Purchasing management of ISO 13485
Purchasing management of ISO 13485
Clause 7.4
7.4.1 Purchasing process
The organization shall establish documented procedures to ensure that purchased product conforms to specified purchase requirements.
The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.
The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements. Criteria for selection, evaluation and re-evaluation shall be established.
Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 4.2.4).
7.4.2 Purchasing information
Purchasing information shall describe the product to be purchased, including where appropriate
a) requirements for approval of product, procedures, processes and equipment,
b) requirements for qualification of personnel, and
c) quality management system requirements.
The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.
To the extent required for traceability given in 7.5.3.2, the organization shall maintain relevant purchasing information, i.e. documents (see 4.2.3) and records (see 4.2.4).
7.4.3 Verification of purchased product
The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.
Where the organization or its customer intends to perform verification at the supplier’s premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.
Records of the verification shall be maintained (see 4.2.4).
Advertisement
Sponsor sites:
1. Phrases For Performance Appraisals.
2. Interview questions and answers.
This entry was posted
on Sunday, November 22nd, 2009 at 10:17 am and is filed under ISO 13485 standard.
You can leave a response, or trackback from your own site.
