ISO 13485 Medical Device Quality Management System CertificationSuitable for the medical device industry to enhance corporate image

What is the ISO 13485 Standard?

ISO 13485 is a quality management system standard applicable to the regulatory environment of medical devices, with the full name .

It adopts the PDCA concept from the ISO 9001 standard. Unlike ISO 9001 which applies to all types of organizations, ISO 13485 is more specialized, focusing on organizations engaged in medical device design and development, production, storage, distribution, installation, service, decommissioning and disposal. Currently, enterprises can establish systems or apply for certification in accordance with ISO 13485:2016.

Key Contents of ISO 13485

01On-site Research

Centering on regulatory requirements, it strengthens enterprises’ primary responsibility for compliance; implements risk-based process management and requires risk control for all quality management processes;
02System Diagnosis & Planning

It emphasizes communication and reporting obligations with regulatory authorities, and puts forward stricter requirements for documented procedures and records on the basis of ISO 9001.

Enterprise Types Applicable to ISO 13485

ISO 13485 certification applies to medical device designers and manufacturers, distributors, service providers, medical software and hardware developers, as well as component and material suppliers. Related products are divided into 7 technical fields:

1. Non-active Medical Devices

2. Active Non-implantable Medical Devices

3. Active Implantable Medical Devices

4. In Vitro Diagnostic Medical Devices

5. Sterilization Methods for Medical Devices

6. Medical Devices Containing Specific Substances & Technologies

7. Medical Device Related Services

Documents Required for ISO 13485 Certification

01
Legal qualification documents;
02
Valid industry qualification certificates;
03
Company profile, staffing information, production and service flow charts (marking key processes, special processes and outsourced processes);
04
Management system documents: quality policy, objectives, scope, appointment letters, procedure documents, work instructions, clean workshop layout, process flow charts, sterilization documents and other process records;
05
Acceptance criteria for products and services covered by the quality management system (product inspection specifications);
06
A list of implemented projects if engaging in installation, maintenance and other services.