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Checklist d'audit ISO 13485

by Kavitha Manicam, from the Community

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Cette checklist d'audit ISO 13485:2016 aide les responsables qualité du secteur des dispositifs médicaux à évaluer la conformité de leur système de management de la qualité. Elle couvre les revues de direction, la planification qualité, les contrôles de conception et de développement, la gestion des risques, les CAPA, le Medical Device Reporting, ainsi que les contrôles de production, de stérilisation et d’achats. Elle inclut aussi les exigences de traçabilité, la maîtrise documentaire et des enregistrements, l’évaluation des fournisseurs, l’infrastructure et la formation. Utilisez-la pour mesurer l’état de préparation à la certification et guider les actions d’amélioration.

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Digitize any process, procedure or policy
Eliminate mistakes made by paper-based processes
Create and share professional reports instantly
Confirm accountability and compliance with a digital log

With SafetyCulture you can

Digitize any process, procedure or policy
Eliminate mistakes made by paper-based processes
Create and share professional reports instantly
Confirm accountability and compliance with a digital log

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This community page makes available free workplace checklists and templates created by other users within the SafetyCulture community. SafetyCulture has re-published this content and where possible, has credited the original author. SafetyCulture has not verified the accuracy, reliability or suitability of any community content. You agree that your use of any of this content is in accordance with SafetyCulture’s Terms and Conditions.