Last Updated on September 25, 2025 by Melissa Lazaro

Transitioning Your Lab to ISO/IEC 17043:2023

If you’re a PT provider or quality manager, chances are the release of ISO/IEC 17043:2023 made you pause.
Not because it’s drastically different from the 2010 version — but because you’re wondering:
What exactly do we need to change… and how soon?

I’ve supported many labs through ISO transitions, and here’s what I’ve noticed:
The standard itself isn’t the hardest part. It’s knowing where to start, how deep to go, and how to make sure you’re ready when your assessor shows up.

In this article, I’ll walk you through the full transition process — step by step — with real-world tips and examples that will help you update your system with confidence (and without overwhelm).

Why the 2023 Revision Matters

A more modern, aligned standard

ISO/IEC 17043:2023 brings the standard in line with the modern ISO structure — the same one used in ISO/IEC 17025, ISO 9001, and ISO/IEC 17020. That means:

• Greater clarity around impartiality, confidentiality, and responsibilities
• Stronger focus on risk-based thinking
• More consistency with how other conformity assessment standards are written

It’s not a complete overhaul — but there are meaningful changes that affect your documentation, planning, and evaluation processes.

What prompted the revision?

The 2010 version served the industry well for over a decade. But with evolving expectations for quality, digital systems, and risk management, the revision ensures PT providers stay relevant, aligned, and effective in delivering trustworthy results.

What’s New in ISO/IEC 17043:2023?

Here are the major updates you need to know:

Clearer structure and layout

The 2023 version follows the ISO CASCO template — the same one used in ISO/IEC 17025. If your lab is already familiar with that structure, the transition will feel smoother.

Introduction of risk-based thinking

The revised standard now asks you to identify, evaluate, and manage risks that could impact your PT schemes. You don’t need a complex risk register — even simple justifications are acceptable if they’re documented.

Stronger focus on impartiality and confidentiality

You’re expected to not just declare impartiality, but also show how you ensure it — especially in scheme design, evaluations, and communication.

Improved technical requirements

The 2023 version reinforces the importance of:

• Valid statistical methods
• Homogeneity and stability testing
• Technical competence of personnel
• Scheme evaluation based on objective data

Example:
One PT provider I worked with added a simple risk log and a 1-page impartiality plan to their system. Both documents were well received by assessors — no fancy formatting, just practical, clear explanations.

Your Step-by-Step Transition Plan

Let’s break it down into a manageable action plan.

Step 1: Conduct a Gap Analysis

Compare your current system to each clause of ISO/IEC 17043:2023.

• Highlight what you already comply with
• Identify what’s missing or needs revision
• Use a clause-by-clause matrix to track progress

Pro tip:
One lab used a color-coded Excel sheet (green = compliant, yellow = partial, red = missing) and assigned each red/yellow clause to a team member with a due date. Simple, but highly effective.

Step 2: Update Your Documentation

Update or create:

• Quality Manual or Quality Policy
• Procedures for scheme planning, risk assessment, and data evaluation
• Records showing impartiality and confidentiality
• Revised document control system (with new clause references)

Make sure your documentation uses the 2023 clause numbers — assessors expect this.

Step 3: Retrain Your Team

Everyone involved in planning or running PT schemes should understand the key changes:

• What’s new in the 2023 version
• How it affects their daily work
• What records they’re now responsible for

Even a 1-hour team briefing with slides and attendance records can serve as strong evidence of implementation.

Step 4: Update Scheme Design and Risk Management

For every PT scheme:

• Identify any risks (e.g., delayed shipping, unstable test items, unclear instructions)
• Document how you reduce or monitor those risks
• Add that info to your scheme plan or records

Example:
A clinical PT provider added a short “risk notes” section to each scheme file. Even basic statements like “delayed shipping could affect viability; packaging includes cold packs” helped demonstrate risk awareness.

Step 5: Run an Internal Audit Against the New Version

Don’t wait for your next accreditation visit to find gaps.
Create an audit checklist that matches ISO/IEC 17043:2023 and audit your system internally.

• Check policies, forms, and communications
• Review scheme records against new requirements
• Document findings and corrections

This shows readiness — and gives you a chance to fix any blind spots before your assessor arrives.

What Will Assessors Expect?

Here’s what most assessors will look for during a transition audit:

• Evidence that your documentation aligns with ISO/IEC 17043:2023
• Demonstrated understanding of new clauses (especially risk, impartiality, evaluation)
• Internal audit and management review records reflecting the transition
• Records of training or communication about the changes
• Consistent use of updated clause references in your forms, SOPs, and reports

If you’re unsure, contact your accreditation body—they often offer transition timelines, guidance, or training support.

Timeline Tips: When to Start, What to Prioritize

You don’t need to panic—but you shouldn’t wait.

Recommended timeline:

3 to 6 months from first review to internal audit and assessor readiness

Start with:

• Your Quality Manual
• Scheme planning templates
• Internal audit checklist
• Team training materials

Build into:

• Management review meetings
• Improvement logs
• Risk register or scheme risk summaries

Example:
One PT provider included the transition as a formal item in their management review agenda, and assigned updates as corrective actions. It kept the process structured and traceable.

Pro Tips from the Field

• Use the new clause numbers from day one.
  Don’t confuse assessors by sticking to 2010 references in updated documents.
• Train your internal auditors early.
  Make sure they’re using the correct checklist and understand the new structure.
• Add “risk-based thinking” even in simple terms.
  You don’t need a 10-page risk register—just clear reasoning about why a decision was made.
• Keep a Transition Log.
  Track what was updated, who did it, and when. It makes assessor questions easier to answer.

Common Mistakes to Avoid

• Delaying action until the next external audit
  Transition takes time—don’t leave it to the last minute.
• Only updating the Quality Manual
  If your procedures, templates, and forms still reflect the 2010 version, you’re not compliant.
• Ignoring risk and impartiality documentation
  These are core focus areas in the new version—assessors will dig into them.
• Updating documents but not informing staff
  If no one on your team knows what’s changed, your system won’t reflect real implementation.

FAQs

Do we need to retrain all staff?
Only those involved in PT scheme design, management, or communication. But you do need to show that they understand and are applying the new clauses.

Do we need to change our PT scheme structure?
Not necessarily. But your planning documents must show you’ve considered technical validity, risk, impartiality, and evaluation methods.

How do we show assessors we’ve transitioned?
With updated documents, internal audit reports, training logs, and clear use of the 2023 structure in your records and scheme plans.

Don’t Just Comply—Improve

Transitioning to ISO/IEC 17043:2023 isn’t just a checkbox exercise.
It’s an opportunity to strengthen your PT program, clarify your systems, and build even more trust with your participants and assessors.

And the good news? It’s absolutely manageable if you start now and follow a structured plan.

Need help getting started?
Download our free ISO/IEC 17043:2023 Transition Checklist, or reach out for a personalized walkthrough of your documentation and scheme structure.

You’ve got this—and we’re here to help if you need a hand.