1. In the new version of the "Quality Management System Certification Rules", Clause 3.9 states "The total on-site audit time for each auditor participating in management system audits, including QMS, shall not exceed 180 days per cycle year" and Clause 3.10 states "The total number of valid management system certification certificates, including QMS, matched per auditor shall not exceed 50 per cycle year". What management systems are referred to by "management systems including QMS"?
The "management systems including QMS" mentioned in Clauses 3.9 and 3.10 of the new version of the "Quality Management System Certification Rules" refers to all management system certifications that are nationally promoted and uniformly implemented, as well as all management system certifications (including those related to food and agricultural products, etc.) filed by certification bodies within the management system certification categories.
2. Do overseas auditors conducting QMS certification audits within China need to comply with the requirements of the new version of the "Quality Management System Certification Rules"?
Overseas auditors conducting QMS certification audits within China must be confirmed by the China Certification and Accreditation Association (CCAA) and comply with the new version of the "Quality Management System Certification Rules" issued by the Certification and Accreditation Administration of the People's Republic of China (CNCA).
3. If the QMS certification client is an overseas organization, and the certification activities conducted by the certification body cover the main site overseas and branch sites within China, do the certification activities conducted within China need to meet the requirements of these Rules?
QMS certification activities conducted within the territory of the People's Republic of China shall comply with the "Regulations of the People's Republic of China on Certification and Accreditation", the "Measures for the Administration of Certification Bodies", and the new version of the "Quality Management System Certification Rules".
4. The requirements related to the approval of certification body qualifications stipulate competency requirements for full-time certification personnel. Do these requirements apply to part-time certification personnel?
Certification bodies shall ensure that the competency of personnel involved in QMS certification activities meets the relevant requirements for the approval of certification body qualifications. The competency requirements for part-time certification personnel shall also meet the relevant requirements for the approval of certification body qualifications.
5. When conducting competency assessments for QMS certification auditors, can accredited certification bodies use the accreditation body's accreditation method to expand the professional fields within the certification scope of business?
Certification bodies shall, based on Appendix A of the new version of the "Quality Management System Certification Rules", subdivide the certification scope of business and its risk types, and establish risk-based competency assessment criteria for auditors in professional fields within the certification scope of business. The competency assessment criteria shall comply with Clause 3.6 of the new version of the "Quality Management System Certification Rules". Accredited certification bodies may use the accreditation body's accreditation method to expand the professional fields within the certification scope of business for QMS certification auditors. However, for non-accredited certification scopes of business, the professional field assessment for the corresponding certification scope of business shall be conducted according to the conditions specified in Clause 3.6 of the new version of the "Quality Management System Certification Rules".
6. Can professional work experience obtained by a Quality Management System certification auditor before obtaining the corresponding academic qualification be used as a basis for assessing professional fields within the certification scope of business?
When conducting professional field assessments for auditors, the auditor's professional work experience shall be calculated from the date they obtained the corresponding academic qualification. Professional work experience obtained before obtaining the corresponding academic qualification cannot be used to assess professional fields within the certification scope of business.
7. Are the management system certification audit man-days participated in by trainee auditors and the management system certification audit man-days conducted by auditors overseas included in the calculation of the 180 days per cycle year?
The total on-site audit time for each auditor participating in management system audits shall not exceed 180 days per cycle year. This includes the number of management system certification audit man-days participated in by trainee auditors, but excludes the number of management system certification audit man-days conducted by auditors overseas.
8. Can an enterprise operate a QMS before obtaining a business license?
The evidence period for the QMS having been in operation for at least 3 months shall be calculated from the date the enterprise obtains its business license. The period before the enterprise obtains its business license shall not be counted towards the QMS operation time.
9. If a certification certificate is suspended, withdrawn, or cancelled for less than one year due to reasons attributable to the certified organization itself, and the intended certification body to accept the application is the original issuing body, can it accept a newly submitted certification application within one year?
If a certification certificate is suspended, withdrawn, or cancelled by the original issuing body due to reasons attributable to the certified organization itself, the certification body (including the original issuing body) cannot accept a newly submitted certification application from that certified organization within one year from the date of suspension, withdrawal, or cancellation of the original certification certificate.
10. Can the certification client appropriately adjust working hours during the implementation of the certification audit to cooperate with the audit time reaching 8 hours?
If the actual working hours of the certification client on a working day are less than 8 hours, the certification body shall reach an agreement with the certification client to adjust the working hours to 8 hours to cooperate with the on-site audit implementation, and retain the certification records.
11. In the new version of the "Quality Management System Certification Rules", is it true that regardless of the reason, the total reduction in audit time cannot exceed 30%?
When determining the Quality Management System certification audit time, the audit time may be reduced if the certification scope is considered low risk, but the reduction shall not exceed 10% of the audit time specified in Appendix B. If there are other reasons for reducing the audit time for the certification scope, the audit time may be appropriately reduced, but the total reduction in audit time shall not exceed 30% of the audit time specified in Appendix B.
12. How should the work unit be indicated for part-time auditors and technical experts who have no work unit or are retired?
For part-time auditors and technical experts who currently have no work unit, it can be filled in based on the social security payment unit. If social security is not paid, fill in "None". For part-time auditors and technical experts who are retired, fill in the retirement unit and indicate "Retired".
13. Among the conditions for the off-site implementation of Stage 1, does it include the certification client having obtained valid product certification and service certification certificates issued by this certification body?
To achieve the purpose and requirements of the Stage 1 audit, if the certification client has obtained valid certification certificates in other management system certification fields issued by this certification body, the Stage 1 audit may not be implemented at the certification client's site.
14. For Quality Management System certification activities in specific industries, what requirements should the certification decision personnel meet?
For Quality Management System certification activities in specific industries (such as IATF 16949 Automotive Quality Management System certification, ISO 22163 Railway Industry Quality Management System certification, etc.), if the certification basis does not include "Quality management systems — Requirements" (GB/T 19001) or "Quality management systems — Requirements" (ISO 9001), the certification decision personnel shall be full-time certification personnel of the certification body, shall not be members of the audit team, their competency shall meet the relevant requirements for the approval of certification body qualifications, and the certification decision must be made by staff within the territory of the People's Republic of China.
15. For the certification basis standards on the certification certificate, can only the standard number and effective version (e.g., GB/T 19001-2016/ISO 9001:2015) be written, without the standard name?
The "Measures for the Administration of Certification Certificates and Certification Marks" stipulates that the content of a management system certification certificate shall include the standards on which the certification is based. Management system certification certificates issued by certification bodies shall list the current effective standard name and standard number.
16. Can certification bodies adjust the risk types of industries in the examples in Appendix A Table A.2 when further subdividing the certification scope of business based on Appendix A Table A.1 and Table A.2 of the new version of the "Quality Management System Certification Rules"? (Appendix A)
Certification bodies shall, based on Tables A.1 and A.2, conduct characteristic analysis and risk level classification for the 39 certification scopes of business, determine the refined certification scope of business categories and their risks, and cannot only use the 39 major categories of certification scopes of business to classify risks. If there are reasonable reasons, the risk types of certification scopes of business in the examples in Appendix A Table A.2 may be appropriately adjusted. However, regardless of the reason, high-risk certification scopes of business in the examples in Appendix A Table A.2 cannot be adjusted to low risk.
17. In the certification certificate numbering rules, the format of the certification body code is "For domestic-funded certification bodies, it is the last three/four digits of the approval serial number of the certification body approval number; for foreign-funded certification bodies, it is F + the last three digits of the approval serial number of the certification body approval number. If less than three digits, the first digit is padded with 0". For domestic-funded certification bodies, if the approval serial number in the certification body approval number is a three-digit number, how should it be numbered?
For domestic-funded certification bodies whose approval serial number is less than 1000, the certification body code in the numbering rules is the last three digits of the approval serial number of the certification body approval number. For domestic-funded certification bodies whose approval serial number is 1000 or more, the certification body code in the numbering rules is the last four digits of the approval serial number of the certification body approval number.
18. In the certification certificate numbering rules, the format of the accreditation body code is "Fill in the accreditation body code if accredited; if not accredited, the code is '00'". How to obtain the accreditation body code field in the certificate numbering naming rules? (Appendix C)
The accreditation body code is the accreditation mark classification code. It is determined by referring to the "Accreditation Mark Classification Code" in the "Basic Code Table for Management System and Service Certification Information Reporting" of the Unified Reporting Platform for Certification and Accreditation Business Information.
19. Can the accreditation body code be marked in the certification certificate number for certification scopes of business that are not accredited? (Appendix C)
For certification scopes of business of a certification body that are not accredited, the accreditation code in the certification certificate number shall be "00".