Last Updated on September 24, 2025 by Melissa Lazaro

How to Build an ISO 15189 2022 Quality Manual

Let’s be real—writing an ISO 15189:2022 Quality Manual isn’t exactly anyone’s idea of fun. I’ve worked with dozens of labs around the world, and this is hands down one of the spots where people get overwhelmed fast. Too many documents, not enough clarity, and everyone’s worried about what the auditor will say.

In my experience helping labs prepare for accreditation, I’ve seen it all—from manuals that read like technical encyclopedias (and confuse everyone), to ones so vague they barely cover the basics. But here’s the truth: your Quality Manual doesn’t have to be complicated to be effective.

In this guide, I’ll walk you through exactly how to build a clear, auditor-ready ISO 15189:2022 Quality Manual that works for your lab. Whether you’re starting from scratch or revising an outdated version, this article will give you the structure, the strategy, and the sanity-saving shortcuts I’ve used with clients time and time again.

Let’s dive in and make this process feel a whole lot easier.

Understand the Purpose of an ISO 15189:2022 Quality Manual

Why This Isn’t Just Another Binder on a Shelf

Before we dive into building your manual, let’s pause and look at the bigger picture. What’s this document really for?

In my experience, a lot of labs either treat the Quality Manual as a formal obligation or simply copy something generic from another organization. And I get it—it’s tempting when you’re pressed for time. But here’s the truth: your ISO 15189:2022 Quality Manual should be the heart of your lab’s quality system. It’s not just for the auditors. It’s for your team. It should reflect how your lab runs, why it’s set up that way, and how quality and patient care are supported through every step.

What ISO 15189:2022 Really Expects

With the 2022 revision, ISO 15189 has moved away from documentation overload. Instead, it emphasizes clarity, accountability, and a risk-based mindset. The manual should explain:

• What your lab actually does—its services and scope

• How your quality management system is structured

• Who’s responsible for what

• How you manage risks, impartiality, and continual improvement

That might sound like a lot, but when it’s done right, the manual becomes a roadmap—not a burden. It sets the tone for both the assessment and your day-to-day operations.

What I Tell My Clients

Here’s what I’ve noticed over the years: the labs that succeed don’t just treat the manual like paperwork. They make it functional. One thing I always recommend is starting with a “Quality Snapshot”—a simple, one-page overview of your lab. Where you are, what you do, what kind of tests you run, and how your QMS supports all of it. This kind of clarity helps your staff stay aligned and makes auditors feel like they’re in good hands.

A Real-World Example

A few years ago, I worked with a diagnostic lab in Malaysia. They had a detailed manual, sure—but it was filled with technical jargon and ISO language that didn’t make sense to their own team. During internal audits, staff couldn’t explain what the manual actually said. We rewrote it using plain English, mapped it to how they actually worked, and suddenly everything clicked. The staff felt more confident, and during their next accreditation audit, the assessors noted how “real” and “useful” the manual was. That’s the power of writing it for the people who actually use it.

Gather Essential Inputs Before You Write

Don’t Start Writing Blank—Here’s What You Need First

One of the biggest mistakes I see labs make? Jumping straight into writing the manual without having the right information in front of them. It’s like trying to build a house without a blueprint or materials. You end up rewriting, backtracking, and second-guessing everything.

In my experience, the labs that move through this process efficiently always start by gathering their inputs first. It’s not glamorous work, but it sets the foundation for everything that follows.

Here’s what you’ll need to collect before putting pen to paper—or fingers to keyboard.

Core Inputs You Can’t Skip

1. Your Laboratory’s Scope of Services
Be crystal clear on what your lab actually does. Are you doing microbiology? Molecular diagnostics? Point-of-care testing? The scope defines what parts of ISO 15189 apply and shapes your entire quality system.

2. Organizational Structure and Roles
You’ll need an up-to-date org chart that reflects reporting relationships and job roles. This supports requirements around competence, authority, and responsibility.

3. Your Quality Objectives and Policies
These should already exist as part of your QMS. If they don’t, now’s the time to define them. Keep them practical and tied to measurable outcomes—not just phrases that sound good on paper.

4. Documented Procedures and SOP Inventory
List all your existing procedures, forms, logs, and SOPs. The manual will reference these frequently, and you’ll need to make sure they’re controlled and versioned.

5. Regulatory and Legal Requirements
Think beyond ISO—what local health regulations, licensing rules, or safety standards do you have to follow? Your manual needs to show that you’re aligned with all relevant frameworks.

6. Risk and Opportunity Records
Since ISO 15189:2022 emphasizes a risk-based approach, you’ll want a log or summary of identified risks and what actions you’ve taken. If you don’t have a risk register yet, start building one now.

What I Recommend in Practice

In real-world consulting, I always start the manual development process with a working checklist. We sit down with the quality manager and technical supervisor and ask: “What documents do we already have—and what’s missing?” Nine times out of ten, we uncover gaps that would’ve caused big problems during an audit.

Here’s the thing: when you gather all of this upfront, writing becomes easier, faster, and way more accurate. You’re not guessing—you’re connecting real, existing systems to the ISO framework.

Insider Tip

Before you write anything, create a document control table. List each policy or SOP, its reference number, who owns it, and its current version. This saves you hours later when the assessor asks, “Where is this documented?” and you can point to it instantly.

Structure the Manual According to ISO 15189:2022 Clauses

Use the Standard to Shape the Story

Now that you’ve gathered everything you need, it’s time to organize it all into a clean, structured manual. This isn’t just about looking professional—it’s about making the document easy to use, easy to audit, and fully aligned with ISO 15189:2022.

Here’s what I’ve noticed: labs that follow the structure of the standard—rather than inventing their own format—usually have a smoother experience during audits. Assessors can follow the logic, staff can find what they need, and updates become much easier down the line.

Recommended Structure Based on ISO 15189:2022

The 2022 version of the standard is organized into four major clause areas, and your manual should reflect this. Here’s how to break it down:

1. General Requirements
Start with policies related to impartiality, confidentiality, and patient rights. This section sets the tone for ethical conduct and legal compliance.

2. Structural Requirements
Describe your lab’s organization, management responsibilities, quality leadership, and how accountability is defined.

3. Resource Requirements
This is where you cover personnel, facilities, equipment, and information systems. Keep this linked to actual procedures—don’t just describe the ideal.

4. Process Requirements
This will likely be the longest section. It includes everything from sample handling to reporting results, internal audits, quality indicators, risk management, and more.

You don’t need to copy-paste the ISO clauses—but you do need to cover them. Use them as a checklist to make sure no critical content is missing.

What I Recommend to Clients

I usually advise labs to include a clause cross-reference matrix—either at the beginning or end of the manual. This shows exactly where in the document each ISO 15189 requirement is addressed. It builds trust instantly because it tells auditors, “We’ve got this covered—and here’s where.”

One of my clients in the UAE included this matrix in their manual and said the audit felt “almost too easy” because assessors weren’t digging through pages to find what they needed.

Insider Advice

Don’t over-engineer the layout. Use simple headings like “4.1 Impartiality” or “6.2 Personnel Competence,” followed by a plain-language explanation of your lab’s approach. Include references to supporting SOPs and policies, but don’t copy them into the manual. Keep the manual clean and lean, with hyperlinks or appendix references for deeper content.

Define Roles, Responsibilities, and Authority

Clarity Isn’t Optional—It’s Required

Here’s the thing: ISO 15189:2022 places a huge emphasis on accountability. If your manual doesn’t clearly spell out who’s responsible for what, you’re leaving room for confusion—and potential nonconformities during audits.

In my experience, this is one of the first things assessors look for. They want to see a system that isn’t just documented, but also understood and owned by the people running it. That means your quality manual needs to clearly show who’s calling the shots, who’s monitoring compliance, and who’s actually doing the work on the ground.

What to Include in This Section

1. Key Roles That Must Be Defined
Start by naming and describing these core positions:

• Laboratory Director or Head of Laboratory

• Quality Manager (or equivalent)

• Technical Managers or Section Heads

• Safety Officer (if applicable)

• Authorized Signatories

Each one should have:

• A clear list of responsibilities

• Lines of reporting and communication

• Authority to act within the system (like approving documents or taking corrective action)

2. Reporting Relationships
Use a simple org chart. Don’t overcomplicate it. The goal is to show how decisions flow and how quality oversight is maintained throughout your lab.

3. Delegation and Backups
You should also note who takes over when someone is absent. It’s a small detail that makes a big difference during audits—and real-life disruptions.

Real-World Example

I once worked with a genetics lab that had everything in place—except a clear description of who handled quality functions. They had a great quality system, but because those responsibilities were buried inside multiple job descriptions, the auditor flagged it as a concern. We added a single, standalone table in their manual with each key role, name, and scope of responsibility. Problem solved—and much easier for the team to reference going forward.

Practical Tip

Create a table summarizing roles, responsibilities, and authorities. Keep it simple. For example:

This not only shows clarity—it makes your manual instantly more usable.

Include Mandatory Policies and Risk Management Statements

Policies Are More Than Paper—They Set the Tone

Let’s be honest—most labs include policies because they have to, not because they believe they’re useful. But when written well, these policies become cornerstones of your lab’s culture. They show regulators, staff, and patients what your lab stands for and how you handle responsibility.

In the ISO 15189:2022 context, there are specific policies that must appear in your quality manual. Skipping them—or treating them like vague mission statements—is one of the quickest ways to land on an auditor’s findings list.

Core Policies You Need to Include

Here’s what the standard expects, and what I always check for when working with clients:

1. Impartiality Policy
You need a clear, written statement that your lab’s decisions are based solely on scientific evidence—not influenced by financial, political, or personal interests.

2. Confidentiality Policy
Define how patient data, test results, and records are protected. Include access control, storage rules, and staff confidentiality agreements.

3. Quality Policy
This should be your lab’s commitment to quality, accuracy, and continual improvement. It must be understood and followed at all levels—not just posted on a wall.

4. Complaint and Feedback Policy
Describe how complaints are logged, investigated, and resolved. ISO 15189 wants to see evidence that you value patient and client input.

5. Risk Management Statement
Under ISO 15189:2022, risk isn’t optional. You must show that your lab identifies, evaluates, and controls risks—especially those affecting quality and patient safety.

How to Keep It Real (and Auditor-Ready)

What I’ve noticed is that labs often copy these policies from templates and forget to make them their own. Auditors can spot generic language a mile away. Your policies should reflect your actual practices—even if they’re still evolving.

One of my clients in Southeast Asia ran into trouble because their policies mentioned digital recordkeeping, but they were still using paper forms. The fix? We rewrote the policies to match their real processes and added a plan for transitioning to digital within the next six months. Not only did the lab pass the audit, they also started making real operational changes that improved efficiency.

Insider Advice

Don’t just list the policies—explain how they’re implemented. For example, don’t just say, “We ensure confidentiality.” Say, “Access to laboratory information systems is restricted to authorized personnel via password-protected logins and two-factor authentication.”

That’s the kind of clarity and transparency that builds trust with auditors—and with your team.

Make It Usable – Formatting, Version Control, and Accessibility

A Quality Manual That No One Reads Is Useless

Let’s be real—if your manual is hard to navigate, buried in outdated files, or written in dense language that only a consultant can understand, it’s not helping your team or your audit.

In my experience, the labs that have the smoothest audits are the ones where everyone knows where the manual is, what version they’re using, and how to find what they need. So don’t just focus on what’s in your manual—focus on how it’s presented, tracked, and accessed.

Here’s What You Need to Get Right

1. Use a Clean, Consistent Format
Stick to a professional template with clear headers, a table of contents, and section numbers that mirror the ISO 15189:2022 structure. Keep language clear and direct. You’re not writing a legal document—you’re creating a working tool.

2. Add a Document Control Section
Every manual should start with a control page that includes:

• Document title

• Version number

• Date of issue and revision history

• Approver’s name and signature

• Distribution list (who has access)

3. Use Version Control You Can Actually Manage
I’ve seen labs using ten different versions of the same manual across departments—because no one was tracking changes. Choose one format (PDF or protected Word), store it in a central location, and set clear rules: who can edit, who approves, and how updates are distributed.

4. Make It Accessible to Your Team
Whether it’s stored on a shared drive, quality management software, or printed in key areas, make sure staff know where to find the manual and how to use it. If no one can find it, it won’t support your system—and that’s a red flag for any assessor.

A Practical Story from the Field

A client of mine in Qatar used to keep the manual on one computer—in the Quality Manager’s office. If she was out, no one had access. When we moved the manual to a controlled shared drive with version history and restricted editing, everything changed. Internal audits became smoother, training got easier, and the team finally started using the manual as a day-to-day tool instead of something “for the auditor.”

Insider Advice

Create a “change log” at the end of your manual. Every time you update a section, add the date, a brief description of what changed, and who approved it. During audits, this shows that your system is not only maintained but actively improving. And when something goes wrong, you can trace changes quickly.

Keep It Dynamic: Integrating Review & Continuous Improvement

Your Manual Isn’t a One-and-Done Document

Here’s what I tell every lab I work with—if your quality manual hasn’t changed in over a year, something’s probably off. Because in a real, functioning lab, things shift. People leave, new tests are introduced, procedures improve. And your manual should reflect that.

ISO 15189:2022 makes it clear that your quality management system—and the documentation that supports it—must evolve. That includes regularly reviewing and updating your manual so it stays aligned with actual practices and ongoing improvements.

How to Build a System for Ongoing Review

1. Set a Review Frequency
At a minimum, review your manual once a year. But also make it clear that revisions can happen after any of the following:

• Internal audits

• External assessments

• Management reviews

• Major changes to services, structure, or equipment

• Significant incidents or nonconformities

2. Assign Responsibility
Make sure it’s clear who owns the review process. In most cases, that’s the Quality Manager—but they shouldn’t be working in isolation. Involve technical staff and management to keep things accurate and practical.

3. Link Updates to Other QMS Activities
Your manual should never live in a silo. It should reflect findings from audits, corrective actions, risk reviews, and even client feedback. If a root cause analysis leads to a process change, the manual should be updated to show that.

4. Document Every Update
Include a revision history table that shows:

• What was changed

• When it was changed

• Who approved it

• Why the update was made

Auditors love this because it shows the system is alive, not just checked off once and forgotten.

What I’ve Seen Work

One of my clients in Indonesia built their manual around a quarterly review cycle that aligned with their internal audit schedule. Each time the audit identified a gap—or even a minor improvement—they’d update the relevant section in the manual. Not only did it keep the document accurate, but it also made it easy to show progress and responsiveness during external audits. Their last surveillance audit had zero nonconformities.

Insider Advice

Tie your manual updates into your Management Review process. Keep a standing agenda item that asks, “Do any changes to the QMS need to be reflected in the Quality Manual?” It’s a simple habit that keeps the document relevant—and helps avoid last-minute scrambles before an audit.

Pro Tips / Insight Boxes 

Pro Tip #1: Use a “Quality Snapshot” at the Front of the Manual

Why it works: This one-page summary gives readers (and auditors) a quick overview of your lab’s location, services, testing scope, and QMS structure.
What to include: Name of lab, address, scope of testing, accreditation status, QMS highlights, and who to contact for questions.
From the field: I’ve added this for multiple clients—it instantly improves clarity and sets the tone for the rest of the document.

Pro Tip #2: Add a Clause Cross-Reference Matrix

Why it works: This table maps ISO 15189:2022 clauses to the corresponding sections in your quality manual. It shows assessors you’re organized and intentional.
Bonus tip: Keep it updated after every revision—it helps during surveillance audits and internal reviews.
In practice: One lab in the UAE I worked with cut their audit prep time in half by using this exact approach.

Pro Tip #3: Keep Your Manual “Living” With a Change Log

Why it works: Every change to your QMS should be tracked in a visible, structured way. A simple log showing date, change, reason, and approver tells assessors that your system is active, not static.
Client-tested advice: I’ve helped labs create shared online logs using simple spreadsheets—no fancy software required.

Pro Tip #4: Write for Your Staff, Not Just the Auditor

Why it works: Your quality manual should be used every day—not just dusted off once a year. Use clear, plain language and real examples your staff will recognize.
What I’ve seen: Labs that write manuals in their “own voice” tend to have better training results and stronger internal audit outcomes.

Common Mistakes and FAQs 

Common Mistakes to Avoid When Creating Your ISO 15189:2022 Quality Manual

Copying Templates Without Customization
Templates are helpful—but only as a starting point. If your manual doesn’t reflect your actual lab processes, auditors will notice. I’ve seen labs lose credibility because their manual referenced equipment or procedures they didn’t even use. Always adapt every section to your reality.

Overloading the Manual With Technical Details
The manual isn’t meant to be a dumping ground for SOPs or equipment manuals. It should provide structure and guidance, not overwhelm the reader. Link to detailed documents—don’t duplicate them here.

Using Complex or Vague Language
Keep it simple. Write the manual like you’re explaining how your lab runs to a new team member. Avoid ISO jargon unless it’s required, and when you use it, define it clearly.

Skipping Version Control and Review Procedures
I’ve walked into labs that hadn’t updated their manual in three years—and it showed. Auditors expect to see a change history, version tracking, and review dates. If these aren’t documented, you risk nonconformities—even if the rest of your system is solid.

Not Involving the People Who Actually Use the System
The best manuals are written with input from the people who manage daily operations—not just the quality manager. When frontline staff are involved, the manual becomes a living, useful tool, not just paperwork.

Frequently Asked Questions

How detailed should the ISO 15189 quality manual be?
It should cover all the required clauses and clearly reference supporting documents, but it doesn’t need to include every SOP. Think of it as a map—it guides users to the right processes, policies, and records without trying to explain everything in one place.

Can we build the manual before we finish our SOPs?
You can start, but it’s best to develop both together. The manual should reference real procedures, so if those aren’t written yet, you may end up rewriting large parts later. Build in parallel to save time and improve consistency.

Does the quality manual need to be in English?
Not necessarily. It should be written in a language your staff can understand and use. However, if your accreditation body or auditors require an English version, you may need to maintain a translated copy. The key is usability—your team should be able to apply what’s written.

Build a Manual That Works—Not Just One That Checks the Box

Let’s face it—creating an ISO 15189:2022 Quality Manual can feel overwhelming. But if you’ve made it this far, you’re already ahead of the curve. Because now you know: this isn’t just about compliance. It’s about building a document that truly supports your lab’s operations, culture, and commitment to quality.

In my experience working with labs across Asia, the Middle East, and beyond, I’ve seen what works—and what doesn’t. The strongest manuals are the ones that are simple, specific, and actually used by the people running the show. They’re reviewed often, updated when things change, and written in a way that staff understand.

So if you’re about to build—or rebuild—your manual, take a step back and remember this: write it for your lab first. Not just for the auditor. Build it around your real processes, real risks, and real people. That’s how you turn it from a static document into a powerful quality tool.

Need help getting started?
Download our free ISO 15189:2022 Quality Manual Checklist or reach out to schedule a one-on-one strategy session. Whether you’re starting from scratch or fine-tuning what you already have, we’ll help you get it right—without the guesswork.