ISO 9001_2015 Clause 10 Improvement.pdf

10. Improvement General The organization shall select opportunities for improvement and implement actions to meet customer requirements and enhance customer satisfaction? Does this include: 10.1 a) improving products and services to meet requirements as well as to address fu...

10. Improvement General The organization shall select opportunities for improvement and implement actions to meet customer requirements and enhance customer satisfaction? Does this include: 10.1 a) improving products and services to meet requirements as well as to address future needs and expectations? b) correcting, preventing or reducing undesired effects? c) improving the performance and effectiveness of the quality management system? NOTE Examples of improvement can include correction, corrective action, continual improvement, breakthrough change, innovation and re-organization. 10.2 Nonconformity and corrective action When a nonconformity occurs, including those arising from complaints, does the organization: a) react to the nonconformity and, as applicable: 1) take action to control and correct it? 2) deal with the consequences? b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by: 1) reviewing and analysing the nonconformity? 2) determining the causes of the nonconformity including, as applicable, those related to human factors? (AS9100-D) 3) determining if similar nonconformities exist, or could potentially occur c) implement any action needed? 10.2.1 d) review the effectiveness of any corrective action taken? e) update risks and opportunities determined during planning, if necessary? f) make changes to the quality management system, if necessary? g) flow down corrective action requirements to an external provider when it is determined that the external provider is responsible for the nonconformity; h) take specific actions when timely and effective corrective actions are not achieved. Are the corrective actions appropriate to the effects of the nonconformities encountered? The organization shall maintain documented information that defines the nonconformity and corrective action management processes. (AS9100-D) NQA-1 / 10 CFR Part 50-Appendix B: XVI Corrective Action. Measures shall be established to assure that significant conditions adverse to quality, such as failures, malfunctions, deficiencies, deviations, defective material and equipment, and nonconformances are promptly identified and corrected to preclude repitition. The cause of the condition and the corrective action taken shall be documented and reported to appropriate levels of management. Does the organization retain documented information as evidence of: a) the nature of the nonconformities and any subsequent actions taken? 10.2.2 b)       the results of any corrective action? DIRECTIVE 2014/68/EU Module D 3-2: Documentation shall contain the means of monitoring the achievement and the effective operation of the QMS. Continual improvement Does the organization continually improve the suitability, adequacy and effectiveness of the quality management system? Does the organization consider the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that 10.3 shall be addressed as part of continual improvement? AS9100-D: The organization shall monitor the implementation of improvement activities and evaluate the effectiveness of the results. NOTE: Examples of continual improvement opportunities can include lessons learned, problem resolutions, and the benchmarking of best practices. QMS Clause Requirements