确定如何在产品/服务的整个生命周期中实现、控制、确保和管理关键质量特性。解决质量要求和对质量至关重要的特性。进行预防性质量评估。描述如何验证产品/服务、验证标准和对不符合项的响应。保留记录以证明符合性。 Establishing how the critical-to-quality characteristics will be achieved, controlled, ensured, and managed throughout the lifecycle of a product/service. Address quality requirements and critical-to-quality characteristics. Conduct a preventive quality assessment. Describe how to verify the product/service, verification criteria, and response to nonconformance. Keep records to demonstrate conformity.