Maintenance of medical devices - Model and definition for establishment and management of the medical device security, quality and maintenance register (RSQM)

Introduction 4

1 Domaine d'application 4

2 Références normatives 5

3 Termes et définitions 5

4 Exigences pour la construction du registre RSQM des dispositifs médicaux 7

4.1 Généralités 7

4.2 Description du RSQM 7

4.3 Description des fiches du RSQM 10

To comply with a standard, you need to quickly understand its issues in order to determine its impact on your activity.

The Requirements department helps you quickly locate within the normative text:
- mandatory clauses to satisfy,
- non-essential but useful clauses to know, such as permissions and recommendations.

The identification of these types of clauses is based on the document “ISO / IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents ”as well as on a constantly enriched list of verbal forms.

With Requirements, quickly access the main part of the normative text!