What is ISO 18091:2021 ?

Title: What is ISO 18091:2021 and EN ISO 17088:2021: A Comprehensive Guide

Introduction:

Healthcare organizations are constantly looking for ways to improve the quality of their services and enhance the safety of their patients. This is where ISO 18091:2021 and EN ISO 17088:2021 come in. These international standards provide guidelines for implementing quality management systems in the healthcare industry and ensure that testing and calibration laboratories produce accurate and reliable results.

ISO 18091:2021 is an updated version of the ISO 19011 standard, which is widely recognized in the healthcare industry. It provides guidelines for healthcare organizations to establish and maintain effective quality management systems. The standard aims to improve the quality of healthcare services and enhance patient safety.

EN ISO 17088:2021 is an updated version of the ISO 17081 standard, which is also widely recognized in the healthcare industry. It specifies the general requirements for the competence of testing and calibration laboratories. The standard aims to ensure that testing and calibration laboratories consistently produce accurate and reliable results.

Key Requirements of ISO 18091:2021 and EN ISO 17088:2021

ISO 18091:2021 and EN ISO 17088:2021 are both designed to ensure that testing and calibration laboratories produce accurate and reliable results. However, they have some differences in their requirements.

ISO 18091:2021 provides guidelines for healthcare organizations to establish and maintain effective quality management systems. The standard has several key requirements, including:

1. The organization should have a clear and defined quality policy that aligns with its mission and goals.

2. The organization should have a system for measuring and monitoring its performance and identifying areas for improvement.

3. The organization should have a process for ensuring that all personnel are competent and trained in their areas of responsibility.

4. The organization should have a system for ensuring that all equipment is maintained and calibrated to ensure accuracy.

5. The organization should have a process for ensuring that all samples are handled and processed in a controlled manner to minimize the risk of contamination or error.

EN ISO 17088:2021 specifies the general requirements for the competence of testing and calibration laboratories. The standard has several key requirements, including:

1. The laboratory should have a clear and defined competence policy that outlines its areas of expertise and the qualifications of its personnel.

2. The laboratory should have a system for ensuring that all personnel are trained and competent in their areas of responsibility.

3. The laboratory should have a system for ensuring that all equipment is calibrated and maintained to ensure accuracy.

4. The laboratory should have a system for ensuring that all samples are processed and analyzed in a controlled manner to minimize the risk of contamination or error.

Conclusion

ISO 18091:2021 and EN ISO 17088:2021 are both essential for ensuring that testing and calibration laboratories produce accurate and reliable results. By implementing these standards, healthcare organizations can identify and address areas for improvement, minimize risks, and ensure consistency in delivering high-quality care.