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◉ Certification Introduction
ISO13485 is called "Medical device quality management system for regulatory requirements" in Chinese. Because medical devices are special products that save lives, prevent and cure diseases, it is not enough to standardize only according to the general requirements of the ISO9000 standard. For this reason, the ISO organization promulgated ISO13485: The 1996 version of the standard (YY/T0287 and YY/T0288) puts forward special requirements for the quality management system of medical device manufacturers, which has played a good role in promoting the quality of medical devices to be safe and effective.
◉ Suitable
Manufacturers of medical products and service providers who fulfill the requirements of international, European and national
laws and regulations, and enterprises that wish to implement a documented management system according to this standard.
Businesses that develop, manufacture and sell medical devices and want to demonstrate their ability to compete and perform in international, European and domestic markets. Suppliers and other service providers in the value-added chain must ensure that their products conform to customer requirements.
◉ Certification Process
ISO13485 certification is divided into initial certification, annual supervision and inspection and re-evaluation certification, as follows:
(1) Initial certification
1. The enterprise will fill in the "ISO13485 Certification Sub-Application Form". After the certification center receives the certification application materials, it will conduct a preliminary review of the documents, and issue a "Notice of Acceptance" after meeting the requirements.
2. The composition of the inspection team and the inspection plan will be formally reported to the enterprise for confirmation one week before the on-site inspection.
3. On-site inspection shall be carried out in accordance with the requirements of the guidelines for safeguard measures for environmental labeling products and the corresponding technical requirements for environmental labeling product certification.
4. The inspection team will write a comprehensive evaluation report on environmental labeling products based on the company's application materials, on-site inspections, and product environmental behavior inspection reports, and submit them to the technical committee for review.
5. After receiving the review opinions of the technical committee, the certification center will summarize the review opinions.
6. The certification center issues environmental label certification certificates to certified companies, and organizes announcements and publicity.
7. If a certified enterprise needs a logo, it can order it from the certification center; if there are special printing requirements, it should file an application with the certification center.
8. Annual surveillance audits are conducted once a year.
(2) Annual supervision and inspection
1. The certification center formulates an annual inspection plan according to the issuance time of the enterprise certification certificate, and issues an annual inspection notice to the enterprise in advance. The enterprise pays the annual supervision and management fee according to the contract requirements, and the certification center forms an inspection team to conduct on-site inspections at the enterprise.
2. During on-site inspection, for the products that need to be inspected, the inspection team is responsible for sampling and sealing the products applying for certification, and sending them to the designated inspection agency for inspection.
3. The inspection team will write a comprehensive evaluation report based on enterprise materials, inspection reports and product inspection reports, and report to the general manager of the certification center for approval.
4. Annual supervision and inspection once a year.
(3) Re-evaluation certification
Enterprises that have expired in 3 years should re-fill the "ISO13485 Certification Sub-Application Form" and submit it to the Certification Center together with the relevant materials. The rest of the certification procedures are the same as the initial certification.
◉ Certified Materials
(1) Application for product quality certification and application for quality system certification signed by the authorized representative of the applicant;
(2) The quality manual of the applicant unit, and if necessary, the procedural documents of the enterprise;
(3) The product applying for certification or the product standard covered by the quality system;
(4) The standards declared by the applicant for implementation;
(5) Medical device product registration certificate (copy);
(6) Summary of the whole process of product production, product production process and special process, key process description;
(7) Product sales and user feedback in the past three years;
(8) List of major outsourcing and outsourcing parts;
(9) Other materials, such as enterprise product catalogues, product profiles, product promotion materials, etc.; information on organizations and personnel who have provided certification consultation.
◉ Certification Significance
(1) Improve and improve the management level of the enterprise, avoid legal risks, and increase the popularity of the enterprise;
(2) Improve and ensure the quality level of products, so that enterprises can obtain greater economic benefits;
(3) It is conducive to eliminating trade barriers and obtaining a pass to enter the international market;
(4) It is beneficial to enhance the competitiveness of products and increase the market share of products.
(5) Through effective risk management, the risk of product quality accidents or adverse events can be effectively reduced.
◉ Compliance Services
As a professional third-party testing and certification service organization, Jiayu Testing has qualifications such as CMA and CNAS, and has obtained laboratory accreditation from multiple authoritative certification institutions at home and abroad. It has a skilled professional technical team, rich industry service experience, and strong testing technology capabilities. Jiayu Testing strictly follows relevant national certification and accreditation laws and regulations, and provides system certification consulting services suitable for enterprise operation. Welcome to contact us at 400-9269-886!
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