Last Updated on December 19, 2025 by Melissa Lazaro

Why an ISO/IEC 17043 Gap Analysis Matters

Here’s what I’ve noticed after working with proficiency-testing providers preparing for ISO/IEC 17043 accreditation.
Most don’t fail because they lack competence. They fail because they don’t know where the gaps are.

A gap analysis isn’t about ticking boxes.
It’s about seeing your operation the way an accreditation assessor will see it.

If you’re planning accreditation, transitioning from an informal system, or preparing for your first assessment, this checklist helps you:

• Spot nonconformities early
• Prioritize what actually matters
• Save time, cost, and audit stress

By the end of this guide, you’ll know exactly how to structure a practical ISO/IEC 17043 gap analysis—and how to avoid the common traps I see every year.

What an ISO/IEC 17043 Gap-Analysis Checklist Actually Covers

This is important because many organizations misunderstand the scope.

An ISO/IEC 17043 gap analysis compares:

• What ISO/IEC 17043 requires
• What you currently do
• What evidence you can actually show

It doesn’t evaluate performance results yet.
It evaluates system readiness.

In my experience, the strongest gap analyses are:

• Clause-by-clause
• Evidence-based
• Honest (no “we plan to do this later” answers)

If it’s not written, implemented, and used, it’s a gap.

Clause 4 Gap Analysis: Impartiality & Confidentiality Requirements

This is where many PT providers underestimate the risk.

What to Check

• Documented impartiality policy
• Identification of risks to impartiality
• Confidentiality agreements for staff, contractors, and experts
• Procedures to protect participant data and results

Pro Tip

Auditors don’t just want a policy. They want proof that you review impartiality risks regularly.

I’ve seen providers fail this clause because they copied a generic policy but never assessed conflicts linked to scheme designers or data analysts.

Common Gap to Watch For

• Confidentiality addressed only in contracts, not procedures
• No documented impartiality risk assessment

Clause 5 Gap Analysis: Organizational Structure & Management Responsibility

This clause tests whether your organization is fit to run PT schemes consistently.

What to Check

• Defined legal status and authority
• Clear organizational chart
• Role descriptions for PT scheme managers, technical staff, and reviewers
• Evidence of management commitment

Pro Tip

If one person wears multiple hats, that’s fine—but document it clearly.

In small organizations, I often help clients map responsibilities rather than creating unnecessary job titles. Auditors appreciate clarity more than complexity.

Common Gap to Watch For

• Responsibilities defined verbally but not documented
• No evidence of management review involvement

Clause 6 Gap Analysis: Resource & Competence Management

This is where competence claims meet reality.

What to Check

• Competence criteria for all roles
• Training records and qualifications
• Technical expertise related to PT items and schemes
• Equipment, software, and facilities suitability

Pro Tip

Competence isn’t just education. It’s demonstrated ability.

I’ve seen assessors ask simple questions like, “How do you know this person is competent?”
If your answer isn’t documented, it’s a gap.

Common Gap to Watch For

• No formal competence evaluation
• Training records without effectiveness checks

Clause 7 Gap Analysis: PT Scheme Design & Operation

This clause carries the most technical weight—and the most audit findings.

What to Check

• Documented PT scheme design procedures
• Statistical design and evaluation methods
• Homogeneity and stability studies (where applicable)
• Instructions to participants
• Handling of PT items

Pro Tip

Don’t over-engineer your documentation.
But don’t leave decisions undocumented either.

I’ve helped clients pass audits simply by explaining why a statistical method was chosen—not just what was used.

Common Gap to Watch For

• Scheme design decisions not justified
• Stability or homogeneity not addressed

Clause 8 Gap Analysis: Management System & Continuous Improvement

This clause ties everything together.

What to Check

• Document control procedures
• Internal audit program
• Corrective action process
• Management review records

Pro Tip

Internal audits don’t need to be perfect. They need to be honest.

I always advise clients:
If your internal audit doesn’t find issues, your accreditation assessor will.

Common Gap to Watch For

• Internal audits done as a formality
• Corrective actions without root-cause analysis

How to Score and Prioritize Gaps Effectively

Here’s what works best in practice:

• Compliant – Implemented and evidenced
• Partially compliant – Implemented but weak or incomplete
• Non-compliant – Not implemented
• Not applicable – Justified and documented

This approach helps you:

• Focus on high-risk gaps first
• Build a realistic action plan
• Avoid last-minute panic before assessment

FAQs About ISO/IEC 17043 Gap-Analysis Checklists

How long does an ISO/IEC 17043 gap analysis take?

For most PT providers, 1–3 days if documentation exists. Longer if systems are informal.

Can we do the gap analysis internally?

Yes, but external reviews often catch blind spots. Internal teams tend to normalize weaknesses.

Should the gap analysis be submitted to the accreditation body?

Usually no. It’s an internal tool—but assessors may ask how you prepared.

Conclusion: Turn Gaps Into an Accreditation Roadmap

A proper ISO/IEC 17043 gap-analysis checklist does more than highlight problems.
It gives you control.

When done right, it:

• Reduces audit surprises
• Clarifies priorities
• Speeds up accreditation readiness

This is exactly how I help PT providers move from uncertainty to confidence—step by step, clause by clause.

Next step:
Use this checklist to build your corrective action plan, or integrate it directly into your ISO/IEC 17043 project plan for a smoother accreditation journey.