borrador-iso-9001-2015

ISO/CD 90017847857867877887897907917927937947957967977987998008018028038048058068078088098108118128138148158168178188198208218228231) the nature of the goods and services to be developed and potential consequences of failure,2) the level of control expected of the development process by customers and other relevantinterested parties, and3) the potential impact on the organization‟s ability to consistently meet customer requirements andenhance customer satisfaction.f) internal and external resource needs for the development of goods and services,g) the need for clarity with respect to the responsibilities and authorities of the individuals and partiesinvolved in the development process,h) the need for the management of the interfaces between individuals and parties involved in thedevelopment task or opportunity,i) the need for involvement of customer groups and user groups in the development process and theirinterface with management of the development process,j) the necessary documented information on the application of development processes, the outputs andtheir suitability, andk) the activities needed to transfer from development to production or service provision.8.5.2 Development controlsThe controls applied to the development process shall ensure thata) the result to be achieved by the development activities is clearly defined,b) inputs are defined to a level sufficient for the development activities being undertaken and do not give riseto ambiguity, conflict or lack of clarity,c) outputs are in a form suitable for subsequent use for production of goods and provision of services andrelated monitoring and measurement,d) problems and issues arising during the development process are resolved or otherwise managed beforecommitting to further development work or setting priorities for that work,e) the planned development processes have been followed, the outputs are consistent with the inputs andthe objective of the development activity has been met,f) goods produced or services provided as a consequence of the development undertaken are fit forpurpose, andg) appropriate change control and configuration management is maintained throughout the development ofgoods and services and any subsequent modifications to goods and services.8.5.3 Development transferThe organization shall ensure that transfer from development to production or service provision only takesplace when actions outstanding or arising from development have been completed or are otherwise managedsuch that there is no adverse impact on the organization‟s ability to consistently meet customer requirements,statutory or regulatory requirements, or to enhance customer satisfaction.16 © ISO 2013 – All rights reserved © ISO 2013 – All rights reserved