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发表于 2011-12-19 13:55:40
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来自： 中国广东深圳
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ISO9001' M' ?2 u: M' {4 c/ J( p6 S! R
7.3.7 Control of design and development changes( Z- n- C( {- F2 I/ V" B) J
设计和开发更改的控制$ h5 e0 P- p4 o
Design and development changes shall be identified and records maintained. The changes4 b. c2 ]/ J0 |; P/ j8 @2 b
shall be reviewed, verified and validated, as appropriate, and approved before
& k" o, a3 F) L! S/ T: x+ I2 Bimplementation. The review of design and development changes shall include evaluation of
; M& C2 n: N& [3 e1 V: s4 J T" Athe effect of the changes on constituent parts and product already delivered. Records of the ~5 y2 r: U) S7 D2 T
results of the review of changes and any necessary actions shall be maintained (see 4.2.4).
) L% a/ F( _" |, E应识别设计和开发的更改，并保持记录。在适当时，应对设计和开发的更改进行评审、验证和确认，并4 F1 M y/ L) Y: k
在实施前得到批准。设计和开发更改的评审应包括评价更改对产品组成部分和已交付产品的影响。更改
5 f9 T* P+ U$ `, n2 N3 Z评审结果及任何必要措施的记录应予保持（见4.2.4）。 |
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