The benefits of the ISO 13485 medical Device Quality Management System

ISO 13485:2016 Medical devices- Quality management systems- Requirements for regulatory purposes(Medical device quality management systems for regulatory purposes) It is the current version as of November 2017.

---- The following is an introduction to the old version, which is now invalid. Some of the content can still be referred to. -----

The full name of the ISO13485:2003 standard is "Medical device-Quality management system-requirements for regulatory". This standard was developed by the SCA/TC221 Technical Committee on Quality Management and General Requirements for Medical Devices and is an independent standard based on ISO9001:2000. This standard stipulates the quality management system requirements for relevant organizations, but it is not an implementation guideline for the ISO9001 standard in the medical device industry.

Since its release in 1996, this standard has been widely implemented and applied all over the world. The new version of ISO13485 standard was officially released on July 3, 2003. Unlike the ISO9001:2000 standard, ISO13485:2003 is a management standard applicable in a regulatory environment: the name clearly indicates that it is used for the quality management system requirements of regulations. Medical devices in the international market are not merely ordinary commodities operating in a commercial environment; they are also subject to the supervision and management of national and regional laws and regulations, such as the FDA in the United States, the MDD(European Union Medical Device Directive) in the European Union, and the "Regulations on the Supervision and Administration of Medical Devices" in China. Therefore, this standard must be subject to legal constraints and operate within a regulatory environment. At the same time, it must fully consider the risks of medical device products and require risk management throughout the entire process of medical device product realization. So, apart from the specific requirements, it can be said that ISO13485 is actually ISO9001 in the context of medical device regulations.

The United States, Canada and Europe generally take ISO 9001, EN 46001 or ISO 13485 as the requirements of the quality assurance system, and the establishment of the quality assurance system for medical devices is all based on these standards. Medical devices that want to enter the markets of different countries in North America, Europe or Asia should comply with the corresponding regulatory requirements.

ISO 13485 evaluation procedure

ISO13485 certification is divided into initial certification, annual supervision and inspection, and re-evaluation certification, etc. The details are as follows:

I. Initial Certification

1. The enterprise will fill out the "ISO13485 Certification Sub-application Form". After receiving the application materials, the certification center will conduct an initial review of the documents. If they meet the requirements, a "Notice of Acceptance" will be issued.

The composition of the inspection team and the inspection plan should be officially reported to the enterprise for confirmation one week before the on-site inspection.

3. On-site inspections shall be conducted in accordance with the requirements of the Guidelines for Protection Measures of Environmental Labeling Products and the corresponding technical requirements for environmental labeling product certification.

4. The inspection team writes a comprehensive evaluation report on environmental label products based on the application materials of the enterprise, the on-site inspection situation, and the product environmental behavior inspection report, and submits it to the technical committee for review.

5. After receiving the review opinions from the technical committee, the certification center summarizes the review opinions.

6. The certification center issues environmental label certification certificates to qualified enterprises and organizes announcements and publicity.

7. If certified enterprises need identification, they can place orders with the certification center. If there are any special printing requirements, an application should be submitted to the certification center and filed.

8. Annual supervision and review are conducted once a year.

Ii. Annual Supervision and Inspection

The certification center formulates the annual inspection plan based on the issuance time of the enterprise's certification certificate and issues the annual inspection notice to the enterprise in advance. The enterprise pays the annual supervision and management fee as required by the contract. The certification center forms an inspection team to conduct on-site inspection work at the enterprise.

2. During on-site inspections, for products that need to be tested, the inspection team is responsible for taking samples of the products applying for certification, sealing the samples, and sending them to the designated inspection institution for testing.

3. The inspection team writes a comprehensive evaluation report based on the enterprise materials, inspection reports and product inspection reports, and submits it to the general manager of the Certification center for approval.

4. Annual supervision and inspection are conducted once a year.

Iii. Re-evaluation and Certification

Enterprises whose three-year period has expired should re-fill the "ISO13485 Certification Sub-application Form" and submit it along with relevant materials to the certification center. The remaining certification procedures are the same as the initial certification.

Certification materials:

1. The application for product quality certification and the application for quality system certification signed by the authorized representative of the applicant;

2. The quality manual of the applying entity, and if necessary, provide the enterprise's procedure documents;

3. The product standards covered by the product or quality system for which certification is applied;

4. The standards declared by the applicant for implementation;

5. Medical Device Product Registration Certificate (copy);

6. Summary of the entire production process of the product, description of the product production process and special and key processes;

7. Product sales situation and user feedback information in the past three years;

8. List of main purchased and outsourced parts;

9. Other materials, such as enterprise product catalogues, product introductions, product promotional materials, etc. Information on the organizations and personnel that have provided certification consulting for it.