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 standard: Quality management systems, requirements. Some sites are also certified to other standards:

• ISO 13485 Medical Devices, quality management systems
• ISO 17034 General requirements for the competence of reference material producers (applicable to certified reference materials)
• ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories (applicable to certified reference materials)
• FSSC 22000 Food safety management systems (applicable to food ingredients)
• ISO 14001 Environmental management systems, requirements with guidance for use
• ISO 45001 Occupational health and safety management systems, requirements with guidance for use
• ISO 50001 Energy management systems, requirements with guidance for use

ISO 9001 standard is based on seven quality management principles available on the ISO website.

Additionally, 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 a large number of Quality Self-Assessments which facilitate qualification and risk assessment. A Quality Self-Assessment is a pre-filled questionnaire about a specific site, service or product range. It is based on Rx-360 Supplier Assessment Questionnaires which are well-known industry standard questionnaires.

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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