Measurement, analysis and improvement 8.1 General The manufacturer shall plan and implement the monitoring, measurement, analysis and improvement processes needed— (a) to demonstrate conformity of the product; (b) to ensure conformity of the quality management system; and (c) to maintain the effectiveness of the quality management system. This shall include determination of applicable methods, including statistical techniques, and the extent of their use. Note : If relevant Indian standards are not available, International standards are applicable. In case no Indian or International standards are available, validated testing process of the manufacturer is applicable.