Quality management software: document control in enaio
Quality management with a DMS means that a document management system controls all QM documents from draft through review and approval to read acknowledgement, and retains inspection reports, audit results and actions so that every piece of evidence is available within seconds during an audit.
AWP Consult implements this as a certified enaio partner with enaio, the document management system in which many companies already manage invoices, contracts and files. Your manual, procedures and forms are then kept in one place, with a clearly valid version, traceable approval and logged read confirmation.
250+completed projects since 2006150+reference customers in the DACH region12 to 18months average payback
Controlled documentSample view
Goods receipt inspectionvalid version, distributed after approval
- CreatedDepartment
- ReviewedQuality management
- ApprovedManagement
Acknowledgement
open items via follow-up reminder
valid
Key facts at a glance
01
Quality management with a DMS means controlling the documented information of a quality management system in a document management system: it governs the creation, review, approval, distribution and revision of specification documents and retains records such as inspection reports and audit results unchanged.
02
ISO 9001:2015 requires in clause 7.5.3 that documented information is available, suitable and protected, and lists distribution, access, storage, version control as well as retention and disposition for this purpose.
03
The new edition ISO 9001:2026 was published on 16 September 2026. Certificates to ISO 9001:2015 remain valid during a transition period of 36 months.
04
Since ISO 9001:2015, a QM manual is no longer mandatory. Instead, the standard distinguishes between documented information that is maintained and documented information that is retained as evidence.
05
A logged read acknowledgement proves who confirmed a new version and when. However, it does not replace proof of training effectiveness.
06
AWP Consult introduces quality management in enaio with workflows, subscriptions, follow-up reminders and QM templates, connected to your ERP system and digital learning portal if required.
What does quality management with a DMS deliver?
Quality management with a DMS ensures that only the valid version of each specification is in circulation in your company, that every change is reviewed and approved, and that evidence such as inspection reports, training records and audit results is complete, unchanged and quickly retrievable. This makes your quality management system demonstrable, not just described.
The core of any quality management software is almost always document control. If instructions, forms and inspection plans sit on network drives and in email attachments, production works with last year's version, and in the audit there is no proof of who approved the current one. In a document management system, by contrast, storage, version, permissions and workflow all relate to the same object.
One valid version
Every controlled document has exactly one approved version. Previous versions are retained in an audit-proof manner but are marked as superseded.
Logged approval
Review and approval run as a workflow. Person, time and version are recorded automatically.
Acknowledgement
Affected employees confirm new versions. Outstanding confirmations are chased up via follow-up reminders.
Evidence at the click of a button
Inspection reports, audit reports and actions are kept in files with search fields instead of folders.
See your document control in enaio
In a QM demo, we show you the valid version, approval and read acknowledgement in enaio using your own document types.
- One valid version per document
- Logged approval
- Acknowledgement per role
Which tasks does QM software in enaio handle?
QM software in enaio handles six tasks: controlling specification documents, approval and revision workflows, logged read acknowledgement, providing QM and QA templates, audit-proof storage of records, and tracking actions from audits and nonconformities. All six use the same platform with uniform permissions, search fields and logs.
Controlled documents
Manual, process descriptions, procedures and work instructions are managed centrally in electronic files, with document type, scope, responsible person and review date as metadata.
Approval and revision workflows
Workflows route drafts to reviewers and approvers, in multiple stages, with deputy rules and escalation. After approval, the new version is automatically distributed to the affected users.
Logged read acknowledgement
Employees confirm specifications they have read in the system. Anyone who has not yet confirmed is visible at a glance and receives a reminder.
Workflow managementQM and QA templates
Forms, inspection plans and checklists are stored and retrieved as controlled templates. Anyone filling in a form is guaranteed to use the current version.
Records and inspection reports
Completed inspection reports, calibration records and audit reports are stored in an audit-proof manner and, if required, linked to the order, batch or supplier from the ERP system.
Actions and follow-up reminders
Corrective actions from audits and complaints are assigned owners and deadlines. Follow-up reminders prompt implementation and effectiveness checks, while subscriptions flag changes.
Not sure where to start? We will assess your starting point.
Which QM documents are controlled, and which are retained as evidence?
Specifications such as the QM manual, process descriptions, procedures, work instructions and form templates are controlled and versioned, while completed forms, inspection reports, audit reports, management review results and training records are retained as unalterable records. The overview shows typical document types and how they are managed in enaio.
| Document type | Examples | Handling in enaio |
|---|---|---|
| QM manual and process map | Quality policy, scope, process overview | Controlled, versioned, approved by management, acknowledgement by everyone |
| Procedures and work instructions | Goods receipt inspection, complaint handling, control of nonconforming products | Controlled, approval per department, acknowledgement per role, review date |
| Forms and inspection plans | Inspection record, checklist, action form | Available as a controlled template, once completed it becomes a record |
| Inspection reports and measurement records | Goods receipt, final inspection, calibration records | Retained, unalterable, linked to order, batch or test equipment |
| Audit and review reports | internal audits, supplier audits, management review | Retained, findings generate actions with follow-up reminders |
| External documents | Standards, customer specifications, supplier certificates | Marked with issue status, subscription for new issues |
Example structure. You decide in the project which document types you control and how long you retain records. ISO 9001 does not specify fixed periods for this.
Archiving inspection reports: what matters
Inspection reports are the records most frequently requested in audits and in the event of complaints. If you want to archive inspection reports, you need three things.
Link to the transaction
The report is linked to the order, item, batch or supplier. Via the ERP integration, this data is transferred automatically instead of being typed in.
enaio interfacesImmutability
Once stored, the report is no longer overwritten. Additions are created as a new version or a separate document, and the original is preserved.
Archiving softwareRetention rule
The period depends on customer requirements, product lifetime and legal obligations. Once it expires, the system proposes deletion.
Deletion concept in the DMSHow does an approval and revision workflow for controlled documents work?
An approval and revision workflow takes every controlled document through six steps, from draft via technical review and approval to publication, then obtains acknowledgement from those affected and starts the next review on the defined date. Each step is logged with person, time and version, so the life cycle of a document can be fully evidenced in an audit.
01
Draft with check-out
The responsible person checks out the document and edits it in Word or Excel. Others continue to see the valid version. On check-in, a new version is created with a short change note, so reviewers do not have to compare the entire text.
02
Technical review
The workflow routes the draft to the defined reviewers, in parallel or sequentially depending on the document type. Queries and comments stay with the case. If the draft is rejected, it is returned with reasons.
03
Approval
The approver signs off the version. Whoever created it does not approve it themselves. Deputies are defined, and if a deadline is exceeded, the workflow escalates to the next level.
04
Publication and distribution
On approval, the new version becomes valid and the previous version is marked as superseded. Affected roles receive the new version automatically, and subscribers are notified.
05
Acknowledgement
Employees confirm that they have read the new version. Outstanding confirmations appear in a list and are chased up via follow-up reminders.
06
Periodic review
Every document has a review date. In good time beforehand, the responsible person receives a follow-up reminder and either confirms the version or starts a new revision.
How do you control your QM documents today? In a demo, we show an approval and revision workflow in enaio with your own document types.
Book a QM demoHow does logged read acknowledgement work?
Logged read acknowledgement works as a workflow: after a new version is approved, all employees in the affected roles receive a task, open the document and confirm with one click, after which enaio logs person, time and version and chases up outstanding confirmations via follow-up reminders. This way you can see at any time who knows a specification.
The confirmation always refers to a specific version. If the document changes again, a new workflow starts and the old confirmation no longer counts. Managers see in an overview which confirmations are still missing in their area. Anyone who does not work with the client confirms in the browser via the enaio webclient.
Roles instead of mailing lists
Who has to confirm is determined by the role and the scope of the document, not by manually maintained email lists.
New employees
When they join, they receive all valid specifications for their role to confirm, without anyone having to compile a list.
Evidence in the audit
A report per document and version shows confirmed and outstanding, with a timestamp.
Limits of acknowledgement
Critical changes are followed by instruction with a learning check, as acknowledgement alone is not sufficient in that case.
What does ISO 9001 document control require from QM software?
ISO 9001 document control requires that documented information is identified, reviewed and approved, available where it is needed, protected against loss and unintended alteration, and governed by version control, retention and disposition. The standard does not prescribe a specific tool. However, software makes these requirements permanently verifiable. The following sections show which rule is reflected in which function.
01
Maintain and retain
With the 2015 edition, ISO 9001 replaced the terms document and record with documented information. The distinction lives on in the wording, however. Documented information that is maintained describes how something should be done and may change. Documented information that is retained proves that something has been done and must no longer change.
The standard has not required a QM manual since 2015. Many companies keep one as an introduction, often leaner than before. For the software, this means: specification documents need versioning and approval workflows, while records need immutability and a retention rule.
- Maintain for example the scope of the QM system (4.3), quality policy (5.2) and quality objectives (6.2)
- Retain for example evidence of competence (7.2), results of internal audits (9.2), results of the management review (9.3) as well as nonconformities and corrective actions (10.2)
Practical tip
Define for each document type whether it is maintained or retained. Workflow, permissions and deletion rule then follow almost automatically.
02
Creating and updating
Clause 7.5.2 of ISO 9001:2015 requires appropriate identification and description when creating and updating, such as title, date, author or reference number, a suitable format and medium, and review and approval for suitability and adequacy. In enaio, this becomes a metadata model per document type.
The standard does not prescribe a specific form of approval. In practice, a logged approval in the workflow is more meaningful than a scanned cover sheet with a signature, because it is linked to the specific version. In regulated industries such as medical technology, further requirements may apply.
- IdentificationDocument number, title, document type, scope, responsible person and version as mandatory fields
- Format editable Office file for the draft, unalterable format for the published version
- Review and approvalApproval workflow with defined roles, logged with person, date and version
03
Control: distribution, protection and version control
Under clause 7.5.3.1, documented information must be available and suitable for use where and when it is needed, and adequately protected, for example against loss of confidentiality, improper use or loss of integrity. Clause 7.5.3.2 lists the activities that must be addressed for this:
- Distribution, access, retrieval and use role-based permissions, automatic distribution after approval, full-text search and search fields, browser access via the enaio webclient
- Storage and preservation audit-proof storage, legibility throughout the entire retention period
- Control of changesVersioning with check-in and check-out, change note, previous versions are retained
- Retention and dispositionRetention rule per document type, followed by a deletion proposal with proof of deletion
Practical tip
Printouts are the main risk for outdated specifications. Mark printouts as uncontrolled copies with the print date, for example via a field in the document template, or allow printouts only for selected document types.
04
Documents of external origin
Documents that do not originate within the company but are needed for planning and operating the QM system must also be identified and controlled under ISO 9001. These include standards, customer specifications, supplier certificates, safety data sheets and test specifications.
It makes sense to store supplier-related evidence in the supplier file. Multi-stage approval of new suppliers can be mapped as a separate workflow, and the evaluation results are retained as documented information in accordance with ISO 9001.
- Separate document type with issuer, issue status and validity
- Follow-up reminder before certificates expire, for example supplier certificates
- Subscription for everyone working with a customer specification, so that a new issue arrives immediately
05
Acknowledgement, competence and awareness
ISO 9001 requires that people have the necessary competence and that evidence of this is retained (7.2), and that they are aware of, among other things, the quality policy, relevant quality objectives and their own contribution (7.3). The standard does not explicitly require a read confirmation. However, it is a simple, verifiable proof that a changed specification has reached those affected.
The distinction is important: an acknowledgement shows that someone has confirmed a version. Whether the person has understood the specification and can apply it is only shown by training with a learning check. For safety or quality-critical changes, you therefore combine both, for example with the digital learning portal from AWP Consult, whose certificates can be stored directly in the digital personnel file.
Practical tip
Assign acknowledgements to roles, not to individual names. New employees then automatically receive all valid specifications for their role to confirm.
06
ISO 9001:2026: what changes and what stays the same
The sixth edition of ISO 9001 was published on 16 September 2026 and replaced the 2015 edition. It adopts the harmonised structure of ISO management system standards, places greater emphasis on quality culture, ethical behaviour and leadership, separates the consideration of risks and opportunities more clearly and sets higher expectations for the management of change.
For document control, the revision does not mean a change of system. If you manage versions, approvals and evidence properly, you can demonstrate the transition in your next surveillance or recertification audit. New topics such as planned changes to the QM system can be mapped as a separate workflow with assessment, approval and effectiveness check.
- Transition period36 months from publication, certificates to ISO 9001:2015 remain valid during this time
- Companion standardsISO 9000:2026 with fundamentals and vocabulary and ISO 19011:2026 as guidance for auditing were already published in May 2026
- Core principles process approach, PDCA cycle and risk-based thinking remain central
Do you have a specific question about your case?
Apply ISO 9001 requirements to your document types
Together with you, we classify each document type as maintained or retained and derive the workflow, permissions and retention rule in enaio from this.
How does quality management with a DMS support audits and audit preparation?
A DMS supports audits by managing the audit programme with dates and responsibilities, showing all specifications in the version valid on the reference date, providing evidence immediately via search fields and tracking every finding as an action with owners, deadline and effectiveness check until closure. Audit preparation thus shifts from collecting to checking.
ISO 9001 requires internal audits at planned intervals and the retention of the audit programme and audit results. How audits are planned and conducted is described in the ISO 19011 guideline, whose current edition was published in May 2026. In the certification audit, what counts is that you can show the evidence for every question: valid instruction, approval, acknowledgements and records.
Audit programme as a file
One file per audit with plan, checklist, report and findings. Follow-up reminders flag upcoming audits.
Status on the reference date
The version history shows which version was valid at a specific point in time and who approved it.
Read access for auditors
If required, external auditors receive time-limited read access to defined files, and every access is logged.
Actions through to effectiveness
Findings become corrective actions with cause, owners and deadline. They are only closed after the effectiveness check.
Further reading on audits and evidence
We will show you what this looks like with enaio in your company.
Book an appointment +49 6104 94738-13What are the most common mistakes when introducing QM software?
The most common mistakes are a folder structure copied one to one, approval workflows without a role model, acknowledgements for everything, missing review dates, uncontrolled printouts and inspection reports without reference to the transaction. None of them is a software problem, and all of them can be avoided at the concept stage.
| Typical mistake | Consequence | Better approach |
|---|---|---|
| Network drive copied one to one | Folders without document types, no mandatory fields, no rules for version and retention. | Define document types with metadata, use folders only as a view for orientation. |
| Approval by people instead of roles | When a manager changes, workflows get stuck and deputy arrangements do not take effect. | Store approval roles per document type and scope, assign people to the roles. |
| Acknowledgement for every document | Confirmation fatigue, clicks without reading, the evidence loses value. | Acknowledgement only for specifications that require action, critical changes with instruction. |
| No review date | Documents become outdated unnoticed, and the audit reveals versions that nobody has looked at for years. | Review date as a mandatory field, follow-up reminder to the responsible person. |
| Printouts without marking | Outdated paper versions hang on the machine and continue to be used. | Mark printouts as uncontrolled copies with the print date, or switch to tablets in the browser. |
| Inspection reports without transaction reference | In the event of a complaint, the right report has to be searched for instead of simply being found. | Order, batch or supplier as search fields, ideally transferred automatically from the ERP system. |
Checklist: what must QM software be able to do for document control?
You should check these points when selecting QM software. They can be transferred directly into a requirements specification.
01
Document control
- Document types with mandatory fields and scope
- Versioning with check-in, check-out and change note
- Clear marking as valid, under review and superseded
- Review date with follow-up reminder
- Control of external documents with issue status
- Marking or blocking of printouts
02
Workflows and evidence
- Multi-stage approval with deputies and escalation
- No approval by the author
- Acknowledgement per role and version with reporting
- Action tracking through to effectiveness check
- Complete log of all access and changes
03
Operation and integration
- Audit-proof storage with retention rules
- Role-based permission concept
- Integration with ERP system and Microsoft Office
- Access in the browser and on mobile devices
- Operation in your own data centre or in the cloud
Not sure where to start? We will assess your starting point.
In which industries do companies use QM software with enaio?
Companies use QM software with enaio wherever many specifications, inspections and records come together across several sites and roles: in industry and manufacturing, in the social sector, in freight forwarding and logistics, and at energy suppliers. The requirements for document control are similar, but the document types differ.
Industry and manufacturing
Work instructions on the line, inspection plans, inspection reports per order, calibration records and customer specifications, linked to the ERP system.
DMS for manufacturingWelfare and social sector
QM manuals per facility, care and hygiene standards, acknowledgements across many sites and shifts.
Solutions for the social sectorFreight forwarding and logistics
Procedures for warehousing and handling, instruction for drivers, evidence for customer audits.
DMS for logisticsEnergy suppliers
Operating instructions, inspection and maintenance records and permit documents with long retention periods.
DMS for energy suppliersWhat customers say about working with enaio
Voices from companies in industry and measurement technology that manage their document-intensive processes with AWP Consult and enaio.
Due to our document-intensive processes, we have a strong need for a reliable DMS solution. With AWP's support, we have been able to master a number of challenges, including customised interface adaptations and company-wide enaio updates. AWP's straightforward, hands-on mentality was particularly helpful in this.
For many years, we have enjoyed a successful and trusting partnership with AWP Consult. enaio reliably supports our processes and makes a significant contribution to efficiency in our day-to-day work.
How is quality management with a DMS introduced in enaio?
Quality management with a DMS is introduced in enaio in five phases: an inventory of the QM documentation, a concept with document types, roles and approval workflows, a pilot in one area with real revisions, migration and rollout, and finally support through to the next audit. Existing documents are cleaned up in the process, not just copied.
01
Inventory
We record existing documents, document types, owners and current approval paths, and flag duplicates and outdated versions.
02
Concept
Metadata, roles, approval and acknowledgement workflows, permissions and retention rules are defined and signed off by you.
03
Pilot
One area starts with real revisions. Workflows and forms are refined based on the experience gained.
04
Migration and rollout
Valid versions are migrated with metadata, further areas follow, and users and key users are trained.
05
Audit support
We support you in preparing for the next audit and continue to develop workflows and reports.
More on this: enaio implementation, training and enterprise content management consulting
How long will it take in your case? We will estimate it with you.
Request an estimate +49 6104 94738-13Which quality management terms should you know?
The key terms that come up again and again in QM projects between quality management, specialist departments and IT.
- Documented information
- ISO 9001 term for all information that must be controlled and maintained or retained, regardless of format and medium.
- Controlled document
- Specification document with identification, approval, version status and regulated distribution. Only the valid version is in circulation.
- Record
- Evidence that an activity has been carried out, such as an inspection report. Records are no longer changed.
- Revision
- Rework of a controlled document that leads to a new valid version after review and approval.
- Acknowledgement
- Logged confirmation by a person that they have read a specific version of a document.
- Documents of external origin
- Third-party documents required for the QM system, such as standards, customer specifications or supplier certificates.
- PDCA cycle
- Plan, Do, Check, Act as the cycle of continual improvement on which ISO 9001 is based.
- Internal audit
- Systematic review at planned intervals of whether the QM system meets its own and the normative requirements and is effective.
- Corrective action
- Action that eliminates the cause of a nonconformity so that it does not recur. Its effectiveness is evaluated.
- Management review
- Regular evaluation of the QM system by top management. Its results are retained as evidence.
- Harmonised structure
- Uniform structure of ISO management system standards, adopted by ISO 9001:2026, which makes it easier to combine with other standards.
Before the next audit: evidence in one place
We discuss with you how your existing QM documents are migrated to enaio and how you present approvals, acknowledgements and inspection reports in the audit.
Sources and standards
The statements on standards and editions on this page are based on the following sources. Last reviewed: October 2026. Texts of standards are protected by copyright and are available from the standards organisations.
- ISO 9001:2026 at ISO Sixth edition, published in September 2026
- ISO announcement on the publication Key points of the new edition and harmonised structure
- ISO 9001:2015 at ISO Fifth edition, replaced by ISO 9001:2026
- ISO 9000:2026 at ISO Fundamentals and vocabulary for quality management systems
- ISO 19011:2026 at ISO Guidelines for auditing management systems
- TÜV SÜD on ISO 9001:2026 Transition period of 36 months and validity of existing certificates
Frequently asked questions about quality management with a DMS
What does quality management with a DMS mean?
In quality management with a DMS, a document management system controls the documented information of a QM system. It governs the creation, review, approval, distribution and revision of specifications and retains records such as inspection reports and audit results unchanged. It also covers acknowledgements, templates and action tracking. In enaio, all of this runs on the same platform as your other files.
Which quality management software is suitable for ISO 9001?
A suitable solution offers versioning, multi-stage approvals, role-based permissions, audit-proof storage and a complete audit log. ISO 9001 does not prescribe a specific tool, but it does require documented information to be identified, approved, available, protected and monitored for changes. A document management system such as enaio meets these requirements if document types, roles and workflows are configured properly. The configuration matters more than the feature list.
What is the difference between QM software and process and quality management software?
Classic QM software focuses on document control, audits and actions. Process and quality management software additionally models processes graphically, for example as a process map. With enaio, workflows control the processes directly instead of merely describing them: approvals, acknowledgements and actions run as real cases with tasks and deadlines.
How does ISO 9001 document control work in enaio?
Each document type is given mandatory fields for identification, owners and review date. Changes are made via check-out and check-in as a new version that passes through an approval workflow. After approval, only the new version is valid, and the previous version is retained in an audit-proof manner. Distribution, acknowledgement and follow-up reminders follow automatically.
How can inspection reports be managed and archived in accordance with ISO 9001?
Inspection reports are records that are retained as evidence and must no longer change. In enaio, they are stored in an audit-proof manner and found via search fields such as order, batch, item or supplier, which ideally come from the ERP system. A retention rule per document type controls when they may be deleted. ISO 9001 does not specify fixed periods for this. You define them yourself.
Is logged read acknowledgement mandatory?
ISO 9001 does not explicitly require a read confirmation. However, the standard does require that specifications are available and that employees know the requirements relevant to them. Logged read acknowledgement is a simple, verifiable proof of this. For critical changes, you should also plan instruction with a learning check.
What changes with ISO 9001:2026?
ISO 9001:2026 was published on 16 September 2026. It adopts the harmonised structure, emphasises quality culture, ethical behaviour and leadership, and separates risks and opportunities more clearly. A transition period of 36 months applies, and certificates to ISO 9001:2015 remain valid during this time. Nothing fundamental changes in the principles of document control.
Do we still need a QM manual?
Since ISO 9001:2015, a QM manual is no longer mandatory. Many companies nevertheless keep one as an introduction with quality policy, scope and process map. In enaio, the manual is managed like any other controlled document, with approval by management and acknowledgement. Being up to date matters more than its length.
How does audit-ready document management help with audit preparation?
It shows the valid version, the approval and the acknowledgements for every specification and provides records immediately via search fields. The version history proves which status applied on a reference date. Findings from previous audits are traceable as actions with their status. Audit preparation thus starts with checking instead of searching.
Is quality management with a DMS suitable for the social sector?
Yes. In welfare and social sector organisations, QM manuals as well as care and hygiene standards apply across many sites and shifts. Acknowledgements by role, browser access and confirmation in the browser help especially where not everyone works at a desk. Welfare and the social sector are among AWP Consult's industry focus areas.
Can the QM software be connected to our ERP system?
Yes. enaio is connected to SAP, Microsoft Dynamics 365, Business Central and NAV, proALPHA, Sage and DATEV, among others. For quality management, master data such as items, suppliers and orders is particularly important, so that inspection reports and supplier evidence are automatically assigned to the correct transaction.
Do you have a specific question about your case?
Related topics
QM in the DMS under ISO 9001Audit preparation and controlled document management in detail.Workflow managementApprovals, deputies and escalations in enaio.GDPR-compliant document managementPermissions, deletion rules and logs for personal data.Digital learning portalInstruction with learning checks and certificates.
Your QM documentation, properly controlled
In a QM demo, we show you document control, approval and revision workflows and logged read acknowledgement in enaio, and discuss how your existing documents will be migrated.
- In person in Dietzenbach or online
- With quality management and departments
- Outcome: a concrete project proposal
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