Dear supplier,

I am acting on behalf of Merck KGaA.
In connection with the process of qualifying our suppliers, I'm kindly asking to complete the following documentation about your material / product (the name in the subject).

Attention! The list includes items without templates (marked *), please send us your statements.
The required documentation is:

• OMT Questionnaire
• Biological Origin
• Change Control Agreement
• ISO certificate (9001, 14001, 18001, 50001, etc.) and GMP certificate (if applicable)*
• Current valid specification *
• IVD Quality Self Assessment

Please complete the questionnaires, sign them manually and send them back in individual files - along with the requested information, no later than 12/02/2025

Thank you for your understanding and cooperation.