borrador-iso-9001-2015

ISO/CD 9001544545546547548549550551552553554555556557558559560561562563564565566567568569570571572573574575576577578579580581582583584Note Infrastructure can include,a) buildings and associated utilities,b) equipment including hardware and software, andc) transportation, communication and information systems.7.1.3 Process environmentThe organization shall determine, provide and maintain the process environment necessary for its operationsand to assure conformity of goods and services and customer satisfaction.NOTE Process environment can include physical, social, psychological and environmental factors (such as temperature,recognition schemes, ergonomics and atmospheric composition).7.1.4 Monitoring and measuring devicesThe organization shall determine, provide and maintain the monitoring and measuring devices needed toverify conformity to product requirements and shall ensure that the devices are fit for purpose.The organization shall retain appropriate documented information as evidence of fitness for purpose ofmonitoring and measuring devices.NOTE 1 Monitoring and measurement devices can include measuring equipment and assessment methods such assurveys.NOTE 2 Monitoring and measurement devices can be calibrated or verified, or both, at specified intervals, or prior to use,against measurement standards traceable to international or national measurement standards.7.1.5 KnowledgeThe organization shall determine the knowledge necessary for the operation of the quality managementsystem and its processes and to assure conformity of goods and services and customer satisfaction. Thisknowledge shall be maintained, protected and made available as necessary.Where addressing changing needs and trends the organization shall take into account its current knowledgebase and determine how to acquire or access the necessary additional knowledge.(See also 6.3)7.2 CompetenceThe organization shall:a) determine the necessary competence of person(s) doing work under its control that affects its qualityperformance, andb) ensure that these persons are competent on the basis of appropriate education, training, or experience;10 © ISO 2013 – All rights reserved © ISO 2013 – All rights reserved