Last month, the American Association of Blood Banks (AABB) published its ‘Quality System Essentials 2011’ document, identifying what it sees as the areas of quality that must be in place in order to show a complete quality approach across a whole blood bank organization. The document states:

“The facility [or program] shall establish and maintain a leadership structure with defined roles and responsibilities to ensure the effective implementation and maintenance of quality management and operational systems that meet the requirements of customers and these Standards.”

Just reviewing the document, it's interesting to see how Quality is covering much more than just the basics of Document Control, Auditing and Corrective/Preventive Actions. The Quality Essentials now include areas such as ‘Human Resources’, ‘Suppliers’ and ‘Supply Management’, ‘Equipment Management’ and ‘Continual Improvement’, also stating that quality should be addressed by all members of the organization, from the top to the bottom.

A consistent organization wide approach to quality is one adopted not just by Blood Banks, more and more companies across the globe are finding the strict regulatory requirements and standards they must achieve and meet require an effective Quality Management System (QMS) to keep on top of all their compliance activities.

Whether your company’s requirements are more effective Document Control, improved management of Audit processes and procedures, better management of Suppliers and Staff Training, your QMS must allow users to take ownership of their actions, and enable Management to have visibility of all quality and compliance activities to identify where improvements could be made.

How does your QMS measure up to the AABB’s Quality System Essentials?