ISO 15189:2022 SOP and form templates
A complete quality-management document set for medical laboratories: 25 procedures and 121 linked forms, logs and QC sheets in editable Word and Excel, each mapped to its ISO 15189:2022 clause.
What's inside
- 25 procedures covering management and technical requirements
- 121 forms, logs and QC sheets, each linked to its parent procedure
- 2 service-agreement templates (POCT and referral MOU)
- 3 process maps
- QC tools with built-in calculations: Levey-Jennings, Westgard, EQA and measurement uncertainty
- A user handbook and a master list to keep it all controlled
Clause mapping
Every procedure and its forms are mapped to ISO 15189:2022. Check references against your licensed copy of the standard.
| Procedure | ISO 15189:2022 clause | Forms & logs |
|---|---|---|
| PD01 Quality Policy and Objectives | 5.5, 8.9 | 2 items |
| PR01 Communication and Meetings | 4.3, 6.2, 7.2.2, 8.4 | 6 items |
| PR02 Control of Documents | 8.3, 8.4 | 4 items |
| PR03 Service Agreements | 6.7 | 1 item |
| PR04 Referral Laboratories and Consultants | 6.8, 7.2 | 4 items |
| PR05 Supplier and Service Evaluation | 6.8 | 2 items |
| PR06 Complaints and Feedback | 7.7, 8.6 | 8 items |
| PR07 Nonconformity and Corrective Action | 5.6, 7.5, 8.5, 8.7, 8.8.2 | 9 items |
| PR08 Control of Records | 8.4 | 4 items |
| PR09 Internal Audit | 6.2, 8.7, 8.8.3 | 9 items |
| PR10 Risk Management and Improvement | 5.6, 8.5, 8.6 | 3 items |
| PR11 Management Review | 8.9 | 4 items |
| PR12 Personnel, Training and Competence | 4.1, 4.2, 6.2 | 16 items |
| PR13 Emergency Preparedness | 7.8 | 2 items |
| PR14 Result Release and Critical Results | 7.4.1 | 4 items |
| PR15 Facilities and Environment | 6.3, 6.4, 6.6 | 8 items |
| PR16 Equipment and Calibration | 6.2, 6.4, 6.5 | 6 items |
| PR17 Laboratory Information Management | 7.6 | 2 items |
| PR18 Reagents and Consumables | 6.6 | 4 items |
| PR19 Lot-to-Lot Verification | 6.6.3 | 1 item |
| PR20 Pre-examination and Sample Handling | 7.2, 7.4.2 | 6 items |
| PR21 Method Verification | 7.3.2 | 5 items |
| PR22 Measurement Uncertainty | 7.3.4 | 2 items |
| PR23 Internal Quality Control | 7.3.7.2 | 7 items |
| PR24 External Quality Assessment | 7.3.7.3 | 4 items |
| PR25 Quality Indicators | 8.8.2 | 2 items |
Who it's for
- Laboratories preparing for their first ISO 15189 accreditation
- Laboratories transitioning to the 2022 edition of the standard
- Laboratories working through WHO SLIPTA / SLMTA stepwise improvement
How it works with the app
The pack is a one-off download of editable files. When you're ready, upload the forms into LabToolkit Pro to turn them into live records with automatic calculations, out-of-range flags, a correction trail and e-signed review — and manage the procedures with version control and electronic signatures.
Frequently asked questions
Yes. Procedures are Word files and forms, logs and QC sheets are Excel files with dropdowns and built-in calculations. Brand them and adapt them to your laboratory.
Editable Word (.docx) and Excel (.xlsx) files, plus PDF process maps. No special software is needed beyond Microsoft Office or a compatible suite.
No; only an accreditation body confirms conformity. The templates help you build and control your documents. Check clause references against your licensed copy of each standard.
Yes. When the pack is updated you can download the newer file from your Payhip purchase page at no extra cost.
A single laboratory or organisation. You may adapt and use the templates internally, but not resell or redistribute them.