As a medical laboratory, providing accurate, reliable, and timely results is crucial for patients’ effective diagnosis and treatment. ISO 15189 accreditation for medical laboratories is an international standard that helps ensure the competence of medical laboratories and the quality of their results.
Introduction to ISO 15189 Accreditation for Medical Laboratories
ISO 15189 is focused on the medical laboratory, and its objectives are to satisfy interested parties. In such cases, stakeholders are not only customers, such as patients, but include internal or external involvement with the medical laboratory, such as professionals, suppliers and accreditation agencies. For this reason, the ISO focuses on a management system and medical laboratory technical specifications. A point to note that below are some terms which are commonly used in many standards:
- Shall – A compulsory requirement;
- Should – A recommendation;
- May – Instructs permission;
- Can – A possibility or a capability.
What Is ISO 15189 Accreditation for Medical Laboratories?
ISO 15189 is an international standard for medical laboratories to help them develop quality management systems, assess their competence and ensure that they function in line with industry and legal standards.
As part of every ISO, a quality manual is required. This is no different from an ISO 15189 accreditation process. This article will explain how the laboratory should function to a high standard.
Why Is ISO 15189 Accreditation for Medical Laboratories Important?
ISO 15189 accreditation for medical laboratories specifies the requirements for the management of a medical laboratory, including the design and operation of the laboratory, the assessment of technical and diagnostic performance, and the reporting of results. The standard is intended to ensure that medical laboratories are able to provide results that are fit for their intended purpose.
ISO 15189, like ISO 17025, is a mark to show competence and confidence awarded to medical laboratories. Nowadays, legal compliances require laboratories to be ISO 17025 accredited, so having medical laboratories up to ISO 15189 is even more crucial to show integrity, impartiality and competence.
What Are the Benefits of ISO 15189 Accreditation for Medical Laboratories?
Becoming certified with ISO 15189 can provide a number of benefits to a medical laboratory. It can help demonstrate the laboratory’s competence and commitment to quality, enhancing its reputation and trust among patients and healthcare providers. Certification can also support continuous improvement, as the standard requires regular assessment and review of the laboratory’s performance.
Risk Reduction
With an ISO 15190 quality system, the organization will operate with a rigorous approach. For this reason, with good traceability and record structure, identification and planning mitigation measures for potential risks will be easier. This will give rise to risk reduction.
Cost
ISO 15189 accreditation can be expensive to run. However, improvement in the issue of results by assuring that they are technically valid and repeatable will save costs associated with retesting.
Legally Compliant
ISO 15189 accreditation for medical laboratories is not legally required. However, policymakers are pushing for more accredited labs and better certification. Therefore, it is essential to look at national legal compliances, where labs might be required to hold ISO 17025 accreditation. This would be equivalent to ISO 15189 for medical laboratories.
Competence And Efficiency Will Lead to Profit.
With improved competence of all staff, staff will be more motivated to continue progressing professionally and get up to speed with modern technologies. This will improve innovation and efficiency, giving rise to more profits.
Challenges For ISO 15189 Accreditation for Medical Laboratories
As with any accreditation certification, ISO 15189 does not come without challenges. Although this list could be exhaustive, and any organization should determine their own challenges, some common challenges will be summarized below to prepare any potential organization.
Trained Staff Turnover
Staff retention is always an issue when competency is required. In an ISO accredited lab, this is more crucial, when organizations spend time and money to train members of staff to a required level, which then moves on to other opportunities. Unfortunately, replacing competent staff is always resource-demanding, and organizations can never guarantee staff retention.
Equipment
The most significant resource in an accredited laboratory would be equipment. Equipment requires capital costs for purchasing, operating, maintaining, verifying and training personnel. Apart from this organizations must ensure that suppliers or manufacturers of such equipment are readily available to provide any required support to ensure proper running or corrective measures when needed.
Management Support
Management’s goal is to get the highest profit with the least amount of expenses. For this reason, ISO accredited laboratories may seem more expensive than profitable without proper support, as more validations and verifications will be required. This goes without saying; the costs of proficiency testing and internal quality controls that would be necessary with every batch of tests quickly pile up. Nonetheless, less repeatability of tests, and greater validity of results, together with an increase in markets, from compliance sectors, will ensure that the return on investment will be beneficial.
