What is ISO 13485 Medical Device Quality Management System?

Why do you need an ISO 13485 certificate?

Medical Device Quality Management System ISO 13485 is a set of international standards that define quality management system requirements for medical device manufacturers.

my country's GMP and GMS use the ISO 13485 reference basis to set the quality management standards for the global medical device industry. Manufacturers applying for GMP and GMS product certification must first meet the requirements of ISO 13485.

Achieving ISO 13485 certification demonstrates the organization's ability to consistently provide medical device products that meet customer and applicable regulatory requirements.

ISO 13485 validation contains the requirements necessary for organizations operating at any level of the medical device, pharmaceutical supply chain. The main goal of this standard is to promote uniform medical device management requirements, therefore, ISO 13485 for quality management systems for medical devices includes some special requirements for manufacturing, installation and maintenance, such as additional requirements for record control, sterilization and risk management.

Like many other ISO standards, the Medical Device Quality Management System ISO 13485 is based on ISO 9001. In particular, the requirements for customer satisfaction and continuous improvement have been modified to make them more suitable for regulatory purposes.

Organizations can register ISO 13485 independently or in combination with ISO 9001 or other registrations. Passing the ISO 13485 verification and obtaining the ISO 13485 certificate for the medical device quality management system, it is a testament to the company's and organization's commitment to provide products and related services that consistently meet customer and regulatory requirements applicable to the medical industry.

Specific benefits of ISO 13485 certification include:

• Support compliance compliance

• Covers the benefits of a quality management system based on ISO 9001

• Create a competitive advantage

• Ways to ensure consistency and effectiveness in business management

• Reduce risk factors by using risk management techniques

• Provides a robust framework for ensuring product consistency

• improve image

• Improve employee ethics

• Raise awareness of corporate social responsibility

​

The definition of medical materials in Taiwan, the United States and Europe

my country's "Medical Device Management Law" stipulates:
Medical devices refer to instruments, apparatuses, appliances, substances, software, in vitro diagnostic reagents and related articles, the design and use of which are intended to act on the human body by means other than pharmacology, immunity, metabolism or chemistry, and achieve the following main functions:
1. Diagnose, treat, alleviate or directly prevent human diseases.
2. Adjust or improve human body structure and function.
3. Regulate fertility.
Assistive devices that are non-invasive, have no risk of harming human health, and do not require the assistance of medical personnel when used, may be reported to the central competent authority for approval, and are exempt from the medical devices listed in the preceding paragraph.

The U.S. Federal Food, Drug, and Cosmetic Act (FD&C Act) states:
Medical devices refer to instruments, devices, tools, machinery, appliances, implants, in vitro reagents and other related items, including components, parts and accessories that meet the following conditions:
1. Medical devices that are clearly listed in the National Formulary or The Unite States Pharmacopeia or its annexes.
2. It is intended to be used for the diagnosis of animal or human diseases or other physical conditions; or for the treatment, mitigation and treatment of diseases.
3. Those who are expected to affect the function or structure of the animal or human body, but do not achieve their main purpose through chemical action or metabolism in the body.

The EU Medical Devices Law (MDR) states:
Medical device means any instrument, instrument, appliance, software, implant, reagent, material or other item that the manufacturer intends to use in humans for the following specific medical purposes:
1. The diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.
2. Diagnosis, monitoring, treatment, mitigation or compensation of injury or disability.
3. Investigation, replacement or modification of anatomical structures or physiological or pathological processes or states.
4. To provide information through in vitro examination of specimens of expected human effects in or on humans by pharmacological, immunological or metabolic means.
5. Devices that control or support conception.
6. Products specially used for cleaning, disinfection or sterilization.

​

Requirements for quality management systems in Taiwan, the United States and Europe
In Taiwan, an application for quality management system (QMS) verification for medical device manufacturers must be submitted to the Ministry of Health and Welfare. The requirements of QMS are not much different from those of ISO 13485:2016. Adverse event notification, recycling and other issues can be included in the relevant procedures when customers build ISO 13485:2016.

In the U.S., 21 Code of Federal Regulations, Section 820, or CFR820, is still required, but the good news is that the U.S. Food and Drug Administration (FDA) is working on replacing the current specification with the ISO 13485 standard. In the research stage, but the arrow is already on the line.

The EU part has recognized the ISO standard and obtained ISO 13485:2016 in EU member states without hindrance!

Through the above analysis, it can be found that:
1. Since most of the standards for the quality management system of medical materials in various countries in the world are revised with reference to the ISO 13485 standard, ISO 13485 can easily be in line with the domestic regulations of various countries.
Second, in order to eliminate trade barriers, countries have begun to research and directly replace domestic regulations with ISO 13485, especially after the first shot of the EU in 2017, the United States followed suit.