Notice on the Changes in the Requirements of the New "Quality Management System Certification Rules"

Notice on the Changes in the Requirements of the New "Quality Management System Certification Rules"

Dear Certified Organizations:

The National Certification and Accreditation Administration (CNCA) officially released the new "Quality Management System Certification Rules" (CNCA-QMS-01:2025) on September 4, 2025 (hereinafter referred to as the "New Rules"). Starting from January 1, 2026, quality management system certification activities shall be implemented in accordance with the new "Rules". The new "Rules" serve as the basic basis and baseline requirement for QMS certification activities, and are also an important basis for local certification regulatory authorities to supervise certification of certified enterprises and certification bodies. To ensure the continued validity of your organization's certification and that QMS certification complies with the requirements of the new Rules, the key provisions and key changes affecting the certified organization in the new Rules are hereby notified as follows:

1. Application Stage

1. Certification Application Conditions (New Edition Rules Article 5.1.2)

Six requirements for organizations applying for QMS certification to be added or changed:

(1) The original QMS certificate issuing institution has had its QMS certification qualification revoked by the CNCA for at least three months (if applicable);

(2) The certificate has been suspended or revoked by the original issuing authority for reasons attributable to the certified organization for one year (if applicable); If the certificate is revoked after the suspension period expires, one year shall be counted from the date the certificate was suspended;

Supplementary Note: If the certification certificate is suspended, revoked, or canceled by the original issuing authority due to reasons attributable to the certification organization itself, the certification body (including the original issuing authority) cannot accept new certification applications submitted by the certification organization if the original certificate has been suspended, revoked, or cancelled for less than one year.

(3) Not currently ordered by administrative regulatory authorities to suspend production or business for rectification;

(4) Not currently listed on the seriously illegal and untrustworthy lists published by the "National Enterprise Credit Information Publicity System" and "Credit China";

(5) No major quality incidents ordered by administrative regulatory departments to suspend production or business for rectification within one year;

(6) Within one year, products within the scope of the certification application have not failed the national supervision spot check, or have failed the product quality national supervision spot check but have been rectified and qualified according to relevant regulations.

2. Information and documents required for certification application (New Rules Article 5.1.3)

Two new requirements have been added to the information and documents required for certification applications:

(1) Evidence that the QMS has been running for at least three months;

(2) Quality incidents, quality-related administrative penalties, failure in national product quality supervision spot checks, other failure in quality spot checks, and rectification status (where applicable) occurred within one year.

3. Conditions for certification conversion (New Rules, Article 5.2.3)

Conditions for converting certification certificates to certification bodies, with one new requirement added:

(1) The original certification body's certification business is operating normally, and there are no issues of expiration, suspension, or revocation of accreditation qualifications.

II. Certification Contract and Related Responsibilities (New Edition Rules, Article 5.3)

Added requirements for payment of certification fees and responsibilities of certification principals/applicant organizations:

1. The certification body shall sign a legally binding certification contract with each certification client, specifying the fees, payment methods, and breach terms of certification services, as well as the responsibilities of the certification client, certification body, and certified organization. Certification fees should be paid directly by the certification client to the certification body.

2. The certified organization shall comply with certification procedures, truthfully provide relevant materials and information, continuously and effectively operate the QMS after QMS certification, cooperate with the supervision and inspection of certification administrative and regulatory departments and investigations by certification bodies regarding complaints, correctly use certification certificates, certification marks, and related information in advertising, publicity, and other activities, promptly notify certification bodies of changes in QMS and conditions in 5.1.2, and bear the risk of certificate inability to use if the chosen certification body's qualification is revoked.

Additional note: Certification contracts signed before December 31, 2025 may continue to be enforced, while those signed after January 1, 2026 must meet the requirements of the new rules.

III. Review Arrangement Requirements (Articles 5.6.1, 5.4.1.4, 5.8.2, 5.10.3, 5.9.2, 5.9.3, 5.9.3 of the new Rules)

1. The initial certification audit should be carried out in two stages: the first stage audit and the second stage audit. The interval between the two stages of review should not be less than 5 days, and the maximum should not exceed 6 months.

2. Supervision and Audit: The first supervision and review after initial certification and re-certification should be conducted within 12 months from the date the certification certificate is issued. After that, the interval between supervision and review should not exceed 12 months.

3. Recertification Audit: The recertification audit should be conducted on-site at the certified organization and completed before the certificate expires. If the on-site audit cannot be completed before the certificate expires, the certification body shall conduct certification activities as if it were the initial certification.

4. For verifications of serious non-compliance, the following requirements should be met:

(1) Initial certification: completed within 6 months from the end of the second phase of the review;

(2) Supervised review: completed within 3 months from the end of the review;

(3) Re-certification: Complete before the original certification certificate expires.

5. Short-Notice Review: To investigate complaints or quality incidents, respond to changes, or track suspended customers, it may be necessary to conduct audits shortly in advance or without notifying the certified organization.

6. If products within the certification scope of the certified organization are found to be non-compliant during the national product quality supervision spot check, the certification body shall, within 30 days of issuing the notification from the market supervision department, conduct a review with a shorter notice in advance for the organization.

Supplementary Note: When major quality incidents, market supervision and inspection authorities, changes in qualification certificate status, failure of national sampling standards, administrative penalties, orders to suspend operations for rectification, inclusion in serious illegal and dishonest lists, or major public opinion occurs, the certified organization should proactively report to HIC and accept HIC's investigation or review with relatively short prior notice.

IV. Review Period (New Version of the "Rules" 5.4.2.1, Appendix B)

1. Review time is calculated in person-days; one person-day equals 8 hours. Increasing working hours on a workday should not reduce the number of reviewers required.

If the certification client's actual working hours on a working day are less than 8 hours, the on-site audit period should be extended to meet the audit time requirements.

2. In Appendix B of the new "Rules," "Quality Management System Certification Audit Time Requirements," the comparison table between the number of valid persons and audit time classifies 15 or fewer people as one tier, eliminating the 1-5 and 6-10 brackets. The valid number includes all personnel involved within the certification scope (including personnel from each shift). Non-permanent personnel (such as contractor staff) and part-time staff covered within the certification scope should also be included in the effective staffing.

V. Review and Implementation Process (Article 5.5 of the New Rules)

1. Participation requirements for the first and last meetings (New Rules, Article 5.5.3)

The audit team shall hold the first and final meetings together with the certification client. The top management of the certification client and heads of relevant QMS functional departments shall attend the first and last meetings. The certification institution shall retain attendance records and photo/audiovisual proof materials from the first and last meetings. If the top manager of the certification client cannot attend the first or last meetings, other senior management members with written authorization shall attend, and the audit team shall record the reasons for the top manager's absence.

2. Key Review Points for Top Management (New Rules, Clause 5.5.4)

The audit team should conduct a focused review of the top management of the certification client in QMS, through face-to-face interviews and other means, and retain on-site photos/audio-visual evidence, audit records, and other supporting materials. If top management is unfamiliar with the organization's own quality policies and objectives and has not personally participated in and promoted QMS implementation, the certification audit should not be approved.

3. Termination of Review (New Rules, Article 5.5.5)

(1) The certification client does not cooperate with the audit activities, making the audit activities impossible;

(2) The highest management or authorized senior management member of the certification client is absent from the first and last meetings;

(3) The actual situation of the certification client is significantly inconsistent with the application materials;

Supplementary Note: If the actual situation of the certification client is significantly inconsistent with the application materials, it refers to the actual situation of the certification client (such as the client's organizational structure, premises, activities, number of personnel within the certification scope, types of products and services, management system operation time, etc.) and the application materials required in Article 5.1.3 of the new "Rules", which significantly affects the audit plan and prevents the audit team from carrying out the review activities as originally planned.

(4) Other circumstances that prevent the completion of the audit process.

6. Certification certificate

1. Validity period of the certification certificate (New Rule 6.2.1)

(1) The validity period of a certificate is up to 3 years. After the implementation of these rules (starting January 1, 2026), newly issued recertification certificates must not exceed 3 years.

(2) For those who fail to complete the recertification decision before the original certificate expires, the QMS certificate of the certified organization will automatically expire upon expiration until a newly issued recertification certificate is obtained. The termination date of the newly issued recertification certificate shall not exceed the previous certification cycle termination date plus 3 years.

2. Certificate Numbering Rules (Appendix C of the New Edition of the Rules)

HIC will combine supervision audits and recertification audits to replace certificates, and will complete all certificate renewals by January 1, 2029.

3. Use of Certification Certificates and Certification Marks (Article 6.1 of the New Rules)

(1) Certified organizations may use the QMS certification certificate and certification mark when the certificate is valid, and accept supervision and management by the certification body. If the certificate is suspended, revoked, or canceled, it may not continue to be used.

(2) Certified organizations must correctly use the QMS certification mark in advertisements and related publicity, and must not only display the QMS certification mark on products. Only after indicating the certification organization and the name of the certification body may the QMS certification mark be displayed on product packaging.

VII. Retention after certification (New Rules Article 5.3.4)

Certified organizations shall comply with certification procedures, truthfully provide relevant materials and information, continuously and effectively operate QMS after QMS certification, cooperate with supervision and inspection by certification administrative authorities and investigations by certification bodies regarding complaints, correctly use certification certificates, certification marks, and related information in advertising, publicity, and other activities, promptly notify certification bodies of changes in QMS and "Certification Application Conditions," and bear the risk of certificate invalidation if the chosen certification body's qualification is revoked.

8. Suspension, Revocation, and Cancellation of Certification Certificates (Articles 7.2, 7.3, 7.4 of the New Rules)

1. Circumstances under which the certificate is suspended or changed:

(1) QMS continuously or seriously fails to meet certification requirements, including serious disconnection between QMS documents and actual business operations;

(2) Failure to meet applicable laws and regulations of QMS and failure to take effective corrective actions;

(3) Having received administrative penalties related to quality and have not yet completed rectification;

(4) Major quality incidents occurring that reflect significant defects in the QMS operation of the certified organization;

(5) Refusing to cooperate with market regulatory authorities' certification law enforcement supervision and inspection, or providing false materials or information;

(6) Failing to correctly cite and promote the obtained certification certificates and related information in accordance with relevant regulations, including the use of certificates and certification marks;

(7) Major public opinion related to quality has occurred.

2. Cancellation of the certification certificate

When the certified organization voluntarily applies to no longer maintain the certification certificate, the certification body should confirm that there are no circumstances of suspension or revocation, cancel the certificate, and retain the relevant evidence.

9. Certification Records (Article 10.5 of the New Rules)

To verify the implementation of certification activities, in addition to the certification records that the certification body must maintain, the certified organization must retain the corresponding certification records during the validity period of the certification certificate, including: (1) certification contract; (2) Review the plan; (3) Attendance forms for the first and last meetings; (4) Non-compliance reports, cause analysis, and corrective actions; (5) Audit report; (6) Notice of suspension or revocation (if applicable).

The new version of the Rules is a regulatory document that certification activities must comply with, setting clearer requirements for both certification bodies and certification clients. All certification clients are urged to attach great importance, organize relevant personnel for training, fully understand the compliance requirements and risks of certification work, actively improve system operations, and ensure certification meets the requirements of the new version of the "Rules." In conjunction with this change in certification rules, HIC aims to provide clients with more professional, compliant, and high-quality certification services, enhancing the market recognition and credibility of certification certificates. Assist certified organizations in improving management systems, continuously enhancing management levels, and enhancing market competitiveness to support high-quality development of enterprises.

Please refer to the attached "Quality Management System Certification Rules" (CNCA-QMS-01:2025) and its definitions for detailed reference. If you have any questions, you may contact our headquarters (Tel: 0755-22656161) or any office at any time.

Attachment 1: "Quality Management System Certification Rules" (CNCA-QMS-01:2025)

https://www.cnca.gov.cn/zwxx/gg/2025/art/2025/art_b10adde5119f42fab7cad959b757ccc7.html

Appendix 2: Interpretation of the New Version of the "Quality Management System Certification Rules"

https://www.cnca.gov.cn/zwxx/gg/2025/art/2025/art_09011b6ec071463e9bb1f818b00b95d3.html

Shenzhen Huakai Inspection and Certification Co., Ltd

November 11, 2025