7. PRODUCT REALISATION 產品實現
7.1. Product requirements 產品要求
7.1.1. Determination of requirements related to the product
與產品有關要求的確定
The Operator shall determine: 經營者應確定：
a) statutory and regulatory requirements related to the product;
與產品有關的法律法規要求；
b) requirements specified by the customer, including requirements related to delivery and
post-delivery activities; and
顧客規定的要求，包括與交付及交付后活動有關的要求；并且
c) requirements not stated by the customer but necessary for specified or intended use,
where known.
顧客雖然沒有明示，但規定的用途或已知的預期用途所必需的要求。
Ensure that: 確保
? A system to identify external requirements is implemented;
一個用于識別外部要求的系統被實施；
? The external requirements are communicated and complied with;
外部要求被溝通和遵照執行；
? Requirements and compliance are documented;
要求和符合性被文件化；
? Requirements specified by customers are controlled and implemented.
顧客指定的要求被控制和實施。
7.1.2. Compliance of the product to the requirements 產品要求的符合性
The Operator shall monitor the compliance of products with the relevant product requirements
and shall ensure that:
經營者應監視與產品有關要求的符合性并應確保：
a) product requirements are defined;
產品要求得到規定；
b) the Operator has the ability to meet the defined requirements; and
經營者有能力滿足規定的要求；并且
c) the existence and handling of products for export outside the EU and which cannot, from a
regulatory point of view, be placed on the EU market, is described in the Operator's MS. If
the Operator markets such non- EU compliant products, the Operator should maintain a list of
products which may be marketed in the EU and those which may be marketed outside the EU only.
出口到歐盟以外以及從法律角度不在歐盟市場銷售的產品的處理和保存，應在經營者的管理體系中描述。
如果經營者從事不符合歐盟要求的產品的貿易，經營者應當保持一個產品清單，注明可能在歐盟境內貿
易和可能僅在歐盟以外貿易的那些產品。
Should product requirements change, the Operator shall ensure that relevant documents are
amended and that relevant personnel are made aware of the changed requirements.
(See also section 7.3.2)
若產品要求變更，經營者應確保相關文件得到修改，并確保相關人員知道已變更的要求。
（可參看7.3.2）
Ensure that: 確保
? Procedures are in place to comply with identified requirements.
程序是適宜的以滿足所識別要求。