Medical device internal auditor has no specific requirements, preferably related professional, and then through the Drug Administration version or the State Medical Device Huaguangguang organization of the training, the assessment of qualified and issued to the internal auditor's certificate (very few unqualified).
The full name of the internal auditor is quality (or / and environmental, occupational health, etc.) management system internal auditor. As a system auditor, in accordance with ISO9001 (medical device industry at the same time the implementation of ISO13458 - YY/T0287) standards and the company according to the system developed by the requirements of the relevant documents on the operation of the company's system to check in order to achieve compliance with the standard requirements of the purpose. This is a general *** position. Internal auditor generally do not need to test, medical equipment to have the relevant certification body training, after completion of the general issue of certificates. The validity period is generally until the introduction of the new standard is invalid. Theoretically, there is actually no concept of expiration date. This is the first time I've ever seen a product in the marketplace, and I've never seen one.
The state requires medical device manufacturers (Class II and Class III) to have two or more internal auditors.
Ⅱ how to get the internal auditor qualification certificate medical device internal auditor what are the limitations
No limitations, but if it is you want to use the internal auditor certificate for permits, or licenses, there are requirements, you can specifically call me, the user name is the phone
Ⅲ medical device internal auditor's role
Medical copy device internal auditor's role.
The internal auditor, known as the internal quality auditor, is usually a person who is proficient in the ISO9000 international standard and familiar with the management of the enterprise. According to the requirements of the ISO9000 standard, where the implementation of ISO9000 organizations have to carry out a certain frequency of internal quality audits each year, internal quality audits by the trained and qualified internal auditor to carry out the audit task. Therefore, where the implementation of ISO9000 organization, usually need to train a number of internal auditors. Internal auditors can be staffed by various departments *** as.
Career prospects for internal auditors
With the growing call for international harmonization, China's outstanding enterprises have crossed into the ranks of ISO9000 certification. The State Council requires the country to complete the ISO certification of 100,000 enterprises within three years. According to the provisions of each unit to be certified at least 2-3 internal auditors, internal auditors will be indispensable talents in this century. In addition, due to the ISO9000 certification vigorously promoted, more and more units want to obtain certification, but these units often do not know how to operate, which creates a large number of ISO9000 consulting organizations. When you have obtained the internal auditor qualification certificate, and in the work of obtaining a certain amount of certification experience, you can cross into the door of the certification and consulting for the need to certify the unit to provide consulting services, to do a freelance freelancers, or to open a certification and consulting company to open their own career path. Therefore, hold an internal auditor qualification certificate, is tantamount to more than one piece of knocking open the door of the cause of the golden stone.
Ⅳ I have a medical device internal auditor's certificate, if I want to engage in other industries, this certificate is still useful
How much of your contact information can be contacted
Ⅳ Medical device industry internal auditor exam where to register how to test
Beijing GuoMedical Instrument Huaguang Certification Co. The industry's internal auditor is generally in their home training. I'm not sure if you're going to be able to do this, but I'm sure you'll be able to do it.
Ⅵ Have sterile medical device inspector qualification certificate, medical device registration certificate, internal auditor certificate, internal proofreader certificate, can do tube generation
tube generation is not just a few certificates can be done, upstairs said the internal auditor certificate is a must, but also participated in the quality system and within the corresponding industry standards of training, can guide the various departments to carry out their normal work; so that you say it, can understand the old boss does not understand, do the old boss can not do! I can understand, do the old master can not do, endure the old master can not endure, so it's almost the same.
Ⅶ How to get iso13485 certification auditor qualification
First need to pass the exam into the copy for the internship auditor, attack and then to be attached to the certification body in the certification body set up full internship hours can be turned into a formal auditor.
The auditor should:
1, ethical;
2, open-minded, willing to communicate with people with different opinions or views and consider their ideas;
3, good at communication, flexible and other people to communicate;
4, good observation, that is, the initiative to recognize the surrounding environment and activities;
5, self-support. Can complete work independently.
Ⅷ medical device internal auditor useful this certificate good test
I am the internal auditor, is the first three years after the national Huaguang medical device. Training and learning after the examination obtained, on the crash course, knowledge, hard test or more difficult, a large state-owned enterprises I have done many years of secretarial, quality QQ group, and learned Chinese language and literature, is a little water did not participate in the hard test, and test excellent, most of them are after the auxiliary into the certificate is better, as long as the whole closed learning period to listen to lectures don't desert, do not want to get a certificate are difficult. I think that after the professor expert so pointing a little bit of understanding a lot of feeling, for their own management in the enterprise useful
The following reproduces the statement of others
The full name of the internal auditor is called internal quality auditor, usually by both proficient in the international standards of ISO9000 and is familiar with the management of the enterprise as a person. According to the requirements of the ISO9000 standard, where the implementation of ISO9000 organizations have to carry out a certain frequency of internal quality audits each year, internal quality audits by the trained and qualified internal auditor to carry out the audit task. Therefore, where the implementation of ISO9000 organization, usually need to train a number of internal auditors. Internal auditors can be staffed by various departments *** as.
Career prospects for internal auditors
With the growing call for international harmonization, China's outstanding enterprises have crossed into the ranks of ISO9000 certification. The State Council requires the country to complete the ISO certification of 100,000 enterprises within three years. According to the provisions of each unit to be certified at least 2-3 internal auditors, internal auditors will be indispensable talents in this century. In addition, due to the ISO9000 certification vigorously promoted, more and more units want to obtain certification, but these units often do not know how to operate, which creates a large number of ISO9000 consulting organizations. When you have obtained the internal auditor qualification certificate, and in the work of obtaining a certain amount of certification experience, you can cross into the door of the certification and consulting for the need to certify the unit to provide consulting services, to do a freelance freelancers, or to open a certification and consulting company to open their own career path. Therefore, holding an internal auditor qualification certificate is tantamount to having a piece of gold and jade stone to open the door of career.
After learning and training, the college diploma is fully capable of this work,
Ⅸ Medical device internal auditor's role
Internal auditor is the internal auditor, in short, is the internal audit of the enterprise system to achieve the purpose of the continuous internal into the content, you can look at the standard, according to the standard to find the relevant examples to look at the standard, it is very simple, college can be
Ⅹ The difference between a medical device internal auditor and an external auditor,
Ⅹ The external auditor is able to work in the certification body, and then be sent to other enterprises to audit. Then they are sent to other companies to conduct audits.
An internal auditor is a person who specializes in self-inspection and improvement within an organization.
So there is no comparison. The industry is different, the external auditor is a profession, the internal auditor is a position within the enterprise (most of them are still ***, only useful in the internal audit)