Introduction: The assurance of quality through accreditation has long been a respected marker within industries such as healthcare, where it serves as a symbol of operational excellence and adherence to stringent standards. However, this noble pursuit is being undermined by the rapid commercialization of the accreditation process, leading to questions about the true value and integrity of these accreditations.
Rapid Commercialization: Accreditation boards have been aggressively promoting their services, pressuring various government ministries and international forums to mandate their accreditation for procurement processes. This campaign has borne fruit; accreditation is now often a prerequisite for government tenders and corporate contracts. Consequently, this has led to a concerning trend where vendors, even those lacking quality infrastructure, secure accreditation. The infrastructure only needs to be presented during the audit, allowing for manipulation, such as setting up a temporary show of compliance. Moreover, assessors, whether untrained or trained under the influence of accreditation body (AB) management, are under pressure to grant accreditations to ensure the financial viability of the ABs. This has led to a lack of proper selection criteria for applicants and a failure to scrutinize applications adequately. The outcome is an increase in the number of accreditations, but not in quality. The market is flooded with Certified Assessment Bodies (CABs) that lack fundamental quality infrastructure, contributing to worthless documentation and no real improvement in quality infrastructure.
Poor Monitoring by ILAC and Regional Cooperation Bodies: The International Laboratory Accreditation Cooperation (ILAC) and regional cooperation bodies have fallen into a similar pattern, focusing on increasing the numbers of ABs and CABs rather than ensuring the integrity of the accreditation process. This expansion is akin to a chain system where quantity trumps quality, undermining the very purpose of accreditation.
The Compromised Rigor of Accreditation: In the face of commercial pressures, the rigorous process of accreditation has been diluted. The competitive drive among ABs to expand their client base has led to a situation where quantity has overshadowed the quality of assessments. This risks certifying laboratories that may not be fully equipped or competent, thereby endangering patient safety and compromising the credibility of ISO 15189 accreditation.
Accreditation vs. Quality Assurance: Accreditation is mistakenly seen as synonymous with quality assurance. While it is meant to verify capabilities, accreditation cannot guarantee the quality of every test result, with factors like human error and equipment failure often falling outside its purview. This distinction is critical for patient safety and underscores the need for labs to prioritize continuous quality improvement over mere certification.
The Need for Reform: Urgent reforms are needed in the accreditation process to address these challenges. These include establishing robust selection criteria for accreditation applicants, implementing effective feedback mechanisms, and ensuring ABs prioritize the integrity of the process over financial interests. Simplifying the language of standards like ISO 15189 can also help ensure consistent application and understanding across labs.
Conclusion: The credibility of global accreditation is in jeopardy due to the prevailing commercialization and lack of stringent monitoring and accountability. A dialogue among all stakeholders, including labs, ABs, ILAC, and regional cooperatives, is essential to reform current practices. The ultimate goal must be to restore the faith in accreditation as a true reflection of a laboratory’s technical competence and commitment to quality.
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 chairmanship in a prominent laboratory organization, 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 info@sambhuchakraborty.com. Additional resourcesand contact information are available on his websites, https://www.quality-pathshala.com and https://www.sambhuchakraborty.com, or via WhatsApp at +919830051583.
Very insightful article. I love your work.