ISO 15189:2022, a standard critical for medical laboratory quality management, is currently failing the very institutions it aims to guide. This standard, integral for ensuring the competence of medical laboratories, lacks the necessary specificity in documentation and record requirements across several crucial clauses. This glaring deficiency hampers uniform quality practices, breeds ambiguity during audits, and ultimately, jeopardizes patient safety.
Clause 4: Misguided Management Requirements
Under Clause 4, which outlines general management requirements, the standard fails to deliver detailed directives on essential documentation to verify compliance. Laboratories are left to navigate a murky framework, resulting in varied and often non-compliant practices. The absence of standardized record-keeping for demonstrating impartiality, confidentiality, and patient care responsibilities is not just inadequate—it’s unacceptable.
Clause 5: Structural Weaknesses Exposed
The structural and governance mandates in Clause 5 similarly lack depth in their documentation directives. While the clause underscores the importance of establishing legal entities and defining roles like the laboratory director, it stops short of detailing the necessary records to substantiate these requirements. This oversight leads to structural vulnerabilities that undermine governance and operational integrity.
Clause 6: Resource Management in Disarray
The resources crucial for laboratory operation covered in Clause 6—from personnel to equipment and external services—are managed without a clear documentation roadmap. The omission of detailed record-keeping instructions across subclauses 6.1 through 6.8 allows inconsistencies that can disrupt laboratory efficiency and effectiveness, laying a precarious foundation for quality and reliability.
Clause 7: Process Control Chaos
In Clause 7, which deals with process requirements from pre-examination to post-examination and everything in between, the lack of explicit documentation instructions creates a procedural black hole. Without clear guidance on how to document and verify processes, laboratories struggle to maintain the accuracy and reliability of their testing, which is at the heart of patient safety and care.
Clause 8: Oversight Overlooked
Finally, Clause 8’s general management system requirements, meant to encapsulate the essence of laboratory quality management, tragically fall short. The failure to specify detailed documentation for quality management systems, management responsibility, and continual improvement processes fosters a compliance landscape marked by confusion and inconsistency.
Conclusion: A Standard That Undermines Standardization
The pervasive lack of clarity in ISO 15189:2022’s documentation and record requirements not only makes uniform quality practices unachievable but also fosters ambiguity that complicates audits by accreditation bodies. Laboratories are left to interpret vague guidelines, leading to a compliance quagmire that dilutes the quality and safety of laboratory services.
The ongoing use of a standard that so fundamentally fails to delineate clear documentation practices is not only unhelpful—it is detrimental. ISO 15189:2022 must be withdrawn and revised with the urgency and seriousness this critical oversight demands. Only through clear, actionable, and detailed documentation guidelines can we hope to uphold the high standards necessary for medical laboratory excellence and reliability.
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 International Organization of Laboratories ( 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 info@sambhuchakraborty.com and contact information are available on his websites,https://www.quality-pathshala.com and https://www.sambhuchakraborty.com , or via WhatsApp at +919830051583.