Ⅰ for the third class of medical devices business license need to have what conditions
three types of medical devices business license conditions
1, the business premises should be used area of not less than 40 square meters, the use of legal entity branches of the business premises should be used area of not less than 25 square meters (except for the setup of the city of the cross-settlement area); business hearing aids, the Business premises area should be not less than 25 square meters; contact lenses and care solutions, business premises area should be not less than 10 square meters.
2, the warehouse area should be not less than 30 square meters; the operation of single-use sterile medical devices, the warehouse should be in the same building, the use of the area should be not less than 200 square meters.
3, quality management, quality institutions should have a nationally recognized, and business products related to the profession, college degree or above, or intermediate or higher technical title in related disciplines. The operation of single-use sterile medical devices, there should be more than one medical device quality management system internal auditor certificate of the internal auditor and other relevant application conditions.
Application for "Medical Device License" materials to be submitted:
1. "Medical Device License Application Form" (original 1);
2. "Business License" (copy);
3. Organization Code Certificate (copy);
4. Legal representative, responsible for the enterprise, the quality of the person in charge of the Proof of identity, education or title certificate (1 copy);
5. Quality management personnel resume (1 original);
6. Professional and technical staff list (1 original) and professional and technical staff of the identity card, proof of qualifications, professional title certificate (copy of 1 each);
7. Organizational and departmental setup instructions;
8. Business scope, business mode description;
9. Business premises, warehouse address location map, floor plan, documents proving ownership of housing or housing rental issued by the housing lease certificate copy. Is warehousing commissioned by the third-party logistics of medical devices, provide a commissioning contract (copy 1,).
10. Business facilities, equipment catalog;
11. Business quality management system, work procedures and other documents catalog. Including procurement, acceptance, warehousing, warehousing, quality tracking, user feedback, adverse event monitoring and quality incident reporting system and other documents (original 1);
12. For medical device license companies have installed computer information management system basic information and functional description , print information management system home page (original 1).
13. Where the application for corporate filings, the person in charge of the material is not the legal representative or the person in charge of the enterprise himself, the enterprise should submit a "power of attorney" (original 1).
14. Self-assurance statement of the authenticity of the declaration materials, including the catalog of application materials and the enterprise to make the material if false to assume legal responsibility for the commitment (original 1).
The process of obtaining a medical device license
The first stage: the application for: drug supervision department to check whether the application information meets the basic requirements, to decide whether to accept or not to accept the decision to apply for; (the application for the need to fill out as many as nearly a hundred copies of the information, acceptance of the application staff, if you find that any one place to fill out the information on the problem will need to be returned to the revision, such as the discovery of major non-compliance items are
The second stage: on-site review: that is, the Department of Pharmaceutical Supervision assigned one to three auditors to the business site audits, audits for the on-site questioning and assessment and on-site inspection and assessment, factual records of audit information and audit conclusions, such as non-compliance with the requirements of the requirements can be required to rectify the business until the rectification meets the requirements, such as rectification of Reng does not meet the requirements of the notice of the disallowance given; (the purpose of the audit is: to review the business site audits, and the audit of the business site) The purpose is: to audit the legality, compliance and authenticity of the business site, such as found not in accordance with the laws and regulations, rules and regulations implemented, the audit conclusion will directly affect whether the audit, the * final impact is whether the enterprise can obtain the license qualification)
Third stage: review, publicity, licensing: that is, by the leadership of the drug supervision department to approve the relevant information to decide whether to give the enterprise to issue a license to operate If the review of the relevant website in the relevant information on the enterprise to publicize, publicity without objection to the notification of the enterprise to receive medical equipment business license.
Ⅱ internal auditor certificate belongs to what level of qualification
Internal auditor certificate belongs to the internal level of qualification.
According to the requirements of the ISO9000 standard, any unit to obtain ISO9000 certification, must be carried out by the unit internal internal quality audit on a regular basis (referred to as internal audit), and the implementation of the internal audit personnel must be trained and capable of internal auditor, ISO9000 standard does not require mandatory internal auditor need to obtain a certificate of qualification, can also be in the unit. The ISO9000 standard does not mandate that internal auditors need to be certified, but can also undertake the task of internal auditing in the organization.
As opposed to an internal auditor, a nationally registered auditor. Generally, this qualification is subject to a more rigorous training examination and internship period, that is, the cumulative audit time reaches a certain number. And need to hang in the national accreditation commission recognized with the qualification of the certification body, can be divided into *** and full-time.
The general enterprise system certification, the first organization of internal auditors to audit their own enterprises to determine whether the system is running effectively, the audit found unqualified, weak links in the rectification, and then by the certification body to send an audit team to audit the enterprise, so as to obtain the certification qualification.
(2) The conditions that the person applying for the internal auditor should have extended reading
In addition to the certified enterprises must have internal auditors, because the internal auditor is familiar with the international standards, the internal auditor in the enterprise to monitor almost all the workflow and links, so the work at the same time is the test of their own ability and enhancement, due to the nature of the work of the internal auditor. As the internal auditor's work is special in nature, he or she is often in contact with the middle and senior leaders of the enterprise, so he or she has more chances to get promoted and develop, and is more capable of realizing his or her own dreams.
ISO
9000 is a series of standards for quality management and quality assurance that are common throughout the world and are issued to promote international trade. It is a recognition of quality by both buyers and sellers, and is the cornerstone of trade activities to establish a relationship of mutual trust.
To obtain ISO9000 quality certification mark is the proof of product quality can be trusted. With the certification mark of the product in the market has obvious competitiveness, by more customers trust.
Ⅲ types of internal audit, I am doing third-party testing, what is the company's internal auditor, if you want to apply for what are the requirements
The internal auditor is the internal auditor, enterprises, companies and so on. Depending on what system is imported into the company, the internal auditor of the company's capacity system to understand, and have the appropriate audit certificate. General requirements for college education and above. Work and audit experience: the professional work experience of not less than 3 years, the audit team leader should have three audit experience, master the main differences between the latest ISO9001:2015 standard and ISO9001:2008 standard; master the latest ISO9001:2015 standard content; will write a practical and operable checklist and preparation of the audit report, to obtain the ability to independently carry out internal audits The first: knowledge requirements: master the standard requirements of the integration management system; familiar with other standard requirements related to the system; master the concept of informationization related to the organization's operation.
Second: skill requirements: to be able to prepare audit plans, test forms, audit reports; with the fusion of two system documents and on-site audit capabilities, good communication, resourcefulness and flexibility, adaptability and other requirements.
Ⅳ ISO internal auditor and external auditor what is the difference between these two certificates is difficult to test what conditions are needed no
1, internal auditor - is in their own units (companies, factories, etc., all all enterprises and institutions) in the work of the personnel with a kind of auditor qualification, for their own unit services. This qualification anyone can learn, whether to participate in the company's professional work (such as commissioner, internal auditor, external auditor, etc.), depending on the company's arrangements. Internal auditors can also participate in the training of registered auditors to obtain a certificate of training.
Internal auditors are usually responsible for first-party audits as a feature, and when the company organizes external audits of suppliers or related parties, it is a second-party audit.
Obtaining an internal auditor certificate is very simple, basically paying for the certificate.
2, registered auditor - refers to work in the certification body, that is, the certification company to work in the qualifications required by the staff, mainly to do the audit of the unit applying for certification, this certification company dispatched to the company to carry out certification audits, we are generally also called external auditor.
Application conditions:
(1) educational experience: should have a nationally recognized college (including college) education.
(2) work experience: should have at least 4 years of work experience in technical or management positions.
(3) quality management work experience: should have at least 2 years of work experience related to quality management in all work experience.
But this does not matter, as long as the company gives you the seal can be examined.
After passing the exam, the report of the commission registered intern auditor.
Registered intern auditor and then complete a certain audit hours can be reported to the registered auditor, quite troublesome.
The registered auditor if working in the enterprise, engaged in internal audit, the certificate is equivalent to the internal auditor.
Currently in China, some certification consulting, certification training companies, the relevant agencies require a certain number of national departments recognized by the registered auditor, such as the national commission under the accreditation of the certification consulting firms. The scope of these services usually refers to ISO9000\\\\ISO14000\\\\\OHSAS18000.
Registered auditors are usually involved in third-party audits as a feature of the work.
However, an organization that audits its suppliers and related parties will appoint its own internal auditor qualified staff to be responsible for second-party audits if the difficulty or workload is not too great or if the workload is relatively normal. But in some cases, organizations may also invite consultants or certification bodies to help conduct second-party audits, depending on the needs of the situation.
Ⅵ internal auditor certificate for what procedures are required
Internal auditor for the process: first submit the relevant information to enroll in training, training, assessment, assessment can be issued through the certificate.
The internal auditor certificate is an internal review mechanism set up within the enterprise in order to strengthen management. By the rich experience, expertise, professional functions of the personnel, by the highest decision-makers in the enterprise assessment, that the ability of the person and the issuance of the qualification appointment certificate.
According to the requirements of the ISO9000 standard, any unit to obtain ISO9000 certification, must be carried out regularly by the unit internal internal quality audit (referred to as internal audit), and the implementation of internal audit personnel must be trained and capable of internal auditors, ISO9000 standard does not require mandatory internal auditors need to obtain a certificate of qualification, but also in the unit to undertake the task of internal audit.
(6) The conditions that the person applying for the internal auditor should have Expanded reading:
Classification of the internal auditor qualification certificate:
ISO9001:2008 internal auditor
ISO14001:2004 internal auditor
TS16949:2009 internal auditor.
OHSAS18001:2007 Internal Auditor
ISO13485:2003 Internal Auditor
ISO22000 Internal Auditor
ISO27001 Internal Auditor
ⅦWhat does an internal auditor do, what major do they study, and what qualification do they need
There is no restriction on the major. Want to become an internal auditor to participate in the internal auditor qualification examination on the line, the name of the certificate within the name: internal auditor qualification certificate.
The internal auditor is a special term put forward by the ISO International Organization for Standardization, relative to the ISO9000 national standard, the full name of the internal auditor is "internal quality management system auditor". There are many standards developed by the ISO International Organization for Standardization, of which the ISO9000 standard is only one, and there is also the ISO14000 standard for environmental management systems, etc. In comparison with the ISO14000 standard, the internal auditor is the internal quality management system auditor. In contrast to the ISO14000 standard, the full name of the internal auditor is "internal environmental management system auditor".
Ⅷ Is there a requirement for internal auditors in the iso9001 2015 standard
iso9001
2015
There is a requirement for internal auditors in the standard, which is the ability to perform internal audits.
Ⅸ IATF16949 internal auditor need to have what qualities
Definitely need to take charge of the company's internal audit work ah. If you don't know how to do this, you should take a training course.
Ⅹ ISO9001 internal auditor registration requirements
company name name of the applicant's name project version electronic version of the photo department position date of issuance of the certificate date of certification can be