Quality - Policy - Quality Policy

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The process outlined in this document will ensure that your company complies with the relevant clauses of ISO 13485 (5.3), 21 CFR (820.20), and EU MDR/IVDR.

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Purpose of Document

A quality policy is a crucial component of an organisation’s commitment to quality. It serves as a guiding document to establish the commitment of your company to comply with relevant quality, regulatory and customer requirements.

Scope of Document/s

This document includes required elements of a quality policy.

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