The Heart of ISO 15189:2022 Compliance Is Documentation
Every laboratory that aims for ISO 15189:2022 accreditation eventually reaches the same realization: compliance begins and ends with documentation. Whether it’s your quality manual, method validation reports, or calibration records, every single clause in the standard depends on documented proof.
In my experience, this is where most labs stumble—not because they don’t follow the right processes, but because they can’t show that they do. A missing approval, an outdated SOP, or an uncontrolled form can turn an otherwise solid system into a series of audit findings.
ISO 15189:2022 raised expectations around control, structure, and accessibility. Auditors now look for a documentation system that’s not just organized, but traceable, current, and risk-aware. That means every document—policy, SOP, form, and record—must tell a consistent story: your lab knows what it’s doing, how it’s doing it, and can prove it at any moment.
This pillar guide walks you through exactly what that system looks like. You’ll see the essential documents every ISO 15189-compliant laboratory needs, how to structure and control them, and how to integrate everything into a modern, audit-ready documentation toolkit.
By the end, you’ll know how to build a documentation framework that not only satisfies ISO 15189 but actually strengthens how your laboratory operates every day.
Understanding ISO 15189:2022 Documentation Requirements
ISO 15189:2022 builds its entire framework on one principle — prove what you do, and do what you’ve documented. Every process, procedure, and policy in your lab must be supported by a written record that shows consistency, traceability, and intent.
Documentation isn’t just about keeping files organized; it’s your laboratory’s evidence of competence. Auditors don’t evaluate how well you talk about your processes — they evaluate how well your records prove you’re following them.
Documents vs. Records — Know the Difference
One of the biggest sources of confusion for labs is mixing up the two.
Documents describe what should happen — policies, SOPs, forms, and manuals.
Records show what actually happened — completed forms, calibration reports, test logs, and training records.
When both are properly controlled, they form a closed loop of accountability.
Example: An SOP describes how to verify pipette calibration (document). The signed calibration log showing that it was done on a specific date (record) proves compliance.
What ISO 15189 Expects
The standard requires your lab to:
Approve and issue documents under controlled conditions.
Keep only current versions accessible to staff.
Maintain all records so they are legible, retrievable, and protected from alteration.
Review and update documents regularly, especially after process or equipment changes.
Pro Tip: Treat every document as part of a living system. The moment an SOP changes, your training records, forms, and validation documents should update with it. That’s what keeps your system coherent.
Common Pitfall
Labs often create excellent procedures but fail to manage them systematically. Uncontrolled Word files, outdated printed SOPs, and missing approvals are among the most frequent audit findings under Clause 8.3 and 8.4.
When ISO 15189 refers to “documented information,” it’s not about volume — it’s about control, relevance, and evidence.
By mastering the documentation requirements first, you set the stage for every other part of the standard — from method validation to risk management. The next step is understanding which core documents your lab actually needs and how to structure them effectively.
The Core Documents Every ISO 15189 Laboratory Needs
Every accredited laboratory runs on documentation, but not all documents carry the same weight. ISO 15189:2022 expects a structured documentation hierarchy — one that connects policies, procedures, forms, and records into a coherent system.
When that structure is missing, information gets fragmented. People follow different versions of the same SOP, and management can’t easily prove control. When it’s done right, though, documentation becomes your strongest audit defense and a daily management tool.
1. Quality Management Documents
These define your laboratory’s intent, scope, and direction. They set the foundation for the rest of your QMS.
Quality Manual – The master document summarizing how your system meets ISO 15189:2022.
Quality Policy and Objectives – State your laboratory’s commitment to accuracy, impartiality, and continual improvement.
Document Control Procedure – Explains how you create, approve, and revise controlled documents.
Pro Tip: Keep the quality manual concise and structured by clauses. Auditors appreciate a document that mirrors the ISO 15189 layout for quick cross-referencing.
2. Technical and Operational Documents
These are the “how-to” guides of your lab — the controlled procedures that keep operations consistent.
Standard Operating Procedures (SOPs) for sample handling, testing, result review, and reporting.
Work Instructions for specialized tasks.
Forms and Checklists used to capture data during testing or review.
Each SOP must be version-controlled, approved by authorized personnel, and readily available to all users.
3. Equipment and Facility Records
ISO 15189 requires proof that every instrument, piece of equipment, and controlled environment is maintained and calibrated.
Common Mistake: Labs often track calibration dates but forget to document the approval of calibration results. That missing review step is an easy nonconformity to avoid.
4. Personnel and Training Documentation
Your people are part of your quality system. Their competence must be documented, traceable, and current.
Job Descriptions
Competence Assessment Records
Training Plans and Attendance Logs
Authorization Lists for Specific Tests
ISO 15189 links personnel competence directly to document control — when an SOP changes, retraining must follow.
5. Method Validation and Verification Records
Every method, whether developed in-house or adopted, needs evidence of reliability.
Validation Plans and Protocols
Verification Reports
Acceptance Criteria and Raw Data Records
These documents demonstrate that your laboratory’s results are scientifically sound and defensible.
6. Risk, Audit, and Improvement Documentation
These records demonstrate that your QMS doesn’t just operate — it improves.
Risk Register and Assessment Forms
Nonconformity Reports
Corrective and Preventive Action (CAPA) Logs
Internal Audit Reports and Management Review Minutes
In My Experience: Labs that manage these records as living tools — not archived paperwork — can track improvement trends and resolve issues before they reach accreditation bodies.
ISO 15189 documentation isn’t about creating endless files. It’s about designing a structure where every document has a clear purpose, owner, and connection within your system.
The quality manual is the backbone of your ISO 15189:2022 documentation system. It doesn’t need to be lengthy or overly technical — it just needs to clearly describe how your laboratory meets the requirements of the standard. Think of it as the map that guides assessors, staff, and management through your quality system.
What the Quality Manual Should Contain
At a minimum, it should include:
Scope of the Laboratory – What types of testing or calibration you perform.
Organizational Structure – Roles, responsibilities, and reporting lines.
Documented Procedures – Reference or link to controlled SOPs, policies, and forms.
Clause Cross-Reference Matrix – How each ISO 15189 clause is addressed within your system.
Quality Policy and Objectives – Your lab’s commitment to impartiality, competence, and continual improvement.
Pro Tip: Write it as if a new staff member could read it and immediately understand how your lab operates. Clear, simple language beats dense technical wording every time.
Control and Review
Your quality manual must be reviewed and approved by top management. Updates should occur whenever there are changes to structure, scope, or the ISO standard itself.
Common Pitfall: Labs treat the quality manual as a one-time document. ISO 15189 expects it to evolve as your QMS matures. An outdated manual signals poor control, even if the rest of your system is solid.
Make It Practical
Don’t copy the standard word-for-word. Instead, describe how your lab actually fulfills each clause. For example, under Clause 6.4 on equipment, summarize your calibration and maintenance system, then link to the detailed SOPs or logs.
In My Experience: The most effective manuals I’ve seen balance compliance and usability. They serve as both a declaration of conformity and a day-to-day reference for how the lab maintains quality.
A well-structured quality manual sets the tone for your entire documentation toolkit. It tells auditors you understand your system — and more importantly, that you control it.
Method validation and verification records are among the most scrutinized parts of an ISO 15189 documentation system. They prove that your laboratory’s test methods are accurate, reliable, and fit for their intended use. Without them, even the most advanced equipment and skilled analysts can’t demonstrate competence.
Validation vs. Verification — Know the Distinction
Validation applies when your lab develops a new method or significantly modifies an existing one. You’re proving that it performs as intended.
Verification applies when you adopt a standard or commercial method. You’re confirming that it performs as expected in your environment with your equipment and staff.
Both require documented evidence — not just raw data, but a structured record of planning, acceptance criteria, results, and review.
Essential Documents and Records
Every validation or verification activity should include:
Validation or Verification Plan – Scope, parameters to be assessed, and acceptance criteria.
Raw Data Sheets – Detailed measurement results, instrument outputs, or observation logs.
Summary Report – Comparison of results against acceptance limits and statistical evaluation.
Approval and Review Sign-Off – Authorization that the method meets ISO 15189 requirements.
Pro Tip: Include the equipment ID and calibration certificate number in every validation record. It creates a direct traceability link that auditors love to see.
Common Pitfalls to Avoid
Skipping the documentation of acceptance criteria.
Failing to record environmental or instrument conditions.
Using outdated templates without version control.
Forgetting to re-verify after a major equipment repair or reagent change.
Integration with the QMS
Validation records connect directly to other parts of your quality system:
Equipment Records show the tools used were calibrated and reliable.
Personnel Records confirm qualified staff performed the testing.
Document Control ensures only approved versions of procedures were used.
In My Experience: Labs that maintain a single “Method Validation Log” — summarizing every method, date, reviewer, and outcome — handle audits far more confidently than those searching through scattered files.
Method validation isn’t just about compliance; it’s about building trust in your results. Every documented study becomes evidence that your lab delivers dependable data — consistently and defensibly.
No matter how advanced your instruments are, they’re only as reliable as the documentation that supports them. ISO 15189:2022 expects every laboratory to maintain complete, traceable records showing that all equipment used in testing is properly calibrated, maintained, and verified for performance.
These records don’t just prove compliance — they prove that your results are trustworthy.
1. What the Standard Requires
ISO 15189:2022 Clause 6.4 outlines clear expectations:
Each piece of equipment must have a unique identifier and record.
Calibration and maintenance must be performed on schedule.
Records must show who performed the work, when it was done, and the next due date.
Equipment out of service must be clearly labeled and isolated.
In short, you must be able to show that every measurement and result is backed by verified equipment performance.
2. The Core Equipment Records You Need
Record Type
Purpose
What It Should Include
Equipment Master List
Overview of all controlled instruments
ID, location, model, serial number, status, responsible person
Calibration Records
Proof of measurement accuracy
Date, standard used, results, pass/fail, next calibration due
Maintenance Logs
Preventive and corrective actions
Description of work, parts replaced, technician, verification
Pro Tip: Use a color-coded digital dashboard to monitor calibration status (e.g., green = up to date, yellow = due soon, red = overdue). It makes compliance visible at a glance.
3. Common Pitfalls
Missing approvals: Technicians complete logs, but no supervisor signs off.
Unclear traceability: Calibration performed, but the standard used isn’t referenced.
Outdated logs: Maintenance performed but never updated in the master list.
Every missing link in documentation weakens traceability — and auditors notice it instantly.
4. Integration with the QMS
Your equipment records tie directly into other ISO 15189 processes:
Validation Records: Confirm that validated methods used calibrated equipment.
Nonconformity Reports: Triggered when failed calibrations impact test validity.
Training Records: Ensure staff maintaining instruments are qualified and authorized.
In My Experience: Labs that manage equipment records electronically, with auto-reminders and approval trails, consistently outperform those using spreadsheets. Automation keeps your lab proactive instead of reactive.
Accurate and current equipment documentation doesn’t just prevent audit findings — it builds confidence in your lab’s results. The next step in your toolkit focuses on maintaining that same level of control across all your documents: your electronic document-control system.
In ISO 15189:2022, document control is no longer just about keeping files organized — it’s about proving control, access, and accountability across your entire quality system. That’s why many laboratories are now moving from paper or shared folders to electronic document-control systems that meet the standard’s expectations for traceability and security.
A well-designed digital system helps your lab maintain compliance while saving time and reducing errors. It ensures everyone works from the same approved version, no matter where they are or what shift they’re on.
1. What ISO 15189 Requires
The standard emphasizes two major principles under Clauses 8.3 and 8.4:
Document Control: Every policy, SOP, and form must be reviewed, approved, and available to those who need it.
Record Control: Completed records must be legible, retrievable, and protected from unauthorized changes or loss.
Pro Tip: An electronic document system that automatically tracks approvals, revisions, and access satisfies these requirements more effectively than any manual setup ever could.
2. Key Features of a Compliant Electronic System
To meet ISO 15189 expectations, your software should include:
Role-Based Access: Assign permissions by function — authors, reviewers, approvers, users.
Version Control: Automatically generate new version numbers when changes are made.
Approval Workflows: Route documents through electronic signatures and timestamps.
Audit Trails: Record who viewed, edited, or approved each document.
Obsolete Control: Archive old versions while preventing accidental use.
Secure Backup: Encrypted data and regular backups to ensure record integrity.
If your system can’t produce a document’s full history in seconds, it’s not truly controlled.
3. Why It Matters
Electronic document control does more than replace paper — it integrates with your quality system:
Links SOP revisions with staff training and competence records.
Connects CAPA actions with updated procedures.
Streamlines audit preparation with instant retrieval and approval evidence.
In My Experience: Labs that switched from manual to electronic systems cut document retrieval time by more than 80%. Auditors often comment that “version control has never been clearer.”
4. Common Mistake
Scanning paper SOPs into PDFs and storing them in shared folders isn’t electronic document control. That’s just digital storage. True compliance requires version history, controlled access, and approval tracking — not just convenience.
When implemented correctly, an electronic document-control system becomes the backbone of your laboratory’s QMS — connecting every department, every change, and every approval under one controlled framework.
Linking Documentation with QMS Processes
One of the biggest shifts in ISO 15189:2022 is its emphasis on integration. The standard no longer views documentation as separate files or binders — it expects a single, connected system where every document supports a broader process.
When your documentation toolkit aligns with your QMS, audits become smoother, risks decrease, and staff can instantly find the information they need to do their jobs correctly.
1. Document Control and Training
Each time you revise an SOP, you’re not just updating a file — you’re triggering a training requirement. Your QMS should link document control with competence management so you can easily show:
Who was trained on the new version.
When the training was completed.
Who still needs to acknowledge or review it.
Pro Tip: Use your document-control system to automatically notify staff when a procedure changes. This keeps everyone aligned without endless email reminders.
2. Equipment and Method Validation
Your method validation records and equipment calibration logs should directly reference controlled documents like SOPs or protocols. This creates a full chain of traceability — showing that the method, equipment, and operator were all under documented control.
Common Pitfall: Labs often keep validation data separate from the QMS, which breaks the evidence chain. Linking them shows assessors that your process is complete, not fragmented.
3. Internal Audits and CAPA
Audit reports and corrective actions depend heavily on documentation. Every finding, root cause, and follow-up should link back to the relevant SOP, form, or policy.
When you can show that a CAPA led to a document revision, retraining, and updated risk control, it proves a functioning feedback loop — exactly what ISO 15189 expects.
4. Risk Management and Improvement
Risk registers, incident reports, and management reviews all depend on reliable data from your controlled records. Your documentation provides the evidence base for identifying trends, measuring performance, and implementing improvements.
In My Experience: When labs stop treating documents as static files and start treating them as part of a living process, their QMS becomes both more compliant and more efficient.
Documentation isn’t just about recordkeeping — it’s about creating visibility, accountability, and connection across your entire system. That’s what transforms a compliant laboratory into a confident, audit-ready one.
Real-World Example – How a Complete Documentation Toolkit Changed an Audit Outcome
A mid-sized clinical laboratory once faced a major challenge before its ISO 15189 re-assessment. Despite having strong technical performance, they were repeatedly cited for “incomplete documentation” — missing approvals, outdated SOPs, and inconsistent calibration records. None of these were critical errors on their own, but together they showed a lack of control.
The lab decided to rebuild its documentation system from the ground up using a structured ISO 15189 documentation toolkit. They standardized every template — from the quality manual to calibration logs — and implemented an electronic document-control system to manage revisions and approvals.
During their next assessment, the auditor’s approach changed completely. Instead of chasing missing records, the conversation focused on performance improvement. The lab could instantly retrieve any SOP, show who approved it, and trace which staff were trained on the latest version. The audit concluded with zero nonconformities.
The laboratory director summed it up perfectly:
“We didn’t change how we worked — we changed how we documented what we do. That’s what finally made us audit-ready.”
Lesson: A well-organized documentation system doesn’t just prevent findings; it creates confidence — both for your team and for the assessors reviewing your work.
FAQs – ISO 15189:2022 Documentation Toolkit
Q1: Do we need to create separate documents for every clause of ISO 15189?
No — and you shouldn’t. The goal is to build a cohesive system, not a pile of paperwork. Group documents logically (e.g., quality policy, SOPs, forms) and cross-reference where needed. The structure matters more than the quantity.
Pro Tip: Use a document matrix that maps each ISO 15189 clause to its corresponding controlled document. It’s a simple way to prove coverage during audits.
Q2: How often should documents be reviewed and updated?
ISO 15189 doesn’t prescribe a specific timeframe, but best practice is at least once a year or whenever there’s a change in methods, equipment, staff, or regulations. A scheduled document review program keeps everything current and shows proactive management.
Q3: Are electronic templates acceptable under ISO 15189?
Yes — in fact, they’re encouraged. Electronic templates make version control and updates easier. Just ensure they’re controlled, approved, and protected from unauthorized modification.
Common Mistake: Using editable “master templates” without restrictions. Always lock originals and issue controlled copies for use.
Q4: How long should we keep old or obsolete documents?
Keep obsolete documents for as long as your accrediting body requires — typically five years — and make sure they’re marked as “superseded” or “archived.” Auditors may ask to review previous versions, especially when tracing historical changes.
Q5: Can a small laboratory use the same documentation toolkit as a large one?
Absolutely. The principles are the same — what changes is the level of detail. A small lab might need fewer SOPs, but the structure (control, approval, versioning) stays identical.
In My Experience: Labs that adapt the toolkit to their actual operations — instead of copying everything — end up with leaner, more practical systems that staff actually follow.
Build a Documentation System That Works for You
Strong documentation is the backbone of ISO 15189:2022 compliance — but it’s also what turns a laboratory from reactive to reliable. The point isn’t to drown your team in forms and procedures; it’s to create a controlled, connected system where information is current, traceable, and easy to find.
When every SOP, log, and record aligns under one structured framework, your laboratory can demonstrate competence with confidence. Auditors stop questioning your control, and your staff stop second-guessing which version to follow.
In my experience, the best systems aren’t the most complex — they’re the most intentional. They focus on clarity, accessibility, and accountability. Whether you manage documentation manually or through a digital system, consistency is what wins every time.
If you’re ready to simplify your ISO 15189 documentation process, start with structure. Standardize your templates, assign clear responsibilities, and make version control part of your culture — not just an audit requirement.
Next Step: Download QSE Academy’s ISO 15189:2022 Documentation Toolkit — a complete set of templates, logs, and checklists designed to help you build, organize, and maintain your documentation system without guesswork.
Because in ISO 15189, documentation isn’t paperwork — it’s proof of competence.
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.
