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Quality & Certifications

Certified. Traceable. Consistent.

Quality is built into every stage of our process — from raw material control and production to validation and final release.

Archem quality-controlled laboratory and instruments
Certifications

Internationally Recognized Standards

Every Archem product is manufactured and released under certified quality systems.

ISO 13485:2016

Medical Devices QMS

Quality management system for the design and manufacture of IVD products.

ISO 9001:2015

Quality Management

Internationally recognized standard for quality management systems.

CE Marked IVD Products

EU Conformity

Products comply with applicable European regulations and requirements.

Certificates & Documents

Access our certificates, declarations and technical documents.

View Certificates & Documents
Quality at Every Stage

Consistent Quality, Batch After Batch

01

Raw Material Control

Incoming materials are carefully inspected and approved before entering production.

02

In-Process Testing

Controls at every production stage ensure specification compliance.

03

Performance Validation

Methods are validated across leading analyzer platforms for reliable performance.

04

Batch Traceability

Full lot traceability and documentation ensure consistent quality for every released batch.

Quality you can rely on, in every result we deliver.

Built on certified systems, validated processes and a commitment to continuous improvement.

Need Documentation?

Access Certificates & Technical Documents

Download IFU, SDS, certificates and value sheets from our Downloads Center — or contact us for issued copies.