A quality management system (QMS) can be defined as a set of policies, processes, and procedures required for planning and execution (production/development/service) in the core business area of an organization.

In the context of life-science businesses the requirements of Quality Management System are defined in accordance with:

• ISO 9001:2008
• ISO 13485:2016
• EU MDR
• ICH Q10

The objective of a QMS is to define and formalize a system that documents processes, procedures and responsibilities for achieving quality policies and objectives. It basically provides the structure for various functions within an organization to work in an integrated manner, for delivering the best quality products and services to the customer.

The adoption of QMS comes with several benefits which include but are not limited to customer satisfaction, regulatory compliance, reduction in cost of poor quality, waste reduction, mistake proofing, a sense of purpose, effective utilization of resources and continuous improvement.

Related links:

• Scilife Platform

• The advantages of a cloud based eQMS over paper based QMS systems

• 8 reasons why you should turn your paper-based QMS into an eQMS

• Choosing a 21 CFR Part 11 compliant QMS