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SOP TEMPLATE

Equipment Management SOP template (ISO 15189:2022)

Selection, acceptance, maintenance, calibration and retirement of laboratory equipment. Supports ISO 15189:2022 6.4, 6.5.

Last reviewed

Purpose

An equipment management procedure sets out how the laboratory selects, introduces, maintains and retires equipment used in its service. It covers the full working life of an item rather than treating maintenance as the only control. The scope should identify which instruments, supporting devices and relevant software are included and how leased, shared or externally serviced equipment is managed.

A good version assigns an equipment owner and describes the evidence needed before an item enters routine use. Acceptance checks should relate to intended use, installation conditions and performance expectations. Maintenance, calibration and verification arrangements need clear schedules, responsible persons and criteria for deciding whether equipment remains suitable. Where traceability is relevant, link to the laboratory's metrological traceability arrangements.

Include practical steps for breakdowns, overdue work, relocation and return to service. Staff should know how to label or otherwise restrict unavailable equipment, assess possible effects on earlier results and obtain authorisation before resuming testing. The equipment history should bring together identification, service visits, checks and important decisions. Retirement instructions should address data removal, decontamination and disposal without assuming that a contractor takes responsibility for every laboratory obligation.

Section outline

  1. Purpose
  2. Scope
  3. Responsibilities
  4. Acceptance testing
  5. Maintenance and calibration
  6. Malfunction and out-of-service
  7. Records

Headings only — the full template is drafted for your laboratory inside the app.

When to use it

  • Introducing equipment or consolidating equipment registers.
  • Clarifying maintenance and calibration responsibilities.
  • Reviewing breakdown response and return-to-service decisions.

Tips for writing it well

  • Define acceptance evidence for each equipment category.
  • Separate maintenance tasks from calibration and performance checks.
  • Specify who can authorise return to patient testing.
  • Include an assessment of results potentially affected by malfunction.

Clauses it supports

Check the exact requirement in your licensed copy of the standard.

Network dual-brand — Lakeside Regional Health · Lab Network (sample). Equipment Calibration and Maintenance; fictional branded SOP cover.

Sample cover design · fictional laboratory. Your own logo and letterhead are used on every controlled copy.