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Tuesday, October 18, 2011

7.2.2 Review of requirements related to the product


ISO 9001:2008, Quality management systems Requirements
7.2.2  Review of requirements related to the product
The organization shall review the requirements related to the product. This review shall be conducted prior to the organization's  commitment to supply a product to the customer  (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that
a) product requirements are defined,
b) contract or order requirements differing from those previously expressed are resolved, and
c)  the organization has the ability to meet the defined requirements.
Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4).
Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.
Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.
NOTE   In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertizing material.

7.2.2.1   Review of requirements related to the product Supplemental
Waiving the requirement stated in 7.2.2 for a formal review (see note) shall require customer authorization.

7.2.2.2   Organization manufacturing feasibility
The organization shall investigate, confirm and document the manufacturing feasibility of the proposed products in the contract review process, including risk analysis. 

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