ISO 15189 is an international standard that defines the quality management system and competency standards for medical laboratories. The purpose of ISO 15189:2022 is to improve patient well-being and happiness by increasing trust in medical laboratories' competency and quality assurance.
Medical laboratories accredited to ISO 15189:2012 have three years (until December 2025) to transition to ISO 15189:2022, whereas labs seeking to be newly accredited to ISO 15189 must comply with the 2022 version.
The Advantages of ISO 15189 Accreditation
Why bother obtaining ISO 15189 accredited if it isn't required?
There are several compelling explanations.
- Patient Safety and Quality Assurance: Because ISO 15189 provides a crucial quality assurance role that maximises the integrity of your operation, obtaining ISO 15189 certification ensures that the results your lab produces for clients are accurate, dependable, and trustworthy. This, in turn, gives healthcare providers and patients confidence that any treatment recommendations based on the results you offer are sound. Results from ISO 15189 accredited labs can be used by healthcare providers (HCPs) in their decision-making process to identify risk factors and predispositions to diseases, confirm or reject a diagnosis, guide therapy management, and monitor the success of a patient's treatment.
- International Recognition: ISO 15189 is a worldwide accepted accreditation. Companies and organizations that outsource medical laboratory testing sometimes employ ISO 15189 accreditation as a minimum criterion before adding a lab to their Preferred Partner List. The NHS in the United Kingdom, for example, requires labs that provide screening services for specific diseases to be ISO 15189 certified. And, as previously said, 60 nations have made ISO 15189 a required criterion for medical laboratory accreditation, with the number rapidly increasing.
- Continuous Enhancement: The positive aspect of ISO 15189 is that it requires laboratories that adhere to the standard to continuously improve their management system. Opportunities for improvement can be discovered in a variety of techniques, as specified by the ISO 15189 standard:
- Findings of internal audit (Clause 8.3.3)
- Disputes (Article 7.7)
- Corrective measures (Clause 8.7)
- Management evaluations (Clause 8.9)
- Employee, cautious, and user input or suggestions (Clause 8.6.2)
- Data analysis (data inputs stated in several clauses)
- Risk evaluations (Clause 8.5)
- Policy and procedure review and implementation (different provisions)
- Assessment of overall goals (Clause 5.5)
- Reports on external evaluation and assessment (Clause 7.3.7.3)
- Cost Savings and Efficiency: Poor quality management methods in a medical laboratory will result in greater expenses and decreased efficiency. One example of this is the usage of resources to repeat testing when failures occur. By identifying faults using the ISO 15189 non-conformance process, labs can implement corrective and preventive activities and assess their success to ensure that such errors do not recur.
Failure to evaluate the effectiveness of corrective actions in line with ISO 15189 can cause the lab to continue an expensive cycle of low quality and inefficiency. If a lab lacks a strong non-conformance, it will not only waste resources (both time and money) on repeat testing, but more errors will necessitate more investigations, root cause analysis, and corrective actions, all of which will cost the healthcare lab even more in the long run.
No comments yet