Quality manual: The manufacturer shall establish and maintain a quality manual that includes— Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 136 of 248 (a) the scope of the quality management system, including details of and justification for any exclusion or non-application or both; (b) the documented procedures established for the quality management system, or reference to them; and (c) a description of the interaction between the processes of the quality management system. The quality manual shall outline the structure of the documentation used in the quality management system. The manufacturer shall prepare documentation in a form of a Plant Master File containing specific information about the facilities, personnel and other details as prescribed in Fourth. 4.2.3 Control of documents : Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in the control of records. Documents shall be approved, signed and dated by the appropriate and the authorised person. A documented procedure shall be established to define the controls needed— (a) to review and approve documents for adequacy prior to issue; (b) to review and update as necessary and re-approve documents; (c) to ensure that changes and the current revision status of documents are identified; (d) to ensure that relevant versions of applicable documents are available at points of use; (e) to ensure that documents remain legible and readily identifiable; (f) to ensure that documents of external origin are identified and their distribution controlled; and (g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose. Changes to document shall be reviewed and approved. Change records shall be maintained which will include a description of the change, identification of the affected documents, the signature of the approving individual, the approval date, and when the change becomes effective. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India.The manufacturer shall ensure that changes to documents are reviewed and approved either by the original approving functionary or another designated functionary which has access to pertinent background information upon which to base its decisions. The manufacturer shall define the period for which at least one copy of obsolete controlled documents shall be retained. This period shall ensure that documents to which medical devices or in vitro diagnostic medical devices have been manufactured and tested are retained for at least one year after the date of expiry of the medical device or in vitro diagnostic medical devices as defined by the manufacturer.