Simplify the Advantages of ISO 15189 Accreditation

ISO 15189 is the international standard that outlines the Quality Management system and competency needs that apply to medical laboratories. The standard was most recently updated in 2022 to better line up with ISO 17025:2017, the benchmark for testing and calibration lab competency.

ISO 15189 includes all the aspects of Quality Management in medical laboratories from the stage of planning and designing up to the final disposal of medical laboratory wastes. It covers the needs of laboratory facilities, ISO 15189 auditor training, and management of laboratory information.

Advantages of ISO 15189 Accreditation

Obtaining ISO 15189 accreditation assures your clients that the findings your lab produces for them are accurate, dependable, and trustworthy because it carries out a crucial quality assurance function that maximizes the integrity of your business. There are lots of advantages to having ISO 15189 accreditation. Below are some of the main advantages of ISO 15189 accreditation for medical laboratories.

Quality Assurance and Safety of Patients: Consequently, ISO 15189 gives patients and medical professionals confidence that any decisions made about therapy based on your findings are sound. Healthcare professionals (HCPs) can use test findings from ISO 15189 accredited labs to help them make decisions about risk factors and disease predispositions, confirm or deny a diagnosis, direct therapy management, and assess how well a patient is responding to treatment. The safety and well-being of patients are thus significantly impacted by a laboratory's reputation for reliability.

Reduced the Risk: Implementing the ISO 15189 needs helps labs to identify the risks with their operations. By adhering, to the proper practices and planning for the risks laboratories can decrease the errors equipment failures as well as other problems that can risk test results' accuracy or patient safety. In medical laboratories, where patient safety is paramount, proactive risk management is extremely important.

International Identification: ISO 15189 is a worldwide recognized standard. ISO 15189 accreditation is frequently used by businesses that outsource medical laboratory testing as a prerequisite before a lab can be included in their Approved Supplier List.

Continual Improvements: The advantages of ISO 15189 are that it needs labs following ISO 15189 to continuously improve its management. The ISO 15189 standard requires that the potential for improvement be identified in several methods, including the following:

• Clause 8.3.3: Findings from internal audits
• Clause 7.7: Complaints
• Clause 8.7: corrective actions
• Clause 8.9: management reviews
• Clause 8.6.2: recommendations or input from staff, patients, and users
• Data analysis (data inputs stated in different clauses)
• Evaluation and application of policies and processes (several clauses)
• Risk assessments (Clause 8.5)
• Review of the general goals (Clause 5.5) Reports on
• External assessments and evaluations (Clause 7.3.7.3)

Cost Savings: ISO 15189 accreditation encourages efficiency and cost savings in the laboratory. By ensuring that the results are valid, laboratories can decrease the require the retesting, and save time and resources. In medical laboratories, poor quality control methods might result in increased expenses and decreased productivity. Through the non-conformance process mandated by ISO 15189, errors can be found, enabling labs to put preventive and corrective measures into place and assess their efficacy. If this isn't done, a cycle of inefficiency and low quality may continue. Due to incorrect diagnoses and ineffective treatment plans, this could endanger people's lives, harm the lab's reputation, and result in more complaints. Thus, to avoid these problems, labs must put in place strong quality management systems.

Enhance the Team Confidence: ISO 15189 significance the importance of staff members. By implementing the ISO 15189 requirements labs can decrease staff errors which leads to improved team morale. Recognizing and encouraging technical proficiency among employees cultivates a culture of excellence and professionalism, which in turn improves the laboratory's performance and reputation.

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