QMS Procedural Framework Implementation

Management Challenge

As a result of a successful growth strategy this major CRO operates across multiple divisions and geographies. Its broad service portfolio continues to be bolstered in scope and scale through a number of strategic acquisitions.

A passive approach to QMS documentation has led to duplicate, redundant, overlapping and contradicting quality documentation. This resulted in a significant and inefficient training burden on the entire organisation.

It also needed to be able to clearly demonstrate a coherent quality and compliance infrastructure to its clients.

Kinapse Approach

Kinapse supported the client to develop an integrated and coherent QMS Procedural Framework. This included:-

• A cross-divisional and intra-divisional governance structure
• Implementation of a new document hierarchy
• Development of a standard set of definitions and templates
• Redesign and implementation of a new QMS procedural framework
• IT improvements for end-users
• Project management and planning support to the implementation

Benefits and Outcomes of our Engagement

Focused client on highest risks and greatest benefits to the organisation.

New governance structure has been implemented with documents being managed in a coordinated and coherent way.

Supported a reduction in document number and complexity.