Migrating Existing Documentation to Meet ISO/IEC 17043:2023
Last Updated on September 25, 2025 by Melissa Lazaro
Migrating Existing Documentation to Meet ISO/IEC 17043:2023
If you’re running a proficiency testing (PT) program, you probably already have a full set of procedures, policies, and forms in place. But with the transition to ISO/IEC 17043:2023, it’s not just about tweaking a few clause numbers.
In my experience helping PT providers update their systems, the migration process tends to go one of two ways:
- A chaotic rewrite that confuses the team, duplicates documents, and leads to nonconformities.
- A smart, strategic update that aligns what already works with the new structure—saving time, effort, and headaches.
Let’s focus on doing it the smart way.
This article walks you through a clear, clause-aligned approach to updating your existing documentation for ISO/IEC 17043:2023, so you don’t have to start from scratch or get stuck in compliance limbo.
What’s Changed in ISO/IEC 17043:2023
First things first—what’s new, and why does it matter for your documentation?
- Clause Structure Overhaul: The 2023 version adopts the Annex SL structure, meaning all management system standards now share a common layout. So your old 2010-based clause numbers won’t map directly anymore.
- Terminology Shift: Terms like “documented procedures” and “records” have been replaced by “documented information.” It’s a broader term, but it still requires clear control.
- Process Approach & Risk-Based Thinking: The new standard asks you to show how processes link together and how risks are identified and managed. This needs to be reflected in your procedures and forms.
So while the technical essence of your PT scheme may not change, your documentation needs to speak the new language—and follow the new flow.
Take Inventory of What You Already Have
Start by laying all your cards on the table.
Step 1: List Every Document
Pull together:
- Your Quality Manual
- All standard operating procedures (SOPs)
- Policies, work instructions, logs
- Forms, checklists, templates
- External references (e.g., subcontractor forms)
Step 2: Note Their Purpose and Clause Alignment
For each document, ask:
- Which clause(s) of ISO/IEC 17043:2010 did it support?
- Is the process still valid?
- Has the content already shifted naturally (e.g., due to internal improvements)?
This will help you assess what’s usable, what’s outdated, and what’s missing.
Build a Clause-to-Document Mapping Table
Now comes the fun part: mapping your current documents to the new 2023 clauses.
Create a simple matrix:
ISO/IEC 17043:2023 Clause | Document Title | Current Status | Action Needed |
---|---|---|---|
4.1 – General Requirements | Quality Manual, Policy on Impartiality | Current | Minor edits |
7.5 – Evaluation of Performance | Statistical Analysis SOP, Report Templates | Outdated | Full review |
8.9 – Management Review | Management Review Procedure | Current | Update references |
Color-code it if needed:
- Green – Still valid, needs minimal edits
- Yellow – Requires some content or format updates
- Red – Missing or significantly outdated
This visual overview will guide your entire update strategy.
Update the Language and Structure
Now that you know what to work on, update the wording, references, and formatting.
Here’s how:
- Replace phrases like “procedure required by ISO/IEC 17043:2010” with “documented information supporting clause 7.5”
- Align section headers with the new clause structure
- Update roles/responsibilities if your org chart changed
- Include inputs and outputs where applicable—this supports the process approach
And remember: keep it simple. Don’t add complexity just for the sake of “modernization.”
Integrate Risk-Based Thinking
This is one of the most significant mindset shifts in ISO/IEC 17043:2023. Your documentation should show how you:
- Identify risks (e.g., missed PT deadlines, unstable samples)
- Evaluate their impact
- Plan actions to address or monitor them
Add a “risk and opportunity” section to your procedures or link them to a centralized risk register.
Example: Your complaints handling procedure could include a step to assess whether the complaint indicates a systemic risk (e.g., recurring issues with a subcontractor).
Don’t Forget Review, Approval, and Training
Updated documents aren’t official until they’re approved and deployed.
Make sure to:
- Use version control and document change history
- Get sign-offs from relevant process owners
- Notify staff of updates—and train them where needed
- Archive the old versions properly (with “obsolete” marked clearly)
Auditors will want to see the full document lifecycle, not just the new version.
Pro Tips
- Pro Tip: Don’t start over—revise what works. Focus on aligning language and structure, not reinventing the wheel.
- Pro Tip: Maintain a “Document Migration Tracker” with update dates, responsible staff, and version history.
- Pro Tip: Assign document ownership by clause or process to spread the workload across your team.
- Pro Tip: Use document collaboration tools (like Google Drive, SharePoint, or a QMS platform) with built-in version control.
Common Mistakes to Avoid
Mistake #1: Just Changing Clause Numbers
Some teams only update the references and call it done. But you need to actually reflect the process approach, risk management, and terminology changes.
Mistake #2: Forgetting About Linked Forms
If you update a procedure but forget to revise the linked checklist or form, you’ll create inconsistencies—guaranteed to raise flags in audits.
Mistake #3: Overcomplicating
Not every clause needs its own 5-page procedure. Keep documentation lean, functional, and easy for staff to follow.
Mistake #4: No Traceability
If you can’t show what changed and why, auditors may question the validity of your updates. Keep change logs!
FAQs
Q: Do we need a new Quality Manual?
Not necessarily. You can revise your current one—but make sure it aligns with the new clause structure and reflects your actual practices.
Q: Can we combine procedures to streamline documentation?
Yes, especially for related areas like internal audits, management reviews, and improvement actions. Just ensure clarity and traceability remain.
Q: Do we need to re-train staff on every updated document?
Only if the updates affect their responsibilities or introduce new processes. But do notify everyone of the updates and where to find the new versions.
Update What Matters, Keep What Works
Transitioning your documentation to ISO/IEC 17043:2023 doesn’t mean starting over. It means evolving your system to reflect current expectations—while keeping it usable and meaningful for your team.
Labs I’ve worked with that took this structured, intentional approach not only passed their transition audits—they actually improved their internal processes along the way.
Want help getting started? I’ve got a clause-to-document mapping table template and a document migration checklist ready to go. Just let me know, and I’ll send it over.
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.