SVENSK STANDARD SS-EN ISO 13485:2016/AC:2017 Fastställd/Approved: Publicerad/Published: Utgåva/Edition: 1 Språk/Language: svenska/swedish ICS:

EN ISO 13485. Scope of Certificate: Manufacturing and sales of semi-finished products and components for medical devices. Applied. Standard(s):. ET. EN ISO

Системы менеджмента качества. Требования SYSTEMS – REQUIREMENTS FOR REGULATORY. PURPOSES. FDBNS X: 20XX. ISO 13485:2015. FDBKS PUBLIC COMME. Bahamas Bureau of Standards ISO 13485 2016 is an international quality management standard for medical devices.

13485 standard pdf

ISO 13485 helps an organization design a quality man-agement system that establishes and maintains the ISO 13485:2016(E) Introduction 0.1 General This International Standard specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and About ISO 13485 Designed in particular for medical device manufacturers Released in 2003; updated in 2016. Is a “stand-alone” Standard, meaning that a company can apply it without the support of any other quality system standard (i.e. the support of ISO 9001). The standard can be used by an organization for the The European Standard EN ISO 13485:2016 / AC:2018 has the status of a Swedish Standard.

The standard provides an effective framework to meet the comprehensive requirements for a medical devices Name of Standards Organization: Bureau of Indian Standards (BIS) Division Name: Medical Equipment and Hospital Planning Section Name: Hospital Planning (MHD 14) Designator of Legally Binding Document: IS/ISO 13485 Title of Legally Binding Document: Medical Devices-Quality Management Systems-Requirements for Regulatory Purposes Number of Amendments: ISO 13485 är en standard för kvalitetsledning avsedd för medicinsk teknik klassning och beskriver hur man skall hantera och ge ut apparatur ägnad för bruk inom sjukvården. Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) , Corrigendum to DIN EN ISO 13485:2016-08 Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2016), Berichtigung zu DIN EN ISO 13485:2016-08 Today, the international standards are sanctioned by the 15 nations of the European Union (EU), making ISO 9001:2008 registration a virtual prerequisite for doing business there. Please note that while ISO 13485:2016 is a stand-alone standard, it is structured similar to ISO 9001:2008, which has been superseded by ISO 9001:2015.

Additionally, the ISO 9001 requirements regarding customer satisfaction are absent from the medical device standard. Other specific differences include: the

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Search all SIS.se; Only search standards Ledningsssystem för kvalitet enligt SS-EN ISO 13485:2016. Wordfil. Buy. Price: 795 SEK. standard ikon pdf. PDF.

30 Jul 2018 For Medical devices look at ISO 13485:2016. [PDF example] Get a copy of your ISO 13485:2016 standard by clicking the below button. SS ISO 13485 : 2016. (ICS 03.100.70; 11.040.01). SINGAPORE STANDARD. Medical devices – Quality management systems – Requirements for regulatory.

ISO 13485:2016.
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Standard Svensk standard · SS-EN ISO 13485:2016 standard ikon pdf Den här utgåvan gäller parallellt med den tidigare (SS- EN ISO 13485:2012) t.o.m. standards and directives. ISO 13485 defines all general requirements for „ Medical. Devices - Quality Management Systems Requirements“ for regulatory DIN EN ISO 13485.

You will need to purchase a copy of the standard to reach certification (sometimes multiple standards are required).
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ISO 13485 is the medical industry's optimal medical device standard, which ensures that all medical devices meet the proper regulatory compliance laws and customer needs. ISO 13485 certification is a valuable credential put in place to keep professionals and customers safe in clinics, hospitals and other medical settings.