Monitoring and measurement of product of ISO 13485
Monitoring and measurement of product of ISO 13485
Clause 8.2.4
8.2.4.1 General requirements
The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1) and documented procedures (see 7.5.1.1).
Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) authorizing release of product (see 4.2.4).
Product release and service delivery shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed.
8.2.4.2 Particular requirement for active implantable medical devices and implantable medical devices
The organization shall record (see 4.2.4) the identity of personnel performing any inspection or testing
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on Sunday, November 22nd, 2009 at 10:33 am and is filed under ISO 13485 standard.
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