ISO13485-2016中英文對照 資源管理（6.1~6.3）

6.1 Provision of resources 資源供給

The organizationshall determine and provide the resources needed to:

組織應當確定并提供以下所需資源:

a) implement thequality management system and to maintain its effectiveness;

實施質量管理體系和維護其有效的資源;

b) meetapplicable regulatory and customer requirements.

符合相應法規和客戶要求的資源。

6.2 Humanresources 人力資源

Personnelperforming work affecting product quality shall be competent on the basis ofappropriate education, training, skills and experience.

對于從事影響產品質量的工作人員應當具有與其工作相適應的教育、培訓、技能和經驗，并且勝任。

The organizationshall document the process(es) for establishing competence, providing needed training,and ensuring awareness of personnel.

組織應當建立程序來促使這些能力的形成、并提供必要的培訓和確保人員的認知。（新增）

The organizationshall: 組織應當

a) determine thenecessary competence for personnel performing work affecting product quality;

確定從事影響產品質量工作的人員所必要的能力;

b) provide trainingor take other actions to achieve or maintain the necessary competence;

提供培訓或采取其他措施來達到或維持必要的能力；

c) evaluate theeffectiveness of the actions taken;

評估采取措施的有效性；

d) ensure thatits personnel are aware of the relevance and importance of their activities andhow they contribute to the achievement of the quality objectives;

確保員工認識到所從事活動的相關性和重要性，以及如何為實現質量目標作出貢獻;

e) maintainappropriate records of education, training, skills and experience (see 4.2.5).

持教育、培訓、技能和經驗的適當記錄(見 4.2.5).

NOTE  The methodology used to check effectiveness isproportionate to the risk associated with the work for which the training orother action is being provided.

注意：評估用于檢查有效性的方法學應當風險相適應，這些風險與從事培訓或提供其他措施有關。（新增）

6.3 Infrastructure 基礎設施

The organizationshall document the requirements for the infrastructure needed to achieveconformity to product requirements, prevent product mix-up and ensure orderlyhandling of product. Infrastructure includes, as appropriate:

組織應當建立形成文件化的基礎設施需求，來符合產品需求、防止產品混淆以及確保產品的正確處理。（新增）

a) buildings,workspace and associated utilities;

建筑物，工作場所和相關的設施；

b) processequipment (both hardware and software);

工藝設備（包括軟硬件）；

c) supportingservices (such as transport, communication, or information systems).

支持性服務（比如運輸、通訊或信息系統（新增））

The organizationshall document requirements for the maintenance activities, including theinterval of performing the maintenance activities, when such maintenanceactivities, or lack thereof, can affect product quality. As appropriate, therequirements shall apply to equipment used in production, the control of thework environment and monitoring and measurement. Records of such maintenanceshall be maintained (see 4.2.5).

組織應建立和和形成文件化的維護措施需求，包括內部維護措施實施，當這樣的維護措施實施時，或缺乏時，都會影響產品質量。如果可以，這些要求應當應用到生產、控制工作環境、檢測和測量的設備上。（新增）應保持此類維護記錄(見 4.2 .5)