Using the App

SOP Writing Simulator

Premium tool. Open from /training-dashboard → SOP Writing card (the dashboard uses the short label, without the "Simulator" suffix), or directly at /sop-writing-simulator.

SOPs are the backbone of every accredited pathology laboratory. This simulator teaches the structure, language, and document-control rules your SOPs must meet.

What it does

• Picks a topic (e.g. "FBC analyser daily start-up", "Sample reception triage", "Cold-chain validation")
• Walks you through drafting the SOP section by section using a guided form
• Validates your draft against the ISO 15189:2022 document control checklist
• Produces a final formatted SOP that you can export as DOCX or PDF
• Optionally peer-reviews your SOP via the AI assistant

SOP structure taught

1. Title and unique identifier
2. Purpose and scope
3. Definitions and abbreviations
4. Responsibilities — by role, not by name
5. Equipment and materials
6. Safety considerations — COSHH, ACDP, sharps, biosafety level
7. Procedure — numbered, imperative-voice steps
8. Quality control — IQC, EQA references
9. Records — what must be retained, where, for how long
10. References — internal SOPs, external standards, manufacturer IFUs
11. Document control footer — version, effective date, review date, approver, document owner

Language conventions

• Imperative voice — "Add 50 µL of reagent A" not "Reagent A is added"
• Numbered steps — never bullets in the procedure section
• Avoid passive voice — direct accountability
• No clinical decisions in technical SOPs — those go in clinical protocols
• Cross-reference other SOPs by ID, not by description (so renaming doesn't break links)

Document-control validation

The simulator flags common SOP defects:

• Missing or unclear review date
• Undefined abbreviations
• "TBD" or placeholder text in a controlled document
• Steps that depend on tacit knowledge (e.g. "process as usual")
• Inconsistent version numbering between header and footer

Standards alignment

• ISO 15189:2022 clauses 5.2 (Document control) and 7.5 (Documentation of examination procedures)
• MHRA Good Documentation Practice (GDP) principles — ALCOA+
• UKAS TPS 70 expectations
• Your laboratory's local document-control SOP (you can upload it; the simulator will validate against it)

Bands and competency mapping

• Band 5 — contribute to SOP review, draft minor revisions
• Band 6 — draft new SOPs in own specialty, lead annual reviews
• Band 7 — service-wide SOP harmonisation, document-control system ownership

Completed SOPs (anonymised) are accepted as IBMS Specialist Portfolio evidence in the Quality Management and specialty-specific sections.

Common interview question themes

• "Walk me through how you would draft a new SOP for a new method"
• "What goes in the references section of an SOP?"
• "How do you handle a conflict between an SOP and the manufacturer's IFU?"
• "Describe a time you had to revise an SOP after a near-miss"