ISO 15189

1. Examination procedures :

* Procedure for carrying out the test ¹

* important requirement and must be reviewed regularly

* may be in the form of textbook instructions, journal article

2. Assuring the quality of examination procedures :

* have an IQC program to verify quality of patient test results¹(e.g. regular testing of QC materials and records¹ etc),

* participating in EQA programs

3. Post-examination process

* review of results before being reported

* used samples disposed in an environmentally and human-safe manner

4. Reporting of results

* used only approved forms

* results must be retained for a minimum period

* relevant information (e.g. reference range) must be included

5. Alteration and amendments of reports

* must be recorded and verified

(104 words excluding citations)

Reference

Cooper, Greg (2004). Preparing Your Laboratory to Certify or Accredit Under ISO 15189. Bio-Rad Laboratories. Retrieved June 16 2008 from http://www.sacb.org.sg/documents/PreparinglabforISO15189-GCooper.pdf