ISO13485 Medical Device Quality Management System Certification

1) Overview

ISO13485 is a quality management system standard for the medical device industry, which adds special requirements for the medical device 

industry on the basis of ISO9001, and puts forward stricter control requirements for product identification, process control, and other aspects.

This certification can enhance the ultimate trust of healthcare workers and end-users in enterprise products.

ISO13485 includes special requirements for the manufacturing, installation, service, and recall of medical devices to facilitate:

*Improving the quality management system

*Use risk management methods to control the implementation process of the product

*Process validation

*Meet legal and regulatory requirements

*Effective control of product risks and recall management

Scope of application of ISO13485:

The requirements of ISO13485 apply to organizations engaged in the design and development, production, storage and distribution, installation, maintenance, 

and final discontinuation and disposal of medical devices;

The requirements of ISO13485 apply to suppliers or other external parties who provide products (such as raw materials, components, components, medical devices, 

sterilization services, calibration services, distribution services, maintenance services) to the aforementioned organizations;

2) What benefits certification brings to you

The benefits of ISO13485 certification

*Helps to eliminate technological barriers in international trade and is a passport to enter the international market

*Improve the management level of the organization

*Improve business reputation

*Improve the level of ensuring product quality

*Beneficial for enhancing the competitiveness of enterprises

*Improve internal management of the organization

3) Essential Conditions and Data List

Essential conditions

Applicable to one or more stages of the medical device lifecycle, including the design and development, production, storage and distribution, installation or maintenance,

 and related activities (such as technical support) of the medical device. It can also be used as a supplier or external party to provide products (including services related

 to quality management systems) to such organizations;

*The system shall operate for no less than three months;

*At least 3 consecutive months of production/quality management records, including complete records of internal and management reviews.

List of Application for Certification Materials

*Contract

*Application form

*Business license and organizational code certificate (confirmed to be valid)

*Other valid qualification certificates (such as product production license, if applicable)

*Company Introduction

*Organizational Chart

*Product Process Flow Diagram

*A list of applicable laws and regulations, including a list of product standards (if applicable, such as the final product needs to be provided);

*Recent national and industry product/service supervision spot check reports (if any);