In August 19th, the National Commission for Discipline Inspection and approval issued the Announcement No. twentieth of 2016, "the notice of the National Commission for Discipline Inspection and approval on Issuing the new version of the" quality management system certification rules ". The new version of the certification rules was formally implemented in October 1, 2016 to replace the old version of the certification rules.

Revised edition of "quality management system certification rules"

In accordance with the quality management system certification activities and the corresponding administrative supervision and inspection work practice, combined with the new changes in the international standard for quality management system (ISO9001) in 2015, the Commission has revised the quality management system certification rules issued by the State Council in 2014 (hereinafter referred to as the old version of the certification rules) in 2014. Compared with the existing rules, the revised contents mainly include several aspects:

1. In order to coordinate with the provisions of ISO/IEC 17021-1:2015, the provisions of the existing rules have been revised, for example:

1, in 4.6.3 (3), the certification body is allowed to "review other general nonconformities" and has accepted the corrective and corrective measures adopted by the organization plan.

2. In 5.2.1, "as the minimum requirement, the first supervision and audit after initial certification shall be carried out within 12 months from the date of issuance of the certificate. Thereafter, supervision and audit shall be conducted at least in each calendar year (except for those which are re accredited), and the time interval between the two supervisory audits shall not exceed 15 months ".

3, in 6.5, it is stipulated that "after certification expires, if the certification body can complete the uncompleted certification activities within 6 months, the authentication can be resumed. Otherwise, at least one stage two stage audit should be carried out before the certification can be resumed. The effective date of the certificate should not be earlier than the date of the re certification decision, and the date of termination should be based on the last certification cycle. "

4, in 8.2, it is stipulated that "the certificate of re certification shall not exceed the validity period of the last valid certification certificate plus 3 years".

Two, in order to coordinate with the provisions of ISO 9001:2015, the provisions of the existing rules have been revised, for example:

1, in the terms of 4.1.2 (4) and 4.3.3.2, replace the quality manual and procedure document with the "management system written information".

Three. According to the practical experience since the implementation of the rules, the contents of the rules are further improved, such as:

1, simplify the contents of the original rules. For example, in the information that the 4.1.1 certification organization affects the public information of the application organization, it added "the complete content of this rule", and at the same time, deleted the regulations of "granting, maintaining, expanding, updating, reducing, suspending or revoking the certification and its certificates". The 4.1.2 certification organization should delete the "multi place activities, subcontracting activities", "quality standards list of products or services covered by the quality management system", and "necessary documents for the quality management system to run effectively for more than 3 months" and "the necessary documents related to the certification audit".

2. In the 4.3.2, the "top management of the application organization and the responsible department responsible for the quality management system" shall be required to attend the first and last meetings; when the application organization requires, the members of the audit team shall produce identification documents to the application organization.

3. In the 4.3.3.3, the first phase of the audit is not applied at the scene of the organization.

4, delete the original 4.3.3.5 "the first phase audit and the second stage audit should arrange the appropriate interval time, so that the auditee has sufficient time to solve the problems found in the first stage".

5. In 4.3.4, the "quality management system of the application organization" has been deleted, "there is a major defect in the quality management system of the application organization, which does not meet the requirements of the GB/T 19001/ISO 9001 standard". "It is found that the application organization has significant quality safety problems or other serious violations of laws and regulations", which adds "the actual situation of the auditee is materially inconsistent with the application materials".

6. In 4.4.3, it is clear that the certification body shall submit the audit report to the application organization within 30 working days after the decision is made.

7, in the 4.6.5 clause, it is added that the certificate can not be issued. "The quality management system of the audited party has significant defects, does not meet the requirements of GB/T 19001/ISO 9001 standard", and "finds that the auditee has significant quality safety problems or other serious violations of the quality of products and services".

8. In 6.2, the re certification audit is required. "When there is no significant change in the quality management system and the internal and external environment of the accredited organization, the re certification audit can omit the first stage audit, but the audit time shall be no less than 2/3 calculated by 4.2.1."

9, in the case of 7.2.1 suspending the certificate, it deleted the problem that the local certification authority found the system running and needed to suspend the certificate.

10, in the case of 7.3.1's certificate revocation, "the list of quality credit serious discredit enterprises" has been added by the State Administration of quality supervision, inspection and quarantine, and "national product quality supervision and spot check" has been refused.

11, in 8.1 (6), "certificates should be noted: the accredited organizations must be regularly supervised and audited, and the certification party shall continue to provide effective reminder information."

12. In the 12.2, the provisions on the use of Chinese should be deleted.

13, in the 12.4, "all records with relevant personnel signature can be made into electronic documents for preservation and use, but the original must be properly preserved, and the storage time should be at least consistent with the validity period of the certification certificate".

14. In Appendix A, the provisions on the effective number of persons "in principle, such as the attached register of social insurance registration certificates" are cancelled; the "non fixed personnel covered by the certification scope (such as contractor personnel) and part-time personnel" should also be included in the number of valid persons, and it is stipulated that the audit time of the organization during normal working period (such as shift organization) can be included in the effective management system certification audit time, but the time spent between the multiple audit sites is not included in the effective management system certification audit time.

Four, according to the changes of relevant government regulations, the provisions of the existing rules have been revised, for example:

1. In the 8.1, the certification certificate should be marked as "unified social credit code (or organization code)".

Five. Requirements for certification bodies

1, the expression in the original rule 2.2 is revised as "authentication ability, internal management and work system conform to the requirements of GB/T 27021/ISO/IEC 17021-1" conformity assessment management system certification body.

2, added the "2.5 not to apply for certification of the organization (hereinafter referred to as the application organization) whether it is accredited with the auditors and other personnel to participate in the certification audit remuneration linked."

What needs to be highlighted is that the industry organizations should pay attention to the changes of the relevant contents in the basic conditions of the certification bodies. There are differences between the two descriptions of the old and new versions. The content of the new version has been raised. It can be understood that if the inspection confirms that the certification body does not meet the 17021 standard, then it does not conform to the requirements of the rules, especially if it does not conform to the conditions for the establishment of the certification body, and may face the punishment of the revocation agency.

The new version of the certification rules was formally implemented in October 1, 2016 to replace the old version of the certification rules.

The following is the new version of the "quality management system certification rules".

Quality management system certification rules

Catalog

1. scope of application

2. basic requirements for certification bodies

3. basic requirements for certification auditors

4. initial certification process

5. monitor the audit process.

6. re authentication procedure

7. suspend or revoke the certification certificate.

8. certification requirements

9. joint audit with other management systems

10. accept conversion certificate.

11. accepting complaints from the organization

12. management of certification records

13. other

Appendix A requirements for quality management system certification audit time

1 scope of application

1.1 the rules are used to standardize the quality management system certification activities carried out in China according to the standards of GB/T 19001/ISO 9001 "quality management system requirements".

1.2 according to the relevant laws and regulations of certification and accreditation, combined with relevant technical standards, the rules make specific provisions on the implementation process of quality management system certification, clarify the management responsibilities of certification bodies for the certification process, and ensure the standardization and effectiveness of the quality management system certification activities.

1.3 the rules are the basic requirements of certification bodies in the quality management system certification activities. Relevant institutions should abide by these rules in this certification activity.

2. Basic requirements for certification bodies

2.1, obtained the approval of the National Commission for accreditation and obtained the qualification for certification of quality management system.

2.2 the certification capability, internal management and working system meet the requirements of GB/T 27021/ISO/IEC 17021-1 "conformity assessment management system audit and certification body".

2.3 establish internal constraints, supervision and responsibility mechanisms to achieve the training (including value-added services), audit and certification decisions and other work processes are separated from each other, in line with the requirements of certification fairness.

2.4 encourages the certification body to certify the certification capability, internal management and work system of the certification authority through the approval of the accreditation body established by the state regulatory commission, which is in line with the requirements of the GB/T 27021/ISO/IEC 17021-1 "conformity assessment management system audit and certification body".

2.5 it is not allowed to link the organization that has applied for certification (hereinafter referred to as the application organization) for certification with the remuneration of auditors and other personnel who have participated in the certification audit.

3. Basic requirements for certification auditors.

3.1 the certified auditor shall obtain the qualification of the auditor for the quality management system issued by the Certification Authority registered by the state regulatory commission.

3.2 certification personnel shall abide by relevant laws and regulations, and bear corresponding legal responsibilities for the certification audit activities, the relevant certification audit records and the authenticity of the certification audit reports.

Four Initial certification process

4.1 acceptance of certification application

The 4.1.1 certification body shall disclose to the applicant organization at least the following information:

(1) the scope and recognition of certification business can be carried out.

(2) the full content of this rule.

(3) certification form.

(4) the complaint procedure for the certification process.

The 4.1.2 certification body shall require the application organization to submit at least the following information:

(1) application for certification shall include instructions for the production, operation or service activities and activities described in the application.

(2) a copy of the proof of legal status. If the quality management system covers multi site activities, copies of the legal status documents of each place should be attached (when applicable).

(3) copies of administrative license, qualification certificate and compulsory certification certificate related to the activities covered by the quality management system.

(4) quality management system written information (when applicable).

The 4.1.3 certification body shall review the application materials submitted by the application organization, and comprehensively determine if it is capable of accepting the certification application according to the scope and place of the application, the number of employees, the time required to complete the audit, and other factors that affect the certification activities.

The certification organization shall not accept the application for approval of the application organization that is ordered by the law enforcement supervision department to suspend business for rectification or to be listed in the "national list of serious illegal enterprises" in the national enterprise credit information publicity system.

4.1.4 the certification body that meets the requirements of 4.1.2 and 4.1.3 may decide to accept the application for certification; if it does not meet the above requirements, the certification body shall notify the application organization to supplement and improve it, or will not accept the application for certification.

4.1.5 sign certification contract

Before implementing the certification audit, the certification body shall conclude a legally binding written certification contract with the application organization, and the contract shall contain at least the following contents:

(1) the commitment to continuously and effectively operate the quality management system after applying for certification.

(2) the application organization shall undertake to comply with the relevant laws and regulations for certification and accreditation, assist in the supervision and inspection of the authorized regulatory departments, and provide relevant materials and information with the promise to inquire and investigate relevant matters.

(3) when applying for an organizational commitment to be certified, the following circumstances should be informed:

(1) there are significant complaints from customers and interested parties.

2. The products or services provided for production and sale are not qualified by the quality or market supervision department.

Third, product and service quality and safety accidents.

4. Changes in relevant circumstances include: legal status, production and operation status, organizational status or ownership changes; administrative licensing qualification, compulsory certification or other qualification certificates change; legal representative, top management change; workplace change in production and operation or service; alteration of scope of activities covered by the quality management system; major changes in quality management system and important process.

(5) other important situations that affect the operation of the quality management system.

(4) apply for an organization's commitment to use the certification certificate, the certification mark and the relevant information correctly after obtaining the certification, do not make use of the certificate of quality management system and the relevant characters or symbols to mislead the public to believe that their products or services are certified.

(5) the scope of activities for production or services covered by the proposed quality management system.

(6) the responsibilities, rights and obligations of the certification body and the application organization shall be borne by the certification body and the application organization within the validity period of the certification audit and the validity period of the certificate.

(7) certification service fees, payment methods and breach of contract terms.

4.2 audit planning

4.2.1 audit time

4.2.1.1 in order to ensure the integrity and effectiveness of the certification audit, the certification authority shall, based on the audit time specified in Appendix A, calculate and draw up the time needed to complete the audit work according to the scope, characteristics, technical complexity, quality and safety risk level, certification requirements and the effective number of coverage in the enclosure according to the application quality management system. Under special circumstances, the audit time can be reduced, but the reduction time should not exceed 30% of the audit time specified in Appendix A.

4.2.1.2 in the entire audit time, the on-site audit time should not be less than 80% of the total audit time.

4.2.2 audit team

4.2.2.1 certification bodies should select auditors with relevant competence according to the professional and technical fields covered by the quality management system, and select the technical experts to participate in the audit team when necessary.Auditors in the audit team undertake audit tasks and responsibilities.

4.2.2.2 technical experts are mainly responsible for providing technical support for certification audit. They are not audited as auditors and are not included in the audit time. Their audits in the audit process are held accountable by the auditors in the audit team.

The 4.2.2.3 audit team can have an internship auditor, who should participate in the audit under the guidance of the auditor, do not include the audit time, and do not issue separate audit records. The auditors in the audit team shall be responsible for the activities in the audit process.

4.2.3 audit plan

4.2.3.1 certification bodies shall prepare written audit plans for each audit (phase 1 audit does not require formal audit plans). The audit plan includes at least the following contents: the purpose of the audit, the audit criteria, the scope of the audit, the date and place of the on-site audit, the duration of the on-site audit, and the members of the audit team (including: the auditor should indicate the registration number of the certification personnel; the technical expert shall indicate professional code, work unit and professional technical title).

4.2.3.2 if the coverage of the quality management system covers the same or similar activities in multiple locations, and these sites are under the authorization and control of the application organizations, the certification bodies may conduct sampling in these audits, but the sampling should be carried out according to the relevant requirements to ensure that the audits of the sampled samples are representative of all the sites contained in the quality management system. If there are obvious differences in the activities of different places or there are regional factors that may have significant impact on quality management among different places, the method of sampling examination can not be adopted.

4.2.3.3 in order for the on-site audit activities to observe the production or service activities, the on-site audit should be arranged in the normal operation of the production or service activities covered by the certification scope.

4.2.3.4 before the start of the audit activities, the audit team shall submit the audit plan to the application for organization confirmation. In case of a temporary change of plan under special circumstances, the application organization shall be notified in time to the application organization and consensus is reached.

4.3 implementing audit

The 4.3.1 audit team shall complete the audit work according to the arrangement of the audit plan. In addition to unforeseen circumstances, the auditor designated by the audit plan must not be replaced during the audit process.

The 4.3.2 audit team shall hold the first and the last meeting with the application organization in accordance with the sequence of procedures. The top management of the application organization and the responsible department responsible for the quality management system shall attend the meeting. Participants should sign in, and the audit team should keep the first and last meeting attendance forms. When applying for the organization's request, the members of the audit team shall produce identification documents to the application organization.

4.3.3 audit process and links

4.3.3.1 initial certification audit is divided into first, second stages of implementation of the audit.

4.3.3.2 phase I audit should cover at least the following:

(1) confirm the consistency between the actual situation of the application organization and the written description of the quality management system, especially the product and service described in the written information, the Department establishment, the duties and powers, the production or service process, etc., which is consistent with the actual situation of the application organization.

(2) combined with the situation of the site, audit the application organization's understanding and implementation of the requirements of GB/T 19001/ISO 9001 standard, evaluate whether the internal audit and management review has been carried out in the process of quality management system, and confirm whether the quality management system has been running for more than 3 months.

(3) confirm the content and scope of activities covered by the quality management system established by the application organization, the effective number, process and place covered by the system, and comply with applicable laws and regulations and mandatory standards.

(4) identify key points that have important impact on the realization of quality objectives combined with the characteristics of the quality management system covering products and services, and combine other factors to scientifically identify important audit sites.

(5) discuss with the application organization to confirm the second stage audit arrangement. If the written information of the quality management system is not in line with the actual situation of the site, the operation of the relevant system has not been more than 3 months, or can not be proved for more than 3 months, and the other two phase audit conditions do not meet, the two stage audit should not be implemented.

4.3.3.3 in the following cases, the first stage audit can not be carried out at the application site, but the reasons for not being there are recorded.

(1) the application organization has received other valid certificates issued by the certification body, and the certification body has fully understood the application quality management system.

(2) the certification body has sufficient reasons to prove that the technical characteristics of the production, operation or service of the application organization are obvious and the process is simple. Through the examination of its submission documents and data, the purpose and requirements of the first phase audit can be achieved.

(3) the application organization has obtained an effective certificate of quality management system issued by the certification bodies accredited by other authorized institutions. Through the examination of its documents and data, the purpose and requirements of the first phase audit can be achieved.

In addition to the above, the first stage audit should be conducted at the site of the auditee's production, operation or service.

The 4.3.3.4 audit team shall inform the application organization by forming a written document in the first stage of the audit. The key points that may be judged as non conformance in the second stage audit should be reminded in time to the application organization for special attention.

The second stage of 4.3.3.5 audit should be conducted at the scene of the application organization. The key point is to examine the quality management system in line with GB/T 19001/ISO 9001 standard requirements and effective operation, and should cover at least the following:

(1) the effectiveness of process control identified by important audit points in the first stage audit.

(2) establishing quality objectives in terms of relevant functions, levels and processes to achieve quality policy is specific, measurable, measurable, and monitored.

(3) management and control of the process and activities covered by the quality management system.

(4) whether the organization's actual work record is true. For the authenticity of the audit findings, the evidence of doubt should be recorded and considered when making the conclusion and certification decision.

(5) whether the internal audit and management review of the application organization is effective.

In case of 4.3.4, the audit team shall report to the certification body and terminate the examination after the consent of the certification body.

(1) the auditee does not cooperate with the audit activities, and the audit activities can not be carried out.

(2) the actual situation of the auditee is significantly inconsistent with the application materials.

(3) other circumstances that led to the failure of the audit process.

4.4 audit report

The 4.4.1 audit team shall form a written audit report for audit activities, and be signed by the head of the audit team. The audit report should accurately, concisely and clearly describe the main contents of the audit activities, including at least the following:

(1) the name and address of the application organization.

(2) apply for the scope and venue of the organization's activities.

(3) types, criteria and objectives of audit.

(4) the head of the audit team, the members of the audit team and their personal registration information.

(5) the date and place of implementation of the audit activities, including the fixed site and the temporary site; the statement of deviations from the audit plan, including the objective statement of the uncertainty of the audit risk and the conclusion of the audit.

(6) describe the audit procedures and requirements from 4.3 items, including: audit requirements, audit findings and audit conclusions shall be described or quoted one by one, and the quality objectives and process and quality performance shall be evaluated in 4.3.3.5.

(7) identified nonconformities.

(8) the audit team shall give suggestions on whether to pass the certification.

The 4.4.2 certification body shall retain evidence for confirming relevant information in the audit report.

The 4.4.3 certification body shall submit the audit report to the application organization within 30 working days after the decision is made, and retain the evidence received or submitted.

4.4.4 for the project to terminate the audit, the audit team shall make a report on the work carried out. The certification body shall submit the cause of the report and the reasons for its termination to the application organization, and retain the evidence signed or submitted.

4.5 corrective actions and corrective actions for nonconformities and verification of their results.

4.5.1 for the non conformance found in the audit, the certification body shall apply for the organization to analyze the cause and propose corrective and corrective measures. For serious non conforming applications, the application organization shall take corrective and corrective actions within a maximum period of 6 months. The certification body shall verify the effectiveness of the corrective and corrective actions taken by the application organization and its results. If it is not possible to verify the corrective and corrective actions that are not in compliance with the implementation within 6 months after the second stage, it should be processed according to the 4.6.5, or the second stage audit will be re implemented according to 4.3.3.5.

4.6 certification decision

The 4.6.1 certification body shall make a certification decision on the basis of comprehensive evaluation of the audit report, the correction and corrective measures and the results of the nonconformities.

The 4.6.2 certification decision personnel shall be the personnel under the management and control of the certification body, and the members of the audit team shall not participate in the certification decision of the audit project.

The 4.6.3 certification authority should confirm the following conditions before making the certification decision:

(1) the audit report complies with the requirements of article 4.4 of the rules, and the audit report and other information provided by the audit team can meet the information required for making the certification decision.

(2) reflecting the nonconformities of the following problems, the certification bodies have reviewed, accepted and verified the effectiveness of corrective and corrective actions.

(1) there are defects in the continuous improvement of the effectiveness of the quality management system, and there are serious doubts about achieving the quality objectives.

2. The quality objectives formulated cannot be measured or the measurement methods are not clear.

3. Monitoring and measurement of key points that have important impact on achieving quality objectives are not functioning effectively, or reports or reviews of these key points are incomplete or invalid.

(4) other serious non conformities.

(3) certification bodies have been reviewed for other general nonconformities, and have accepted corrective and corrective actions taken by the application organization plan.

4.6.4 on the basis of meeting the requirements of 4.6.3, the certification body has sufficient objective evidence to certify that the application organization meets the following requirements, and the application organization shall be assessed to meet the requirements for certification and to issue certification certificates to it.

(1) the quality management system of the application organization meets the standard requirements and runs effectively.

(2) products and services covered by the certification scope comply with relevant laws and regulations.

(3) the application organization fulfil its relevant obligations in accordance with the certification contract.

If the 4.6.5 application organization fails to meet the above requirements or has the following circumstances, it shall assess that the application organization fails to meet the certification requirements, inform the application organization in writing and explain the reasons for its failure to pass the certification.

(1) the quality management system of the auditee has significant defects and does not meet the requirements of GB/T 19001/ISO 9001 standard.

(2) it is found that the auditee has significant quality safety problems or other serious violations related to the quality of products and services.

4.6.6 certification bodies shall submit the relevant information of the certification results within the 30 working days to the National Commission for accreditation within the next specified working days.

5 monitor the audit process.

5.1 the certification body shall effectively follow up the organization (hereinafter referred to as the accreditation organization) holding its certificate of quality management system certification, and supervise the sustained operation of the quality management system and compliance with the certification requirements.

5.2 in order to ensure that 5.1 requirements are met, the certification body shall determine the frequency of supervision and examination of the accredited organization in accordance with the quality risk degree or other characteristics of the products and services of the licensed organization.

5.2.1 as the minimum requirement, the first supervision and audit after initial certification should be carried out within 12 months from the date of issuance of the certificate. Thereafter, supervision and audit shall be conducted at least in each calendar year (except for those which are re certified), and the time interval between the two supervision and auditing shall not exceed 15 months.

If 5.2.2 exceeds the deadline and fails to carry out the supervision and examination, it shall be dealt with in accordance with 7.2 or 7.3 articles.

When the products of 5.2.3 certified enterprises are found to be unqualified in the state supervision and spot check of product quality, the certification body shall supervise and examine the enterprise within 30 days from the notification issued by the AQSIQ.

5.3 the time to supervise the audit shall not be less than 1/3 calculated by 4.2.1.

5.4 the audit team that monitors the audit shall comply with the requirements of 4.2.2 and 4.3.1.

5.5 supervision and auditing shall be conducted at the scene of the accredited organization and shall satisfy the conditions specified in section 4.2.3.3. Due to market and seasonal reasons, it is difficult to cover all products and services during each supervision and audit. Supervision and audit within the validity period of the certification certificate shall cover all products and services within the scope of certification.

5.6 at least, the following contents should be examined when supervising the audit:

(1) since the last audit, the activities covered by the quality management system and the important changes in the impact system and the resources of the operation system have been changed.

(2) according to 4.3.3.2 (4), whether the identified key points are normally and effectively operated according to the requirements of the quality management system.

(3) whether corrective and corrective actions taken for non conformance identified in the last audit are still valid.

(4) the activities covered by the quality management system relate to whether the regulations are consistent with the relevant regulations.

(5) whether the quality objectives and quality performance are up to the established value of the quality management system. If it does not meet, whether the accreditation organization runs the internal audit mechanism, identifies the reasons, and whether or not it runs the management review mechanism, determines and implements the improvement measures.

(6) whether the certification organization's use of certification mark or certification qualification is in conformity with the certification and accreditation Ordinance and other relevant provisions.

(7) whether internal audit and management review are standardized and effective.

(8) timely acceptance and handling of complaints.

(9) in the light of problems or complaints found in the operation of the system, effective improvement measures are formulated and implemented in time.

5.7 in case of non conformance found in the supervision and examination, the certification body shall require the accreditation organization to analyze the cause, stipulate the time limit, and request the certification organization to complete the corrective and corrective actions and provide evidence for correcting and correcting the effectiveness of the measures.

The certification body should adopt appropriate methods to verify the effect of the accredited organization on the disposal of non conformance in time.

5.8 to supervise the audit reports, the audit evidence, audit findings and audit conclusions shall be described or quoted one by one in accordance with the 5.6 specified audit requirements.

5.9 according to the supervision report and other relevant information, the certification body shall make a decision to continue or suspend or revoke the certificate.

6 re authentication procedure

6.1 before the expiration of the certificate, if the certificate organization continues to hold the certificate of authentication, the certification body shall carry out the re certification audit and decide whether to continue the certificate.

6.2 the certification body shall form an audit team according to the requirements of 4.2.2 and 4.3.1. In accordance with the requirements of 4.2.3 and combined with previous supervision and auditing, the re certification audit plan is formulated and handed over to the audit team for implementation.

When there is no significant change in the quality management system and the internal and external environment of the accreditation organization, the re certification audit can omit the first stage audit, but the audit time shall be no less than 2/3 calculated by 4.2.1.

6.3 in respect of serious non conformance found in re certification audit, the certification body shall set the time limit for the certification organization to implement corrective and corrective actions, and complete the verification of corrective and corrective actions before the expiration of the original certificate.

6.4 certification bodies shall make re certification decisions according to the 4.6 requirements. If the certifying organization continues to meet the certification requirements and fulfil the obligations of the certification contract, it shall issue a certificate of authentication to it.

6.5 if the re certification activity is completed before the expiration date of the current certification certificate and the certificate is changed, the date of termination of the new certification certificate can be based on the date of the current certification certificate.The date of issue of the new certificate should not be earlier than the date of the re certification decision.

If the certification authority fails to complete the re certification audit or fails to verify the corrective and corrective actions for serious non conformance before the expiration date of the current certificate, it should not be re certified or extended the validity period of the original certificate.

If the certification authority can complete the uncompleted certification activities within 6 months after the expiration of the certificate, the authentication can be resumed. Otherwise, at least one stage of the two stage audit should be conducted before the certification can be resumed. The effective date of the certificate should not be earlier than the date of the re certification decision, and the date of termination should be based on the last certification cycle.

7, suspend or revoke the certification certificate.

7.1 the certification body shall formulate a stipulation and a documented management system for suspending or revoking the certification certificate or reducing the scope of certification, and the regulations and management systems shall meet the relevant requirements of this regulation. The suspension and revocation of the certificate shall conform to its management system and shall not be suspended or revoked at any time.

7.2 suspension of certificates

7.2.1 certification organization has one of the following circumstances, the certification body shall suspend its certification within 5 working days after investigation and verification.

(1) the quality management system continues or seriously fails to meet the certification requirements, including requirements for the effectiveness of the quality management system.

(2) do not undertake and fulfill the responsibilities and obligations stipulated in the certification contract.

(3) ordered by the relevant law enforcement and supervision departments to suspend business for rectification.

(4) the administrative license certificate, qualification certificate, compulsory certification certificate related to the scope of the quality management system are expired, and the application submitted has been accepted but not yet changed.

(5) active request for suspension.

(6) other certificates should be suspended.

The period of suspension of the 7.2.2 certificate shall not exceed 6 months. However, a period of suspension in case 7.2.1 (4) may be made on the date of the decision of the relevant unit.

The 7.2.3 certification body shall disclose the information on the certificate of authentication in an appropriate manner, clarify the starting date and the time limit for the suspension, and declare that, during the period of suspension, the certifying organization shall not use the certification certificate, the authentication mark or the authentication information in any way.

7.3 revocation certificate

7.3.1 certification organizations have one of the following circumstances, the certification bodies should withdraw relevant certificates within 5 working days after obtaining relevant information and investigation and verification.

(1) cancellation or cancellation of legal status documents.

(2) listed by the State General Administration of quality supervision, inspection and quarantine, a list of serious credit breaking companies.

(3) refuse to cooperate with the supervision and inspection carried out by the certification and supervision department, or provide false materials or information for inquiries and investigations on related matters.

(4) refuse to accept spot checks of product quality supervision.

(5) major safety incidents such as products and services were identified by law enforcement and regulatory authorities.

(6) there are other serious violations of laws and regulations.

(7) the time limit for suspending the certificate is already full, but the problem of causing the suspension has not been solved or corrected (including the administrative license certificate, qualification certificate, compulsory certification certificate, etc.) related to the scope of the quality management system, which has expired but the application has not been approved.

(8) no operation of the quality management system or operation conditions.

(9) the certification information that is not properly quoted and publicized according to relevant regulations, causing serious consequences or consequences, or which has been corrected by the certification authority but has not been corrected for more than 2 months.

(10) other certificates that should be revoked.

7.3.2 after the certificate is revoked, the certification authority shall withdraw the certificate of revocation in time. If it can not be recovered, the certification authority should publish or declare the decision in relevant media and websites in time.

7.4 the certification authority suspends or revoke the certification certificate, and shall publish relevant information on its website, and report it to the National Commission for discipline inspection according to the prescribed procedures and requirements.

7.5 certification bodies should take effective measures to prevent all kinds of invalid certificates and certification marks from being used.

8 certification requirements

8.1 the certificate should contain at least the following information:

(1) the name and address of the accredited organization and the unified social credit code (or organization code). This information should be consistent with the information of its legal status certificate.

(2) the address and business scope of production management or services covered by the quality management system. If the accredited quality management system covers multiple sites, it describes the name and address information of the relevant places covered.

(3) the quality management system is in line with the GB/T 19001/ISO 9001 standard.

(4) certificate number.

(5) the name of the certification body.

(6) the date of validity and the date of the month.

The certificate should be marked: the accredited organization must be regularly supervised and audited, and the certificate will continue to provide effective reminder information.

(7) the relevant recognition mark and recognition registration number (when applicable).

(8) certificate inquiry mode. In addition to announcing the way of authentication on the website of the institution, the certification authority should also indicate in the certificate: "this certificate information can be inquired" on the official website of the national certification and Accreditation Commission (www.cnca.gov.cn), so as to facilitate social supervision.

8.2 the validity period of the initial certification certificate is the longest period of 3 years. The certificate of re certification is not valid for more than 3 years.

8.3 certification bodies shall establish a certificate information disclosure system. In addition to providing certification information to law enforcement and regulatory departments such as application organizations, certification and supervision departments, they shall also provide certificate information and accept social supervision according to the request of relevant social parties.

9. Combine audit with other management systems.

9.1 when the quality management system is combined with other management systems, the general or common requirements should meet the requirements of the rules. The audit report should clearly reflect 4.4 requirements and be easy to identify.

9.2 the number of days of audit in combination with audit shall not be less than 80% of the audit time required by many separate systems.

10. Accept conversion certificate.

10.1 the certification body should fulfill its social responsibilities and strictly prohibit the transformation of the organization's application certification which does not conform to the GB/T 19001/ISO 9001 standard and can not effectively implement the quality management system.

10.2 the certification body accepts the organization's application for conversion to the certificate of this organization. It should know the reasons for the application conversion in detail and conduct on-site audit if necessary.

The 10.3 conversion is limited to the current valid certificate. The certificate of application that has been suspended or is being suspended or revoked is not acceptable.

10.4 if a certification body revoked the certificate, unless the organization has made a thorough rectification, it has resulted in the cancellation or cancellation of the certificate. Otherwise, it should not accept its certification application.

11. Acceptance of complaints by the organization

When an application organization or accreditation organization has any objection to the certification decision, the certification body shall accept the complaint and handle it in a timely manner, and within 60 days, the written result of the processing result shall be sent to the complainant.

Written notice should inform the complainant that if the certification body fails to comply with the relevant laws and regulations or the relevant rules and regulations, and causes serious infringement on its legitimate rights and interests, it may directly complain to the local certification authority or the National Commission for Discipline Inspection, or to the relevant authorized institutions.

12. Management of certification records.

12.1 certification bodies shall establish a record keeping system, record the whole process of certification activities and keep them properly.

12.2 records should be truthful and accurate to verify the effective implementation of certification activities. The recorded data should be in Chinese, and the storage time should be at least consistent with the validity period of the certificate.

12.3 the electronic document format should be used in electronic records.

12.4 all written records signed by the relevant personnel can be made into electronic documents for preservation and use, but the original must be properly preserved, and the storage time should be at least consistent with the validity period of the certification certificate.

13

13.1 the contents of this rule refer to the GB/T 19001/ISO 9001 standard, which refers to the valid version of the standard when the certification activity occurs. When the standard number is described in the certification activity and certification certificate, the full standard number of the valid version at that time should be adopted.

13.2 the photocopy of all kinds of proof documents mentioned in this rule should be Photocopying on the original and signed by the auditor to confirm that it is identical with the original.

13.3 certification bodies can carry out the publicity and training of quality management system and related technical standards, and urge all employees of the organization to correctly understand and implement the quality management system standards.

Appendix A

Quality management system certification audit time requirements

Note: 1. the effective number includes all personnel involved in the certification scope (including the staff of each shift). Non fixed personnel (such as contractor's personnel) and part-time staff who are covered by the certification scope should also be included in the effective number.

2. the effective number of non fixed personnel (including seasonal personnel, temporary staff and sub contractors) and part-time staff can be approved or reduced to equivalent full-time staff according to their actual hours of work.

3. during the normal working period (such as shift organization), the audit time can be included in the effective management system certification audit time. However, the time spent between the multiple audit sites is not included in the effective management system certification audit time.