, Module Admin, Navigator) with module-scoped permissions, plus a full audit log of who changed what and when. | Platform |
| 7.5.3.2: distribution, access, retrieval | Control how documented information is distributed, accessed, retrieved and used. | The Register and Folder views give role-based access and retrieval today. Distribution with read-and-acknowledge tracking is planned with Internal Document Control. | Planned with IDC |
| 7.5.3.2: version control | Control changes to documented information, such as version control. | "Upload New Version" keeps full version history in EDC. Workflow Manager templates version as "New version" or "Copy", so a change never overwrites what auditors relied on. | EDC and WFM |
| 7.5.3.2: retention and disposition | Set retention periods and disposition for documented information. | Document Status is computed automatically: Active, Expiring soon, Expired, or No expiry set. Documents move to Archive, and you can unarchive them again. | EDC |
| 7.5.3: documents of external origin | Identify and control documented information of external origin that your QMS needs. | Documents auto-file into a Supplier → Manufacturer → Product folder tree as soon as they’re approved, so external certificates and specs stay organised without manual filing. | EDC |
| 8.4 | Control externally provided processes, products and services, based on their effect on your QMS. | Supplier certificates and specifications live in EDC with expiry tracking. A Nonconformance or CAPA record in Workflow Manager handles a supplier falling short. | EDC and WFM |
| 8.7 | Identify and control outputs that do not conform to requirements. | The Nonconformance template routes a finding through five stages, including verification, with approvals assigned by job title. | WFM |
| 9.2 | Keep records as evidence of your internal audit programme and its results. | Internal audit findings are raised as Nonconformance records. The NC Source field includes Internal Audit, so they run through the same stages and audit trail as any other finding. | WFM |
| 9.3 | Feed relevant information into management review: audit results, nonconformities and process performance. | Every record has a Report tab with a PDF, and AI stage and executive summaries give a quick brief to take into a management review meeting. | WFM |
| 10.2 | React to nonconformity, evaluate the need for corrective action, and check that it worked. | Nonconformance and CAPA records track cause and correction, and effectiveness verification closes the loop with Mark Effective or Mark Ineffective. | WFM |
What you still own
A QMS is more than software. Obel-MS supports the tasks below. Your organisation still does them.
- Obel-MS stores your quality policy and quality objectives as records. You write them.
- Obel-MS supplies the inputs for your management review meetings: records, reports and trends. You hold the meeting.
- You keep training and competence records for your people.
- Obel-MS records the findings from your internal audits. Your team carries out the audits.
ISO 9001 questions
Does Obel-MS support ISO 9001:2026?
Yes. ISO 9001:2026 was published on 16 September 2026 and keeps clause 7.5 on documented information, so the controls in Obel-MS apply to both editions. Certificates to ISO 9001:2015 stay valid through a three-year transition, so you can move at the pace your certification body agrees.
Is Obel-MS ISO 9001 certified?
No software can be ISO 9001 certified. Only your organisation’s quality management system can, through an accredited certification body. Obel-MS is built around clause 7.5 (documented information), which is in both ISO 9001:2015 and the new ISO 9001:2026, to support that certification.
Does Obel-MS work for ISO 13485 or GxP environments?
Obel-MS is built for ISO 9001 today. It does not yet support regulated GxP environments or ISO 13485 validation. If that is what you need, tell us about your requirements.
Guides on this topic
- ISO 9001:2026: what changed for document controlWhat ISO 9001:2026 changed, the transition timeline for your 2015 certificate, and what it means for clause 7.5 document control.
- ISO 9001 document control: what clause 7.5 asks forWhat documented information ISO 9001 requires you to control, what a controlled document is, and what auditors check.
- ISO 9001 document control procedure: a worked exampleA complete, plain-language document control procedure for a small company, section by section.