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ISO 15189:2007 requirements

Quality control is addressed in section 5.6, ‘Assuring the quality of examination procedures’.

Laboratories are required to design IQC systems that verify that results are of the required quality, with special attention being paid to the elimination of mistakes in the process of handling samples, requests, examinations, reports, etc.

Specific activities identified in the standard include:

• participation in a suitable programme of interlaboratory comparisons (EQA)
• use of suitable reference materials
• examination or calibration by another procedure.

The CPA (Clinical Pathology Accreditation (UK) Ltd) Standards for the Medical Laboratory (2007) has broadly similar requirements to ISO 15189 but contains some additional detail on IQC activities. Laboratories are required to have IQC procedures for all examinations which will verify that the intended quality is achieved. The IQC activities must include:

• records of date, source and storage requirements of QC materials
• the process of validation of QC materials before use
• appropriate statistical procedures
• acceptance criteria for results obtained from the QC materials (where applicable)
• ensuring that all QC results are recorded and regularly evaluated, and that any subsequent remedial or corrective actions taken are recorded.