ISO 13485

Medical devices - Quality management systems - Requirements for regulatory purposes

2003-07-00

Có hiệu lực

DIN EN ISO 13485 (2003-11), IDT * DIN EN ISO 13485 (2007-10), IDT * DIN EN ISO 13485 (2010-01), IDT * DIN EN ISO 13485 (2012-11), IDT * ANSI/AAMI/ISO 13485 (2003), IDT * ABNT NBR ISO 13485 (2004-07-30), IDT * BS EN ISO 13485 (2003-07-24), IDT * BS EN ISO 13485 (2012-03-31), IDT * EN ISO 13485 (2003-07), IDT * EN ISO 13485 (2012-02), IDT * EN ISO 13485/AC (2007-06), IDT * NF S99-101 (2004-02-01), IDT * NF S99-101 (2012-09-01), IDT * JIS Q 13485 (2005-10-01), IDT * CAN/CSA-ISO 13485-03 (2003-12-01), IDT * CSA Plus 13485 (2006-02-01), IDT * SN EN ISO 13485 (2003-09), IDT * SN EN ISO 13485 (2012-09), IDT * SN EN ISO 13485/AC (2007-10), IDT * OENORM EN ISO 13485 (2003-11-01), IDT * OENORM EN ISO 13485 (2007-11-01), IDT * OENORM EN ISO 13485 (2010-02-15), IDT * OENORM EN ISO 13485 (2012-11-01), IDT * PN-EN ISO 13485 (2004-02-15), IDT * PN-EN ISO 13485 (2005-11-16), IDT * PN-EN ISO 13485 (2012-04-20), IDT * PN-EN ISO 13485 (2014-12-19), IDT * PN-EN ISO 13485/AC (2007-08-31), IDT * SS-EN ISO 13485 (2003-08-15), IDT * SS-EN ISO 13485 (2012-03-06), IDT * SS-EN ISO 13485/AC (2007-09-07), IDT * UNE-EN ISO 13485 (2012-05-23), IDT * UNE-EN ISO 13485 (2013-05-29), IDT * GOST ISO 13485 (2011), IDT * GOST R ISO 13485 (2004), IDT * TS EN ISO 13485 (2004-04-29), IDT * UNI CEI EN ISO 13485:2004 (2004-06-01), IDT * UNI CEI EN ISO 13485:2012 (2012-04-05), IDT * STN EN ISO 13485 (2004-05-01), IDT * STN EN ISO 13485 (2012-10-01), IDT * CSN EN ISO 13485 (2003-12-01), IDT * CSN EN ISO 13485 (2012-08-01), IDT * DS/EN ISO 13485 (2003-09-12), IDT * DS/EN ISO 13485 (2012-03-09), IDT * NEN-EN-ISO 13485:2003 en (2003-08-01), IDT * NEN-EN-ISO 13485:2003 nl (2003-08-01), IDT * NEN-EN-ISO 13485:2012 en (2012-02-01), IDT * SANS 13485:2004 (2004-11-25), IDT

ISO 9000 (2000-12)

ISO 13485 (1996-12) * ISO 13488 (1996-12) * ISO/FDIS 13485 (2003-02)

ISO 13485 (2003-07) * ISO 13485 (1996-12) * ISO 13488 (1996-12) * ISO/FDIS 13485 (2003-02) * ISO/DIS 13485 (2002-02) * ISO/FDIS 13485 (1996-10) * ISO/DIS 13485 (1996-01) * ISO/DIS 13485 (1993-03) * ISO/FDIS 13488 (1996-10) * ISO/DIS 13488 (1996-01) * ISO/DIS 13488 (1993-03)

After-sales services * Applications * Auditing * 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 * Cords * Supplying * Bearings * Processes * 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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