SIST EN ISO 13485:2003/AC:2009

Oznaka standarda: SIST EN ISO 13485:2003/AC:2009
Koda projekta: JT003C04
Organizacija: SIST
Naslov (angleški): Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)
Naslov (slovenski): Medicinski pripomočki - Sistemi vodenja kakovosti - Zahteve za zakonodajne namene (ISO 13485:2003/Cor 1:2009)
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Dokumenti
Ime Jezik Status Cena Dodaj v košarico
SIST EN ISO 13485:2003/AC:2009 angleški jezik Withdrawn SIST-AC: 0.00 EUR
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Tehnični odbor: VAZ - Varovanje zdravja
ICS: 03.100.70 11.020.01
Status: Razveljavljen
Objavljen: 01-dec-2009
Refer. št. objave: Sporočila 2009-12
Razveljavitev: 01-apr-2012
Referenca razveljavitve: Sporočila 2012-04
Področje projekta (angleško): 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 requirements and regulatory requirements applicable to medical devices and related services. The primary objective of this International Standard is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001 (see Annex B).
Povezava na standarde
Povezava Ime Datum
Popravek k SIST EN ISO 13485:2003 - Medicinski pripomočki – Sistemi vodenja kakovosti – Zahteve za zakonodajne namene (ISO 13485:2003) 27-jun-2009
Nadomešča SIST EN ISO 13485:2003/AC:2008 - Medicinski pripomočki - Sistemi vodenja kakovosti - Zahteve za zakonodajne namene (ISO 13485:2003) 27-jun-2009
Nadomeščen z SIST EN ISO 13485:2012 - Medicinski pripomočki - Sistemi vodenja kakovosti - Zahteve za zakonodajne namene (ISO 13485:2003) 01-apr-2012


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