Secure · Assessment grid

ISO 11137-1 radiation sterilization readiness grid

Self-assessment of a radiation sterilization process per ISO 11137-1:2025 (development, validation, routine control).

Available (Edition 2025)

ISO 11137-1:2025

FormatExcel (.xlsx)

$0Free

Currency

What this resource includes

The 43 requirements across 9 sections (QMS, sterilizing agent, process and equipment, product, dose, validation, routine control, release, maintaining effectiveness).
A conformity scale with rate and dashboard computed automatically.
Covers dose setting, dose mapping and IQ, OQ, PQ qualification (with ISO 11137-2 and ISO 11137-3).
Original HEMC content, no reproduction of the normative text.

HEMC methodological reference. It does not replace a full reading of the standard or tailored support.

Online version

The same ISO 11137-1 standard, scoring itself as you go

The ISO 11137-1 workbook you have here also exists as an online audit, with 56 control points, a rate that updates as you go and a history of your passes. It is not the same document, it is the same standard tooled differently.

Guided entry, score computed continuously
Structured summary report, printable to PDF in one click
Fourteen-day trial, no credit card

Open the ISO 11137-1 audit checklist

NormePulse is published by HEM Consulting. The trial commits you to nothing and asks for no payment method.