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DIN EN ISO 13485:2021-12

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016 + AC:2018 + A11:2021

Edition date: 2021-12-01
In Force
Available languages: English, German
Summary: This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e. g. technical support). This International Standard can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. Amendment 11 replaces the European Annexes Z which disclose the relationship between clauses of the standard and the EU Directives by the European Annexes Z which disclose the relationship between clauses of the standard and the EU Regulations on medical devices and in vitro diagnostics respectively.
Keywords: Acceptance specification|After-sales services|Applications|Auditing|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
ICS: 03.100.70-Management systems, 11.040.01-Medical equipment in general, 35.240.01-10-
CTN:

International Equivalence

Identic EN ISO 13485:2016/A11:2021

Identic ISO 13485:2016

Reemplazo Normas

Reemplaza a DIN EN ISO 13485:2016-08

Reemplaza a DIN EN ISO 13485 Berichtigung 1:2017-07

Reemplaza a DIN EN ISO 13485/A1:2019-11

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