Monitoring and measurement of product: 8.2.4.1 General requirements The manufacturer 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 and documented procedures. Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) authorizing release of product. Product release shall not proceed until the planned arrangements have been satisfactorily completed. 8.2.4.2 Particular requirement for active implantable medical devices and implantable medical devices wherever applicable The manufacturer shall record the identity of personnel performing any inspection or testing. 8.3 Control of nonconfomting product The manufacturer shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with non-conforming product shall be defined in a documented procedure. The manufacturer shall deal with non-conforming product by one or more of the following ways:— (a) by taking action to eliminate the detected non-conformity; (b) by authorizing its use, release or acceptance under concession; Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 156 of 248 (c) by taking action to preclude its original intended use or application.