Recognize The Requirements And Benefits Of Iso 15189 Accreditation

By Author: Smith
Total Articles: 80
Comment this article

ISO 15189:2012 is a global standard for medical laboratories. Laboratory accreditation supports labs to develop quality management systems, assesses their competence, and guarantees that they are functioning properly with industry and legal standards. ISO 15189 standard is closely based on ISO/IEC 17025 and ISO 9001. ISO 15189 accreditation tries to create a system that is failure-resistant, catching mistakes before it becomes serious issue. Also, it aims to achieve precise results in one try by reducing the number of errors. Accreditation helps to identify the opportunities for continuous improvement in labs and empowers lab staff by involving them in serious problem-solving and implementation of solutions. The accreditation ensures that labs or organizations are fully up-to-date with all the complex legal requirements and it also shows that the customers and key stakeholders a commitment to best practices.

The benefits of ISO 15189 accreditation
Here are some of the several benefits of ISO 15189 accreditation.

• Risk reduction: When an organization structures its operation around best practices, the systems ...
... will be more difficult. Also, planning for and identifying any potential risks will help massively decrease them, especially in laboratories that deal with delicate information, complex equipment, and matters about people’s wellbeing.

• Cost-saving: By promising results that are technically valid, the laboratory will save costs associated with retesting. There will also be other cost-saving procedures implemented across the standard as the efficiency increases.

• Improved team morale: The standard everything to reduce staff mistakes and other unnecessary errors. Organization staff motivation will not only be improved by their demonstration of better performance, but also by recognizing and promoting the staff’s technical competence.

• Legally compliant: By implementing legislation and industry standards into the medical laboratory, ISO 15189 assures that the clinical services are safe, reliable and of good value. That carries trust to stakeholders and decision-makers who recognize and grow the commitment. Also, the legal challenges will be less likely and, if they do arise, the organization can ensure the framework will support them.

• Continual improvement: Best practices will not start and end with the ISO 15189 certification. But also, by integrating the framework into the core of what organizations do, organizations will develop additional programs over time. The framework acts as a tool for measuring quality developments and continually supporting consistency.

• Globally recognized: Being a universally recognized standard not only has reputational benefits. For ISO 15189, global acknowledgment is particularly pertinent. A sequence of Multilateral Mutual Recognition Arrangements within the International Laboratory Accreditation Cooperation (ILAC) means that laboratories accredited to ISO 15189 will have their certificates and test reports accepted in over 80 countries around the globe. That way, organizations can benefit medical health not just domestically, but all over the globe.

The List of ISO 15189 accreditation Requirements
To implement ISO 15189 accreditation there are two types of requirements that are mandatory one is management requirements and the second is technical requirements.

Management requirements
• Organization and management responsibility
• Quality management system
• ISO 15189 documents control
• Service agreements
• Examination by referral laboratories
• External services and supplies
• Advisory services
• Resolution of complaints
• Identification and control of nonconformities
• Corrective action
• Preventive action
• Continual improvement
• Control of records
• Evaluation and audits
• Management review

Technical Requirements
• Personnel
• Accommodation and environmental conditions
• Laboratory equipment, reagents, and consumables
• Pre-examination processes
• Examination processes
• Ensuring quality of examination results
• post-examination of processes
• Reporting of results
• Release of results
Source: https://accreditationconsultancy.wordpress.com/2022/07/07/recognize-the-requirements-and-benefits-of-iso-15189-accreditation/