What Is a Medical Auditor?

The registration of CCAA-QMS auditors only indicates that the registered personnel possess the personal qualities and corresponding knowledge and abilities for conducting QMS audits, and do not identify and confirm the professional technical scope and capabilities of the registered personnel.

Quality management system auditor

Right!

CCAA-QMS auditor registration only indicates that the registered personnel are qualified

CCAA complies with GB / T27024-2004, implements the quality management system (QMS) auditor registration system established by this standard, and has passed the accreditation implemented by China National Accreditation Service for Conformity Assessment (CNAS) in accordance with GB / T27024-2004.

Although CCAA has made every effort to ensure the scientificity, effectiveness and completeness of the evaluation process and registration system, if the audit or other services provided by a registered person fail to meet all the requirements of the client or the employing agency, CCAA does not Take responsibility.

Application requirements for quality management system auditors

1. Applicants for registration at all levels should carefully read the CCAA-QMS auditor registration guidelines and understand the registration requirements.

2. The applicant should provide true and complete registration information and materials. Application information and materials shall be in Chinese or English. If information and materials in other languages are provided, a Chinese translation confirmed by the certification body of the applicant shall be attached.

3. Applicants should use CCAA's unified registration application form. The application form should be completed, signed by the applicant, signed by the registration guarantor and the person in charge of the recommending agency, and affixed with the official seal of the recommending agency, together with all required certification materials, and submitted to CCAA together with the registration fee.

Note: The application form can be downloaded from the CCAA website and filled in. At the same time, the online application can be completed in the "Registration Application" section of the website.

4. The applicant should sign a statement expressing its agreement to abide by the requirements of the CCAA-QMS Auditor Registration Standards, especially the requirements of the auditor's code of conduct.

5. After the applicant submits complete registration application materials and registration fees, the CCAA can accept the application and start the evaluation registration process. For registration fees, please refer to the "Registration Charges for Certified Persons".

6. If the applicant has special requirements on the registration process or the release method and content of the registration information, it should provide a written explanation when applying.

Quality management system auditor applicant qualification experience requirements

1. Educational experience

Applicants should have a tertiary education or above (see definition in 1.3.8).

2. Work experience

Applicants should have at least 4 years of work experience in a technical or management position.
Note: The experience of business operators (such as sales staff, medical care staff, financial teller, equipment operator, service industry personnel who engage in specific services, etc.) cannot be accepted as auditors' acceptable work experience.

3.Quality management work experience

4. The applicant should have at least 2 years of work experience related to quality management in all work experience.

Appropriate quality management work experience includes QMS implementation, operation, consulting, auditing, research and teaching experience.

Note: The implementation of QMS refers to the experience of the personnel in the business management department in the organization and the person in charge of the quality management system implementation department in the organization in the specific implementation of the management system. "QMS operation" experience refers to the experience of the top management and quality management department personnel in the organization in planning and operating the quality management system.

5. Auditor training experience

Applicants should complete at least 40 hours of QMS auditor training in accordance with the corresponding provisions of Article 7.4 of GB / T19011-2003 Standard;

Auditor training institutions shall be approved by CNCA and provide certification that their training complies with the corresponding provisions of Article 7.4 of GB / T19011 Standard or be confirmed by the CCAA course.

CCAA confirmation requirements and procedures are detailed in the CCAA Auditor Training Course Confirmation Rules.

Note: Applicants participating in training by overseas training institutions shall be handled in accordance with the mutual recognition agreement between CCAA and relevant institutions.

6.QMS audit experience

There is no requirement for QMS audit experience for applicants for internship auditor registration.

Auditor registration applicant QMS audit experience requirements

As a trainee auditor, as a member of the audit team, complete at least 4 complete QMS audits under the guidance and assistance of senior auditors. The total audit experience should be no less than 20 days and cover all the provisions of the GB / T19001 standard, including field audit Experience no less than 15 days.

All auditing experience should be obtained within 3 years before the application and complete the on-site witness evaluation specified above.

7.QMS audit experience requirements for senior auditor registration applicants

As the internship audit team leader, under the guidance and assistance of senior auditors, lead the audit team to complete at least 3 complete QMS audits, and the total audit experience is not less than 15 days, of which the field audit experience is not less than 10 days.

All auditing experience shall be obtained within 2 years before the application, and the on-site witness evaluation specified in 3.3.1 shall be completed.

The guidance and assistance required in an audit is determined by the audit team leader or senior auditor. Guidance and assistance does not imply continuous supervision and does not require separate designation of personnel to complete this task.

8. Acceptable audit experience

A. Third-party auditing experience should be obtained from a CNCA-approved certification body; overseas third-party auditing experience should be obtained from a QMS certification body recognized by an accreditation body that signed the IAF mutual recognition agreement;

B. Second-party audit experience should be obtained from a second-party audit agency recognized by CCAA;

C. The accreditation, review and evaluation experience shall be obtained from the accreditation, review and evaluation activities recognized by CCAA.

Personal quality and auditing requirements of quality management system auditors

1. Auditors at all levels should possess the following personal qualities:

a) be ethical, that is, fair, reliable, loyal, honest and cautious;

b) open-minded, that is, willing to consider different opinions or opinions;

c) good at communication, that is, flexible interaction with people;
d) good at observation, that is, proactive understanding of the surrounding environment and activities;
e) Perceived, that is, the instinct to understand and understand the environment;
f) strong adaptability, that is, easy to adapt to different situations;
g) perseverance, that is, persistence in achieving the purpose;
h) Be assertive, that is, draw conclusions in a timely manner based on logical reasoning and analysis;
i) Self-reliance, that is, to work independently and play a role in effective interaction with others.

2. Auditors at all levels shall work in accordance with the following principles:

a) Ethical conduct: The foundation of a profession For auditing, integrity, integrity, confidentiality, and caution should be the most basic.
b) Fair expression: the obligation to truly and accurately report the audit findings, audit conclusions and audit reports shall truly and accurately reflect the audit activities. Reports on major obstacles encountered during the audit and the differences of views that have not been resolved between the audit team and the auditee.
c) Professionalism: Diligent and judgmental in audits. Auditors should value the importance of the tasks they perform and the trust placed on them by the audit client and other interested parties. Having the necessary competencies is an important factor.
d) Independence: The basis for the impartiality of the audit and the objectivity of the audit conclusions shall be independent of the activity being audited, without prejudice and without conflicts of interest. The auditor should maintain an objective mindset during the audit to ensure that audit findings and conclusions are based only on audit evidence.
e) Evidence-based approach: During a systematic audit, a reasonable approach to draw credible and reproducible audit conclusions. Audit evidence should be verifiable. Since the audit is conducted within a limited time and with limited resources, the audit evidence is based on a sample of available information. The reasonableness of sampling is closely related to the credibility of audit conclusions.