borrador-iso-9001-2015

ISO/CD 90016246256266276286296306316326336346356366376386396406416426436446456466476486496506516526536546556566576586596606617.5.3 Control of documented InformationDocumented information required by the quality management system and by this International Standard shallbe controlled to ensurea) it is available and suitable for use, where and when it is needed, andb) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).For the control of documented information, the organization shall address the following activities, as applicablea) distribution, access, retrieval and use,b) storage and preservation, including preservation of legibility,c) control of changes (e.g. version control), andd) retention and disposition.Documented information of external origin determined by the organization to be necessary for the planningand operation of the quality management system shall be identified as appropriate, and controlled.NOTE Access implies a decision regarding the permission to view the documented information only, or the permissionand authority to view and change the documented information, etc.8 Operation8.1 Operational planning and controlThe organization shall plan, implement and control the processes needed to meet requirements and toimplement the actions determined in 6.1, bya) establishing criteria for the processesb) implementing control of the processes in accordance with the criteria, andc) keeping documented information to the extent necessary to have confidence that the processes havebeen carried out as planned.The organization shall control planned changes and review the consequences of unintended changes, takingaction to mitigate any adverse effects, as necessary.The organization shall ensure that outsourced processes are the operation of a function or process of theorganization by an external provider is controlled (see 8.4).Note Operation of a function or process of the organization by an external provider is often referred to as outsourcing.8.2 Determination of market needs and interactions with customers8.2.1 General12 © ISO 2013 – All rights reserved © ISO 2013 – All rights reserved