De Glosario Médico-IT-Administración para Hospitales
Saltar a: navegación, buscar

The most recent edition of the INTERNATIONALE ORGANISATION FÜR STANDARDISIERUNG 9001 standard ISO 9001 2008 Quality Management Devices Requirements was officially posted by ISO the Essential Organization for Standardization on November 14 2008. It's the fourth edition of the ISO 9001 standard since it was first posted in 1987.

ISO 90012008 is a standard that provides a generic place of requirements for organizations wishing to develop a quality management QMS. The ISO 90012008 standard centers on increasing an organizations business processes. That identify any requirements for product or service quality. Buyers typically set product and service quality requirements. Nevertheless the expectation is that an organization with an efficient ISO 9001 based QMS will indeed improve the ability to meet customer statutory and regulatory requirements.

This is the only QMS standard to which an organization may obtain formal third party recognition. Because requirements are universal rather than specific organizations have overall flexibility in tailoring their QMS to fit their business culture and hazards.

ISO 9001 requirements go with contractual and applicable lawful and regulatory requirements. All those implementing a QMS contouring to ISO 9001 must ensure that the particular requirements of their customers and relevant statutory and corporate agencies are met.

That is Responsible For Revising QMS Requirements

The ISO Technological Committee no. 176 Subcommittee number 2 ISOTC 176SC 2 is in charge of the revision process in effort with consensus among quality and industry experts nominated by ISO Member body and representing all interested parties.

Does ISO 90012008 Have Additional Requirements Over and above ISO 90012000

This latest 4th edition of INTERNATIONALE ORGANISATION FÜR STANDARDISIERUNG 9001 does not contain new requirements compared to the 3rd year 2050 edition which it changes. What it does is provide clarification to the present requirements of ISO 90012000 based on eight years connection with worldwide employing of the conventional and presents changes meant to improve persistence with environmentally friendly management system standard ISO 140012004.

The clarifications and within ISO 90012008 represent finetuning rather than a comprehensive overhaul. It focuses on changes that organizations might make to better abide with the spirit of the standard without adding deleting or altering it is requirements. The changes are minor in nature and address such issues as the need to explain provide greater consistency solve perceived ambiguities and improve compatibility with ISO 14001. The numbering system and the structure of the standard remain unchanged. While a result the new standard looks much like the old standard.