Quality management system certification registration application materials 　　

1. The application for quality management system certification signed by authorized representatives of the organization;

　　

2. Application for organization business License (copy)

　　

3. Other qualifications (if required by national or departmental regulations); Such as, belong to 3C certification products, should also provide 3C certification certificate (copy);

　　

4. List of quality manual and procedure documents, and provide procedure documents if necessary;

　　

5. Manufacturers of non-medical devices shall also provide a list of applicable regulations for their products;

　　

6. If the products covered by the system are only for export, the list of applicable laws and regulations of the exporting country shall be provided, and export certification documents shall also be provided;

　　

7. Management review report and internal audit report;

　　

8. Product production process, special process and key process description;

　　

9. List of mandatory standards/requirements and enterprise standards involved in products or services;

　　

10. Product technical report or specification;

　　

11. For medical device manufacturers, "Medical Device Enterprise Production License" should be submitted at the same time, and "Medical Device Product Registration Certificate" (copy) (including medical device registration form) should be submitted for products that have obtained medical device product registration;

　　

12. Medical device products without registration certificate should submit the following materials:

　　

A) Product standards and specifications;

　　

B) Product registration test report;

　　

C) clinical trial data in compliance with the relevant provisions or instructions for clinical exemption;

　　

D) Product specifications;

　　

E) Product technical report and risk management report for Class II and III medical devices;

　　

Note: if applying for medical device certification at the same time, only one copy of the same materials need be submitted.

　　

Risk management system certification registration application materials

 

Quality management system certification fees

Different products, different process demand price gap, please consult professional consultants for details.

　　

2.1.6 The quality management system certification registration is granted, maintained, expanded, updated, reduced, suspended and cancelled quality management system certification workflow

　　

1.Purpose

　　

This document provides for NCE in the quality management system certification activities, the quality management system certification of the award, maintain, expand, update, reduce, suspend and cancel/cancel management.

　　

2. Granting or updating of quality management system certification registration (recertification)

　　

- through the on-site audit to confirm the application certification organization according to the standard requirements of the establishment of the quality management system in line with the requirements of the certification criteria, and can be effectively implemented and maintained;

　　

- The audit process meets the requirements of the quality management system certification procedures, the on-site audit issued by the non-compliance with all effectively closed;

　　

- The physical quality of the product meets the requirements;

　　

- Comply with relevant laws and regulations.

　　

Note: the certification organization should apply for recertification four months before the expiration of the certification period (three years).

　　

3. Maintain quality management system certification and registration

　　

- Through supervision and audit to confirm that the quality management system of the certified organization continues to meet the requirements of the certification criteria, and can effectively operate, management review, internal audit and corrective and preventive measures effective implementation.

　　

-Supervise the audit process in accordance with the provisions of the quality management system certification procedures, all the non-conformance issued by the on-site audit have been effectively closed, and the corrective measures of the non-conformance of the last audit have been verified to be effective;

　　

- Correct use of certificates and marks;

　　

- The physical quality of the product meets the requirements;

　　

- Comply with relevant laws and regulations.

　　

4. Expand the scope of quality management system certification

　　

4.1 A certified organization may apply in writing to NCE to expand the scope of quality management system certification for the following reasons:

　　

A) Significant changes have taken place in the quality management system of the certified organization, such as setting up branches and covering them within the scope of the quality management system certification;

　　

B) The product range covered by the quality management system of the certified organization is increased.

　　

4.2 In case of the above changes in the quality management system of the certified organization, the application for expanding the scope of the quality management system certification shall be submitted to the NCE Market Service Department in advance and corresponding materials shall be submitted.

　　

NCE determines the way to change the certification scope by considering the location involved in the expansion of the certification scope, audit criteria, process, product complexity and other factors; If on-site audit is required, the required audit time shall be clearly extended and the certification agreement shall be signed with the certified organization. Audits that extend the scope of certification may be conducted in conjunction with supervisory audits or separately.

　　

5. Suspension of quality management system certification registration

　　

5.1 In one of the following circumstances, NCE will suspend the quality management system certification of the certified organization:

　　

A) unable to accept NCE supervision audit and recertification audit within the specified period;

　　

B) The certified organization fails to pay the fees on time and fails to correct them after being pointed out;

　　

C) suspension requested by the certified organization on its own initiative;

　　

D) In the national, provincial and municipal product supervision and sampling inspection activities, the certified organization fails to keep the physical quality of the product in conformity with the requirements and fails to take effective measures within the specified time limit;

　　

E) Supervision and audit found that the quality management system of the certified organization does not meet the certification requirements, but the severity does not constitute the cancellation of the quality management system certification qualification;

　　

F) Failing to take effective correction and corrective measures for nonconformance items proposed in THE NCE supervision and audit within the prescribed time limit;

　　

G) Customers raise serious quality problems to the products covered by the quality management system of the certified organization, which are verified to cause harm;

　　

H) The use of the quality management system certification certificate and certification mark by the certified organization does not comply with the PROVISIONS of NCE;

　　

I) Found other violations of the quality management system certification rules.

　　

5.2 The organization whose certification registration has been suspended shall immediately stop the use of the certification certificate upon receipt of the notice of suspension. The suspension information will be posted on the NCE website.

　　

5.3 The organization whose certification registration is suspended shall be responsible for any consequences caused by the use of the certificate during the suspension period.

　　

5.4 The organization whose certification registration is suspended shall solve the problems causing the suspension within the suspension period and apply for the resumption of certification before the expiration of the suspension period. In general, an on-site audit should be scheduled before the NCE makes a decision on whether certification can be reinstated.

　　

6. Cancellation or reduction of quality management system certification registration

　　

6.1 Under any of the following circumstances, THE NCE shall revoke the registration qualification of the certified organization using the quality management system or reduce the scope of certification:

　　

A) failure to resolve the issue causing the suspension within the time limit set by the NCE;

　　

B) The product quality covered by the certified quality management system of the organization has serious quality problems and causes serious consequences;

　　

C) Supervision and audit finds that the quality management system of the certified organization does not meet the required requirements seriously;

　　

D) The certification scope cannot continue to meet the certification requirements, such as: the covered products are no longer in production or have been eliminated products, resources and other conditions change, the original certification scope can not be maintained;

　　

E) Serious violation of certification requirements (such as: transfer of quality management system certification documents);

　　

F) Discover other circumstances as required by the formal agreement between the NCE and the certified organization that constitute the revocation of the quality management system certification.

　　

6.2 The reduction of the scope of certification shall be consistent with the requirements of certification standards. If it can not meet the requirements of certification standards because of narrowing, it should be cancelled. The NCE will make a decision on whether to withdraw the certification altogether or reduce the scope of the certification.

　　

6.3 The organization whose certification registration has been revoked shall return all certification documents; The certificate needs to be changed for narrowing the scope of certification . Cancellation or reduction information will be posted on the NCE website.

　　

6.4 The organization whose certification registration has been revoked shall not continue to use the certification certificate or carry out relevant publicity. The organization whose certification registration has been revoked shall be fully responsible for any consequences caused by the continued use of the certification certificate or carry out relevant publicity.

　　

6.5 In principle, the organization whose qualification of quality management system certification has been revoked can re-apply for quality management system certification one year later.

　　

7. Cancellation of quality management system certification registration

　　

7.1 Cancellation of certification refers to that the certified organization voluntarily proposes not to continue to maintain the qualification of quality management system certification and registration due to some reason.

　　

7.2 Deregistering an organization shall return all its certification documents. Cancellation information will be posted on the NCE website.

　　

7.3 The organization that has cancelled its certification registration shall not continue to use the certification certificate or carry out the relevant publicity. If it continues to use the certification certificate or carry out the relevant publicity, the organization that has cancelled its certification registration shall be fully responsible for any consequences.

　　

Risk management system certification fees