ISO13485 certification,ISO13485 certification requires what materials

ISO13485 certification,ISO13485 certification requires what materials

The full name of ISO13485:2016 standard is "Medical device quality management system for regulatory requirements", which puts forward special requirements for the quality management system of medical device manufacturers, and plays a good role in promoting the quality of medical devices to achieve safety and effectiveness.

Scope of application

This standard applies to the design and development, production, installation and service of medical devices or the design, development and provision of related services.

A medical device, as defined in the Standard, means an instrument, device, appliance, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, whether alone or in combination, whose intended use by the manufacturer is for human use for one or more of the following specific purposes.

ISO13485 certification conditions

According to the "Medical Device Registration Administration Measures" issued by the State Drug Administration, medical device quality management system certification registration conditions and its application materials requirements and medical device product certification registration conditions and its application materials requirements, the announcement is as follows:

Application for quality management system certification registration conditions:

The applicant organization shall have a business license or a document certifying its legal status.

2. Production license or other qualification certificate has been obtained (when required by national or departmental regulations);

The products covered by the quality management system applied for certification should meet the relevant national standards, industry standards or registered product standards (enterprise standards), and the products are set and produced in batches.

The applicant organization shall establish a management system in line with the certification standards to be applied for, and the medical device manufacturer and operator shall also meet the requirements of the YY/T 0287 standard. The quality management system shall be in operation for no less than 6 months for the production of three types of medical devices, and no less than 3 months for the production and operation of other products. At least one comprehensive internal audit and one management review have been conducted.

5 Within one year prior to submitting the certification application, the products of the applicant organization have no major customer complaints and quality incidents.

ISO13485 certification process

ISO13485 certification is divided into initial certification, annual supervision and inspection and re-evaluation certification, as follows:

First, the initial certification

1, the enterprise will fill in the "ISO13485 certification sub-application form", the certification center receives the application for certification materials, will conduct a preliminary review of the documents, and issue the "Acceptance Notice" after meeting the requirements.

2, on-site inspection a week before the composition of the inspection team and inspection plan officially reported to the enterprise for confirmation.

3, the on-site inspection is carried out according to the requirements of the environmental labeling product safeguard measures guide and the corresponding environmental labeling product certification technical requirements.

4, the inspection team according to the enterprise application materials, on-site inspection, product environmental behavior inspection report to write a comprehensive evaluation report of environmental labeling products, submitted to the technical committee for review.

5, certification center received the technical committee review comments, summary review comments.

6, the certification center to the certification of qualified enterprises to issue environmental label certification certificate, organization announcement and publicity.

7. If the certified enterprise needs identification, it can order from the certification center; If there are special printing requirements, an application should be submitted to the certification center and put on record.

8, annual supervision and review once a year.

2. Annual supervision and inspection

1, the certification center according to the enterprise certification certificate issuance time, formulate an annual inspection plan, in advance to the enterprise annual inspection notice. The enterprise shall pay the annual supervision management fee according to the contract requirements, and the certification center shall form an inspection team to carry out on-site inspection work in the enterprise.

2, on-site inspection, for the products that need to be inspected, the inspection team is responsible for sampling and sealing the products that apply for certification, and send them to the designated inspection institution for inspection.

3, the inspection team according to the enterprise materials, inspection report, product inspection report to write a comprehensive evaluation report, the certification center general manager approval.

4, annual supervision and inspection once a year.

Third, review and certification

Enterprises that expire in 3 years should fill in the "ISO13485 Certification sub-Application Form" again, together with the relevant materials to the certification center. Other certification procedures are the same as the initial certification.

What materials are required for ISO13485 certification

1. Application for product quality certification and quality system certification signed by the authorized representative of the applicant;
2. Apply for the quality manual of the unit, and provide the procedure documents of the enterprise if necessary;
3. Apply for certification of products or product standards covered by the quality system;
4. The standards declared by the applicant;
5. Medical device product registration certificate (copy);
6. Summary of the whole process of product production, description of product production process, special process and key process;
7. Product sales and user feedback in the past three years;
8. List of main outsourced and outsourced parts;
9. Other materials, such as enterprise product catalog, product introduction, product promotional materials, etc.; Information on the organizations and persons who have provided certification consultation.

ISO13485 certification meaning

1. Improve the management level of the enterprise, avoid legal risks, and increase the visibility of the enterprise;

2, improve and ensure the quality level of products, so that enterprises to obtain greater economic benefits;

3, conducive to the elimination of trade barriers, access to the international market pass;

4, help to enhance the competitiveness of the product, improve the market share of the product.

5, through effective risk management, effectively reduce the risk of product quality accidents or adverse events.

6, improve the staff's sense of responsibility, enthusiasm and dedication.

The above is about the general content of applying for ISO13485 certification, if you want to understand the certification costs and consulting services, you can consult online. Consulting telephone: 0755-27787866 13828761196 Mr. Chen 0755-27753399/19925332787 Miss Chen

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ISO13485 certification,ISO13485 certification requires what materials