Information source: Certification and Accreditation Administration of the People's Republic of China
1.Do quality management system certification activities conducted before December 31, 2025, need to meet the requirements of the new version of the "Quality Management System Certification Rules"?
The new version of the "Quality Management System Certification Rules" will be officially implemented from January 1, 2026. From that date onwards, certification bodies carrying out quality management system certification activities shall comply with the requirements of the new version of the rules.
2. For quality management system certification activities in specific industries, if the certification basis does not include "Quality Management System Requirements" (GB/T 19001) or "Quality Management System Requirements" (ISO 9001), what requirements should be met in the new version of the "Quality Management System Certification Rules"?
For specific industry quality management system certification activities such as IATF 16949 Automotive Industry Quality Management System Certification and ISO 22163 Railway Industry Quality Management System Certification, as well as certification activities carried out by certification bodies based on the registered specific industry quality management system certification rules, if the certification basis does not include "Quality Management System Requirements" (GB/T 19001) or "Quality Management System Requirements" (ISO 9001), it should meet the requirements of clauses 3.9, 3.10, and 5.12.1 of the new version of the rules. At the same time, members of the audit team should obtain QMS auditor registration qualifications.
3. The scope of QMS certification business to be carried out requires at least 2 QMS professional field auditors. Can QMS professional field auditors be QMS internship auditors?
Within the scope of the proposed QMS certification business, at least 2 QMS professional field auditors are required. Professional field auditors cannot be QMS internship auditors, and QMS internship auditors do not assess professional fields.
4. In the scope of certification business that has already carried out QMS certification activities, if the certification body does not have two QMS professional field auditors, can certification activities continue from January 1, 2026?
The certification body shall ensure that there are at least 2 QMS professional field auditors within the scope of the certification business where QMS certification activities have been carried out. If there are less than 2 professional field auditors within the scope of the QMS certification business to be carried out, QMS certification activities within the scope of the certification business cannot be carried out.
5.Can the professional field assessed by the original certification body continue to be maintained after the QMS auditor is transferred to another organization?
Certification bodies should establish risk-based competency assessment criteria for QMS certification business scope professional auditors based on the conditions listed in the new version of Rule 3.6, to ensure that the QMS professional auditors of this certification body meet the requirements of the new version of Rule 3.6.
6.How to understand "interning in the same group with professional auditors or technical experts throughout the entire process" when evaluating the professional field of QMS certified auditors based on professional audit experience?
When evaluating the professional field based on professional audit experience, it should be limited to the experience obtained within the certification body. The calculation of professional audit experience is based on the complete on-site audit participated from the first meeting to the last meeting (audit types can be preliminary review, supervision, or re certification), and the audit person days are calculated based on the professional process audit person days of the on-site audit. QMS auditors for professional internships should be grouped with QMS professional field auditors or technical experts throughout the entire process, managed by QMS internship auditors, and not included in the audit time of the QMS certification audit, but included in the on-site audit days within their cycle year.
When QMS auditors who have completed professional internships accumulate professional audit experience and are in the same team as QMS professional field auditors throughout the entire process, their activities and findings during the audit are the responsibility of QMS professional field auditors; For those who are in the same team as technical experts throughout the entire process, a QMS auditor needs to be assigned within the audit team to be responsible for their activities and findings during the audit.
7.Can specific industry quality management system certifications such as IATF16949 Automotive Quality Management System Certification be used for audit experience when QMS auditors assess professional fields?
The assessment of the professional field of QMS auditors can only use professional audit experience from QMS certification audits, and cannot use audit experience from specific industry quality management system certifications such as IATF16949, AS9100 (9110/9120), TL9000, etc.
8. For QMS professional field auditors who do not meet the requirements of clause 3.6 of the new version of the rules and have participated in 10 or more professional audits with this certification body in the 5 years before the release of these rules, how can witness reviews be conducted?
Witness review is the process in which a witness, in the second stage of the initial certification audit, supervisory audit, or re certification audit, is grouped with the person being witnessed to witness their ability to audit professional processes in production/service activities. The witness should be a QMS professional field auditor who has been assessed by a certification body to meet the requirements of clause 3.6. When the witness's ability is insufficient, the witness should take over the audit task. The witness's witnessing time is not counted towards the auditor's day, but is counted towards the number of on-site audit days during the witness and witnessed period of the year.
9.How should a QMS auditor arrange for another on-site audit for a certification project that exceeds 180 days in the annual audit cycle?
If an auditor whose on-site audit days exceed 180 days within a cycle year still participates in the on-site audit as a member of the QMS audit team, the on-site audit is invalid. The certification body should reorganize an audit team that meets the requirements of the new version of the rules, and conduct another on-site audit within one month after the invalid on-site audit is completed.
How to calculate the number of valid QMS certification certificates at the statistical time point for the new version of Rule 3.10?
The statistical time point can be any time point after January 1, 2026, and the number of valid QMS certification certificates is the number of certificates with "valid" and "suspended" certification status at the statistical time point.
11. Can QMS intern auditors be assessed as technical experts within the scope of QMS certification business?
QMS intern auditors shall not be assessed as technical experts within the scope of QMS certification business.
12.Can the certification client operate QMS before obtaining the administrative license required by relevant laws and regulations?
If the business matters within the scope of certification application by the certification client involve administrative licensing, the starting date of QMS operation shall not be earlier than the date of obtaining administrative licensing.
13.Does the certification certificate suspended, revoked, or cancelled by the certified organization due to its own reasons include product certification certificate or service certification certificate? Does it include expired certification certificates?
If the certified organization's QMS certification certificate is suspended, revoked, or cancelled for less than one year due to its own reasons, the certification body shall not accept its certification application. If the original QMS certification certificate is suspended but not restored, and the certificate expires after the expiration date, a new QMS certification application can be submitted after the certification certificate has been suspended for one year.
14.Starting from January 1, 2026, must certification fees be directly paid by the certification client to the certification agency?
The certification fee should be directly paid by the certification client to the certification body. It is acceptable for the superior or subordinate unit of the certification client to pay fees to the certification body. When individual businesses act as certification agents, the operator may pay certification fees to the certification agency, and certification fees for other types of certification agents shall not be paid by individuals.
If the payment method stipulated in the certification contract signed before December 31, 2025 does not meet the requirements of the new version of the rules, the certification body should promptly sign a supplementary agreement or re sign the certification contract with the certification client, clarifying that the certification fee will be directly paid by the certification client to the certification body after January 1, 2026.
15.How to understand that the interval between each supervision and audit should not exceed 12 months?
The interval between supervision and audit shall not exceed 12 months, that is, the start date of this supervision and audit shall not exceed 12 months from the end date of the previous supervision and audit. Supervisory audits need to be conducted once every calendar year, and under normal circumstances, at least two supervisory audits should be included in the audit plan during a certification cycle.
If the certification certificate is suspended due to the inability to undergo the first supervision and audit on schedule, and the status of the certification certificate is restored during the suspension period, but the second supervision and audit cannot be carried out within 24 months from the date of issuance of the certification certificate, the certification body shall suspend the certification certificate.
16. The certified organization has undergone the first supervision audit at planned intervals. Can it apply for re certification to carry out subsequent certification activities before the second supervision audit?
The certified organization may negotiate and agree with the certification body based on its own needs to conduct a re certification audit in advance. If the certified organization chooses to re certify in advance, the certification body shall ensure that there is a supervision audit or re certification audit in each calendar year during the certification period, and the time for the early re certification audit shall not exceed 12 months from the last supervision audit. Otherwise, the certification certificate shall be suspended.
17.Does it require at least one full-time auditor from a certification body for each management system certification field when QMS is combined with other management systems for auditing?
QMS cannot be combined with the implementation of management system certification activities for which the State Administration for Market Regulation (State Administration for Market Regulation) or accreditation institutions have not specified audit time requirements. When QMS and other management systems are combined for audit, the audit team should have at least one full-time auditor from the management system field involved in the combined audit to participate in the audit throughout the process.
18.How to calculate the on-site audit time for branch offices?
The certification body should clarify the method for determining the audit time of the branch office and meet the requirements of clause 5.4.2 of the new version of the rules. When conducting QMS single system audits, the minimum on-site audit time for branch offices shall not be less than the audit time specified in Appendix B multiplied by 50% (branch offices) multiplied by 80% (on-site audits).
19. If the verification of serious non conformities during on-site re certification audit or re certification audit is not completed before the expiration of the original certification certificate, the original certification certificate will automatically become invalid upon expiration. The certification body should carry out certification activities according to the initial certification. Can the first stage audit be conducted in an off-site form?
If the on-site audit of re certification or the verification of serious non conformities in re certification audit is not completed before the expiration of the original certification certificate, the original certification certificate will automatically become invalid upon expiration, and the certification body should carry out certification activities according to the initial certification. The first stage audit may not be carried out on the site of the certification client, but the specific applicable circumstances shall comply with the provisions of Article 5.6.2.2 of the new version of the rules.
20.When should the second stage audit be re conducted for serious non conformities in the initial certification audit if the verification is not completed within the prescribed deadline?
If the serious non-compliance of the initial certification audit is not verified within 6 months from the end of the second stage audit, the certification body shall conduct a second stage audit within 30 days after the expiration of the verification period.
21. After investigation and verification, it has been found that there is a suspension situation in the certified organization. However, if the suspension situation has been eliminated within 5 days after investigation and verification, is it still necessary to suspend the certification certificate?
If the certified organization has a suspension situation, the certification body shall make a decision to suspend its certification certificate within 5 days after investigation and verification. If the certification body has confirmed that the suspension situation has been completely eliminated and there is no risk of recurrence within 5 days after investigation and verification before making the suspension decision, the suspension may not be suspended; If a suspension decision has been made, the certification body must formally verify and confirm that the reason for the suspension has been eliminated before the certification certificate can be restored.
If the first supervision audit fails to be conducted within 12 months after the issuance of the certification certificate, and if the second supervision audit fails to be conducted within 12 months after the scheduled end of the first supervision audit, the certification body shall suspend the certification certificate.
22. Can authorized personal seals be used for authentication records?
The electronic signature used in the authentication record shall comply with the provisions of the Electronic Signature Law and shall be certified by electronic authentication. If electronic signatures are not used, handwritten signatures should be used.
23.Should the certification certificate number for the Quality Management System Certification (EC9000) of engineering construction enterprises be prepared according to Appendix C?
The certification activities based on GB/T 19001 and/or ISO 9001 should be carried out in accordance with the new version of the Quality Management System Certification Rules, and the certification certificate number should also comply with the requirements of Appendix C.
24.How to determine the certification period in the certification certificate number when converting the certification certificate of the certification body?
If the certification conversion is implemented according to the requirements of 5.2.3, the number of the new certification certificate can continue the certification cycle of the original certification certificate.