The Medical Devices Introductory Course 2020

EN ISO 13485.1 Scope

The standard applies to organizations: • involved in design and development, production, storage, distribution, installation, servicing, etc • regardless of their size and type • even if the processes are not performed by the organizations (i.e. the processes are subcontracted) • even if the organizations are not involved in design and development, if applicable regulatory requirements permit (for example MDR Annex XI, Part A).

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

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EN ISO 13485.4: Quality Management System

1. The organization shall document (establish, implement and maintain) a QMS and maintain its effectiveness. It shall: a) identify the processes needed for the QMS and their application throughout the organization, b) determine the sequence and interaction of these processes c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes e) monitor, measure and analyse these processes, and f) implement actions necessary to achieve planned results and maintain the effectiveness of these processes. 2. The documentation requirements are specified.

HOWARD DOBBS

The Organisation for Professionals in Regulatory Affairs

10