Last Updated on September 25, 2025 by Melissa Lazaro

ISO/IEC 17043:2023 Management System Requirements (Clause 8) – Option A vs. B

Let’s be honest—Clause 8 of ISO/IEC 17043:2023 tends to make people pause. You’re reading along about technical competence, scheme planning, statistical evaluations… and then suddenly you’re asked to pick between Option A and Option B for your management system.

What does that even mean? And more importantly, which one should you choose?

If you’ve ever found yourself asking that, you’re not alone. I’ve worked with proficiency testing (PT) providers of all shapes and sizes, and this is one of the most common points of confusion. The good news? It’s not as complex as it seems.

Whether you’re a small PT provider just starting out or a larger organization already certified to ISO 9001, Clause 8 gives you a way to build a quality management system that fits. This article will help you figure out which path—A or B—is right for you.

What Clause 8 Is Really Asking For

Before we get into the differences, it’s important to understand why Clause 8 exists. At its core, it’s all about building a reliable, consistent, and continually improving quality system around your PT activities.

Think of Clause 8 as the foundation that keeps your technical work stable. You can have great sample prep, clever statistics, and fancy reports, but if your internal processes aren’t documented, reviewed, and improved over time—things start to unravel.

Clause 8 gives you two choices for how to meet the standard’s quality management expectations:

• Option A: Follow the requirements outlined directly in Clause 8.
• Option B: Use an existing ISO 9001–style quality management system.

Both are valid. Neither is “better.” The key is choosing the one that fits how your organization already works.

Option A – Structured Flexibility Without ISO 9001

Option A is a great fit for PT providers who aren’t already certified to ISO 9001. It allows you to build a management system based on what ISO/IEC 17043 spells out directly—no need to bring in another standard.

But let’s clear something up: Option A doesn’t mean “less work.” You still need to show you’ve got:

• A quality policy and clear objectives
• Document control and version tracking
• Risk-based thinking embedded into your planning
• Internal audits (yes, even if it’s a small team)
• Management reviews
• Corrective actions and improvement mechanisms

What makes Option A appealing is the freedom to organize your system in a way that suits your workflow. You’re not boxed into ISO 9001 terminology or structure—you just need to demonstrate that you’re managing your operations, risks, and improvements effectively.

When Option A Makes Sense:

• You’re a smaller PT provider or start-up
• You want a lean, customized management system
• You’re not currently using ISO 9001 and don’t plan to
• You prefer simplicity over structure—as long as it still meets the intent

Option B – Leverage Your Existing ISO 9001 System

Option B is perfect for organizations that already have a quality management system based on ISO 9001:2015. If that’s you, great news: you don’t need to create something new. ISO/IEC 17043 recognizes that ISO 9001 already covers the essentials—so if you’re doing that well, you’re halfway there.

That said, Option B doesn’t let you skip the PT-specific stuff. You’ll still need to show that your ISO 9001–based system covers all the unique needs of proficiency testing—like impartiality, result evaluation, and scheme-specific risk handling.

When Option B Makes Sense:

• Your organization is already ISO 9001 certified
• You’re part of a larger testing or calibration lab
• You want to integrate PT operations into your central QMS
• You’re comfortable with structured documentation and process audits

Option B helps streamline oversight and aligns everything under one system—which is a huge time saver during external assessments.

Option A vs. Option B – Quick Comparison

Sometimes it helps to see things side by side. Here’s a simple breakdown of how the two options compare:

Aspect	Option A	Option B
Based on ISO 9001?	No	Yes
Flexibility	High – design your own structure	Lower – must follow ISO 9001 framework
Best for…	Smaller or standalone PT providers	Larger orgs with ISO 9001 already in place
Certification needed?	No	ISO 9001 certification helps but not required
Audit approach	Focused on Clause 8 elements directly	Checks that ISO 9001 covers all needs
Documentation expectations	Tailored to your PT context	Aligns with ISO 9001 system structure

Pro Tips for Making the Right Choice (and Getting It Right)

Pro Tip 1: Match your system to your reality.
If you’re a small team running a few schemes per year, Option A gives you enough structure without overwhelming you. You can build procedures that mirror your actual workflow, rather than fitting into ISO 9001’s mold. Just don’t mistake “flexible” for “optional.” You’ll still need evidence for everything—auditors expect to see it.

Pro Tip 2: Don’t duplicate systems.
If your PT activities are part of a larger organization that already uses ISO 9001—go with Option B. It saves time, aligns everything under one roof, and avoids the risk of conflicting systems. Just make sure your PT processes are visible and integrated into the existing QMS.

Pro Tip 3: Keep it practical, not perfect.
Whether you choose A or B, avoid writing documents just for the sake of it. Focus on clarity, usability, and reflecting what actually happens. A slim, clear procedure that staff follow is far more powerful than a beautifully formatted SOP that no one uses.

Pro Tip 4: Review your choice periodically.
Your organization might start with Option A and later move to Option B as you grow or get certified to ISO 9001. That’s perfectly fine. The key is to make sure the system you’re using supports your operations, not the other way around.

Common Mistakes to Avoid

• Choosing Option A and then forgetting to implement internal audits or management reviews
• Saying you’re using Option B but having no trace of ISO 9001 structure or records
• Creating excessive documentation for Option A, trying to mimic ISO 9001
• Not training staff on which option you’re using and what it means
• Treating Clause 8 as “less important” than technical clauses—it’s not

FAQs – Quick Clarifications

Do I need ISO 9001 certification to use Option B?
Nope. You just need to follow a system that meets ISO 9001 principles. But if you are certified, that’s a big plus.

Can I switch from Option A to Option B later?
Absolutely. Many organizations start with Option A and switch once they mature or align with ISO 9001. It’s allowed—as long as your system stays compliant.

Is Option A easier than Option B?
Not necessarily. It’s more flexible, but you still need to fully implement and document everything Clause 8 requires.

Will accreditation bodies accept both options?
Yes. Both Option A and B are fully accepted under ISO/IEC 17043:2023. What matters is how well you implement your chosen path.

Choose the Option That Supports You Best

ISO/IEC 17043:2023 doesn’t give you two options to confuse you—it gives you a choice to fit your context. Whether you’re running a lean operation from scratch or working within a robust ISO 9001 system, you can meet Clause 8 confidently.

The real key is intentionality. Don’t choose Option A just because it sounds easier. Don’t default to Option B without understanding what that structure requires. Choose the one that reflects how your organization really works—and build a system that helps your team succeed, not just pass an audit.

If you’re still unsure, start by reviewing what’s already in place. Are you closer to ISO 9001, or do you need more flexibility? Either way, you’ve got a valid path forward.

Need help implementing Option A or integrating your PT work into Option B? I’ve helped dozens of PT providers build smart, efficient systems—and I’d be happy to walk you through it.