03.120.10: Quality management and quality assurance

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  1. UNE-EN ISO 13485:2004 ERRATUM:2009▹

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

    Corrigenda by UNE-EN ISO, 10/21/2009.

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  2. HISTORICAL

    UNE-EN ISO 13488:2001▹

    This document has been replaced. View the most recent version.

    Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002. (ISO 13488:1996)

    standard by UNE-EN ISO, 07/13/2001.

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    Historical Editions: UNE-EN ISO 13485:2004, UNE-EN ISO 13485:2001, UNE-EN 46003:2000

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  3. UNE-EN 13549:2002▹

    Cleaning services - Basic requirements and recommendations for quality measuring systems.

    standard by UNE-EN, 02/22/2002.

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  4. UNE-EN 13980:2003▹

    Potentially explosive atmospheres - Application of quality systems

    standard by UNE-EN, 06/20/2003.

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  5. UNE-CEN ISO/TR 14969:2006 IN▹

    Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004)

    standard by UNE-CEN ISO/TR, 02/15/2006.

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  6. UNE-EN 14969:2007▹

    Railway applications - Track - Qualification system for railway trackwork contractors

    standard by UNE-EN, 10/10/2007.

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  7. UNE-ISO 15161:2005▹

    Guidelines on the application of ISO 9001:2000 for the food and drink industry.

    standard by UNE-ISO, 01/26/2005.

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  8. HISTORICAL

    UNE-EN ISO 15189:2003▹

    This document has been replaced. View the most recent version.

    Medical laboratories - Particular requirements for quality and competence (ISO 15189:2003)

    standard by UNE-EN ISO, 10/03/2003.

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    Historical Editions: UNE-EN ISO 15189:2007

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  9. UNE-EN ISO 15189:2007▹

    Medical laboratories - Particular requirements for quality and competence (ISO 15189:2007)

    standard by UNE-EN ISO, 09/05/2007.

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    Historical Editions: UNE-EN ISO 15189:2003

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  10. UNE-CEN/TS 15224:2007 EX▹

    Health services - Quality management systems - Guide for the use of EN ISO 9001:2000

    standard by UNE-CEN/TS, 12/19/2007.

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