Building Quality as a Team Effort – How Klavant prepares for ISO 13485 with MedQdoc
Document Management in Practice:
Folder-Based Administration vs Digital Document Control
Many organizations still manage controlled documents using a folder-based structure, where files are manually moved between Draft, Approved, Published and Archived. This approach may work on a small scale, but as requirements for traceability, version control and formal approvals increase, it quickly becomes time-consuming and risk-prone.
Paper-Based and Folder-Based Document Management
In paper-based or folder-based document management, a document’s status is often determined by which folder the file is stored in, rather than by the document’s actual lifecycle status. This frequently leads to poor document control, where users edit documents that are already released, or where archived documents remain accessible as if they were current versions.
The problem is further amplified when multiple copies of the same document are distributed across systems such as SharePoint, Google Drive, Dropbox or OneDrive. This makes version control more difficult, increases the risk of errors, and significantly complicates traceability during audits.
As a result, document management becomes heavily dependent on administrative discipline and manual routines, rather than on controlled, traceable and regulatorily compliant processes.
Typical Steps in a Folder-Based Document Structure
In a folder-based structure, documents are managed through manual status steps, where files are moved between different folders depending on where they are in the process:
- Draft – documents are created and updated, often with multiple parallel copies and no centralized version control.
- Ready for Review – the document is manually moved to a separate folder for review.
- Reviewed – the document is considered reviewed, typically based on comments exchanged via email or external files.
- Ready for Approval – the document is considered ready for formal approval.
- Approved – the document is approved but not yet formally released.
- Pusblished – the document is made available for use by manually moving it to a “current” or “released” folder.
- Archived – previous versions are manually stored in archive folders without automated traceability.
In many organizations, document review and approval are still performed outside the actual document management system.
Review and Approval Outside the Document Management System
In folder-based document management, review and approval often take place outside the storage environment itself, for example via email or electronic signatures using tools such as Adobe Sign or DocuSign.
This means that evidence of review and approval — such as comments, decisions and signatures — is spread across separate threads and attachments, making follow-up, audits and regulatory compliance more difficult.
Digital Document Management in MedQdoc
Draft → Review → Approval → Pubslihed → Archived
MedQdoc is a digital document management system and eQMS designed for controlled document management in regulated environments. The entire document lifecycle is handled within a single, structured workflow – from creation and review to approval, release and archiving – with built-in traceability, version control and access management.
How the Document Workflow Works in MedQdoc
In MedQdoc, document status is governed by system-supported processes, not by manual file movement between folders. Each step in the document workflow is clearly defined, traceable and linked to specific roles and responsibilities.
- Draft – documents are created and edited with full version control.
- Review – review is performed directly within the system with traceable comments and document history.
- Approval – formal approval is carried out in a controlled manner with a clear audit trail (who, what and when).
- Pubslished – only approved versions become effective and available for use within the organization.
- Archived – previous versions are archived in a structured way and kept separate from current documents.
- Deleted – controlled deletion, where permitted, with access control and full traceability.
This represents a common and well-established document lifecycle in modern document management systems and eQMS platforms.
Why Digital Document Control Is Critical for Quality and Regulatory Compliance
Regulations and standards such as ISO 13485 and the EU MDR impose strict requirements on organizations to demonstrate control over documents, versions, reviews, approvals and availability. With digital document control in MedQdoc, it becomes significantly easier to ensure that the correct version is used and that all decisions can be reviewed and traced afterwards.
For medical device organizations, this not only results in better structure, but also in more efficient processes and reduced administrative burden.
- Reduced risk of incorrect or outdated document versions being used in operations.
- Clear audit trails and easier preparation for internal and external audits.
- Reduced administration through automated document workflows and status management.
Document control is a core element of a compliant ISO 13485 QMS implementation and should be established early in the process.
As regulatory requirements for medical device companies continue to increase — including MDR, IVDR, ISO 13485, QSR and MDSAP — paper-based or folder-oriented document management is no longer sufficient. Manually handling documents across stages such as draft, ready for review, ready for release, released and archived creates ambiguity and significantly increases the risk of errors.
Key Benefits of MedQdoc
Controlled document lifecycle
from draft to archiving, ensuring that only
approved and valid documents are used.
Built-in version control
with full traceability provides clear
audit trails for changes
and approvals.
Integrated review and approval
performed directly within the system,
without external tools or
manual document handling.
Automated document workflows
reduce administrative effort,
streamline processes and
minimize the risk of errors.
Regulatory-ready document control
supports compliance with
ISO 13485, IVDR, MDR, QSR
and 21 CFR Part 11.
Document template library
that simplifies and streamlines
the creation and management of
controlled and regulatory documentation.
Introduction Video
Want to learn how MedQdoc works in practice? Watch our introduction video below.
Related
Downloads
Regulatory references
Frequently Asked Questions About Document Management and MedQdoc
1. Is an EQMS mandatory under MDR, IVDR, MDSAP, QSR or ISO 13485?
An eQMS is not always explicitly mandated by law. However, both ISO 13485 and the EU MDR require controlled document management, including version control, traceability, formal reviews and approvals, and ensuring that only approved documents are in use. An eQMS such as MedQdoc makes it significantly easier to meet these requirements in a structured and auditable way.
2. Why is a folder-based solution such as SharePoint or Google Drive not sufficient for document control?
In folder-based document management, a document’s status is often determined by which folder it is stored in, rather than by its actual lifecycle status. This commonly results in released documents being edited, archived documents remaining accessible, and multiple versions of the same document circulating within the organization.
3.How does review and approval in MedQdoc differ from email-based or external signing tools?
When review and approval are handled via email or external signing tools, comments, decisions and signatures are stored outside the document context. In MedQdoc, review and approval are performed directly within the system, with defined roles, traceable comments and a complete audit trail.
4.What do version control and traceability mean in practice?
Version control ensures that it is always clear which document version is current, what has changed and who made the change. Traceability means that the full document history can be followed — from draft, through review and approval, to release and archiving.
5.What are the key benefits of digital document management in MedQdoc?
MedQdoc replaces manual, folder-based routines with a system-driven document workflow and provides:
- A controlled document lifecycle from draft to archive.
- Built-in version control with full traceability.
- Integrated review and approval within the system.
- Automated document workflows that reduce administrative effort.
- Support for compliance with ISO 13485, MDR and other regulatory requirements.
MedQdoc is used across the medical device industry
