1. Do quality management system certification activities conducted before December 31, 2025, need to comply with the requirements of the new version of the "Regulations for Quality Management System Certification"?
The new version of the "Regulations for Quality Management System Certification" officially takes effect on January 1, 2026. From that date onwards, quality management system certification activities carried out by certification bodies must comply with the requirements of the new regulations.
2. For quality management system certification activities in specific industries where the certification criteria do not include "Quality management systems — Requirements" (GB/T 19001) or "Quality management systems — Requirements" (ISO 9001), which requirements of the new "Regulations for Quality Management System Certification" must they satisfy?
For quality management system certification activities in specific industries such as IATF 16949 for the automotive industry and ISO 22163 for the railway industry, as well as certification activities conducted by certification bodies based on filed specific industry quality management system certification rules, where the certification criteria do not include "Quality management systems — Requirements" (GB/T 19001) or "Quality management systems — Requirements" (ISO 9001), they must satisfy the requirements of clauses such as 3.9, 3.10, and 5.12.1 of the new regulations. Simultaneously, audit team members must hold QMS auditor registration qualifications.
3. For a proposed QMS certification scope, at least 2 QMS auditors with expertise in that scope are required. Can QMS trainee auditors serve as QMS auditors with expertise in a scope?
For a proposed QMS certification scope, at least 2 QMS auditors with expertise in that scope are required. Auditors with expertise in a scope cannot be QMS trainee auditors. QMS trainee auditors are not assessed for expertise in specific scopes.
4. If a certification body does not have 2 QMS auditors with expertise in a specific scope for QMS certification activities already being conducted, can it continue those activities from January 1, 2026?
Certification bodies shall ensure they have at least 2 QMS auditors with expertise in the specific scope for the QMS certification activities they are already conducting. For a proposed QMS certification scope, if the number of auditors with expertise in that scope is less than 2, QMS certification activities for that scope cannot be conducted.
5. After a QMS auditor transfers to a different certification body, can the expertise in a scope assessed by the original certification body be maintained?
Certification bodies shall establish risk-based criteria for assessing the competence of QMS auditors with expertise in specific scopes, based on the conditions listed in clause 3.6 of the new regulations. They must ensure that their own QMS auditors with expertise in specific scopes meet the requirements of clause 3.6 of the new regulations.
6. When assessing a QMS auditor's expertise in a scope based on specialized audit experience, how should "the full internship conducted within the same audit team as an auditor with expertise in that scope or a technical expert" be understood?
When assessing expertise in a scope based on specialized audit experience, it should be limited to experience gained within the certifying body itself. The count of specialized audit experiences is based on participation in complete on-site audits from the opening meeting to the closing meeting (audit types can be initial, surveillance, or recertification). Audit man-days are calculated based on the man-days spent auditing specialized processes during that on-site audit. The QMS auditor undergoing a specialized internship must be in the same team throughout the entire audit with a QMS auditor having expertise in that scope or a technical expert. They are managed as a QMS trainee auditor, their time is not counted towards the audit time for that QMS certification audit, but it is counted towards their on-site audit days within the cycle year.
When a QMS auditor undergoing a specialized internship is accumulating specialized audit experience, if they are with a QMS auditor having expertise in that scope throughout, that auditor is responsible for the intern's activities and audit findings. If they are with a technical expert throughout, a QMS auditor must be assigned within the audit team to be responsible for the intern's activities and audit findings.
7. When assessing a QMS auditor's expertise in a scope, can audit experience from specific industry quality management system certifications like IATF 16949 be used?
The assessment of a QMS auditor's expertise in a scope can only use specialized audit experience from QMS certification audits. Audit experience from specific industry quality management system certifications such as IATF 16949, AS9100 (9110/9120), TL9000, etc., cannot be used.
8. For QMS auditors with expertise in a scope who do not meet the requirements of clause 3.6 of the new regulations but have participated in 10 or more specialized audit experiences within this certification body in the 5 years prior to the release of these regulations, how should witness evaluation be conducted?
Witness evaluation involves a witness being in the same team as the person being witnessed during the stage 2 audit of an initial certification, a surveillance audit, or a recertification audit, to witness their ability to audit specialized processes within production/service activities. The witness should be a QMS auditor with expertise in the scope who has been assessed by the certification body as meeting the requirements of clause 3.6. If the person being witnessed lacks competence, the witness should take over the audit tasks. The witness's time is not counted towards audit man-days but is counted towards the on-site audit days for both the witness and the person being witnessed within their respective cycle years.
9. If a QMS auditor's on-site audit days exceed 180 days in a cycle year, how should the re-audit be arranged for certification projects where audits were conducted during the excess days?
If an auditor whose on-site audit days exceed 180 days in a cycle year still participates in an on-site audit as a member of a QMS audit team, that on-site audit is invalid. The certification body shall reconstitute an audit team meeting the requirements of the new regulations and conduct a new on-site audit within one month after the invalid on-site audit concludes.
10. Regarding clause 3.10 of the new regulations, how is the number of valid QMS certification certificates at the statistical point calculated?
The statistical point can be any point in time from January 1, 2026, onward. The number of valid QMS certification certificates is the number of certificates with a status of "valid" or "suspended" at that statistical point.
11. Can a QMS trainee auditor be assessed as a technical expert for a QMS certification scope?
A QMS trainee auditor shall not be assessed as a technical expert for a QMS certification scope.
12. Can a certification client operate its QMS before obtaining the administrative licenses required by relevant laws and regulations?
If the business scope applied for by the certification client involves administrative licenses, the start date of QMS operation cannot be earlier than the date of obtaining the administrative license(s).
13. Do certification certificates suspended, withdrawn, or cancelled due to the certified organization's own reasons include product or service certification certificates? Do they include certificates that have expired and become invalid?
If a certified organization has had its QMS certification certificate suspended, withdrawn, or cancelled due to its own reasons for less than one year, the certification body shall not accept its new certification application. If a QMS certificate was suspended and not reinstated, becoming invalid after its validity end date, the organization can submit a new QMS certification application after the certificate has been suspended for one full year.
14. Starting from January 1, 2026, must certification fees be paid by the certification client directly to the certification body?
Certification fees shall be paid by the certification client directly to the certification body. Payment of fees to the certification body by the certification client's parent or subsidiary unit is an acceptable form. When an individual business operator is the certification client, the operator may pay the certification fees to the certification body. For other types of certification clients, certification fees shall not be paid by an individual.
For certification contracts signed before December 31, 2025, if the payment method stipulated does not meet the requirements of the new regulations, the certification body shall promptly sign a supplementary agreement or a new certification contract with the certification client, specifying that certification fees after January 1, 2026, are to be paid by the certification client directly to the certification body.
15. How should 'each surveillance audit interval shall not exceed 12 months' be understood?
The time interval between surveillance audits shall not exceed 12 months, meaning the start date of the current surveillance audit shall be no more than 12 months from the end date of the previous surveillance audit. One surveillance audit is required per calendar year. Normally, the audit program within one certification cycle shall include at least two surveillance audits.
If a certification certificate is suspended due to failure to undergo the first surveillance audit on schedule, and its status is restored during the suspension period, but the second surveillance audit is not conducted within 24 months from the certificate issuance date, the certification body shall suspend the certification certificate.
16. If a certified organization undergoes its first surveillance audit at the planned interval, can it apply to conduct subsequent certification activities as recertification before the second surveillance audit?
A certified organization may, based on its own needs and by mutual agreement with the certification body, conduct a recertification audit in advance. If a certified organization opts for early recertification, the certification body shall ensure that there is one surveillance or recertification audit each calendar year within the certification cycle. Furthermore, the time of the early recertification audit shall not exceed 12 months from the previous surveillance audit; otherwise, the certification certificate shall be suspended.
17. For combined audits of QMS with other management systems, is it required that there be at least 1 full-time auditor from the certification body for each management system certification field?
For management system certification activities where the State Administration for Market Regulation (CNCA) or accreditation bodies have not specified audit time requirements, QMS cannot be combined with them for audit. When QMS and other management systems are combined for audit, the audit team shall have at least one full-time auditor from each management system field involved in the combined audit participating throughout the audit.
18. How is the on-site audit time for branch sites calculated?
Certification bodies shall define a method for determining audit time for branch sites, meeting the requirements of clause 5.4.2 of the new regulations. For single-system QMS audits, the minimum on-site audit time for a branch site shall not be less than the audit time specified in Appendix B × 50% (for branch sites) × 80% (for on-site audit).
19. If the verification of major nonconformities from the recertification on-site audit or recertification audit is not completed before the expiry of the original certification certificate, and the original certificate expires and becomes invalid automatically, requiring the certification body to conduct certification activities as an initial certification, can the stage 1 audit be conducted off-site?
If the verification of major nonconformities from the recertification on-site audit or recertification audit is not completed before the expiry of the original certification certificate, and the original certificate expires and becomes invalid automatically, the certification body shall conduct certification activities as an initial certification. The stage 1 audit may not be conducted on-site at the certification client's premises, but the specific applicable conditions must satisfy the provisions of clause 5.6.2.2 of the new regulations.
20. If major nonconformities from an initial certification audit are not verified within the specified time limit, by when at the latest should a new stage 2 audit be conducted?
If major nonconformities from an initial certification audit are not verified within 6 months from the end date of the stage 2 audit, the certification body shall conduct a new stage 2 audit within 30 days after the verification deadline.
21. If, after investigation and verification, a certified organization is found to have grounds for suspension, but those grounds are eliminated within 5 days after the investigation, must the certification certificate still be suspended?
If a certified organization has grounds for suspension, the certification body shall make a decision to suspend its certification certificate within 5 days after investigation and verification. If, before making the suspension decision, the certification body confirms that the grounds for suspension have been completely eliminated within 5 days after the investigation with no risk of recurrence, suspension may not be imposed. If the suspension decision has already been made, the certification body must formally verify and confirm that the reasons for suspension have been eliminated before the certification certificate can be restored.
If the first surveillance audit is not conducted within 12 months from the certificate issuance date, or the second surveillance audit is not conducted within 12 months from the scheduled completion date of the first surveillance audit, the certification body shall suspend the certification certificate.
22. Can authorized personal name seals be used on certification records?
Electronic signatures used in certification records shall comply with the provisions of the "Electronic Signature Law" and shall be verified through electronic certification. If electronic signatures are not used, handwritten signatures shall be used.
23. For certification certificates for Quality Management System Certification for Construction Enterprises (EC9000), must the certificate numbering comply with Appendix C?
Certification activities where the certification criteria include GB/T 19001 and/or ISO 9001 shall be conducted in accordance with the new "Regulations for Quality Management System Certification", and the certification certificate numbering shall also comply with the requirements of Appendix C.
24. How should the certification cycle in the certificate number be determined for a certification certificate transferred from another certification body?
For certification transfers conducted in accordance with the requirements of 5.2.3, the new certification certificate's number may continue the certification cycle of the original certification certificate.