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论坛里关于删减合理性的讨论也许是最容易引起争议的- |' a& L0 h5 S
谁也难以说服对方，因为到这里来讨论的谁也不是权威+ t: X" O' l. _, R/ U
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还是建议楼主仔细研读一下权威的解释：% b8 B/ g) |. `* l: k. S& V
TC176关于《Guidance on ISO 9001：2008 Sub-clause 1.2 'Application'》（ISO9001：2008 子条款 1.2“应用”指南）. L# v" ]0 l2 D( L+ z. O x! j- P
ISO9001：2008 子条款 1.2“应用”指南.pdf
(316.07 KB, 下载次数: 46)
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7 y7 d+ E9 v3 K! u% f% A; R另外，今天看到一份ANSI-RAB在2004/05/25发出的关于2000版删减许可的文件（ISO 9001: 2000 Permissible Exclusions），Randy Dougherty, Director of Registrar Accreditation 在文中提出了判断能否删减的四个步骤，据他说是“屡试不爽”。下面就是他介绍的四个步骤（同样可以应用于2008版）：
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4 P' y; a( h$ C+ s" N$ rUse of the tool first requires a careful definition of the organization. Second, that there be a clearly statement of the product (or service) included in the scope of a QMS. Then one asks the following questions to determine if the product realization process (PRP) may be excluded.
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1. Is the PRP within clause 7?
3 j; A* q* L7 |! f: R* `1 O0 vIf no, the exclusion is not acceptable. Stop. (ISO 9001:2000, 1.2)
0 N/ I0 [/ o* t8 S8 ^If yes, go to question 2.
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2. Is the PRP necessary to meet customer requirements for the product?
4 j/ A/ _) U# r2 QIf no, the exclusion is acceptable. Stop. (ISO 9001:2000, 1.2)
! u/ z/ [3 a& N) v, ~4 g5 rIf yes, go to question 3. * O5 j2 [9 P5 b g+ u% w
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3. Does the organization do the PRP?
* _5 `& c9 m/ P+ e# zIf yes, the exclusion is not acceptable. Stop. (ISO 9001:2000, 1.2)
3 P$ Y) U) `8 ~ }If no, go to question 4. ! D8 B. t2 A9 D) [# {6 h
7 t# O3 U7 S9 ]7 E7 G& c4. Is the organization responsible for the PRP?
4 M: A) I; w) p9 G8 o# @$ v U8 t8 JIf yes, the exclusion is not acceptable. Stop. (ISO 9001:2000, 1.2)
: E' w8 X* U2 A, a, Y# s* t- ~If no, the exclusion is acceptable. Stop. (ISO 9001:2000, 1.2)
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/ |) {* }* F: l6 V8 J* V# j }I applied this tool to the examples in guidance 524R4 and reached the same conclusions.
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Randy Dougherty 在该文中也申明了他对7.2.1条款能否被删减的观点：* B' D4 |0 Y- W6 m; s0 t2 e
And we know from clause 7.2.1 that it does not matter if these requirements are explicitly specified by the customer, or are required by regulations or otherwise necessary for the product for its intended use, the requirements cannot be excluded.$ L" S* i+ I/ z# a" B
4 f6 i2 \ `9 n* p# ^, ~本人提供该文，供各位参考。
ISO 9001：2000 Permissible Exclusions(ANSI-RAB).pdf
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