Prepare evidence that allows you to reconstruct the routine.
An audit needs to find the link between the defined procedure, what was performed and the review of its results. Having too many records doesn't help when there is a lack of context, responsible parties or a conclusion. The IQC must allow you to go from a control result to a critical analysis and evaluation of the actions taken.
Enlarge screenSeparate health standard and accreditation program
RDC 978/2025 deals with the health requirements of the covered services. Programs such as PALC and DICQ and ISO 15189 have their own scopes and processes. Identify the edition and reference applicable to the laboratory before assembling the checklist. The purchase of software does not replace the evaluation of the program nor does it confer accreditation.
Choose an occurrence and reconstruct the path
Locate equipment, material, batch and level; examine the graph and the criteria used; recover inquiry and action; check who reviewed it and how effectiveness was verified. If a step can only be explained from memory, record this gap as an opportunity to organize the evidence.
Use internal audit to track improvement
In QualiChart, the internal audit report brings together assessments, nonconformities and actions. Define the scope of the checklist and evidence criteria before applying it. A score is a summary; Review the outstanding items, assignees, and conclusions to know what the result represents.
Connect performance studies to routine control
Keep method verification studies, specification selection, and uncertainty assessment linked to quality procedures. The control chart provides routine information, but does not alone replace these studies. Plan revisions after relevant changes to the process or adopted framework.
References: ISO 15189:2022, PALC Program. Also follow the contents of measurement uncertainty and method verification.
Prepare your assessment
Gather the number of units and equipment, who will use the system and how the data reaches the team. The values depend on this scope and are upon request. Compare the plans and request a demo for your scenario.
Other routines: IQC for small laboratories · IQC for hospital laboratories · IQC for laboratory networks · IQC in the veterinary laboratory