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This Eurosmart guide explains how to use Module H – Full Quality Assurance to meet those obligations through an auditable, process-centric approach.
The following represents our interpretation of how Module H could be applied in practice, based on our current understanding and experience with quality assurance frameworks. By leveraging existing quality systems (e.g., ISO 9001) and aligning them with the CRA’s essential cybersecurity requirements (Annex I, Parts I & II), Module H enables Notified Bodies to audit the manufacturer’s quality system and verify its implementation on representative products and without mandating exhaustive product-by-product testing. |