What is a QMS?
In terms of regulatory compliance, ISO 9001 is the most widely used standard for quality management. ISO 9001 builds a foundation for organizations to consistently deliver value, improve performance, and adapt to change to strengthen leadership, culture and strategic alignment, and focus on opportunities and potential risks via Quality Management Systems.
A Quality Management System (QMS) provides the processes and controls a company uses to maintain quality and meet customer and regulatory requirements. A QMS based on ISO 9001 ensures formal systems are in place so that processes are controlled, team members are trained, and investigations occur if a deviation occurs, followed by a process correction.
While ISO 9001 is the most popular as a QMS, there are other types of management systems, like ISO 14001 for environmental management systems and ISO 45001 for occupational health and safety management systems. Currently, ISO has more than 30 management standards, varying from being applicable to most organizations to being industry-specific.
What is an IMS?
An Integrated Management System (IMS) combines all aspects of an organization’s systems, processes, and standards into one system for improved efficiency. IMS allows the incorporation of multiple management systems into one coordinated framework to ensure departments work together with established, clear priorities and consistent oversight as well as help to identify gaps that might otherwise be missed.
At its core, the goal is to look beyond siloed requirements from individual management systems for a more holistic view of the organization for coordinated control across departments that strengthens accountability and improves consistency.
Does SciSafe have a QMS or an IMS?
While the IMS reflects a broader approach to supporting global life science supply chains, its existence does not replace a QMS. Certifications are issued against individual standards and have defined scopes, so the IMS will describe how the ISO certified management system processes are integrated, but it will not replace applicable regulatory obligations.
The purpose of this change is to connect managing requirements, risks, training, audits, and improvements to better support day-to-day decisions and reliable service. As SciSafe transitions to an Integrated Management System, the foundation will be built on existing quality, information security, environmental management, and occupational health and safety structures.
To learn more about SciSafe’s current certification and which sites and services they cover, contact us today!