Chapter 1 Application Background Information

1. Introduction

The ISO 13485 standard is a quality management system standard applicable to the regulatory environment of medical devices. Its full name is "Medical devices — Quality management systems — Requirements for regulatory purposes." The ISO 13485 quality system originates from ISO 9001, but ISO 13485 has more targeted requirements for the quality system of medical devices, focusing on the design and development, production, storage, distribution, installation, service, decommissioning, and disposal of medical devices, as well as related industries or organizations.

The content of ISO 13485:2016 includes: scope of application, normative references, terms and definitions, quality management system, management responsibility, resource management, product realization, measurement analysis and improvement, totaling 8 parts, as well as Appendix A and Appendix B. When establishing a quality management system for medical devices, it is necessary to strictly follow this standard, and reasons must be provided for any inapplicable clauses.

2. Regulatory Authorities

Currently, each country regulates ISO 13485 and product regulation simultaneously. The European Union and countries in East and Southeast Asia generally use ISO 13485 as a common standard, requiring manufacturers to establish a QMS and obtain an ISO 13485 certificate issued by a certification body. ISO 13485 certificates issued by IAF/IAS member organizations have a good mutual recognition mechanism, and it is strongly recommended to obtain an ISO 13485 certificate issued by an IAF member organization. Although countries such as Canada, the United States, and Brazil have their own independent QMS requirements, they still add special requirements based on ISO 13485.

3. Scope of Application

Types of organizations: The types of organizations to which ISO 13485 applies include medical device design and manufacturing, operation, service providers, software and hardware developers, as well as component/material suppliers.

Types of products: It includes passive, active non-implantable, active implantable, IVD, sterilization class devices, and devices that contain or use specific substances or technologies.

4. Conditions Required for Certification

Any organization with legal status can apply for ISO 13485 certification. Before submitting an application, it is necessary to ensure that the organization has established a documented management system in accordance with the requirements of ISO 13485:2016, including a quality manual, procedure documents, internal audit materials, management review materials, and other related forms required by procedure documents. Moreover, the system must have been effectively operating for at least 3 months, during which a complete internal audit and management review have been conducted. For organizations producing implantable device products, the system operation time must be at least 6 months.

5. Certification Application Language

Chinese/English

6. Significance of Certification

a. Improve the management level of the enterprise and avoid legal risks;

b. Enhance and maintain the quality level of products;

c. Eliminate trade barriers and obtain a passport to enter the international market;

d. Enhance the competitiveness of products and increase market share;

e. Reduce the risk of product quality accidents or adverse events through risk management.

7. Documents Required for Certification

a) Certification application form;

b) Quality manual, procedure documents;

c) Standards for the products to be certified or the products covered by the quality system;

d) Medical device product registration certificate (copy);

e) Summary of the entire product production process, product production process and explanations of special processes and key processes;

f) Sales situation of products in the past three years and user feedback information;

g) List of main purchased and outsourced parts;

h) Other materials, such as enterprise product catalog, product introduction, product promotional materials, etc.; information of organizations and personnel that have provided certification consulting for it.

Chapter 2 Certification Process

Chapter 3  FAQ

Q: How long does it take to get ISO 13485 certification?

A: The certification time depends on the size of the enterprise and the scope of certification. The larger the organization and the wider the scope of certification, the longer the time required for certification.

Q: What are the costs associated with ISO 13485 certification?

A: ISO 13485 certification is generally reviewed and certified by a certification body. The specific costs depend on the market quotation of the certification body, as well as the size of the enterprise and the scope of certification.

Q: How can I verify the ISO 13485 certification after it is completed?

A: Certification data is generally publicly available and can be queried through the official website of the certification body, but the certificate number and basic enterprise information must be provided.