What is BS EN ISO 11092:2010 ?

What is BS EN ISO 11092:2010 and EN ISO 27294:2011?

BS EN ISO 11092:2010 and EN ISO 27294:2011 are both international standards that provide guidelines for the implementation and operation of a quality management system (QMS) for technical product documentation and medical laboratories, respectively.

BS EN ISO 11092:2010 is an international standard that outlines the requirements for creating, organizing, and delivering product information throughout its entire lifecycle. The main purpose of this standard is to ensure that technical product documentation meets the needs of end-users, customers, and other stakeholders.

EN ISO 27294:2011 is a technical standard that outlines the requirements for a quality management system in medical laboratories. The purpose of this standard is to ensure that medical laboratories meet certain standards in their operations.

Key Requirements of EN ISO 11092:2010 and EN ISO 27294:2011

EN ISO 11092:2010 and EN ISO 27294:2011 both have key requirements that outline the minimum requirements for establishing, implementing, and maintaining a QMS. These requirements are designed to ensure that organizations can effectively manage their product information and improve their overall quality management systems.

The key requirements of EN ISO 11092:2010 and EN ISO 27294:2011 include:

Establishment of a management system: Both standards require organizations to establish a management system that is designed to ensure that their quality management systems meet the requirements of the standard.

Implementation of the management system: Both standards require organizations to implement their management systems in a way that meets the requirements of the standard.

Integration of the management system: Both standards require organizations to integrate their management systems into their overall business strategy and operations.

Continual improvement: Both standards require organizations to continually improve their quality management systems through the implementation of new processes, procedures, and controls.

Documentation: Both standards require organizations to maintain accurate and up-to-date documentation that demonstrates their compliance with the requirements of the standard.

Conclusion

BS EN ISO 11092:2010 and EN ISO 27294:2011 provide guidelines for establishing and maintaining a quality management system for technical product documentation and medical laboratories, respectively. By following these standards, organizations can ensure that their quality management systems are effective, efficient, and meet the needs of their stakeholders.