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Normas DIN – AENOR
DIN EN ISO 13485:2015-05

DIN EN ISO 13485:2015-05

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO/DIS 13485:2015); German and English version prEN ISO 13485:2015 / Note: Date of issue 2015-04-17

Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires (ISO/DIS 13485:2015); Version allemande et anglaise prEN ISO 13485:2015 / Attention: Date de parution 2015-04-17

Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO/DIS 13485:2015); Deutsche und Englische Fassung prEN ISO 13485:2015 / Achtung: Erscheinungsdatum 2015-04-17

Fecha Anulación:
2016-08 /Withdrawn
Equivalencias internacionales:

ISO/DIS 13485 (2015-02)

prEN ISO 13485 (2015-02)

Relación con otras normas DIN:

Reemplaza a: DIN EN ISO 13485:2014-04

Reemplazada por: DIN EN ISO 13485:2016-08

Resumen:
This International Standard specifies requirements for an organization that needs to demonstrate that its quality management system has the ability to manage the life-cycle of medical devices and associated activities consistently to meet customer and appropriate regulatory requirements. It may also be used by suppliers or external parties that provide goods and quality system related services to medical device organizations. The main objective of this International Standard is to facilitate global alignment of appropriate regulatory requirements for quality management systems applicable to organizations providing medical devices. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001:2008 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001:2008 unless their quality management systems conform to all the requirements of ISO 9001:2008.
Keywords:
Acceptance specification, After-sales services, Applications, Auditing, CE marking, Conduits, Consumer-supplier relations, Corrections, Customers, Data, Definitions, Delivery, Delivery conditions, Design, Detail specification, Developments, Documentation, Editing, Electrical engineering, Erecting (construction operation), Establishment, Evaluations, Handbooks, Handling, Industries, Inspection, Installation, Installations, Instruments, International standards, Maintenance, Management systems, Medical devices, Medical equipment, Medical instruments, Medical products, Medical sciences, Methods, Organization, Packages, Planning, Preservation, Preventive actions, Process, Process management, Procurements, Product design, Product planning, Production, Products, Quality, Quality assessment systems, Quality assurance, Quality assurance systems, Quality auditing, Quality control, Quality improvement, Quality management, Quality requirements, Responsibility, Return current, Sellers, Services, Shipping, Specification, Specification (approval), Standards, Steering gear, Storage, Surveillance (approval), Testing, Training, Treatment, Use, Verification
164,02
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