7. PRODUCT REALISATION 產(chǎn)品實現(xiàn)
7.1. Product requirements 產(chǎn)品要求
7.1.1. Determination of requirements related to the product
與產(chǎn)品有關(guān)要求的確定
The Operator shall determine: 經(jīng)營者應(yīng)確定：
a) statutory and regulatory requirements related to the product;
與產(chǎn)品有關(guān)的法律法規(guī)要求；
b) requirements specified by the customer, including requirements related to delivery and
post-delivery activities; and
顧客規(guī)定的要求，包括與交付及交付后活動有關(guān)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(guī)定的用途或已知的預(yù)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(tǒng)被實施；
? The external requirements are communicated and complied with;
外部要求被溝通和遵照執(zhí)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(chǎn)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(jīng)營者應(yīng)監(jiān)視與產(chǎn)品有關(guān)要求的符合性并應(yīng)確保：
a) product requirements are defined;
產(chǎn)品要求得到規(guī)定；
b) the Operator has the ability to meet the defined requirements; and
經(jīng)營者有能力滿足規(guī)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(chǎn)品的處理和保存，應(yīng)在經(jīng)營者的管理體系中描述。
如果經(jīng)營者從事不符合歐盟要求的產(chǎn)品的貿(mào)易，經(jīng)營者應(yīng)當(dāng)保持一個產(chǎn)品清單，注明可能在歐盟境內(nèi)貿(mào)
易和可能僅在歐盟以外貿(mào)易的那些產(chǎn)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(chǎn)品要求變更，經(jīng)營者應(yīng)確保相關(guān)文件得到修改，并確保相關(guān)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。