ISO13485 is called "medical device quality management system" in Chinese. Since medical devices are special products that save lives, heal the wounded, prevent and cure diseases, it is not enough to standardize only the general requirements of the ISO9000 standard. /T0287 and YY/T0288), put 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.
Introduction
The full name of the ISO13485:2003 standard is "Medical device-Quality management system-requirements for regulatory". The standard is formulated by the SCA/TC221 Medical Device Quality Management and General Requirements Standardization Technical Committee and is an independent standard based on ISO9001:2000. The standard specifies the quality management system requirements for relevant organizations, but it is not a guide for the implementation of the ISO9001 standard in the medical device industry.
Since the standard was released in 1996, it has been widely implemented and applied all over the world. The new ISO13485 standard was officially released on July 3, 2003. Different from the ISO9001:2000 standard, ISO13485:2003 is a management standard applicable to a regulatory environment: from the name, it is clearly a quality management system requirement for regulations. Internationally, medical devices are not only general marketed commodities operating in a commercial environment, but 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 Medical Device Directive in China. Regulations on the Supervision and Administration of Devices. Therefore, the standard must be constrained by law and operate in a regulatory environment. At the same time, the risk of medical device products must be fully considered, and risk management must be carried out in the entire process of medical device product realization. So in addition to special 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 medical device quality assurance system is based on these standards. To enter the market of different countries in North America, Europe or Asia, medical devices should comply with the corresponding regulatory requirements.
standard change
ISO 13485:2012 is the standard used by the European Union. The current international standard is still ISO 13485:2003. The upgrade of the 2012 version has the following changes compared to ISO 13485:2003. ISO 13485:2012 is in the preface of the standard. Appropriate adjustments have been made, mainly in terms of wording, and some revisions to the details of the scope of application. Major changes have been made in the appendix. The three catalogs of ANNEX ZA, ANNEX ZB and ANNEX ZC have been revised, and ISO 13485 and ANNEX ZC have been added. The relationship between the three medical device directives. The 2012 version of this upgrade is worth looking forward to. The standard is still only implemented in the EU, and ISO 13485:2003 is still used in China.
Certification conditions
Revision and adjustment of medical device quality certification registration conditions and application material requirements
On August 9, 2004, the State Food and Drug Administration issued the No. 16 Bureau Order "Administrative Measures for Medical Device Registration", which came into force on the date of promulgation. The "Administrative Measures for Medical Device Registration" issued by the former State Drug Administration on April 5, 2000 shall be repealed at the same time. In order to implement medical device regulations in the process of medical device quality certification and ensure that CMD certification meets the requirements of medical device regulations, CMD will also revise and adjust medical devices according to the content and requirements revised and adjusted in the newly released "Administrative Measures for Medical Device Registration". The registration conditions for quality management system certification and the requirements for application materials, and the registration conditions for medical device product certification and requirements for application materials are hereby announced as follows:
Application for quality management system certification registration conditions:
1 The applicant organization should hold a legal person business license or documents proving its legal status.
2 The production license or other qualification certificates have been obtained (when required by national or departmental regulations);
3 The products covered by the quality management system applying for certification shall comply with relevant national standards, industry standards or registered product standards (enterprise standards), and the products shall be finalized and produced in batches.
4 The applicant organization should establish a management system that complies with the certification standards to be applied for, and the medical device production and operation enterprises should also meet the requirements of the YY/T 0287 standard. For enterprises that produce Class III medical devices, the quality management system should run for no less than 6 hours. For enterprises that produce and operate other products, the quality management system shall run for no less than 3 months. At least one comprehensive internal audit and one management review have been conducted.
5 Within one year before submitting the application for certification, the products of the applicant organization have no major customer complaints and quality accidents.
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 out the "ISO13485 Certification Sub-Application Form". After the certification center receives the application materials, it will conduct a preliminary review of the documents, and issue the "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. The on-site inspection shall be carried out in accordance with the requirements of the Guidelines for Safeguarding 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 inspection, and product environmental behavior inspection report, and submit it 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 enterprises, 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 apply to the certification center and put it on record.
8. Annual supervision and audit 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 the 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 are conducted 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 applicant unit quality manual, if necessary, provide the company's program documents;
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 main outsourcing and outsourcing parts;
9. Other materials, such as enterprise product catalogues, product introductions, product promotional materials, etc.; information on organizations and personnel who have provided certification consultations for them.
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 passport 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, effectively reduce the risk of product quality accidents or adverse events.
6. Improve employees' sense of responsibility, enthusiasm and dedication.
contact us:
Lanya Technology Service (Shenzhen) Co., Ltd. is an accredited laboratory by international institutions such as National CNAS, China Metrology Certification CMA, American Laboratory Accreditation Association A2LA, Wireless Power Consortium WPC, Bluetooth Certification and Evaluation Committee SIG Amazon Amazon, etc. Lanya's mission: to make your products available all over the world!
Consulting Contact: Benson Zhang
Mobile/Mob:(+86)13632500972
Email/E-mail: sales13@cblueasia.com
Address/Add: Building C, Hongjingda Industrial Park, No. 107, Beihuan Road, Shiyan Street, Baoan District, Shenzhen
Lanya Testing is more than service!
