EN ISO 13485/AC

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)

2009-08-00

Hết hiệu lực

DIN EN ISO 13485 (2010-01), IDT * ISO 13485 Technical Corrigendum 1 (2009-08), IDT * SN EN ISO 13485/AC (2010-01), IDT * OENORM EN ISO 13485 (2010-02-15), IDT * PN-EN ISO 13485/AC (2009-11-02), IDT * PN-EN ISO 13485/AC (2013-03-31), IDT * PN-EN ISO 13485/AC (2015-01-13), IDT * SS-EN ISO 13485/AC (2009-09-15), IDT * UNE-EN ISO 13485 ERRATUM (2009-10-21), IDT * TS EN ISO 13485/AC (2012-04-12), IDT * UNI CEI EN ISO 13485:2004 (2004-06-01), IDT * CSN EN ISO 13485 (2003-12-01), IDT * DS/EN ISO 13485/AC (2009-10-24), IDT * EC 1-2011 UNI EN ISO 13485:2004 (2011-05-03), IDT * NEN-EN-ISO 13485:2003/C1:2009 en (2009-09-01), IDT

EN ISO 13485 (2003-07)

EN ISO 13485/AC (2007-06)

EN ISO 13485 (2012-02)

EN ISO 13485 (2012-02) * EN ISO 13485/AC (2009-08) * EN ISO 13485/AC (2007-06)

After-sales services * Applications * Auditing * Bearings * CE marking * Conduits * Consumer-supplier relations * Corrrections * 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 * 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 requirements * Responsibility * Return current * Sellers * Services * Shipping * Specification * Specification (approval) * Standards * Steering gear * Storage * Surveillance (approval) * Testing * Training * Treatment * Use * Verification * Processes * Supplying * Cords * Procedures * Electric cables * Implementation * Manuals * Pipelines * Presentations

03.120.10. Quản lý chất lượng và đảm bảo chất lượng
11.040.01. Thiết bị y tế nói chung

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