An international standard that specifies the requirements for medical laboratories. The standard provides a framework for quality management and technical competence, and is designed to help medical laboratories deliver accurate, reliable, and timely results.

The standard covers a wide range of laboratory activities, including sample collection, pre-analytical processing, analytical testing, and reporting of results. It also covers the management of laboratory processes, including quality management systems, laboratory equipment and facilities, human resources, and the use of reference materials and internal and external quality control.

ISO 15189:2022 is based on the principles of ISO 9001:2015, the international quality management standard, and is designed specifically for medical laboratories. By implementing ISO 15189:2022, medical laboratories can demonstrate their commitment to quality and technical competence, and can provide assurance to their clients, patients, and stakeholders that their results are accurate and reliable.

The standard is suitable for all types of medical laboratories, including hospital-based, independent, and reference laboratories. It is applicable to all types of laboratory testing, including chemical, microbiological, and pathological testing.

By implementing ISO 15189:2022, medical laboratories can:

• Improve the accuracy and reliability of their results
• Enhance their reputation and credibility with clients and stakeholders
• Streamline their processes and reduce the risk of errors
• Foster a culture of continuous improvement and innovation
• Enhance patient safety and well-being

MS & KOTCH company is committed to helping medical laboratories implement ISO 15189:2022. We offer a range of services, including quality management system implementation, training, and certification. Our experienced team of experts has a deep understanding of the standard and can help you navigate the process and achieve certification quickly and efficiently.

ISO 9001:2015 is an international standard for quality management systems (QMS). It provides a set of standardized requirements for organizations looking to establish, maintain, and improve their QMS. The standard is based on a number of quality management principles, including a strong customer focus, the involvement of top management, a process-based approach, and continuous improvement.

ISO 9001:2015 is applicable to organizations of all sizes and industries, and is recognized globally as the benchmark for quality management. By implementing ISO 9001:2015, organizations can demonstrate their commitment to quality and customer satisfaction, and can improve their processes, products, and services.

The standard covers all aspects of an organization's operations, including management processes, customer-related processes, and support processes. It requires organizations to implement a QMS that addresses all relevant requirements and continually improve their processes.

ISO 9001:2015 can help organizations:

• Improve customer satisfaction by meeting their needs and expectations
• Enhance their reputation and credibility with customers, suppliers, and stakeholders
• Increase efficiency and reduce costs by streamlining processes and reducing waste
• Foster a culture of continuous improvement and innovation
• Enhance their competitiveness by meeting international quality standards

MS & KOTCH company is committed to helping organizations implement ISO 9001:2015. We offer a range of services, including quality management system implementation, training, and certification. Our experienced team of experts has a deep understanding of the standard and can help you navigate the process and achieve certification quickly and efficiently.