Last Updated on September 25, 2025 by Melissa Lazaro

Creating Your ISO/IEC 17043:2023 Quality Manual

Let’s face it—writing a quality manual isn’t anyone’s favorite task. But when you’re working toward or maintaining ISO/IEC 17043:2023 accreditation, it’s one of the most important tools you can have.

Even though the 2023 version doesn’t require a formal quality manual, most accreditation bodies and assessors still expect to see one. And more importantly—your team needs one.

In my experience working with PT providers, the best-run operations all had one thing in common: a quality manual that actually reflected how their system worked. Not a bloated, copy-pasted document—but a lean, clear, structured guide that tied everything together.

In this guide, I’ll show you exactly how to create a practical, compliant quality manual under ISO/IEC 17043:2023—and how to make it useful, not just audit bait.

What Is the Purpose of a Quality Manual Under ISO/IEC 17043:2023?

At its core, the quality manual explains:

• What your organization does
• How you meet the standard’s requirements
• Where to find the procedures and documents that support your QMS

With the 2023 update, ISO/IEC 17043 now follows the Annex SL structure, which aligns it with other modern ISO standards like ISO/IEC 17025 and ISO 9001. That makes your manual easier to organize and cross-reference—but also more essential.

Even though ISO/IEC 17043:2023 doesn’t mandate a manual, most PT providers still rely on it as:

• A summary of the management system
• A training and onboarding tool
• A way to show assessors your system at a glance

What Should Be Included in the Quality Manual?

Here’s what I recommend including—based on what assessors look for and what works well in practice:

1. Quality Policy and Objectives

• Show leadership’s commitment to impartiality, quality, and continual improvement (Clause 5 & 8)

2. Scope of Activities

• Define the schemes, services, and locations covered under your QMS

3. Organizational Structure

• Describe reporting relationships, roles, and responsibilities (Clause 5.3)

4. Management System Overview

• Summarize how you meet requirements in Clauses 4 through 10
• Include how documents are controlled, how audits are conducted, how complaints are handled

5. Risk-Based Thinking

• Brief overview of how your organization identifies, assesses, and manages risks (Clause 9)

6. Impartiality and Confidentiality

• State how conflicts of interest are avoided and participant data is protected (Clause 4)

7. Documented References

• Point to detailed procedures, forms, and work instructions—not full content, just references

This structure helps staff understand the system and gives assessors a roadmap to follow.

How to Structure the Manual for Clarity and Compliance

You have two options:

Option 1: Clause-Based Manual

• Organize sections based on ISO/IEC 17043:2023 clauses (4 through 10)
• This is great for cross-referencing and preparing for audits

Option 2: Process-Based Manual

• Organize around how your organization actually works (e.g., planning, operation, reporting, improvement)
• Easier for staff to relate to—but you’ll need a cross-reference matrix to show clause coverage

Whichever approach you use, be sure to:

• Include a revision history and approval page
• Clearly state which procedures are referenced and where to find them
• Use document control (version numbers, page headers, issue dates)

Creating a Clause Crosswalk or Matrix

This is where many providers gain bonus points with assessors.

Why use a crosswalk?

• It helps internal auditors and staff see how your manual aligns with ISO/IEC 17043:2023
• Assessors can quickly verify that all clauses are addressed
• It becomes a living checklist for updates as your system evolves

Example layout:

ISO Clause	Manual Section	Supporting Documents
6. Resources	Section 4	HR Policy, Competence Procedure
7. Process	Section 5	Scheme Procedure, Data Eval SOP

Integrating the Manual into Daily Use

Here’s the difference between a helpful quality manual and one that just collects dust: accessibility.

• Train your staff on how to use the manual—not just that it exists
• Store it in your document control system or quality drive
• Use it during management reviews, internal audits, and staff training

Example: One PT provider I worked with added a “Staff Reference” section in the back of their manual with FAQs, clause summaries, and examples. It became a go-to resource for new hires and audit prep.

Pro Tips

• Pro Tip: Don’t rewrite procedures in the manual. Reference them. This keeps the manual short and easier to maintain.
• Pro Tip: Use visual elements like process maps or flowcharts for complex sections, especially around PT operation and data handling.
• Pro Tip: Keep the language simple and realistic—describe what you actually do, not just what the standard says.
• Pro Tip: Set a recurring calendar reminder to review and update the manual—at least annually or after significant changes.

Common Mistakes to Avoid

Mistake #1: Copying a template without customization

Assessors can tell when you don’t understand your own manual. Customize everything.

Mistake #2: Making the manual too long

Avoid redundancy. Use links or references instead of repeating entire procedures.

Mistake #3: Failing to update after changes

If your internal audit or document control process changes, the manual should reflect that.

Mistake #4: Leaving out risk, impartiality, or improvement sections

These are core elements of the 2023 standard—omitting them creates major gaps.

FAQs

Q: Do we have to keep a quality manual under ISO/IEC 17043:2023?
No, it’s not strictly required. But it’s highly recommended—especially to show how your system aligns with the standard.

Q: Can I use my ISO/IEC 17025 manual as a base?
Yes, especially with the Annex SL structure. But be careful to address the PT-specific clauses in 17043, especially around scheme design and evaluation.

Q: Should the quality manual include technical procedures?
No. Reference them by title and document number, but keep them in your controlled document library.

Make It Useful, Not Just Compliant

A well-written quality manual should help you run your PT system—not just impress auditors.

The best manuals I’ve seen aren’t flashy. They’re clear, practical, and actually used by the team. They’re part of onboarding, part of audits, and part of decision-making.

If you’d like a starter template or clause-mapping worksheet to help draft your ISO/IEC 17043:2023 manual, I’m happy to send it over. Let me know what format works best—Word, Excel, or Google Docs.