12 Requirements Must Be Fulfilled For Effective Medical And Clinical Laboratory Accreditation

By Author: John
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Modern healthcare systems increasingly rely on medical laboratories because laboratory data are a crucial component of doctors' decision-making processes. Any healthcare or medical lab that intends to deliver findings that are therapeutically applicable and adhere to the highest ethical standards should pursue ISO 15189 accreditation, however, it is not required. The accreditation shows clients and other important stakeholders the dedication to best practices while ensuring that labs or organizations are completely compliant with all the intricate regulatory requirements.

Medical laboratories can use ISO 15189 to establish their management systems and evaluate their proficiency. It is also applicable for laboratory users, regulatory agencies, and accreditation bodies to confirm or recognize the proficiency of medical laboratories. A crucial revision to the ISO 15189 standard was published in December 2022. To provide accurate, dependable, and timely laboratory results, the medical laboratory quality management system must cover all 12 requirements. The 12 fundamental requirements must be put into practice in a manner ...
... that will benefit each laboratory most significantly. A medical laboratory quality management system can help maintain a high-quality laboratory that can identify errors and stop them from happening again, but it cannot guarantee a risk-free laboratory.

• Organization: The management must promote the laboratory QMS and find strategies to make personnel aware of its significance. According to this quality principle, important organizational elements include:
o Leadership: The leaders' dedication to the implementation process through teamwork, motivation, and communication abilities
o Structure: Organisational charts are necessary to define the organization's structure accurately
o Planning: Setting up a plan for skill development
o Implementation: When adopting the LQMS, management should address any problems
o Monitoring: Systems of observation ensure that LQMS designs adhere to requirements. Additionally, it is essential for the ongoing development

• Personnel: They are in charge of establishing and adhering to QMS in a laboratory. It is the laboratory director's responsibility to provide accurate job descriptions and hire qualified personnel. He should also be in charge of their continuous education, including ISO 15189 awareness training and keeping them up to date on the latest technology and trends. Employees must go through a performance appraisal, which includes a detailed evaluation of things like policy adherence, safety regulations compliance, communication skills, punctuality, and behaviors.

• Equipment: It is critical to have well-working equipment because
it improves performance, confidence, and reliability in the findings. It also reduces repair costs and extends service life. Installation, calibration, maintenance, troubleshooting, and validation can all contribute to efficient equipment management.

• Purchasing and Inventory: To guarantee that demands for essential
supplies and services are constantly supplied, it describes the agreements the laboratory has with clients and outside vendors. The availability of inventory when needed and the efficiency and cost-effectiveness of operations are both guaranteed by proper purchasing and inventory rules.

• Process Control: It outlines activities related to the laboratory's course of workflow, both directly and indirectly, to meet requirements and maintain efficient resource usage. Sample management is one of the processes that are crucial to laboratory performance. To avoid damage, the sample must be properly preserved as soon as it is collected.

• Information Management: Guidelines for managing information generated and entered into laboratory record-keeping systems, such as patient demographics, examination outcomes, and reports and interpretations.

• Documents and records: Any necessary information must be available and reachable. wherever necessary in ISO 15189 documents. It is necessary to update the ISO 15189 documents and use standardized forms and formats for logging data.

• Occurrence Management: It is necessary to look at incidents to determine the root causes. This stops a subsequent occurrence. By implementing the proper Corrective and Preventive Actions (CAPAs), incidents can be corrected once they have been discovered.

• Assessment: An LQMS's evaluation of all its operations and proof that it complies with legal and customer criteria are both essential components of the assessment quality principle. Assessments are replaced with audits in ISO.

• Process Improvement: A continuous improvement process, according to ISO 15189, should: identify deficiencies, establish an improvement plan, implement it, evaluate its efficacy, and adjust.

• Customer service: Customers (patients, physicians, and public health agencies) frequent laboratories, and the laboratory director is responsible for guaranteeing and monitoring client satisfaction. Satisfaction can be measured using a variety of methods, including surveys, indicators, and audits.

• Facilities and Safety: The laboratory manager is in charge of safety and quality. A person must actively participate in laboratory design, identify all potential dangers, and provide feedback on the development of a safe laboratory.