INTERNATIONAL STANDARD ISO 13485:2016

Đăng ngày 28/03/2022

ISO 13485:2016(E)

Introduction

0.1   General

This International Standard specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g. technical support). The requirements in this International Standard can also be used by suppliers or other external parties providing product (e.g. raw materials, components, subassemblies, medical devices, sterilization services, calibration services, distribution services, maintenance services) to such organizations. The supplier or external party can voluntarily choose to conform to the requirements of this International Standard or can be required by contract to conform.

Several jurisdictions have regulatory requirements for the application of quality management systems by organizations with a variety of roles in the supply chain for medical devices. Consequently, this International Standard expects that the organization:

• identifies its role(s) under applicable regulatory requirements;
• identifies the regulatory requirements that apply to its activities under these roles;
• incorporates these applicable regulatory requirements within its quality management system.

The definitions in applicable regulatory requirements differ from nation to nation and region to region.

The organization needs to understand how the definitions in this International Standard will be interpreted in light of regulatory definitions in the jurisdictions in which the medical devices are made available.

…