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ISO 9001 - 8.3 不合格品的控制
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4 s! ~. v& E' C8.3 不合格品的控制
4 g" L* t$ ~; [( {* |) z组织应确保不符合产品要求的产品得到识别和控制,以防止非预期的使用和交付。不合格品控制以及不合格品处置的有关职责和权限应在形成文件的程序中作出规定。
, X4 [! }. n4 y& b组织应采取下列一种或几种方法,处置不合格品:
8 d9 ^7 O1 y% P. T6 Ja)采取措施,消除发现的不合格;. ?, K. R) K f' O/ \
b)经有关授权人员批准,适当时经顾客批准,让步使用、放行或接收不合格品;
^ l# p) W1 \# ^0 N$ A3 K5 Mc)采取措施,防止原预期的使用或应用。
! D- G5 f- E' F, E" f8 q* n7 l: _应保持不合格品的性质以及随后所采取的任何措施的记录,包括所批准的让步的记录(见4.2.4)。
0 J; J. b h4 ?- {$ U7 x在不合格品得到纠正之后应对其再次进行验证,以证实符合要求。
; _. Y/ z- t8 T8 `当在交付或开始后发现产品不合格时,组织应采取与不合格的影响或潜在影响的程度相适应的措施。
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1 p, J n- L8 M- X9 J8.3 Control of nonconforming product
8 T/ E% f5 \ x& nThe organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure.
9 r8 f( W* l1 c7 jThe organization shall deal with nonconforming product by one or more of the following ways:1 U. T" ~ t# w6 n) i% s
a) by taking action to eliminate the detected nonconformity;/ S: t9 ]+ w. K
b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer;6 G( E% l" T1 a c5 q& M
c) by taking action to preclude its original intended use or application." r" r1 b6 } V3 L5 W
Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4).' }' ^; a1 k' [
When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements.
- l D% `+ A( O1 y- O# }When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity. |
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