How to Implement ISO/IEC 17043:2023 in Your Lab: A 90-Day Roadmap
Last Updated on September 25, 2025 by Melissa Lazaro
How to Implement ISO/IEC 17043:2023 in Your Lab: A 90-Day Roadmap
Let’s be honest—rolling out ISO/IEC 17043:2023 in your lab probably isn’t at the top of your “fun” list. There’s pressure, deadlines, and uncertainty, especially with a revised version of the standard in your hands. But in my experience working with labs across Asia, the Middle East, and Europe, the ones that succeed share one thing: they follow a structured, realistic plan.
This 90-day roadmap isn’t just a theory. It’s based on real implementation timelines I’ve helped clients deliver—on budget, under pressure, and with successful accreditation outcomes. If you’re looking for clarity on where to begin, what to focus on each week, and how to stay audit-ready, you’re in the right place.
Week 1–2: Start with a Gap Analysis and Action Plan
This phase is all about getting clear. Before you draft a single policy or train your staff, you need to know where your current system stands against the 2023 version.
Steps to take:
- Compare your current system to each clause of ISO/IEC 17043:2023.
- Identify gaps in documentation, process, training, or oversight.
- Assign responsibilities and set internal deadlines.
Example:
A lab in Malaysia color-coded a giant whiteboard with each clause—green for compliant, yellow for partial, red for missing. It gave the whole team instant visibility and sped up weekly alignment.
Pro Tip #1: Don’t skip the clause-by-clause review. One of my clients skipped this and later discovered they missed new documentation requirements for risk-based planning—resulting in last-minute scrambling before their audit.
Week 3–4: Draft or Update Core Documents
With your gaps identified, this is where the real work begins. You’ll build or revise the foundation of your management system.
Focus areas:
- Quality Manual aligned with ISO/IEC 17043:2023 structure
- Document control procedures
- Policies on impartiality, confidentiality, and complaints
- Organizational structure with clear roles
Example:
A European PT provider restructured their Quality Manual using a clause-by-clause template. By integrating visuals like flowcharts and a responsibility matrix, their documentation was not only audit-ready but easier to maintain.
Week 5–6: Validate Technical Resources and Team Competence
Now shift focus from the “paper” system to real-world capability. ISO/IEC 17043:2023 expects you to demonstrate that your lab is technically equipped and your staff are competent.
Checklist:
- Ensure personnel files include job descriptions, qualifications, and training records
- Confirm calibration and maintenance of all PT-related equipment
- Document environmental controls where relevant (e.g., storage or prep areas)
Example:
One lab I worked with had all the equipment—but nothing was calibrated or labeled. Once they established a simple calibration log and tagged their equipment, they passed their audit without issue.
Week 7–8: Refine PT Scheme Design and Introduce Risk-Based Thinking
This is where you zero in on what you actually provide—your PT schemes—and ensure they’re designed, delivered, and evaluated according to the standard.
What to cover:
- Document PT scheme design criteria
- Validate statistical methods for result evaluation
- Identify and document risks at each stage (design, delivery, analysis, reporting)
Example:
A provider in Kenya created a simple risk register in Excel listing each process step, associated risks, and mitigation actions. It wasn’t fancy, but it was complete—and well received by assessors.
Week 9–10: Conduct a Thorough Internal Audit
An internal audit isn’t just about ticking boxes—it’s your chance to find issues before your external auditor does.
How to make it count:
- Create a checklist specific to ISO/IEC 17043:2023 (not reused from ISO 9001 or 17025)
- Include interviews, file reviews, and a walkthrough of one or two actual PT schemes
- Log nonconformities and implement root cause-based corrective actions
Example:
A PT provider in the Philippines audited their most recent scheme and found a documentation gap in how participant feedback was handled. Fixing it led to a more robust management review—and avoided audit trouble.
Week 11–12: Hold a Management Review and Finalize Your Prep
The final stretch. Here’s where you evaluate how everything fits together and ensure you’re ready for submission.
Make sure to:
- Conduct a management review that includes audit results, risk evaluations, PT scheme performance, complaints, and improvement activities
- Finalize and version-control all your documentation
- Reach out to your accreditation body with your readiness documents
Example:
One lab in Jordan included visual summaries of audit results, risk trends, and improvement logs in their management review. The assessor called it “one of the most mature systems” they’d seen that year.
Pro Tips
Start documentation only after completing the gap analysis.
It’s tempting to get straight into drafting, but if you don’t know what’s missing, you’ll likely end up rewriting most of it later.
Use templates, but rewrite them in your lab’s voice.
Accreditation bodies can spot a generic template a mile away. Make sure your documents reflect how your lab actually works.
Train more than one person on each critical process.
It’s not just smart—it shows you’ve considered risk and continuity. Assessors love seeing built-in resilience.
Audit real process flows—not just documents.
Follow a PT scheme from start to finish during your internal audit. It proves your system works in practice.
Track small improvements—and document them.
Whether it’s improved instructions for participants or a faster packaging method, record it. That’s what “continuous improvement” looks like.
Look at published nonconformities from other labs.
Some accreditation bodies publish anonymized findings. These can be gold for spotting issues before they happen to you.
Common Mistakes to Avoid
Skipping or rushing the gap analysis
This is foundational. Without it, you’re working blind—and risk duplicating effort or missing critical updates from the 2023 revision.
Recycling ISO 17025 documents without customization
They may look similar, but the structure, intent, and scope of ISO/IEC 17043 are different. Assessors can tell when you’ve repurposed documents without tailoring them.
Ignoring statistical evaluation requirements
It’s not enough to have a results summary. You must validate and document the statistical basis for performance evaluation.
No evidence of risk-based thinking
A few vague sentences in your Quality Manual won’t cut it. You need a clear, reviewed, and updated risk log or matrix tied to your PT operations.
Overreliance on one person
If everything lives in one person’s head, you’ve got a risk. Build redundancy and document knowledge across roles.
Minimal or generic management reviews
This should be a meaningful analysis of how your system performed—not just a list of dates and attendees.
Frequently Asked Questions
Can I implement ISO/IEC 17043 without ISO/IEC 17025?
Yes. You can operate as a PT provider without being ISO/IEC 17025 accredited. But if your PT schemes involve in-house testing or calibration, those activities must comply with ISO/IEC 17025 principles.
What’s different in ISO/IEC 17043:2023?
Key changes include a stronger focus on impartiality, documented risk-based thinking, refined statistical evaluation expectations, and better alignment with other conformity assessment standards like ISO/IEC 17025 and ISO 9001.
How long does accreditation take after submission?
Typically three to six months, depending on your readiness and the accreditation body’s schedule.
Final Thoughts
Getting accredited to ISO/IEC 17043:2023 in 90 days isn’t a dream—it’s doable with structure, clarity, and the right pace. Labs that succeed don’t overcomplicate. They focus on alignment, documentation that reflects actual practices, and a clear implementation rhythm.
You don’t need a massive team or external consultants to make it work. But you do need a clear plan—and the discipline to follow it.
Need a head start? Download our free ISO/IEC 17043:2023 toolkit or schedule a quick strategy session with our team.
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.