Chapter 3 · Key technical requirements

Clause 7 covers: pre-examination (collection, transport, receipt), examination processes (methods, QC, EQA), post-examination (result validation, reporting, critical values), and the information management system. Each section must have documented procedures. Method verification is required before introduction of any new method.

Practical example

A laboratory wants to introduce a new analyser for HbA1c. Good practice: The section head runs a formal method verification against a reference method, documents bias, imprecision, and clinical decision limit performance, and obtains the QM’s sign-off before the method goes live. Poor practice: The analyser is unpacked and put into routine use the same day it arrives — no verification, no documentation, and a nonconformity waiting to happen.

What this means for your practice: Every new method must be verified before it is used for patient results. ‘It works fine on the vendor’s data’ is not verification.