Last Updated on September 25, 2025 by Melissa Lazaro

Preparing Objective Evidence for ISO/IEC 17043:2023 Audits

If you’ve ever walked into an ISO/IEC 17043 audit thinking, “We’ve done everything, we just don’t know how to show it,” you’re not alone.

In my years supporting PT providers through audits and transitions, I’ve seen this time and time again. Labs are doing good work. They’re technically sound. Their PT schemes run smoothly. But when the assessor asks, “Can you show me the record of that?” the answer is either a blank stare or a frantic document hunt.

The truth? Good systems aren’t enough—you need solid, accessible, clause-aligned objective evidence.

And that’s what this article is all about. I’ll walk you through what objective evidence actually means under ISO/IEC 17043:2023, what records you need to show, and how to organize them so your next audit feels more like a conversation than an interrogation.

What Is Objective Evidence, Really?

It’s not just paper—it’s proof

ISO defines objective evidence as “data supporting the existence or verity of something.” That could be documents, records, direct observations, or even digital logs. In the context of ISO/IEC 17043:2023, it means anything that:

• Confirms you’ve implemented what the standard requires
• Shows how you did it
• And can be reviewed, verified, and traced

Verbal explanations won’t cut it.
Assessors need to see records that are dated, controlled, and linked to your QMS. It’s not about how well you talk—it’s about what you can show.

How to Identify What Evidence You Actually Need

Start by reviewing the clauses of ISO/IEC 17043:2023 alongside your current processes. Then create a “Clause-to-Evidence Map” that aligns each requirement with at least one record or document.

Here’s an example layout:

Clause	Requirement	Objective Evidence
4.2	Impartiality	Signed declaration, risk log
6.2	Personnel competence	Training matrix, qualifications, evaluation reports
7.5.1	Homogeneity testing	Raw data, ANOVA printout, test report
7.9.2	Participant instructions	Finalized instructions, email logs
8.5.1	Internal audit	Audit plan, completed checklist, summary report
8.7.2	Management review	Meeting minutes, inputs reviewed, action tracker

Pro tip: Keep this matrix as a live document. Update it each time your process changes or when new evidence is generated. It becomes your audit roadmap.

Essential Documents and Records You Should Have Ready

Let’s break it down into categories—because assessors often ask for evidence by function, not just clause number.

1. Policies & Commitments

• Quality policy
• Impartiality statement
• Confidentiality agreements (staff & subcontractors)

2. Personnel & Competence

• Job descriptions
• Training records
• Competency assessments
• Authorizations for scheme design or evaluation

3. PT Scheme Documentation

• Scheme planning forms
• Risk assessments for each round
• Instructions to participants
• Assigned value justification
• Statistical analysis records
• Homogeneity and stability testing results
• Scheme summary reports

4. Quality Management System

• Document control logs
• Internal audit checklists and findings
• Corrective action reports
• Management review records
• Change logs or version control

5. Participant Communication

• Email logs
• Dispatch notifications
• Reminder messages
• Feedback and complaints records
• Survey responses and analysis

How to Organize and Present Your Evidence During an Audit

Here’s the truth: You could have the best QMS in the world, but if your evidence is scattered across folders, emails, and private drives, your audit will feel like chaos.

Here’s how to fix that:

1. Create a “Clause-Based” Folder System

Set up folders (physical or digital) that align directly with the ISO/IEC 17043:2023 sections:

• 4_General_Requirements
• 5_Structure
• 6_Resources
• 7_Processes
• 8_Management_System

Inside each, include documents or links that prove you meet the requirements.

2. Build a Document Index

A single document that maps each clause to your evidence, with file names and storage locations. You’ll thank yourself when an assessor asks, “Where can I see how you control PT item distribution?”

3. Use Version Control and Clear Labels

Make sure each document:

• Has a version number or date
• Shows who approved it
• Matches your document control procedure

Example:
One lab I worked with used a single PDF index with hyperlinks to cloud-based folders for each clause. The assessor finished the audit half a day early—and praised their system.

Tips for Answering Assessor Questions With Confidence

Tip 1: Don’t just talk—show

If they ask, “How do you evaluate PT participant performance?” don’t start explaining formulas. Open your statistical evaluation report. Point to the method, inputs, and results.

Tip 2: Be honest if something is missing

If you don’t have a required record, don’t cover it up. Say so. Then explain:

• Why it’s missing
• What you’re doing to correct it
• When it will be implemented

Assessors care more about system maturity than perfection.

Tip 3: Anticipate common questions

Prepare evidence in advance for high-risk or high-interest areas:

• Statistical methods
• Impartiality and confidentiality controls
• Risk-based decisions
• Corrective actions
• Scheme planning and result evaluation

Pro Tips to Stay Audit-Ready Year-Round

• Maintain a live “Clause-Evidence Tracker” so you’re not scrambling right before the audit.
• Archive internal emails or notes—these can show evidence of decision-making, planning, or communication.
• Convert working documents into records by including a date, initials, and version.
• Run a mock audit two weeks ahead. Don’t rely on memory—use your evidence tracker only.

Remember: In an audit, if you didn’t document it, it didn’t happen.

Common Mistakes That Hurt Audit Performance

Relying too much on verbal explanations

Assessors can’t verify what’s said—they need to see it.

Using outdated templates or policies

If your documents still reference ISO/IEC 17043:2010, that’s a red flag.

Not connecting risks to actions

Risk management isn’t a policy—it’s a set of documented decisions. Show the link.

Waiting until the last minute to organize

Rushing to build an audit binder the week of your audit? That’s how errors sneak in.

FAQs

Q: Can we use digital records instead of printed binders?
Absolutely. Many assessors prefer digital formats now—just make sure the system is well-organized and accessible.

Q: What if a clause doesn’t apply to our lab?
Mark it “Not Applicable” and explain why. Never leave gaps unaddressed.

Q: How much evidence is enough?
Enough to show implementation. Sometimes that’s one strong record. Sometimes it’s two or three supporting files. The key is quality, not volume.

Confidence Comes From Clarity

You don’t need hundreds of pages of documents to pass an ISO/IEC 17043:2023 audit. You need well-chosen, well-organized, and clearly aligned objective evidence that tells the story of how your system works.

The best-prepared labs aren’t perfect—they’re transparent, consistent, and confident in their documentation.

Want a head start?
I’ve created a free ISO/IEC 17043:2023 Evidence Tracker template you can use to map your clauses to records, simplify preparation, and walk into your next audit ready for anything.

Or if you’d like a personalized document review, I’m happy to walk through it with you.

Because proving compliance shouldn’t be harder than achieving it.