One of the medical laboratory missions is to produce credible and reliable pathology reports in direct support of diagnostic decision-making. Most medical laboratories accomplish this by implementing the contemporary quality management system guideline, such as ISO 15189:2012. Since its release by the International Organization for Standardization on 1 November 2012, ISO 15189:2012 has become the primary source of guidance for the pathology industry. Competent implementation enables operational success by maintaining and enhancing the medical laboratory’s capability to improve patient safety, risk mitigation and operational optimisation. A comparative study of ISO 15189:2007 and ISO 15189:2012 administrative requirements has been performed in order to highlight the main changes required for implementation. A total of 22 administrative requirement headings are used in the gap analysis. There are several main administrative requirements that have been identified, requiring significant resources for the implementation. These include criteria, documented procedures, instructions, processes and contingency plans. ISO 15189:2012 requires further consideration of at least 14 criteria, 23 documented procedures, 17 instructions, 18 processes and 2 contingency plans. This paper is divided into four sections: first, other international standards that are relevant to medical laboratory operations are correlated; second, compliance requirements for ISO 15189:2012 implementation are discussed; third, the strengths and weaknesses of ISO 15189:2012 are analysed; and fourth, change management recommendations for implementation are considered. This paper will highlight the required changes and likely challenges that will be encountered by medical scientists involved in quality process enhancements.