1. What are the requirements for applying for the business license of Class III medical devices?

Operating license conditions for three types of medical devices

1. The use area of the business premises shall not be less than 40 square meters, and the use area of the business premises of the legal person branch shall not be less than 25 square meters (except for those set up across regions and cities); Operating hearing AIDS, the use area of business premises shall not be less than 25 square meters; Sales of contact lenses and care solutions, business premises use area shall not be less than 10 square meters.

2, warehouse area should be not less than 30 square meters; For the operation of disposable sterile medical devices, the warehouse shall be in the same building, and the use area shall not be less than 200 square meters.

3. The quality manager and the person in charge of the quality organization should have a nationally recognized product-related major, a college degree or above, or a technical title above the intermediate level in related major. To operate disposable sterile medical devices, there should also be more than one internal auditor who holds the internal auditor certificate of the medical device quality management system and other relevant application conditions.

Materials to be submitted when applying for the Medical Device Business License:

1. medical device business license application form (1 original);

2. Business license (copy);

3. Organization code certificate (copy);

4. The identity certificate, education or professional title certificate of the legal representative, the person in charge of the enterprise and the person in charge of quality (copy1);

5. Resume of quality management personnel (original 65438+ 0 copies);

6. List of professional and technical personnel (original 1 copy) and professional and technical personnel's ID cards, academic certificates and professional title certificates (each 1 copy);

7. Description of organizational structure and department setting;

8. Description of business scope and mode of operation;

9. A copy of the geographical location map, floor plan, house property certificate or house lease certificate of the premises and warehouse address. If the warehousing entrusts the third-party logistics of medical devices, an entrustment contract shall be provided (1 copy).

10. Catalogue of operating facilities and equipment;

1 1. Directory of documents such as operation quality management system and working procedures, including procurement, acceptance, warehousing, storage, quality tracking, user feedback, adverse event monitoring and quality accident reporting system (1 original);

12. Basic introduction and functional description of the computer information management system installed by enterprises that handle medical device business licenses, and print the homepage of the information management system (original 1 copy).

13. If the applicant is not the legal representative or the person in charge of the enterprise, the enterprise power of attorney (original 1 copy) shall be submitted.

14. Self-assurance statement on the authenticity of the application materials, including the catalogue of application materials and the enterprise's commitment to bear legal responsibility for any falsehood in the materials (1 original).

Medical device business license handling process

The first stage: application acceptance: the drug supervision department examines whether the application materials meet the basic requirements and decides whether to accept the application; (As many as 100 documents are required for application. If the applicant finds any problems when filling in the documents, he/she needs to go back for revision. If he/she finds any major nonconformities, he/she will be directly detained. )

The second stage: on-site review: the drug supervision department assigns one or three auditors to the business site of the enterprise for review. The audit methods are on-site inquiry and on-site inspection, and the audit information is truthfully recorded and the audit conclusion is given. Do not meet the requirements, you can ask the enterprise to carry out rectification until the rectification meets the requirements. If the rectification still does not meet the requirements, a notice of disapproval shall be given; (The purpose of the audit is to audit the legality, conformity and authenticity of the business premises of the enterprise. If it is found that it is not implemented in accordance with laws, regulations and rules, the audit conclusion will directly affect whether the enterprise can pass the audit and ultimately affect whether the enterprise can obtain the business license qualification. )

The third stage: evaluation, publicity and certification: after reviewing the relevant information, the leaders of the drug supervision department decide whether to issue a business license to the enterprise. If the information passes the review, the enterprise shall be publicized on the relevant website, and if there is no objection to the publicity, the enterprise shall be notified to obtain the medical device business license.

What level of qualification does the internal auditor certificate belong to?

The internal auditor certificate is a qualification certificate belonging to the internal level of the enterprise.

According to the requirements of ISO9000 standard, any unit that wants to obtain ISO9000 certification must conduct internal quality audit (internal audit for short) on a regular basis, and the personnel who carry out internal audit must be trained and competent internal auditors. The standard "O9000" does not require internal auditors to obtain qualification certificates, but they can also undertake internal audit tasks in their own units.

Relative to the internal auditor, it is a national registered auditor. Generally, this qualification has to go through a more rigorous training examination and internship period, that is, the cumulative audit time reaches a certain amount. Moreover, it needs to be hung in a certification institution with certification qualification recognized by the National Accreditation Committee, which is divided into * * * and full-time.

General enterprises carry out system certification, first organize internal auditors to audit the enterprise to determine whether the system is effective, rectify the unqualified and weak links found in the audit, and then the certification body sends an audit team to audit the enterprise, thus obtaining the certification qualification.

(2) The conditions that the internal auditor should have to expand reading.

In addition to requiring certified enterprises to have internal auditors, internal auditors should be familiar with various international standards and monitor almost all the work processes and links in the enterprise, so it is also a test and improvement of their own capabilities. Because of the particularity of their work, internal auditors often have to contact with middle and senior leaders of enterprises, so they have more opportunities for promotion and development and can realize their dreams.

International Organization for Standardization (ISO)

9000 is a series of standards on quality management and quality assurance, which are widely used all over the world. Its release is to promote international trade, is a kind of recognition of quality by buyers and sellers, and is the cornerstone of building mutual trust in trade activities.

Obtaining the ISO9000 quality certification mark is a reliable proof of product quality. Products with certification marks have obvious competitiveness in the market and are trusted by more customers.

Three. Types of internal audit. I do third-party tests. Who are the company's internal auditors? If I want to apply, are there any requirements?

Internal auditors are internal auditors, enterprises, companies, etc. It depends on what system the company introduces, and the internal auditor should know the company's ability system and have the corresponding audit certificate. College degree or above is generally required. Work and audit experience: the professional work experience is not less than 3 years, and the audit team leader should have three audit experiences, and master the main differences between the latest ISO900 1:20 15 standard and ISO900 1:2008 standard; Master the latest standard content of ISO90065438+0: 2015; Will write a practical checklist and prepare audit reports, gain the ability to carry out internal audit independently, and use ISO900 1 system to improve management concept and work efficiency.

Ⅳ Please briefly describe what basic requirements you should have as an internal auditor in the audit process.

Internal auditors should have the following qualities:

First: knowledge requirements: master the standard requirements of the two-in-one management system; Familiar with other standard requirements related to system response; Master information concepts related to organizational operation.

Second: skill requirements: be able to prepare audit plans, inspection forms and audit reports; Have the ability to integrate documents and on-site audit, be good at communication, be smart and flexible, and be adaptable.

What is the difference between an ISO internal auditor and an external auditor? Are these two certificates difficult to test? What are the requirements?

1, internal auditor-is a person who works in the company (companies, factories and other enterprises and institutions) and is an auditor qualification for serving the company. Anyone can learn this qualification and whether to participate in the professional work of the company (such as Commissioner, internal auditor, external auditor, etc.). ) look at the company arrangement. Internal auditors can also participate in the training of registered auditors and obtain training certificates.

Internal auditors are usually responsible for the first-party audit. When the company organizes an audit of suppliers or related parties, it belongs to the second party audit.

Obtaining the certificate of internal auditor is very simple, and basically you can get the certificate by spending money.

2. Registered auditor-refers to the qualification required by the personnel who work in a certification body, that is, a certification company, mainly to do the audit work of the unit applying for certification. This certification company sends the company to conduct certification audit, and we are generally also called external auditors.

Application conditions:

(1) education experience: you should have a college degree or above recognized by the state.

(2) Work experience: at least 4 years working experience in technical or management positions.

(3) Quality management work experience: Among all work experiences, you should have at least 2 years of work experience related to quality management.

But it doesn't matter, as long as the company stamps you, you can take the exam.

After passing the exam, register as an intern auditor at CNCA.

It is quite troublesome for a registered intern auditor to report to the registered auditor after completing the audit for a certain period of time.

If a registered auditor works in an enterprise and engages in internal audit, the certificate is equivalent to an internal auditor.

At present, some certification consulting and certification training companies in China require a certain number of registered auditors recognized by relevant state departments, such as certification consulting companies recognized by CNCA. These service ranges usually refer to ISO 9000 \ \ ISO14000 \ \ OHSAS18000.

Registered auditors usually take part in third-party audits as their work characteristics.

However, the enterprise will appoint its own qualified internal auditor to be responsible for the second-party audit when it is not difficult or the workload is relatively normal. However, in some cases, the enterprise organization may invite auditors from consulting companies or certification bodies to help with the second-party audit according to different needs.

ⅵ What are the procedures for handling the internal auditor certificate?

Internal auditor's process: first submit relevant materials for registration and training, then conduct assessment after training, and issue certificates after passing the assessment.

The internal auditor's certificate is an internal audit mechanism set up in an enterprise to strengthen management. A qualification certificate issued by a person who has rich experience, professional skills and professional functions and is considered capable by the top decision-maker of the enterprise.

According to the requirements of ISO9000 standard, any unit that wants to obtain ISO9000 certification must conduct internal quality audit (internal audit for short) on a regular basis, and the personnel who carry out internal audit must be trained and competent internal auditors. The O9000 standard does not require internal auditors to obtain qualification certificates, and they can also undertake internal audit tasks in their own units.

(6) The personnel applying for internal auditors require extended reading:

Classification of internal auditor qualification certificate:

O65438 internal auditor

TS 16949: 2009 internal auditor

OHSAS 1800 1: 2007 Internal Auditor

Iso 13485: 2003 internal auditors

ISO22000 internal auditor

ISO2700 1 internal auditor

ⅶ What do internal auditors do, what major do they study, and do they need any qualification certificates?

Major is not limited. If you want to be an internal auditor, you just need to take the examination for the qualification certificate of internal auditor. The name of this certificate is: internal auditor qualification certificate.

Internal auditor is a special term put forward by ISO International Organization for Standardization. Compared with ISO9000 family standard, the full name of internal auditor is "internal quality management system auditor". There are many standards formulated by ISO International Organization for Standardization, among which ISO9000 family standard is only one, and there are ISO 14000 environmental management system standards. Compared with ISO 14000 standard, the full name of internal auditor is "internal environmental management system auditor".

8. Are there any requirements for internal auditors in ISO 900 1 20 15?

iso900 1

20 15

There is a requirement for internal auditors in the standard, that is, they have the ability to conduct internal audits.

ⅸ IATF 16949 What qualities do internal auditors need?

It is definitely necessary to undertake the internal audit of the company. If you don't understand, it is recommended to participate in training.

What are the requirements for ISO 900 1 internal auditor registration?

The name of the company, the name of the applicant, the electronic photo, the date of certification of the department position, and the date of obtaining the certificate will be fine.