ISO 9001 Document Control with Workflow, Versioning, and Read-and-Understand
Synesis QMS Document Management replaces shared drives, email approvals, and forgotten revisions with a single controlled library. Every SOP, work instruction, form, specification, policy, manual, and external document moves through a configurable Draft → In Review → Pending Approval → Effective lifecycle. Reviewers and approvers receive notifications in-app, by email, and inside Microsoft Teams — and decisions sync back automatically, so a status change in any channel updates the record.
Once a document becomes Effective, it lands in the Published Documents Library where the right people can find it instantly and the right people get a Read-and-Understand task. AI assists with description enhancement, classification, and review routing, while a complete audit trail records every change, signature, and timestamp. Native integration with SharePoint, Teams, Outlook, Azure, Power Automate, and Microsoft Copilot, on a modern Microsoft license-free platform. Deploy where you want — on-premise, on Microsoft Azure, on Amazon Web Services, or on the hosted solution of your choice.
Single Source of Truth
All controlled documents — SOPs, Work Instructions, Forms, Specifications, Policies, Manuals, Procedures, Record Templates, External Documents — managed in one library with type, owner, reviewer, approver, and retention period.
ISO 9001 Compliant
Draft → In Review → Pending Approval → Effective. Configurable per document type. Reviewers and approvers get notified in-app, by email, and via Microsoft Teams. Rejection sends documents back with comments.
Complete Traceability
Every revision is preserved with its content, reviewer, approver, decision, and timestamps. Compare any two versions side-by-side. Effective documents move to the Published Library with the previous version marked obsolete.
Read-Only, Searchable
Effective documents only. Sorted by published date. Searchable by type, owner, department, tags. End users always see the current effective version with no risk of accessing draft or obsolete content.
Acknowledgments & Evidence
Assign acknowledgment requirements per document. Track who has read and understood, who hasn't, and when. Each acknowledgment recorded with user, version, and timestamp. Audit-ready evidence on demand.
OpenAI-Powered
One-click AI assistant to expand, rewrite, reformat, or summarize document descriptions. Generate learning objectives, outlines, and standardized language. Preview before applying.
Compliance Controls
Per-document retention period (years), confidentiality level (public, internal, confidential, restricted), and review interval. Automatic notifications when documents are due for periodic review.
Lifecycle KPIs
Dashboard tracking total documents, documents in approval, average review time, average approval time, average total cycle, first-pass approval rate, overdue reviews, and reviews due in next 30 days.
Documented Information — creation, update, control of documents, and retention. Full lifecycle workflow with audit trail and electronic signatures.
Electronic records, electronic signatures, audit trail, and access controls. Validated workflow with user authentication and decision logging.
Document and record control with revision history, distribution control, and read-and-understand for affected personnel.
Aerospace and medical device document controls. Configurable confidentiality, retention, and approval routing per document type.
Document control software manages the full lifecycle of controlled documents such as SOPs, work instructions, forms, specifications, and quality manuals. For manufacturers, it enforces the version control, review, approval, and distribution rules required by ISO 9001 Clause 7.5, ensuring everyone works from the current approved revision and that obsolete versions are removed from use. Synesis QMS document control gives manufacturers a single auditable system of record that stands up to customer and registrar audits.
Yes. The Synesis QMS document control module is built around ISO 9001:2015 requirements for documented information, and it also supports ISO 13485, IATF 16949, and AS9100 environments. It enforces a configurable draft, review, approval, and published workflow with electronic approvals, full version history, and read-and-understand acknowledgments. Every change is captured in a complete audit trail that demonstrates control during an audit.
Each document moves through a controlled workflow with an assigned owner, reviewer, and approver. The software automatically increments version numbers, records who approved what and when, and publishes the effective revision to a read-only library while archiving superseded versions. Rejections return the document to the owner with reviewer comments so corrections are tracked rather than lost, giving manufacturers a clean, defensible revision history.
Yes. Synesis is an SAP Gold Partner and the Synesis QMS platform offers native SAP Business One integration so document control links to the same item, supplier, and order master data used on the shop floor. The platform also works with Microsoft 365, SharePoint, Teams, and Outlook for approvals and notifications, and it can be deployed in the cloud or on-premise. Because controlled documents tie directly to CAPA, audit, and nonconformance records, you get true closed-loop quality traceability.
Watch Synesis AI eQMS Document Management run a real ISO 9001 review and approval cycle. We'll demo it on your processes, with your roles.
Request a QMS Demo