HomeQuality & RegulatoryISO certificates and Site Quality Self-Assessments

ISO certificates and Site Quality Self-Assessments

As a leader in the Life Sciences industry, we are committed to product quality, manufacturing effectiveness and meeting customer expectations. Accordingly, the majority of our Life Science sites are certified to the ISO 9001:2015 standard.

Some sites are additionally certified to the ISO 13485 device standard (for applicable products), ISO 17034 / ISO Guide 34 and ISO/IEC 17025 (applicable to certified reference materials) or ISO 22000 Food Standard (applicable to food ingredients). Several sites have registered ISO 14001 environmental and OHSAS 18001 work safety management systems.

Our ISO 9001 Quality Self-Assessment provides in-depth information about our Life Science Quality Management System. The table of content of this document is aligned to « Contents of ISO 9001:2015 Quality Management Systems ». The company profile is aligned to « RX-360 Supplier Assessment Questionnaire, Module 1 ».

We also provide Site Quality Self-Assessments based on Rx-360 Supplier Assessment Questionnaire Module 2, Site Specific Information.

Rx-360 is an industrial consortium with initiatives covering the supply chain for drug products marketed in the word. We are an active member. For more information, please refer to the Rx-360 website.


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