Upgrading the Iranian national laboratory standard to conform to ISO 15189:2012

Abstract

The Reference Health Laboratory (RHL) of Iran is the national authority responsible for making policies and plans for providing quality laboratory services throughout the country. RHL composed a national laboratory standard in 2007 as the minimum mandatory quality requirements for clinical laboratories. The reference of that standard was ISO 15189:2007, with considerable modifications. It also contained many technical details from other credible references to become applicable for Iranian laboratories. Shortly afterward, complying with the national standard became a condition for renewing laboratory licenses. The success rate of license renewal in 2016 revealed that the majority of laboratories had implemented the main requirements of the standard. Therefore, we decided to upgrade the national standard and make it more compatible with ISO 15189:2012. Nevertheless, we tried to keep it comprehensible and user friendly, and adjusted it to the national regulations. To ensure that the new edition matches the local needs, all laboratory stakeholders were involved in revising the related sections. The second edition of the national laboratory standard is used as a scale for competency assessment. It follows the structure and format of the ISO 15189:2012. The content is also similar, although some explanations, examples and regulatory requirements are added to clarify or adapt it to the local condition. Here, we reviewed the process of upgrading the standard and discussed why and how we elaborated on certain sections of the international standard to make it easily understandable and facilitate its application while preserving the format and structure of the ISO 15189.