Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled or sterilized. 3.11 Management with executive responsibility means those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer's quality policy and quality system. 3.12 Medical device including substances used for in vitro diagnosis referred to in rule 3 of these rules. 3.13 Quality audit means a systematic, independent examination of a manufacturer's quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures, that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives. 3.14 Quality policy means the overall intendon and direction of an organization with respect to quality, as established by management with executive responsibility. 3.15 Quality system means the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management. 3.16 Rework means action taken on a non-conforming product that will fulfill the specified Device Master File requirements before it is released for distribution. 3.17 Specification means any requirement with which a product, process, service, or other activity must conform. 3.18 Validation means confirmation by examination and provision of objective evidence that the particular requirement for a specific intended use can be consistently fulfilled. 3.18.1 Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 134 of 248 3.18.2 Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s). 3.19 Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.