ISO 15189:2022 · Section 6 · Resource requirements
Clause 6.6: Reagents and consumables
Check the exact requirement in your licensed copy of the standard.
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What this clause is about
Reagents and consumables can introduce error before an instrument produces any warning. A laboratory therefore needs a controlled route from ordering and receipt through storage, acceptance, use, and disposal. The depth of control should reflect the item's influence on patient results, not simply its purchase price. Collection tubes, stains, culture media, calibrators, and disposable reaction vessels may all deserve specific checks.
Define who receives deliveries, what they inspect, and how they identify material awaiting acceptance. Check delivery conditions, packaging integrity, identity, expiry, and any temperature information relevant to stability. An item should not become available for patient work merely because someone placed it on the normal shelf. Where a new lot or shipment could change performance, establish suitable acceptance criteria before examining the comparison data.
Inventory records should connect each important item to its supplier, lot, receipt, acceptance decision, storage location, and period of use. Record preparation and opening dates when these affect usable life. Staff need clear instructions for stock rotation, expiry checks, unusual storage excursions, recalls, and shortages. Locally prepared reagents need enough preparation detail to reproduce the preparation and identify who authorized release.
Review recurring wastage, failed acceptance checks, and supply interruptions to improve purchasing and stock levels. Keep rejected material separate or unmistakably blocked from use. LabToolkit Pro can support controlled reagent procedures, receipt forms, and approval records; the laboratory remains responsible for selecting appropriate technical checks and making release decisions.
What assessors typically ask to see
- How do staff distinguish newly received stock from material already accepted for patient testing during busy shifts?
- What evidence supports the acceptance criteria chosen for each reagent category, including clinically important lot changes?
- Can a patient testing period be connected to the reagent lots, preparation records, and acceptance decisions used?
- Who decides whether a delivery temperature excursion affects usability, and where is the technical justification recorded?
- How are shortages handled without silently substituting unassessed consumables or bypassing established acceptance checks?
- How do staff identify recalled, expired, damaged, or rejected stock at every location where it could be used?
Documents and records that usually provide evidence
- Controlled receipt and acceptance procedure describing responsibilities, segregation arrangements, and release authority for relevant product groups.
- Delivery inspection records showing item identity, lot, expiry, condition, temperature concerns, and the receiving staff member.
- Lot comparison worksheets with predefined acceptance criteria, actual observations, interpretation, and authorization before routine use.
- Stock registers linking available quantities, storage locations, opening dates, preparation dates, and applicable usable life.
- Storage monitoring logs and excursion assessments that explain the final disposition of affected reagents or consumables.
- Recall and rejection records showing stock containment, supplier communication, replacement arrangements, and any patient impact assessment.
Ready-made forms mapped to clause 6.6: Refrigerator Temperature Monitoring Log, Freezer (–20 °c) Temperature Monitoring Log, Freezer (–80 °c) Temperature Monitoring Log, Goods Receiving Inspection Checklist, In-house Reagent Preparation Log, Reagent Label, Stock-take & Expired Items Record, Lot-to-lot Verification Log.
Common findings to avoid
- Acceptance records contain signatures but omit the measurements or observations supporting the decision to release a new lot.
- Opened containers have no revised expiry date even though their stability differs from the unopened product.
- Stock software lists an item as available while its physical container remains under investigation or recall.
- Substitute collection devices enter routine use without checking their compatibility with the examination and specimen requirements.
How LabToolkit Pro maps documents to this clause
Each SOP, form and record in LabToolkit Pro can carry clause tags. When a document tagged 6.6 becomes effective, it counts as direct evidence on the readiness dashboard for ISO 15189:2022; links from other standards through the crosswalk are shown separately as indicative coverage. Gaps appear clause by clause, so you can see which parts of 6.6 still need a controlled document or a current record. Readiness is a planning aid — only an accreditation body confirms conformity.
Frequently asked questions
Does every new lot need the same comparison study?
No. Choose checks according to intended use, known variation, clinical risk, and available manufacturer information. A high impact reagent may need patient sample comparisons, while another consumable may need a documented physical or functional check. Explain the rationale and retain the acceptance evidence rather than applying an identical exercise to everything.
What should happen after a storage excursion?
Identify the affected stock and prevent unintended use while a competent person evaluates stability information, excursion duration, and likely impact. Obtain supplier advice where useful, but record the laboratory decision. If material was already used, consider whether patient results require investigation and whether communication or correction is necessary.
Can electronic forms replace paper stock records?
Yes, provided the records remain identifiable, protected, retrievable, and suitable for their purpose. Define required fields and access permissions, preserve changes, and ensure staff can work during system interruptions. A completed electronic form is useful only if it reflects an actual check and links reliably to the physical stock.
Check the exact requirement in your licensed copy of the standard.
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