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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