CAN/CSA-ISO 13488-F98:2000 Edition
$17.55
Systèmes qualité – Dispositifs médicaux – Exigences particulières relatives à l’application de l’ISO 9002
| Published By | Publication Date | Number of Pages |
| CSA | 2000-01-19 | 21 |
Domaine d'application
La présente Norme internationale, conjointement avec l'ISO 9002, prescrit les exigences relatives aux systèmes qualité en matière de production, et lorsque c'est approprié, d'installation des dispositifs médicaux et de prestations associées.
La présente Norme internationale, conjointement avec l'ISO 9002, est applicable lorsqu'il est nécessaire d'évaluer le système qualité d'un fournisseur de dispositifs médicaux.
Dans le cadre de l'évaluation par une tierce partie en ce qui concerne les exigences réglementaires, il peut être exigé du fournisseur de permettre l'accès à des données confidentielles pour démontrer la conformité à la présente Norme internationale. Le fournisseur peut être tenu de montrer ces données mais n'est pas obligé de fournir des copies pour conservation.
NOTE – Dans la présente Norme internationale, l'expression «s'il y a lieu» est utilisée plusieurs fois. Lorsque cette expression accompagne une exigence, on considère que celle-ci «doit être respectée», sauf si le fournisseur peut justifier du contraire. Une exigence «doit être respectée» si son non-respect risque d'avoir les conséquences suivantes:
- le produit n'est pas conforme aux exigences prescrites; et/ou
- le fournisseur n'est pas en mesure de mener une action corrective.
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