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  • Abbiamo il piacere di comunicarvi che, in data 7 Novembre 2017, Fonderia Taroni ha ottenuto la certificazione di conformità alla norma ISO 13485 in materia di Sistemi di Gestione Qualità per Dispositivi Medici.

    La ISO 13485 è la norma internazionalmente riconosciuta per i Sistemi di Gestione Qualità nel settore dei dispositivi medici; è destinata ad essere utilizzata da qualsiasi organizzazione che si occupi di progettazione, sviluppo, produzione, installazione e assistenza tecnica di dispositivi medici o di servizi ad essi collegati.

    La ISO 13485 è uno standard di sistema di gestione qualità specifico per le aziende del settore medicale, che include aspetti dello standard ISO 9001 e requisiti specifici per il settore dei dispositivi medici
    La EN ISO 13485:2012 è stata armonizzata in considerazione delle tre Direttive Europee sui Dispositivi (Dispositivi Medici, Dispositivi Medici Diagnostici In Vitro e Dispositivi Medici Impiantabili Attivi), quindi la certificazione in accordo a questa norma da parte di un organismo di certificazione accreditato quale DNV-GL presume automaticamente il rispetto delle clausole specifiche presenti in queste tre direttive.

    Con il raggiungimento di questo obiettivo abbiamo valorizzato il nostro Sistema Integrato di Gestione Aziendale già certificato in base agli standard ISO 9001 e ISO 14001 a conferma dell’impegno, nei confronti dei nostri clienti, dell’ambiente e dei nostri dipendenti, al rispetto degli standard normativi di riferimento.

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  • ISO 13485 Medical device

    Quality Management Systems are an essential requirement for Medical Device Manufacturers and provide evidence of ongoing product quality and regulatory compliance.

    What is the ISO 13485 standard? 

    ISO 13485 is the internationally recognized standard for quality management systems in the medical device industry.
    It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices, and that related services consistently meet customer requirements and applicable regulatory requirements. It is designed and intended for use by organizations for the design and development, production, installation, servicing and sales of medical devices.  

    The primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for quality management systems. ISO 13485 is a standalone standard. It is largely based on the structure of ISO 9001, but includes some particular requirements for medical devices such as risk analysis, sterile manufacturing and traceability. Organizations certified to ISO 13485 can not claim conformity to ISO 9001

    In 2017 Taroni foundry has obtained the certification of compliance with ISO 13485 on Quality Management Systems for Medical Device.

    DOWNLOAD CERTIFICATE ISO 13485

    Connection with national requirements for approval of medical devices 

    Legal access to markets for products is essential for manufacturers of medical devices. ISO 13485 is often required by national regulations as part of the approval process for medical devices, e.g. for the EU directive on medical devices (Medical Device Directive 93/42/EEC, In Vitro Diagnostic Directive 98/79/EC, Active Implantable Medical Devices 90/385/EEC). 

  • ISO 13485 Medical device

    Quality Management Systems are an essential requirement for Medical Device Manufacturers and provide evidence of ongoing product quality and regulatory compliance.

    What is the ISO 13485 standard? 

    ISO 13485 is the internationally recognized standard for quality management systems in the medical device industry.
    It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices, and that related services consistently meet customer requirements and applicable regulatory requirements. It is designed and intended for use by organizations for the design and development, production, installation, servicing and sales of medical devices.  

    The primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for quality management systems. ISO 13485 is a standalone standard. It is largely based on the structure of ISO 9001, but includes some particular requirements for medical devices such as risk analysis, sterile manufacturing and traceability. Organizations certified to ISO 13485 can not claim conformity to ISO 9001

    In 2017 Taroni foundry has obtained the certification of compliance with ISO 13485 on Quality Management Systems for Medical Device.

    DOWNLOAD CERTIFICATE ISO 13485

    Connection with national requirements for approval of medical devices 

    Legal access to markets for products is essential for manufacturers of medical devices. ISO 13485 is often required by national regulations as part of the approval process for medical devices, e.g. for the EU directive on medical devices (Medical Device Directive 93/42/EEC, In Vitro Diagnostic Directive 98/79/EC, Active Implantable Medical Devices 90/385/EEC). 

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