In the realm of quality management and standardization, two terms often emerge: accreditation and certification. While these terms might seem interchangeable at first glance, they represent distinct processes with unique purposes and outcomes. In this article, we delve into the disparity between accreditation and certification, shedding light on why ISO 15189, specifically, is classified as an accreditation standard rather than a certification standard.
Accreditation vs. Certification: Deciphering the Contrast
Before we explore the nuances of ISO 15189, it’s imperative to grasp the fundamental disparities between accreditation and certification.
Accreditation: Accreditation is a formal recognition process by which an authoritative body assesses the competence, integrity, and impartiality of organizations against predetermined standards. It focuses on evaluating the overall quality management system and processes of an organization within a specific industry or sector. Accreditation is typically conducted by external bodies known as accreditation bodies, which are tasked with ensuring that organizations meet rigorous standards set forth by international or national accrediting bodies.
Certification: Certification, on the other hand, is a process whereby an independent third party verifies that an organization, product, service, or process meets specified requirements outlined in a standard or set of standards. Certification tends to be more product- or service-specific and focuses on confirming compliance with predetermined criteria or specifications. It is often carried out by certification bodies, which evaluate individual products, services, or processes against established benchmarks.
Accreditation and certification of medical laboratories serve different purposes and are based on different standards. Certification, such as ISO 9000, focuses on the quality management system (QMS) of an organization. It demonstrates that the laboratory has a consistent process for ensuring quality in its operations, but it does not specifically assess the technical competence of the lab in performing specific tests.
Accreditation, on the other hand, such as ISO 15189, is specific to medical laboratories and evaluates both the QMS and the technical competence of the lab. It assesses the ability of the lab to produce precise and accurate test results, ensuring the laboratory meets both international standards and the specific requirements necessary to perform medical testing.
Why ISO 15189 is an Accreditation Standard
ISO 15189 is a quality management standard specifically tailored for medical laboratories. It outlines the requirements for competence and quality in medical laboratory processes, encompassing factors such as personnel competence, quality control, laboratory equipment, and the handling of samples and data. While ISO 15189 shares similarities with certification standards like ISO 9001, it is fundamentally an accreditation standard. Here’s why:
Comprehensive Assessment: ISO 15189 evaluates the entire quality management system of a medical laboratory, encompassing all aspects of laboratory operations. Accreditation against ISO 15189 involves a thorough assessment of the laboratory’s processes, procedures, personnel competency, equipment, and facilities to ensure compliance with the standard’s requirements.
Focus on Competence: Unlike certification standards, which may focus primarily on product or service specifications, ISO 15189 places significant emphasis on the competence of laboratory personnel and the reliability of laboratory results. Accreditation to ISO 15189 validates the proficiency and expertise of laboratory staff, ensuring that they possess the necessary skills to perform accurate and reliable testing.
Enhanced Credibility: Accreditation to ISO 15189 enhances the credibility and reliability of medical laboratories by demonstrating their compliance with internationally recognized quality standards. Accredited laboratories are perceived as more trustworthy and competent, instilling confidence in patients, healthcare providers, and regulatory authorities.
Continuous Improvement: ISO 15189 accreditation promotes a culture of continuous improvement within medical laboratories, encouraging ongoing monitoring, evaluation, and enhancement of processes and practices. Accredited laboratories are required to implement quality management systems that facilitate continuous learning and adaptation to evolving technological advancements and best practices.
In conclusion, while both accreditation and certification play vital roles in ensuring quality and conformity to standards, ISO 15189 stands out as an accreditation standard tailored specifically for medical laboratories. By emphasizing competence, comprehensive assessment, and continuous improvement, ISO 15189 accreditation elevates the quality and reliability of medical laboratory services, ultimately contributing to improved patient care and outcomes.
About the Author
Dr. Sambhu Chakraborty is a distinguished consultant in quality accreditation for laboratories and hospitals. With a leadership portfolio that includes directorial roles in two laboratory organizations and a consulting firm, as well as chairman of IOL ( An ILAC stakeholder organisation), Dr. Chakraborty is a respected voice in the field. For further engagement or inquiries, Dr. Chakraborty can be contacted through email at director@iaqmconsultants.com and contact information are available on his websites,https://www.quality-pathshala.com and https://www.sambhuchakraborty.com , or via WhatsApp at +919830051583