Illumina Quality System Compliance Statement

Document Reference: CoC-SH00948

Commitment to Quality

Illumina is dedicated to maintaining the highest standards in its operations and product development. This commitment is underpinned by a robust and certified Quality System.

Quality System Development and Validation

The Illumina Quality System has been meticulously developed and validated. It adheres strictly to the requirements of ISO 13485, a globally recognized standard for quality management systems in the medical device industry.

This conformance ensures that processes are consistently controlled and that products meet regulatory and customer requirements.

Illumina Singapore Pte Ltd

Illumina Singapore Pte Ltd operates under this certified Quality System, reflecting the company's global commitment to quality and regulatory compliance.

[Note: Specific registration details like 'Co. Reg. No.' are typically found on official certificates but are not detailed here.]

Integrity of the Quality System

The integrity of the Illumina Quality System is paramount. It is subject to continuous monitoring, internal audits, and management review to ensure its ongoing effectiveness and suitability.

[The original text mentioned '30 ago 2025', which is unclear. Assuming it relates to a date or validity period, but without clear context, it's omitted from the main narrative for clarity.]

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CoC-SH00948 ApeosPort C5570 ApeosPort C5570

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