ISO 15189 SOPs, forms and document control for medical laboratories
Draft controlled SOPs in your lab's branding, approve and e-sign them, keep every version tracked, and give your whole team the current SOP on any device — with clause-by-clause readiness for ISO 15189:2022, CLSI, WHO SLIPTA, ISO/IEC 17025 and ISO 15190.
v3.1 · Effective · read by 8 of 10Fictional sample
One controlled system for your laboratory
125forms & logs
40SOP templates
5standards
4languages
1controlled system
SEE THE DOCUMENTS
Controlled copies that look like your laboratory
Not another folder of mismatched files. A clear, consistent identity — from the first page to the final signature.
Corporate letterhead
Upload your logo or letterhead once — every document uses it.
Classic crest
Upload your logo or letterhead once — every document uses it.
Hospital side rail
Upload your logo or letterhead once — every document uses it.
Modern minimal
Upload your logo or letterhead once — every document uses it.
Network dual-brand
Upload your logo or letterhead once — every document uses it.
Édition française
Upload your logo or letterhead once — every document uses it.
Clarity, from purpose to procedure.
Numbered clauses, definitions and notes make controlled procedures easy to follow at the bench.
Structured purpose, scope and procedure sections
Hanging clause numbers and clean tables
Highlighted placeholders and verification notes
Consistent document number and page footer
Ready for the work at the bench.
See a filled temperature log with clear acceptance limits and a place to record corrective action.
Printable monthly grids and record fields
Clear acceptable ranges
Out-of-range results and corrective action
Traceable form number and version
See the signal. Record the action.
A sample Levey-Jennings chart shows control results against the mean and standard-deviation limits.
20 illustrative control results
Mean and ±1, ±2 and ±3 SD lines
Marked 1-3s and 2-2s rejection signals
A concise Westgard rule legend
Approval with a traceable meaning.
A signature manifest ties each approval to a person, a role, a time and a specific version.
Preparation, review and authorisation
Date-time recorded in UTC
Document hashes and verified signatures
Password re-check for every signature
Your brand kit sets logo, letterhead, colours and layout. Brand kit Enhance automatically fits your logo and letterhead to the page.
SOP VERSION CONTROL
Version control that keeps every SOP current
Every change is drafted, reviewed and authorised before it replaces the effective version — and every step is recorded. SOP version control for medical laboratories, built into the same workflow as drafting and signing.
Riverbend Clinical Laboratory (sample) · PR-23 Internal Quality Control Procedure
Version 3.1
Effective
Added Westgard 2-2s rule and new control lot.
Effective
03 Sep 2026
Prepared
T. Naidoo · 28 Aug 2026
Reviewed
R. Mokoena · 31 Aug 2026
Authorised
A. Pillay · 02 Sep 2026
Fingerprint
4b1e…a07d
Change summary recorded with every version
What changed in v3.1
+Added: Westgard 2-2s rejection rule
~Changed: Control lot updated to SAMPLE-26
−Removed: Obsolete lot SAMPLE-24 target values
Reviewers can compare a draft with the effective version before they sign.
One effective version at a time — the bench never sees a draft.
Edit safely: changes go into a new draft while the effective version stays in use.
Major and minor versions with a recorded change summary.
Superseded versions kept read-only in the history.
Review dates tracked so nothing goes out of date.
Read-and-acknowledge records show who has read the current version.
Every authorised version carries a tamper-evident fingerprint, and each step is written to an append-only audit trail.
Your SOPs in a secure cloud workspace — on every bench, on every device
Nothing to install and no shared drives. Every member signs in from a browser and always opens the current effective version — cloud SOP management that works at the bench.
Document librarySAMPLE
Search title, code or clause
PR-23Internal Quality Control ProcedureEffective
PR-07Reagent Receipt and StorageEffective
FR-12Refrigerator Temperature LogEffective
PR-31Critical Result ReportingReview due
Current effective version
PR-23 · v3.1
Internal Quality Control Procedure
6.1.1 Prepare control material and record the lot.
6.1.2 Run both control levels before patient results.
6.1.3 Plot results and apply the approved rules.
SAMPLE
v3.0 superseded
Open the effective version 3.1
PR-23 · v3.1
Read ✓SAMPLE
Fictional Riverbend sample: the document library on a laptop, the effective PR-23 version on a tablet, and a phone pointing from a superseded version to the current one.
Always the current version — the library shows only effective controlled copies.
Find any SOP in seconds by title, code, department or clause.
Phones and tablets at the bench, laptops in the office.
Role-based access — authors, reviewers, readers and time-limited assessors see only what they should.
Private file storage; files are shared only through links that expire.
Encrypted connections (HTTPS), drafts saved automatically, and Word/PDF export whenever you want your own copies.
Your documents stay yours — export them at any time.
A CONNECTED QUALITY SYSTEM
Everything your quality system needs, in one place
From the first draft to the evidence you show an assessor, every step belongs to the same controlled workflow.
01 /
Automatic SOP drafting in four languages
Describe your laboratory once: tests, analysers, departments and standards. Choose Draft for me for a complete first draft, rewrite a section or use Convert my old SOP to restructure an existing document and list its gaps. Highlighted [VERIFY] items and [PLACEHOLDER] fields keep local checks visible before approval.
English, Français, Português and Español
Complete drafts and focused section rewrites
Local verification and missing information highlighted
To monitor analytical performance and identify changes before patient results are released.
2 Scope
This procedure applies to routine chemistry testing at Riverbend Clinical Laboratory (sample).
3 Responsibilities
Bench scientists run and record controls; the section head reviews QC weekly.
4 Definitions
Term
Definition
IQC
Internal quality control
SD
Standard deviation
Control material
Material used to monitor analytical performance
… section 5 Materials omitted in this sample …
6 Procedure
6.1.1 Prepare control material according to the manufacturer's instructions. Record the lot number, expiry date and operator initials.
6.1.2 Run the required control levels on [ANALYSER MODEL] before reporting patient results.
6.1.3 Plot each result on the Levey-Jennings chart and assess the laboratory's approved rejection rules.
7 Records
Retain control charts, review evidence and corrective-action records according to the laboratory retention policy.
SAMPLE
Fictional internal quality control SOP inside page: numbered clauses, definitions, verification highlights and safety notes.
02 /
Your branding on every controlled copy
Upload your logo or letterhead once and set your colours, fonts and layout in the brand kit. Brand kit Enhance automatically fits your logo and letterhead to the page, while the same document design follows every Word and PDF controlled copy, in A4 or Letter.
ISO/IEC 17025 §6.4Biomedical EngineeringNext review 19 Aug 2028
Approval
Name and role
Site
Date
Prepared
F. Wanjiru · Calibration Officer
Central
07 Aug 2026 · Signed ✓
Reviewed
G. Otieno · Engineering Lead
North
12 Aug 2026 · Signed ✓
Authorised
B. Kariuki · Network Quality Manager
East
17 Aug 2026 · Signed ✓
Revision · 2.2 — Added pipette calibration intervals for all sites
SAMPLE
Network dual-brand — Lakeside Regional Health · Lab Network (sample). Equipment Calibration and Maintenance; fictional branded SOP cover.
03 /
Review, approval and e-signatures
Move each document through preparation, review and authorisation with clear responsibilities. Every electronic signature re-checks the signer's password and records its meaning, time and document hash; saved signatures can be reused without skipping verification.
Internal Quality Control Procedure · Controlled version 3.1
Name / role
Meaning
Date-time UTC / hash
T. Naidoo · Senior Scientist
Prepared
28 Aug 2026 · 08:30 UTC · sha256 4b1e…a07d
R. Mokoena · Section Head
Reviewed
31 Aug 2026 · 10:05 UTC · sha256 4b1e…a07d
A. Pillay · Quality Manager
Authorised
02 Sep 2026 · 14:20 UTC · sha256 4b1e…a07d
Document integrity
Version locked after authorisation. Any subsequent change requires a new revision and approval.
SHA-256 · 4b1e90c27f35…a07d All names and signatures on this page are fictional.
SAMPLE
Fictional SOP signature manifest showing three signers, roles, meanings, UTC timestamps and signature hashes.
04 /
Version control and an audit trail assessors trust
Keep one effective version while preserving the history of every revision. Locked versions, a tamper-evident hash chain and an append-only audit log make it possible to follow who changed, reviewed and authorised each document.
Browse ready-made forms and logs, including temperature records, corrective action, training and internal audit sheets. Start free, inspect a filled example, then create, print or download a draft form for use at the bench, with your laboratory brand kit included free.
October 2026 · Unit RF-02 · Chemistry · Acceptable range 2–8 °C
Date
Time
°C
2–8 °C
Initials
Action
01 Oct
08:00
4.2
✓
ND
—
02 Oct
08:00
4.6
✓
ND
—
03 Oct
08:00
4.1
✓
ND
—
04 Oct
08:00
3.8
✓
ND
—
05 Oct
08:00
8.7
✗
ND
CA-011
06 Oct
08:00
4.5
✓
ND
—
07 Oct
08:00
4.3
✓
ND
—
08 Oct
08:00
4.8
✓
ND
—
09 Oct
08:00
5.1
✓
ND
—
10 Oct
08:00
4.7
✓
ND
—
11 Oct
08:00
1.4
✗
ND
CA-012
12 Oct
08:00
4.2
✓
ND
—
13 Oct
08:00
4.8
✓
ND
—
14 Oct
08:00
4.5
✓
ND
—
15 Oct
08:00
4.4
✓
ND
—
16 Oct
08:00
4.1
✓
ND
—
17 Oct
08:00
4.7
✓
ND
—
18 Oct
08:00
9.2
✗
ND
CA-013
19 Oct
08:00
4.4
✓
ND
—
20 Oct
08:00
4.6
✓
ND
—
Reviewed: E. Moyo (fictional) · 21 Oct 2026
SAMPLE
Fictional filled refrigerator temperature log for October 2026, with three out-of-range readings and a corrective-action record.
06 /
Internal QC with Levey-Jennings and Westgard rules
Put internal quality control results in context with Levey-Jennings charts and Westgard rules. QC sheets and the practical guide help your team review shifts, identify rejection signals and document investigation and corrective action.
Analyte: Glucose · Control level 1 · Lot SAMPLE-26
Mean 5.0 mmol/LSD 0.2 mmol/LRuns 20
1-3s · Reject One result exceeds ±3 SD.
2-2s · Reject Two consecutive results exceed +2 SD.
Westgard rule legend · Illustrative sample only.
SAMPLE
Fictional Levey-Jennings QC chart with 20 runs, a red 1-3s violation and an amber 2-2s pair; illustrative results only.
07 /
Clause coverage and readiness across five standards
Review readiness for ISO 15189:2022, CLSI, WHO SLIPTA, ISO/IEC 17025 and ISO 15190 from one quality system. See gaps by clause and department, with indicative crosswalk coverage displayed separately from direct evidence; readiness is not accreditation.
Fictional Riverbend laboratory readiness dashboard, showing direct clause coverage and separate indicative crosswalk coverage.
08 /
Built for the whole team
Give Quality Managers, directors, reviewers, authors and readers the access their work needs. Time-limited, read-only assessor access supports assessment, while phone and tablet reading, recommended starter packs and a 40-template SOP bank help the team stay coordinated.
Pay with the email you sign up with and access turns on automatically.
Extra members
US$30 each
One-time per extra member
Add people beyond 10 at any time from the Members page.
Available inside the app for laboratories with a lab licence.
Prices in US dollars. Secure checkout by Payhip.
INCLUDED WITH YOUR LAB LICENCE
The ISO 15189 template pack. Ready to make your own.
A complete editable quality-management set in Word and Excel, with supporting QC tools, process maps and agreements. Download it instantly, adapt it to your laboratory and approve it through your local quality system.
Your documents, your local checks, your quality system. Here is what to expect from LabToolkit Pro.
What do I get for US$149?+
One-time payment. Full access for your lab (10 members) plus the complete template pack. Extra members US$30 each. Create your free account with the same email you pay with and access turns on automatically.
Is there a user guide?+
Yes. The 27-page LabToolkit Pro user guide covers set-up, documents, approvals, version control, forms and logs.
Is LabToolkit Pro or the template pack certified?+
No. They help you build and control your documents. Only an accreditation body can confirm conformity. Check clause references against your licensed copy of each standard.
Which standards are supported?+
ISO 15189:2022, CLSI quality system essentials, WHO SLIPTA/SLMTA, ISO/IEC 17025 and ISO 15190. You can also add your own framework.
Which languages can documents be written in?+
English, French, Portuguese and Spanish.
Can I bring my existing SOPs?+
Yes. Upload a Word or PDF file and LabToolkit Pro restructures it into the controlled format and shows its gaps.
What's the difference between the template pack and the app?+
The US$149 one-time lab licence includes both: full app access for 10 members and the complete editable template pack. The app drafts, approves, signs and tracks documents for your whole team.
How does SOP version control work in LabToolkit Pro?+
Each SOP has one effective version. Changes go into a new draft — major or minor, with a recorded change summary — while the effective version stays in use. After review and e-signed authorisation the draft becomes effective and the previous version is kept read-only as superseded. Review dates, read acknowledgements, version fingerprints and an append-only audit trail are recorded.
Can staff read SOPs on their phones at the bench?+
Yes. LabToolkit Pro runs in the browser, so members sign in from a phone, tablet or laptop with nothing to install. The document library shows the current effective version, and staff can acknowledge that they have read it.
Where are our documents stored, and are they secure?+
In your laboratory's private cloud workspace. Access follows each member's role, files are kept in private storage and shared only through links that expire, and all connections are encrypted (HTTPS). Drafts save automatically, and you can export Word and PDF copies at any time.
What is ISO 15189 document control?+
Document control means identifying, reviewing, approving and issuing the current documents people need, while controlling changes and withdrawing obsolete copies. ISO 15189:2022 clause 8.3 addresses management system document control.
Which SOPs does a medical laboratory need for ISO 15189:2022?+
The set depends on your laboratory's scope and services. Typical procedures cover document control, specimen handling, examination methods, quality control, equipment, personnel, nonconforming work and internal audit. Use the documentation checklist to plan your local set.
Yes. The free plan lets up to 3 members create, print and download forms and logs. Automatic drafting is not included; advanced document control features require the lab licence.
Is this a subscription?+
No. Pay US$149 once for a lab licence with 10 members and the complete template pack. There is no end date or subscription. Extra members cost US$30 each, one-time.
Can assessors view our documents?+
Yes. With a lab licence, you can give assessors time-limited, read-only access to your controlled document library, without giving access to drafts.
Can we print forms and use them on paper?+
Yes. Forms and logs can be printed and used on paper. The free plan includes draft form printing and downloads, both with your laboratory branding. A lab licence adds controlled copies.
Does it work for WHO SLIPTA and ISO/IEC 17025 laboratories?+
Yes. WHO SLIPTA and ISO/IEC 17025 are among the five supported standards. Choose your frameworks and review direct evidence and indicative crosswalk coverage separately.
LABTOOLKIT PRO
Your next assessment, with every document in order.
