Is Iso 15189 Accreditation Required For All Laboratories?

By Author: Rohan
Total Articles: 57
Comment this article

As we are all aware, a significant number of medical decisions depend on the outcomes of tests. Insufficient services are primarily responsible for the high rate of medical errors. With so much at risk, it is advisable to frequently review the standards and proficiency of the services that an organization offers. Equipment that is not suitable for the purpose or ordinary use might cause issues. To give the best outcomes as securely as possible, laboratories must meet the International Standards Organization's (ISO) requirements for technical expertise. Laboratory testing is becoming increasingly crucial in the delivery of data-driven healthcare results. Because the eventual recipients of such testing are patients whose systems have been damaged by disease, it is vital that such testing is only performed by qualified individuals who follow to the highest ethical standards. The results of such testing must be therapeutically relevant as well as meet the highest quality standards.

Accreditation works best when it is based on a policy framework for reviewing laboratory quality and patient safety. Accreditation is a compulsory ...
... requirement for testing operations in some nations, but in other nations, the accreditation is voluntary and motivated by market forces. Management may demand laboratories functioning under the accrediting standard to provide specific improvement plans and take timely action to demonstrate compliance, with persistent failure to comply resulting in penalties, service limitations, and prohibitions from future testing. An ISO 15189 accreditation can assist considerably in reducing errors in some circumstances. A laboratory's dedication to providing outcomes that satisfy widely acknowledged criteria for competence and quality is demonstrated by accreditation to the ISO15189 International Standard. The accreditation requires a great effort to get. It will frequently demand expertise that the laboratory does not regularly utilize, and it might not be cost-effective to keep such knowledge in the permanent employees.

Medical laboratories can use ISO 15189, because it is a widely accepted accreditation, to evaluate proficiency. It can also be used for confirming or recognizing the competence of the customers, leading authorities, and accreditation bodies, according to its official document. In essence, it can be utilized as a gauge for how potential clients evaluate your firm on factors like trustworthiness and credibility, in addition to assuring the dependability of the organization’s services. Integrity, impartiality, and capabilities are the three most important aspects of a laboratory, that are verified by accreditation.

Being ISO 15189 accredited is strongly advised if the organization work in the medical industry but is not mandatory. A certificate that testifies to the abilities and consistency of the equipment used to provide the services will help to ensure that errors occur as infrequently as possible, and that customer confidence remains unquestioning. The services that organizations provide should be as reliable as possible to prevent compromising customer health. Additionally, the accreditation will show stakeholders that organizations are dedicated to protecting their data.

If an organization wants to constantly increase business resilience, improve team morale & staff confidence, achieve preferred supplier status, besides attracting new customers and business opportunities. To get a competitive advantage, improve processes and competence along with improving quality, and rises brand reputation, every organization needs to be ISO 15189 accredited.