Benefits and Importance of ISO 15189 Medical Laboratory

What is ISO 15189?

ISO 15189:2012 is an international standard for medical laboratories. Laboratory accreditation helps labs develop quality management systems, measures their competence and confirms they are functioning in line with industry and legal standards. As part of ISO 15189 accreditation process, create a document that explains how laboratory can work to conform to each requirement to a high standard of quality. This handy document will provide each member of team with instructions for performing the tasks to an ISO-accredited standard.

Why is ISO 15189 Important?

Capability in any field is crucial, but it’s even more relevant in the medical sphere where the patient’s system is compromised by disease or injury. ISO 15189 is a mark of confidence awarded to medical laboratories – an accreditation that proves enthusiastic to delivering a proficient and quality service across all aspects of operation.

Who needs ISO 15189?

Laboratory testing is very important in the delivery of information-based healthcare outcomes – this is very important in a world where decisions need to be driven by facts, science and data. Any medical laboratory that wants to deliver clinically relevant results that meet the highest ethical standards should become ISO 15189 accredited.

Is ISO 15189 Mandatory?

ISO 15189 accreditation is not mandatory in every authority, but it’s worth checking local regulations. Nevertheless, the importance of laboratory accreditation should never be overlooked, especially when dealing with public health. As part of accreditation process, get organization up-to-date with all the complex legal requirements that a medical laboratory must adhere to. With the ISO’s culture of continuous improvement, any changes to law or regulation will be implemented as part of ongoing commitment to best practice.

What are the benefits of ISO 15189 accreditation?

• Risk reduction:

When structure operation around best practice, systems will be more rigorous. Planning for and identifying any potential risks will help massively decrease them – especially in laboratories that deal with sensitive information, complicated equipment and matters pertaining to people’s health.

• Cost-saving:

By assuring results are technically valid, then laboratory will save costs associated with retesting. There will also be other cost-saving measures implemented across the standard as efficiency increases.

• Improved team morale:

The standard works to decrease staff mistakes and other preventable errors. staff motivation won’t only be improved by their demonstration of better performance, but also by recognizing and promoting staff’s technical competence.

• Legally compliant:

By implementing legislation and industry standards into medical laboratory, ISO 15189 guarantees that clinical services are safe, reliable and of good value. This takes trust to stakeholders and decision-makers who recognize and appreciate the assurance. Legal challenges will be less likely and, if they do occur, than ensure that framework will support.

• Constant improvement:

Best practices won’t start and end with ISO 15189 certification: through integrating this framework into the core of what organization do, and will develop additional programs over time. The framework acts as a tool for measuring quality developments and continually supporting consistency.

• Globally recognized:

Being a globally recognized standard not only has reputational benefits. For ISO 15189, global recognition is particularly pertinent. Laboratories accredited to ISO 15189 will have their certificates and test reports accepted in over many countries around the world. This way, work can benefit medical health not just in one country, but all over the globe.

As ISO Consultant profession since last many years Charles has rich experience in preparing such certification documents within ISO guideline to his global clients to acquire better ISO Certification Solution to their Organization.