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.*

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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 control notification support
• Documentation support

The M-Clarity™ matrix includes 6 MQ levels from MQ100 to MQ600 defining the quality attributes, documentation and services offered with our products in each level.

	Quality Levels
	MQ100	MQ200	MQ300	MQ400	MQ500	MQ600
Application scope	For non-regulated applications with no change notification requirements	For non-regulated applications with limited change control 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	✔	✔	✔	✔	✔	✔
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.