''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 and documented,
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 advertising material.
bag
quality_public
created
Thu, 19 Mar 2015 23:29:54 GMT
creator
dirkjan
modified
Thu, 19 Mar 2015 23:31:06 GMT
modifier
dirkjan
tags
ISO13485