What is BS EN ISO 11890-2: 2010 ?

Title: What is EN ISO 11890-2: 2010 and EN ISO 27290: 2011?

Quality management systems are essential for ensuring that organizations meet the requirements of customers and stakeholders, and deliver high-quality products and services. EN ISO 11890-2: 2010 and EN ISO 27290: 2011 are two important technical standards that provide guidelines for establishing and maintaining a quality management system. In this article, we will explore the purpose and key aspects of these two standards.

What is EN ISO 27290: 2011?

EN ISO 27290: 2011 is a technical standard published by the International Organization for Standardization (ISO) and the European Committee for Standardization (CEN). It outlines the requirements for a quality management system in medical laboratories. The purpose of EN ISO 27290: 2011 is to ensure that medical laboratories meet certain standards in their operations, focusing on areas such as management responsibility, resource management, process control, and continual improvement.

Key Requirements of EN ISO 27290: 2011

EN ISO 27290: 2011 provides several key requirements for medical laboratories to establish and maintain a quality management system. These requirements include:

Management Responsibility: The laboratory must establish and maintain a written policy for quality management, including the responsibilities of management and staff.

Resource Management: The laboratory must ensure that it has the necessary resources, including personnel, equipment, and supplies, to perform its duties.

Process Control: The laboratory must establish and maintain procedures for monitoring and controlling its processes to ensure that they are being followed correctly.

Continual Improvement: The laboratory must continuously evaluate its quality management system and identify opportunities for improvement.

What is EN ISO 11890-2: 2010?

EN ISO 11890-2: 2010 is a technical standard published by the ISO and CEN. It provides guidelines for establishing and maintaining a quality management system in various industries, including the automotive industry. The purpose of EN ISO 11890-2: 2010 is to enhance customer satisfaction by meeting customer requirements and ensuring continuous improvement.

Key Components of EN ISO 11890-2: 2010

EN ISO 11890-2: 2010 provides several key components for establishing and maintaining a quality management system, including:

Customer Requirements: The laboratory must identify and understand the requirements of its customers, including their expectations for quality and delivery times.

Process Requirements: The laboratory must establish and maintain procedures for performing its work, including the specific processes that are critical to its operations.

Documentation: The laboratory must maintain accurate and complete documentation of its processes and procedures.

Continuous Improvement: The laboratory must continuously evaluate its quality management system and identify opportunities for improvement.

Conclusion:

EN ISO 11890-2: 2010 and EN ISO 27290: 2011 provide guidelines for establishing and maintaining a quality management system. By implementing these standards, medical laboratories can enhance the quality of their services, improve patient safety, and reduce the risks associated with their activities. Therefore, it is important for medical laboratories to carefully review and follow the requirements outlined in these standards to ensure that they are meeting the needs of their customers and stakeholders.