ISO 15189:2022 Gap‑Analysis Checklist
ISO 15189:2022 Gap‑Analysis Checklist
Last Updated on October 17, 2025 by Melissa Lazaro
Why Gap Analysis Is the First Step to ISO 15189 Success
Here’s what I’ve noticed working with medical laboratories: a lot of teams dive straight into writing SOPs and policies the moment they hear “ISO 15189.” They’re excited, they want to show progress—and I get it. But without knowing where they actually stand, they end up rewriting documents, retraining staff, and fixing the same issues twice.
That’s why the gap analysis is always the smart first step. It gives you a clear picture of what’s already working, what needs improvement, and what’s missing entirely. It’s your roadmap for everything that comes next.
In my experience, labs that take the time to perform a proper gap analysis not only save weeks of effort but also walk into audits more confident because they already know their weak spots.
In this guide, I’ll walk you through how to perform your own ISO 15189:2022 gap analysis—from understanding the process to using a checklist you can customize for your lab.
Now that you know why it matters, let’s talk about what a gap analysis really means under ISO 15189:2022.
Understanding What a Gap Analysis Really Means in ISO 15189:2022
A lot of labs think a gap analysis is just a quick checklist exercise—but it’s more than that. It’s a structured self-assessment that tells you how close (or far) your current system is from meeting ISO 15189:2022 requirements.
In simple terms, you’re comparing your “as-is” operations with the “to-be” requirements of the standard. That includes everything from how you manage personnel and equipment to how you handle test results, risks, and continual improvement.
Here’s what I’ve seen make the difference: the best gap analyses look beyond documents. They also assess whether people actually follow what’s written and if processes are producing reliable results.
Pro Tip: Treat your gap analysis as the foundation of your project plan. The insights you uncover here become your action list for implementation.
Common mistake: only reviewing documents without checking if they’re actually practiced. Auditors will always look for evidence that your system works in real life—not just on paper.
Once you understand what it really means, you can move on to how to actually perform a gap analysis step by step.
Step-by-Step: How to Conduct an ISO 15189 Gap Analysis
Conducting a gap analysis might sound complex, but when you break it into simple steps, it becomes a straightforward, practical exercise. Here’s how I guide labs through it:
Step 1: Gather your references.
Start with the ISO 15189:2022 standard, your national regulations, and any accreditation body guidance documents. These are your benchmarks.
Step 2: Review each clause.
Go clause by clause, comparing what your lab currently does versus what the standard requires. Be honest—this isn’t about perfection; it’s about finding the truth.
Step 3: Document evidence.
For every requirement, record what you already have (like SOPs, training records, or calibration logs). If something’s missing, note it clearly.
Step 4: Prioritize your findings.
Not every gap carries the same weight. Label them as high, medium, or low priority. High-priority gaps usually relate to risks, competence, or equipment.
Step 5: Create your action plan.
Assign responsibilities, set deadlines, and define how progress will be tracked. This turns your analysis into a working project plan.
Pro Tip: Use color codes—green for compliant, yellow for partial, red for missing. It gives you a visual snapshot of where you stand.
Real-world example: One medium-sized diagnostic lab I worked with discovered during their gap analysis that 70% of their SOPs didn’t include version control. They fixed it early and avoided a major nonconformity later.
Once you’ve completed your initial assessment, the next step is to make sure you’re checking the right areas—and that’s where your detailed checklist comes in.
Key Areas to Include in Your ISO 15189 Gap-Analysis Checklist
Your checklist is the backbone of your analysis. It keeps the process organized and ensures you don’t miss a single requirement. ISO 15189:2022 covers a lot of ground, but you can make it manageable by grouping items under the main clause categories.
Here’s how I usually structure it when working with clients:
Clause 4 – General Requirements
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Impartiality and confidentiality
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Handling of complaints and feedback
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Ensuring ethical conduct and professional independence
Clause 5 – Structural Requirements
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Clear organizational chart and defined responsibilities
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Documented authority for decision-making
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Contract review and communication processes
Clause 6 – Resource Requirements
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Competence and training of personnel
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Equipment maintenance and calibration records
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Environmental conditions and supplier control
Clause 7 – Process Requirements
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Pre-examination procedures (sample handling, identification)
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Examination procedures and method validation
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Post-examination reporting, data integrity, and result release
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Quality control and participation in proficiency testing
Clause 8 – Management System Requirements
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Document and record control
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Internal audits and management reviews
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Corrective and preventive action systems
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Risk management and continual improvement
Pro Tip: Add a column labeled “Evidence Available.” It forces your team to think about what proof exists—like training logs, calibration certificates, or audit reports. Auditors don’t just want to hear you’re compliant; they want to see it.
Common mistake: Checking “yes” or “no” without verifying evidence. Always back your answers with documentation or observation notes.
Once you’ve mapped these areas, the next step is analyzing and prioritizing the gaps you’ve found.
How to Analyze and Prioritize Gaps
Once you’ve filled in your checklist, the real work begins—turning all that data into a practical action plan. Not every gap deserves the same level of urgency, and learning to prioritize correctly is what keeps your project realistic and efficient.
Here’s how I recommend breaking it down:
1. Group gaps by risk level.
High-risk gaps affect patient safety, result accuracy, or compliance—things like uncalibrated equipment or untrained staff. Medium risks might involve documentation clarity or missing forms. Low risks could be formatting or record retention issues.
2. Focus on impact, not just quantity.
Ten minor documentation issues won’t derail accreditation, but one unaddressed calibration problem might. Fix what matters most first.
3. Assign ownership.
Every gap needs a name beside it. Whether it’s the quality officer, section head, or lab director, someone must be accountable for closing it.
Pro Tip: During follow-up meetings, track progress visually—green for completed, yellow for ongoing, red for pending. It keeps everyone aligned and motivated.
Common mistake: Trying to fix everything at once. It overwhelms staff and dilutes effort. Always start with high-impact areas like competence, equipment control, and internal audits.
Once your priorities are clear, you can transform your findings into a structured Gap-Analysis Template—something that makes tracking progress simple and transparent.
Example ISO 15189 Gap-Analysis Checklist Template
Now it’s time to see what all of this looks like in action. Below is a simple version of an ISO 15189:2022 gap-analysis checklist you can adapt for your laboratory. It’s organized for clarity, showing what’s required, where you stand, and what needs to happen next.
| Clause | Requirement Summary | Current Status | Evidence Available | Action Needed | Priority |
|---|---|---|---|---|---|
| 4.1 | Impartiality & confidentiality maintained | Partially met | Confidentiality policy exists | Add impartiality declaration and training record | High |
| 5.2 | Defined roles and responsibilities | Met | Organizational chart and job descriptions | Review annually for accuracy | Medium |
| 6.2 | Personnel competence evaluation | Not met | None | Develop competency matrix & training program | High |
| 7.4 | Examination procedures validated | Partially met | Validation data incomplete | Complete verification studies | High |
| 8.4 | Internal audit program in place | Met | Annual audit schedule and reports | Continue maintaining evidence | Low |
This table gives you a clear picture of where your lab stands and what requires immediate attention.
Pro Tip: Keep this checklist in a shared folder or quality management software so updates are easy and transparent. It should be reviewed monthly during implementation meetings.
Common mistake: Treating the checklist as a one-time document. It’s a living tool—update it as procedures evolve, new staff join, or processes change.
Once you’ve completed your checklist, the next logical step is turning it into a project plan that moves your lab from “identified gaps” to “implemented solutions.”
Turning Gap-Analysis Results Into a Project Plan
Your gap analysis gives you the “what.” Now you need the “how.” This is where you turn findings into an actionable project plan—one that guides your team from discovery to full ISO 15189 compliance.
Start by grouping your gaps into phases. For example:
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Phase 1: Address critical compliance issues (training, equipment calibration, method validation).
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Phase 2: Develop and finalize QMS documentation.
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Phase 3: Conduct internal audits and management review.
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Phase 4: Prepare for accreditation assessment.
Then, assign owners and timelines for each item. Accountability keeps progress steady. Use your gap-analysis checklist as the foundation—just convert it into a project tracker with deadlines and completion status.
Pro Tip: Schedule a short review meeting every two weeks. It’s easier to fix small delays early than to catch up right before an audit.
Common mistake: Letting the action plan sit in a file while operations continue unchanged. Implementation should start immediately after the gap analysis—momentum is everything.
Once your project plan is rolling, it’s normal for questions to come up. So let’s tackle some of the most common ones I get from labs during this stage.
FAQs – Gap-Analysis Best Practices
Q1. How often should a lab perform a gap analysis?
At minimum, do one at the start of your ISO 15189 implementation—and again before your accreditation assessment. After that, repeat it annually or whenever you make major process changes. It’s a great way to ensure your system stays aligned with the latest standard updates and real-world practices.
Q2. Who should lead the gap analysis?
Ideally, your quality manager should take the lead, supported by section heads or senior technologists. Involving multiple perspectives helps catch blind spots. For example, a technical supervisor might notice equipment or calibration issues that a quality officer might overlook.
Q3. Can a gap analysis double as an internal audit?
Not quite. A gap analysis identifies what’s missing before your system is fully implemented. An internal audit, on the other hand, verifies that your system already meets the standard. Think of the gap analysis as your “diagnosis” and the internal audit as your “checkup.”
Now that you’ve covered the essential questions, let’s wrap up with a short conclusion to help you turn your gap-analysis results into real accreditation progress.
Your Lab’s Roadmap Starts Here
A solid gap analysis is more than a formality—it’s your laboratory’s starting line for ISO 15189:2022 accreditation. By taking the time to assess your current practices, identify what’s missing, and prioritize your next steps, you’re building a foundation for accuracy, efficiency, and long-term compliance.
In my experience, labs that invest in this first step always move faster through implementation because they’re not wasting time fixing the same issues twice. They know exactly where to focus their energy—and that confidence shows during audits.
If you’re ready to take the next step, download QSE Academy’s ISO 15189:2022 Gap-Analysis Checklist—a practical, editable tool designed to help you start strong and stay organized.
Your roadmap is already in front of you. All that’s left is to take the first step.
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.
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