M-Clarity™ Program

The development and manufacture of products in the Life Science industry has become progressively more challenging in recent years. Because of the increasing complexity of the processes, regulatory requirements and local standards, it is crucial to understand, assess and manage risks while ensuring business continuity.

In this dynamic context, we present the M-Clarity™ Program which defines product quality levels and improves product and service transparency throughout our broad Life Science portfolio.*

   Download Brochure

   Download FAQ

   Download Notifiable Changes

   Download Quality Attributes




The M-Clarity™ Matrix

Industry-driven regulations require that products of higher criticality or those used in highly-regulated industries, such as pharma or in vitro diagnostics manufacturing, need enhanced supplier quality support.

The MQ levels of the M-Clarity™ Program provide transparency so that you can choose, with confidence, suitable products that meet your needs with respect to:

  • Compliance with the appropriate quality and regulatory standards
  • Portfolio transparency
  • Change Notification service
  • Documentation and Support

The M-Clarity™ matrix includes 6 MQ levels from MQ100 to MQ600 defining the quality attributes and the notifiable changes in each level.

To learn more about the quality attributes and the notifiable changes, please click on the appropriate link.



Quality Levels
  MQ 100 MQ 200 MQ 300 MQ 400 MQ 500 MQ 600
Application scope For non-regulated applications with no change notification requirements For non-regulated applications with limited change notification requirements

For products used in applications requiring enhanced change control and quality agreement For critical products and applications driven by high expectations and requiring verified process control or manufacturing control For regulated applications
For highly-regulated applications under authority surveillance

Discriminating features Standard control Increased control Enhanced Control Driven by customer expectation Driven by authority regulations Driven by authority regulations and surveillance
Quality systems ISO 9001 ISO 9001 ISO 9001 ISO 9001 IPEC or HACCP; FSSC 22000 or ISO 13485 ICH Q7 or 21 CFR medical device
Quality attributes
Notifiable changes  
Basic change control  
Enhanced level of control    
Verified process      
Certified/validated process        
Highly regulated application          

*Instruments, custom products, and contract manufacturing products are not part of the M-Clarity™ Program.

For more information on the M-Clarity™ Program, please contact your local representative.