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
• Checks your draft against the ISO 15189:2022 document control checklist
• Ends with an assessment and a PDF certificate when you pass

The SOP you draft stays on screen for you to copy into your own document-control system; there is no DOCX or PDF export of the SOP itself, and no upload of your laboratory's documents.

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, which always takes precedence

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

Cite your drafted SOPs (anonymised) and the certificate in your IBMS Specialist Portfolio quality evidence.

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"