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Quality and Qualification

Validation for healthcare calibration

Validation provides documented evidence that equipment, a process or an environment performs as intended for a defined use.

Technical explanation

What it means

Validation is broader than calibration because it focuses on intended use, process performance, acceptance criteria and documented evidence.

Why it matters

  • Supports controlled processes and quality systems.
  • Applies to equipment such as autoclaves, refrigerators, freezers and incubators where performance over time or space matters.
  • May include protocols, mapping, qualification and deviation review.
  • Helps teams show suitability for intended use.

How hospitals and biomedical teams use it

  • Define intended use and acceptance criteria before validation.
  • Use approved protocols for IQ, OQ, PQ or mapping where applicable.
  • Document deviations and corrective actions.
  • Review validation reports alongside calibration certificates where both are needed.

Related services

Helpful downloads

Frequently asked questions

Is validation the same as calibration?

No. Calibration checks measured accuracy, while validation confirms suitability for intended use.

What documents are needed for validation?

A protocol, measured data, acceptance criteria, deviations and final report are commonly used.