7. PRODUCT REALISATION 产品实现
7.1. Product requirements 产品要求
7.1.1. Determination of requirements related to the product
与产品有关要求的确定
The Operator shall determine: 经营者应确定：
a) statutory and regulatory requirements related to the product;
与产品有关的法律法规要求；
b) requirements specified by the customer, including requirements related to delivery and
post-delivery activities; and
顾客规定的要求，包括与交付及交付后活动有关的要求；并且
c) requirements not stated by the customer but necessary for specified or intended use,
where known.
顾客虽然没有明示，但规定的用途或已知的预期用途所必需的要求。
Ensure that: 确保
A system to identify external requirements is implemented;
一个用于识别外部要求的系统被实施；
The external requirements are communicated and complied with;
外部要求被沟通和遵照执行；
Requirements and compliance are documented;
要求和符合性被文件化；
Requirements specified by customers are controlled and implemented.
顾客指定的要求被控制和实施。
7.1.2. Compliance of the product to the requirements 产品要求的符合性
The Operator shall monitor the compliance of products with the relevant product requirements
and shall ensure that:
经营者应监视与产品有关要求的符合性并应确保：
a) product requirements are defined;
产品要求得到规定；
b) the Operator has the ability to meet the defined requirements; and
经营者有能力满足规定的要求；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.
出口到欧盟以外以及从法律角度不在欧盟市场销售的产品的处理和保存，应在经营者的管理体系中描述。
如果经营者从事不符合欧盟要求的产品的贸易，经营者应当保持一个产品清单，注明可能在欧盟境内贸
易和可能仅在欧盟以外贸易的那些产品。
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)
若产品要求变更，经营者应确保相关文件得到修改，并确保相关人员知道已变更的要求。
（可参看7.3.2）
Ensure that: 确保
Procedures are in place to comply with identified requirements.
程序是适宜的以满足所识别要求。