Do you own a medical laboratory? Enhance the quality of your service management with the ISO 15189 certification standard! Get certified in less time with Compliancehelp Consulting LLC!
ISO 15189 is the global benchmark offering comprehensive guidelines for maintaining the quality and competence level of services by medical laboratories. The set of requirements it provides helps companies with process management. From pre-analytical to post-analytical phases, the standard ensures each stage cooperates to achieve the bigger goal – increasing the level of customer satisfaction. With an effective implementation of ISO 15189 clauses, medical laboratories can produce reliable and accurate test results for health monitoring, medical treatment, and diagnosis.
The fundamental design and purpose of the standard align with the original ISO 17025 standard, which is the management standard for testing/calibration centers. However, ISO 15189 precisely focuses on the laboratory firms that work with medical devices, treatment facilities, and pathological diagnosis. The focus of the standard is solely on enhancing quality for competence and clinical support.
1. Builds trust among the target segment – A certified laboratory represents itself as a committed body for providing reliable test results. The stringent control measures designed by the benchmark ensure dependable and precise test results. Therefore, both the medical professionals and the patients start relying on the firm.
2. A steady revenue margin – To ensure a steady revenue and market hold, medical laboratories need to maintain their commitment towards serving results that can be trusted without a second opinion. Quality is the key to keeping customer loyalty, and that drives revenue.
3. Brand image and market exposure – With the certification in hand and a loyal and niche customer segment, a laboratory establishes and subsequently strengthens its brand image. It opens the door for more business opportunities, both domestically and internationally.
4. Competitive edge – As quality is paramount in the industry of medical laboratories, ISO certification is a strategic move to stay competitive in the market. When quality and consistency are met, laboratories obtain loyal customers who are less likely to shift to other vendors.
5. Credibility and cost-effective operations – A certified laboratory always adheres to the relevant regulatory obligations. When compliant, a strong bond is insured with stakeholders and the regulatory bodies. On the other hand, ISO 15189 ensures effective optimization of relevant resources that gradually reduces waste and unnecessary costs.
6. Risk management – Like other ISO standards, ISO 15189 is no less in enhancing management’s capability in managing risks. From detecting to aggregating and mitigating the likelihood of potential disruptions, the ISO standard minimizes failures that often occur in the testing process.
7. Patient care is improved – If we can look at the bigger picture, then the ISO 15189 certification standard is an indispensable aspect when it comes to patient care. Reliable test results help with correct diagnosis, which leads to proper and timely treatment of patients.
For maintaining optimum quality and strengthening competence level, the laboratories must consider the following requirements –
To get certified, you are obliged to pass the formal audit organized by your chosen ISO registrar. We at Compliancehelp Consulting LLC are available to advise on-site or online and help you prepare your system for compliance management. Allow our expert consultants to support you in meeting each clause of ISO 15819. Why are we the best in the market?
Fastest certification – Our approach towards system modification is simple. With a concise and methodical framework, our professionals ensure that your system is certified in the shortest time possible. Get certified faster!
Tailored solutions – We do not believe in generic templates. Avoiding assumptions and coming up with system-specific solutions is our way of working. Customized solutions provide real business results.
Industry Expertise – Our ISO 15819 certification consultants possess the best industry knowledge. Their in-hand experience in the relevant industry helps you implement AI management systems across different sectors.
It is the quality and competence management standard designed for medical laboratories across the globe. It comes with a predefined set of clauses that provide comprehensive guidance for service management.
Though both of the standards focus on the quality of service management for laboratories, ISO 15189 focuses only on medical labs. It also sheds light on enhancing competence, unlike ISO 17025.
If you are new to the medical laboratory industry, then yes, you can enhance the presence of your brand by being ISO 15189 certified.
If you think your system has recurring problems and is unable to meet the clauses, then calling on professional consulting services is a wise idea.