borrador-iso-9001-2015

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ISO/CD <strong>9001</strong>945946947948949950951952953954955956957958959960961962963964965966967968969970971972973974975976977978979980981982983984985a) determine what needs to be monitored and measured in order to:- demonstrate conformity of goods and services to requirements,- evaluate the performance of processes (see 4.4),- ensure conformity and effectiveness of the quality management system, and- evaluate customer satisfaction; andb) evaluate the performance of external provider(s) (see 8.4);c) determine the methods for monitoring, measurement, analysis and evaluation, as applicable, to ensurevalid results;d) determine when the monitoring and measuring shall be performed;e) determine when the results from monitoring and measurement shall be analysed and evaluated; andf) determine what performance indicators of the quality management system are needed.The organization shall establish processes to ensure that monitoring and measurement can be carried out andare carried out in a manner that is consistent with the monitoring and measurement requirements.The organization shall retain appropriate documented information as evidence of the results.The organization shall evaluate the quality performance and the effectiveness of the quality managementsystem.9.1.2 Customer satisfactionThe organization shall monitor data relating to customer perceptions of the degree to which requirementshave been met.As appropriate, the organization shall obtain data relating to:a) customer feedback , andb) customer views and perceptions of the organization, its processes and its goods and services.The methods for obtaining and using this data shall be determined.The organization shall evaluate the data obtained to determine opportunities to enhance customersatisfaction.9.1.3 Analysis and evaluation of dataThe organization shall analyse and evaluate appropriate data arising from monitoring, measurement (see9.1.1 and 9.1.2) and other relevant sources. This shall include determination of applicable methods.The results of analysis and evaluation shall be used:a) to determine the suitability, adequacy and effectiveness of the quality management system,20 © ISO 2013 – All rights reserved © ISO 2013 – All rights reserved
ISO/CD <strong>9001</strong>9869879889899909919929939949959969979989991000100110021003100410051006100710081009101010111012101310141015101610171018101910201021102210231024b) to assure that the goods and services can consistently meet customer requirements,c) to ensure that the operation and control of processes is effective, andd) to identify improvements within the quality management system.The results of analysis and evaluation shall be used as an input to the management review.9.2 Internal AuditThe organization shall conduct internal audits at planned intervals to provide information on whether thequality management system;a) conforms to1) the organization‘s own requirements for its quality management system; and2) the requirements of this International Standard;b) is effectively implemented and maintained.The organization shall:a) plan, establish, implement and maintain an audit programme(s), including the frequency, methods,responsibilities, planning requirements and reporting. The audit programme(s) shall take intoconsideration the quality objectives, the importance of the processes concerned, the related risks, and theresults of previous audits;b) define the audit criteria and scope for each audit;c) select auditors and conduct audits to ensure objectivity and the impartiality of the audit process;d) ensure that the results of the audits are reported to relevant management for evaluation,e) take appropriate action without undue delay; andf) retain documented information as evidence of the implementation of the audit programme and the auditresults.NOTE See ISO 19011 for guidance.9.3 Management reviewTop management shall review the organization's quality management system, at planned intervals, to ensureits continuing suitability, adequacy, and effectiveness.Management review shall be planned and carried out, taking into account the changing business environmentand in alignment with the strategic direction of the organization.The management review shall include consideration of:a) the status of actions from previous management reviews;b) changes in external and internal issues that are relevant to the quality management system;c) information on the performance of the quality management system, including trends and indicators for:1) nonconformities and corrective actions;© ISO 2013 – All rights reserved© ISO 2013 – All rights reserved 21
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