Last Updated on October 29, 2025 by Melissa Lazaro

Why Document Control Under ISO/IEC 17021-1 Matters More Than Ever

Every certification body runs on documents — procedures, templates, audit forms, decision records, and more. When those documents aren’t properly controlled, things fall apart fast: outdated versions circulate, forms go missing, and assessors lose confidence in your system.

That’s exactly why document control sits at the heart of ISO/IEC 17021-1 Clause 10.

In my experience helping certification bodies move from manual systems to digital ones, I’ve seen this transformation make life easier for everyone — auditors, reviewers, decision-makers, and even clients. With the right setup, you can stop chasing files and start managing your certification system like a true quality engine.

In this article, we’ll look at how to design, implement, and maintain an electronic document-control system that meets ISO/IEC 17021-1 requirements — and keeps your accreditation assessor impressed, not frustrated.

ISO/IEC 17021-1 Requirements for Document and Record Control (Clause 10 Overview)

Clause 10 of ISO/IEC 17021-1 outlines what your management system must include to remain effective and auditable. That includes controlling documents (your live, operational instructions) and records (the evidence that you followed them).

Here’s what the standard expects you to demonstrate:

• Every document is approved before release.
• Revisions are tracked and identifiable.
• Only current versions are available to staff.
• Obsolete versions are removed or clearly marked.
• Records are protected and retrievable when needed.

Pro Tip: Think of document control as your CB’s memory system. Without it, you can’t prove what was approved, who did what, or when something changed.

Common pitfall: Uploading procedures to shared drives with no metadata. Assessors can’t tell which version is valid or who approved it — that’s a finding waiting to happen.

Example:
One certification body built a central SharePoint library where every controlled document was linked to its approval workflow. When their assessor checked version control, every file showed who approved it, when, and under what revision. That’s exactly what accreditation bodies want to see.

Transitioning from Manual to Electronic Document Control

Moving from paper files or random folders to an electronic system sounds simple, but it can get messy fast without structure.

Here’s the practical sequence I use with clients:

1. Map your current documents. Know what you have before you migrate.
2. Define clear folder or library structures. Match your QMS hierarchy — Policies, Procedures, Forms, Records.
3. Assign ownership. Each document needs a named “owner” responsible for keeping it current.
4. Digitize approvals. Use built-in e-signature or workflow functions.
5. Train your users. Even the best system fails if people don’t know how to use it.

Pro Tip: Don’t migrate every old version. Keep the last approved one, archive the rest, and clean as you go.

Common pitfall: Uploading 10 years of uncontrolled files — you’ll spend more time fixing chaos than improving control.

Example:
One CB phased its migration by clause. They started with Clauses 6–8 (structure, competence, information), then moved to Clause 9 (process). Each week, they validated old documents, renamed them with controlled codes, and published the approved versions. Their next accreditation audit? Zero findings in document control.

Core Features of a Compliant Electronic Document-Control System

A good electronic document-control system doesn’t just store files — it manages them. It should make compliance easier, not harder.

Here’s what your system should include:

• Role-based access (different permissions for auditors, reviewers, decision-makers)
• Automatic version numbering and revision history
• Searchable library by document type or clause
• Approval workflow and electronic signatures
• Obsolete version archiving
• Backup and disaster recovery protocols
• Integration with audit records and certification decisions

Pro Tip: If your assessor can log in and instantly see the approved version, your system is working.

Common pitfall: Using basic file-sharing tools like Dropbox or Google Drive without version control enabled. They’re fine for collaboration, but not for accredited document management.

Example:
A CB using SharePoint activated version tracking and limited editing rights to the QMS coordinator. Every time someone updated a procedure, the system automatically generated a revision log and routed it for approval — no manual tracking, no guesswork.

Defining Roles, Responsibilities, and Access Rights

The biggest strength of an electronic system is that it can control who sees and edits what — but only if you set it up right.

Here’s a clear structure that works for most CBs:

• Document Owner: Maintains accuracy and initiates revisions.
• Approver: Reviews and authorizes updates before release.
• System Administrator: Manages access, backups, and version settings.
• User: Accesses only current, approved versions for daily use.

Pro Tip: Limit edit rights to just a few trained personnel. Everyone else should have “read-only” access.

Common pitfall: Letting everyone upload or rename documents. One wrong file saved over an approved procedure can trigger a major non-conformity.

Example:
A CB restricted editing rights to two QMS coordinators. Everyone else could comment but not publish changes. Result: 80% fewer version-control errors and faster approvals.

Ensuring Data Integrity and Security in Electronic Systems

Document control doesn’t stop at approvals — you also need to protect data from unauthorized access or loss. ISO/IEC 17021-1 connects this with Clause 8 (Information Requirements) on confidentiality.

Your electronic system should include:

• Password protection and user authentication
• Encrypted backups (preferably daily)
• Access logging (who viewed or edited what)
• Document retention rules
• Controlled deletion and archiving policies

Pro Tip: Include IT-security controls in your management-system procedure. When assessors ask, you can show that both physical and digital security are covered.

Common pitfall: Forgetting to back up decision records or audit reports. Losing those is not just inconvenient — it’s a compliance failure.

Example:
One CB created a “Records Backup Log” that tracked daily backups and retention periods. When their accreditation body checked Clause 10 compliance, they passed with commendation.

Common Non-Conformities in Electronic Document Control (and How to Avoid Them)

Over the years, I’ve seen the same findings appear again and again during accreditation audits. Here are the big ones:

1. Procedures missing approval signatures or version history.
2. Staff using outdated forms found in email attachments.
3. No control over obsolete files in shared drives.
4. Lack of backup or disaster recovery plan.
5. Users unaware of document control rules.

Pro Tip: Run an internal audit focused solely on document control. Randomly pick 10 files and check for approval date, revision number, and accessibility.

Example:
A CB’s internal audit revealed that staff were still using pre-approval versions of the audit report form. They fixed it by creating a “forms-only” portal where all current templates lived. Problem solved before the next accreditation audit.

Example: ISO/IEC 17021-1 Electronic Document-Control Template

Here’s a simple document register you can adapt:

Document Code	Title	Version	Author	Approver	Issue Date	Next Review	Status	Storage Location	Access Level

Pro Tip: Include auto-generated “last updated” timestamps and review reminders. Assessors see those as strong signs of active control.

Example:
One CB used a live dashboard where each document card showed version, owner, and next review date. Staff could filter by clause or document type — it made accreditation prep effortless.

FAQs – ISO/IEC 17021-1 and Electronic Document Control

Q1: Can we use cloud-based platforms like Google Drive or OneDrive?
Yes — as long as they’re access-controlled, backed up, and include traceable version history. Assessors don’t mind cloud systems; they mind uncontrolled ones.

Q2: Do we still need to print anything?
No. Digital-only systems are fully acceptable if you can demonstrate control, traceability, and accessibility during audits.

Q3: How often should documents be reviewed?
At least once a year — or whenever there’s a change in standards, scope, or structure. A scheduled review shows your system is proactive, not reactive.

Turning Digital Document Control into a Compliance Advantage

A well-built electronic document-control system does far more than help you pass accreditation. It keeps your certification body consistent, efficient, and audit-ready at all times.

In my experience, once CBs move to controlled digital systems, their internal audits get cleaner, and their assessors spend less time chasing files and more time validating competence.

If you’re ready to modernize your system, you can:

• Download QSE Academy’s ISO/IEC 17021-1 Electronic Document-Control Template Pack, or
• Book a consultation to design a fully digital, accreditation-ready document management system for your CB.

Because the goal isn’t just compliance — it’s control that actually works in real life.