Last Updated on December 22, 2025 by Melissa Lazaro

Why Electronic Document Control Matters Under ISO/IEC 17043

Here’s what I see again and again during ISO/IEC 17043 assessments.
The documents exist. The system exists. But control is missing.

Staff are using the wrong version.
Approvals can’t be traced.
And when the assessor asks, “How do you know this is the current procedure?” the answer isn’t clear.

ISO/IEC 17043 doesn’t require fancy software.
It requires confidence that documents are approved, current, accessible, and protected.

In this guide, I’ll show you:

• What ISO/IEC 17043 really expects from an electronic document-control system
• Where PT providers usually get it wrong
• How to demonstrate control without overengineering your setup

Let’s start with the basics.

ISO/IEC 17043 Document-Control Requirements Explained in Plain Language

At its core, ISO/IEC 17043 wants assurance that:

• Documents are approved before use
• Only current versions are available
• Obsolete documents don’t accidentally get used
• Changes are controlled and traceable

That’s it.

The standard doesn’t care how you achieve this.
It cares that you can prove it works.

Pro tip:
If you can’t explain your document-control process in two minutes, it’s probably too complicated.

A common mistake is assuming that storing files online automatically means control.
It doesn’t. Without rules, permissions, and approvals, it’s just digital chaos.

What an ISO/IEC 17043-Compliant Electronic Document-Control System Must Do

An electronic document-control system doesn’t need every feature on the market.
It needs to do a few things well.

At minimum, it must:

• Control who can edit and approve documents
• Track versions and changes
• Prevent use of obsolete documents
• Protect confidential information

That’s the functional core.

Pro tip:
A simple system that everyone follows beats a powerful system no one understands.

I’ve seen PT providers invest in complex platforms, then fail audits because staff bypassed them and used local copies instead.

Assessors notice that immediately.

Managing Procedures, Records, and Forms Electronically for PT Providers

This is where confusion often creeps in.

Procedures, templates, and records are not the same thing—and shouldn’t be controlled the same way.

Your system should clearly distinguish:

• Procedures and policies (controlled documents)
• Blank forms and templates
• Completed records (read-only evidence)

Pro tip:
Once a record is completed, it should never be editable.

A common mistake is storing blank templates and completed records in the same folder.
That makes it hard to prove what was actually used.

Assessors usually test this by asking for a record and tracing it back to the version of the procedure that applied at the time.

Version Control, Change Management, and Document History Tracking

This is one of the fastest ways to gain—or lose—auditor confidence.

ISO/IEC 17043 expects you to show:

• Clear version identification
• Documented approval of changes
• Controlled withdrawal of obsolete versions

Renaming files like “Procedure_v3_FINAL_FINAL” doesn’t count.

Pro tip:
A short change summary helps assessors understand why updates were made.

One common pitfall is editing documents directly without formal review or approval.
That usually leads to findings around uncontrolled changes.

If you change a document, the system should clearly show who approved it and when.

Access Control, Confidentiality, and Data Protection in Electronic Systems

PT providers handle sensitive information.
Participant data. Performance results. Internal evaluations.

Your electronic system must reflect that.

ISO/IEC 17043 expects:

• Role-based access
• Protection of confidential information
• Controls that match responsibilities

Pro tip:
Shared logins are a red flag. Assessors almost always ask about them.

A common issue is granting full access “for convenience.”
That undermines confidentiality and traceability.

I’ve seen audits go smoother simply because access levels were clearly defined and enforced.

Using Off-the-Shelf Software vs Custom Systems for ISO/IEC 17043

This question comes up a lot.
“What software do we need to be compliant?”

Here’s the honest answer.
ISO/IEC 17043 doesn’t approve software. It evaluates implementation.

PT providers successfully use:

• Controlled shared drives
• Cloud platforms like SharePoint or Google Drive
• Integrated QMS tools

Pro tip:
Choose tools your team will actually use—every day.

A common mistake is selecting software based on features rather than usability.
If staff avoid it, control breaks down.

Simple, consistent use wins audits far more often than advanced features.

Demonstrating Effective Electronic Document Control During ISO/IEC 17043 Audits

When assessors review document control, they usually ask for three things:

• The current approved version of a procedure
• Evidence of change history
• Proof that obsolete versions aren’t used

They don’t want a tour of your software.
They want real examples.

Pro tip:
Prepare one or two documents you know well and walk the assessor through them.

A common mistake is showing system capability instead of actual use.
Screenshots don’t replace real records.

Confidence comes from familiarity with your own system.

FAQs – ISO/IEC 17043 Electronic Document-Control Systems

Is an electronic document-control system mandatory?
No. But document control is mandatory, and electronic systems are widely used to meet the requirement.

Can cloud storage be compliant?
Yes—if access, version control, and approvals are properly managed.

Do auditors approve specific software tools?
No. They assess how well your system is implemented and followed.

Conclusion – Building an Electronic Document-Control System That Supports ISO/IEC 17043

Electronic document control isn’t about technology.
It’s about trust.

When documents are current, approved, and easy to access, everything else works better—from training to audits.

From real assessment experience, one thing is clear.
PT providers rarely fail because of missing documents.
They fail because documents aren’t controlled.

Your next step is practical.
Review how your electronic system actually works day to day—and close gaps before an assessor points them out.