borrador-iso-9001-2015

ISO/CD 90013113123133143153163173183193203213223233243253263273283293303313323333343353363373383393.15monitoringdetermining the status of a system, a process (3.12) or an activityNote 1 to entry: To determine the status there may be a need to check, supervise or critically observe.3.16measurementprocess (3.12) to determine a value3.17auditsystematic, independent and documented process (3.12) for obtaining audit evidence and evaluating itobjectively to determine the extent to which the audit criteria are fulfilledNote 1 to entry: An audit can be an internal audit (first party) or an external audit (second party or third party), and it canbe a combined audit (combining two or more disciplines).Note 2 to entry: ―Audit evidence‖ and ―audit criteria‖ are defined in ISO 19011.3.18conformityfulfilment of a requirement (3.03)3.19nonconformitynon-fulfilment of a requirement (3.03)3.20correctionaction to eliminate a detected nonconformity (3.19)3.21corrective actionaction to eliminate the cause of a nonconformity (3.19) and to prevent recurrence3.22continual improvementrecurring activity to enhance performance (3.13)3403413423433443453463473483493503514 Context of the organization4.1 Understanding the organization and its contextThe organization shall determine external and internal issues, that are relevant to its purpose and its strategicdirection and that affect its ability to achieve the intended outcome(s) of its quality management system.The organization shall update such determinations when needed.When determining relevant external and internal issues, the organization shall consider those arising from:a) changes and trends which can have an impact on the objectives of the organization;b) relationships with, and perceptions and values of relevant interested parties;c) governance issues, strategic priorities, internal policies and commitments; and4 © ISO 2013 – All rights reserved © ISO 2013 – All rights reserved