If you’ve ever gone through an ISO 17034 audit, you already know how much assessors focus on documentation. Every clause, every record, every approval trail eventually traces back to one question:
“Can you show me the current approved version of that document?”
That’s why document control isn’t a formality — it’s the backbone of your quality system.
In my work helping Reference Material Producers (RMPs) implement ISO 17034, I’ve seen the same pattern: paper folders, scattered spreadsheets, or shared-drive chaos eventually reach their limit. That’s when the move to an electronic document-control system becomes not just convenient, but necessary.
In this article, we’ll cover what ISO 17034 expects, how to translate those requirements into an electronic setup, and how to build a digital system that auditors will immediately trust.
Understanding ISO 17034 Document-Control Requirements
Clause 4.2 of ISO 17034 spells it out clearly — your management-system documentation must be approved, controlled, and accessible.
That means:
Documents are reviewed and approved before issue.
Each has a version or revision status.
Only current versions are available at points of use.
Obsolete documents are removed from circulation but kept for reference.
Records are retained for traceability.
In a paper system, that’s handled through stamps, binders, and sign-off sheets. In a digital world, those same controls need to be built into the software.
Pro Tip: Before choosing any tool, map each requirement to a system feature — approval workflows, version tracking, access control, and archiving.
Pitfall: Simply uploading files to a shared folder and calling it a “system.” Assessors expect clear evidence of review, approval, and version control — not just cloud storage.
Transitioning from Manual to Electronic Document Control
Switching from paper to electronic can feel overwhelming, but it’s actually a structured process. Here’s how I guide clients through it:
Inventory your documents. Identify policies, procedures, forms, and templates that need control.
Assign responsibilities. Define who drafts, reviews, and approves.
Digitize. Convert approved versions into controlled electronic files.
Configure versioning and approval workflows. The system should automatically record who did what and when.
Train staff. Everyone must know where to find documents and what their access rights are.
Pro Tip: Start small. Pilot the system in one department before rolling it out across your organization. You’ll spot permission and process gaps early.
One RMP I worked with reduced document-review turnaround time by 60 percent simply by replacing manual signatures with digital approvals and automated reminders.
Pitfall: Uploading outdated or draft versions during migration. Once those slip in, version confusion spreads quickly.
Core Features of an ISO 17034-Compliant Electronic System
A compliant e-system does more than store files — it manages their lifecycle. Look for these essential features:
Role-based access control. Authors, reviewers, and approvers have defined permissions.
Automatic revision tracking. Every edit is logged with a timestamp and username.
Linked documents. Procedures can reference related forms or records.
Controlled distribution. Users are notified of new releases and must acknowledge receipt.
Audit trails. The system can show who approved, viewed, or changed a file.
Pro Tip: Use a platform that allows exporting controlled, read-only PDFs for audits while protecting the editable master inside the system.
Pitfall: Using basic cloud storage without workflows or audit trails — convenient, but not compliant.
Integration with ISO/IEC 17025 and ISO 9001 Systems
If your organization already operates under ISO/IEC 17025 or ISO 9001, there’s no need to maintain separate document systems. ISO 17034’s requirements align neatly with both.
Here’s how they overlap:
Function
ISO 17034
ISO/IEC 17025
ISO 9001
Integration Tip
Document Control
Clause 4.2
Clause 8.3
Clause 7.5
One unified approval workflow
Record Retention
Clause 6.3
Clause 8.4
Clause 7.5.3
Single retention policy saves audit time
Pro Tip: Tag documents with multiple standard references — for example, “ISO 17034 §4.2 / ISO 17025 §8.3.” It immediately shows integration maturity.
Pitfall: Keeping different versions of the same document for each standard. One system, one source of truth, is always stronger.
Managing Electronic Signatures, Access, and Security
Electronic approvals are acceptable under ISO 17034 — but only if they’re secure and traceable.
Your system should ensure that:
Each user has a unique ID and password.
Approvals are timestamped and irreversible.
You can prove who signed what and when.
Regular backups and disaster-recovery procedures are in place.
Pro Tip: Two-factor authentication for approvers adds an extra layer of trust — many accreditation bodies now recommend it.
Common mistake: Allowing shared logins. If two people use the same credentials, you lose traceability instantly — a serious nonconformity in any audit.
Record Retention and Obsolescence Control
Every controlled document follows a lifecycle: draft → approved → archived → obsolete.
Your electronic system should manage each stage automatically:
Set review intervals (annually or biannually).
Flag documents due for review.
Retain obsolete versions for traceability but restrict their access.
Pro Tip: Automate reminders for document reviews. It prevents expired procedures from being used on the lab floor.
Pitfall: Deleting obsolete files completely. ISO 17034 requires keeping historical versions to prove how your system evolved.
Validation and Audit Readiness
Even the best system must be proven to work. Validation doesn’t have to be complicated — it just means showing that the software performs as intended.
Evidence might include:
User-acceptance testing results
Access-control verification
Backup-and-restore test logs
Change-management records
Pro Tip: Keep a one-page “System Overview” that explains how your e-QMS meets ISO 17034 Clause 4.2. When assessors ask about document control, that summary becomes your quick win.
Pitfall: Relying on verbal explanations. Auditors need documented evidence — screenshots, logs, or validation reports.
FAQs: ISO 17034 Electronic Document-Control Systems
Q1: Can I use Google Drive, SharePoint, or Dropbox for document control? Yes — but only if they’re configured with version control, restricted permissions, and documented approval workflows. Otherwise, they’re just storage spaces.
Q2: Do I need validation for off-the-shelf software? Yes. Even commercial tools need user-validation to confirm they meet your specific ISO 17034 requirements.
Q3: How often should documents be reviewed? At least once a year, or sooner if a process changes. A good system will notify reviewers automatically.
Conclusion: Build a Controlled, Audit-Ready QMS
Moving to an electronic document-control system isn’t just a tech upgrade — it’s a strategic move toward efficiency, transparency, and full ISO 17034 compliance.
With the right setup, approvals become faster, version control becomes foolproof, and audit preparation becomes almost effortless.
At QSE Academy, we’ve helped RMPs implement systems that meet ISO 17034, ISO/IEC 17025, and ISO 9001 requirements — all within one secure platform.
Your next step:
Download the ISO 17034 Electronic Document-Control Template Pack, or
Book a consultation to have your e-QMS configured to match your scope and accreditation needs.
The future of quality management is digital — and a well-controlled electronic system keeps your compliance solid and your audits stress-free.
Melissa Lavaro is a seasoned ISO consultant and an enthusiastic advocate for quality management standards. With a rich experience in conducting audits and providing consultancy services, Melissa specializes in helping organizations implement and adapt to ISO standards. Her passion for quality management is evident in her hands-on approach and deep understanding of the regulatory frameworks. Melissa’s expertise and energetic commitment make her a sought-after consultant, dedicated to elevating organizational compliance and performance through practical, insightful guidance.
