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In order to standardize the quality management system certification activities, improve the effectiveness of certification, and promote the healthy development of quality management system certification, according to the “Certification and Accreditation Ordinance”, “certification body management approach” and other relevant laws and regulations, the CNCA developed the “quality Management System Certification Rules “(the” Rules “) are hereby promulgated and shall be announced as follows:

1. As from July 1, 2014, the relevant certification agencies GB / T 19001 / ISO 9001 quality management system certification activities, shall comply with the provisions of the “rules” of.
2.the relevant certification body should do a good job of the “Rules” before the implementation of the preparation, adjustment and improvement of the agency’s certification procedures, work requirements, so that in line with the “rules” provisions.

3, the relevant certification body should do a good job of the “Rules” of the publicizing, so that the certification organization to understand the “rules” provisions.

4. After the implementation of these Rules, the certification issued by the certification body shall comply with the requirements of these Rules.

State Commission for Accreditation
March 11, 2014

Quality management system certification rules

catalog
1. Scope of application
2. Requirements for the certification body
3. Requirements for certification personnel
4. Initial certification procedures
5. Supervise the audit procedures
6. Re-certification procedures
7. Suspend or revoke the certificate
8. Certification requirements
9. Combined audit with other management systems
10. Accept the conversion certificate
11. Complaint of the receiving organization
12. Management of certification records
13. Others

Appendix A quality management system certification audit time requirements

1 Scope of application
1.1 The rules to regulate the certification body to apply for certification and certification of various types of organizations in accordance with GB / T 19001 / ISO 9001 “Quality Management System Requirements” standards to establish quality management system certification activities.
1.2 The purpose of this rule is to make specific provisions on the implementation process of the quality management system certification in accordance with the relevant laws and regulations of the certification and accreditation and the National Outline of Quality Development (2011-2020) and the technical standards, and strengthen the management and responsibility of the certification body in the certification process.
1.3 The Rules are the basic requirements for certification bodies engaged in quality management system certification activities, the certification body engaged in the certification activities should comply with these rules.

2 Requirements for certification bodies
2.1 access to the national commission for approval, to obtain quality management system certification in the qualification.
2.2 The establishment of GB / T 27021 “conformity assessment management system audit certification body requirements,” the internal management system, so that engaged in the quality management system certification activities in line with laws and regulations and technical standards.
2.3 The establishment of internal control, supervision and accountability mechanisms to achieve acceptance, training (including related value-added services), audit and certification decisions and other aspects of the separation of each other.
2.4 The certification body is encouraged to demonstrate its ability to meet the requirements of the quality management system certification through an accreditation body.

3 Requirements for certification personnel
3.1 The certification personnel shall obtain the qualifications of the auditors of the quality management system issued by the certification body’s registration authority as determined by the CNCA.
3.2 Certification personnel should comply with the relevant laws and regulations, and certification activities and the certification audit report and the authenticity of the certification conclusions bear the corresponding legal responsibility.

4 Initial certification procedures
4.1 Accept the application for certification
4.1.1 The certification body shall disclose at least the following information to the organization applying for certification (hereinafter referred to as the applicant organization):
(1) The scope of the certification business, and the status of accreditation.
(2) the institutions of the grant, maintain, expand, update, reduce, suspend or revoke the certification and its links and other aspects of the system requirements.
(3) certification certificate style.
(4) Appeal procedure for certification decision.
(5) branches and offices of the name, scope of business, address and so on.
4.1.2 The certification body shall request the applicant organization to submit the following documents:
(1) certification application, including the application of the organization’s production and operation or service activities such as the description.
(2) the legal status of the documents (including: business license, business unit legal person certificate, social organization registration certificate, non-enterprise legal person registration certificate, party and government documents, etc.) copy. If the quality management system covers multi-site activities, a copy of the legal status document (where appropriate) of each location should be attached.
(3) a copy of the organization code certificate.
(4) Quality management system covered by the activities of the laws and regulations involved in the requirements of the administrative license, qualification certificate, a copy of the mandatory certification certificate.
(5) multi-site activities, activities, subcontractors.
(6) quality management system manual and the necessary program files.
(7) quality management system covered by the product or service quality standards list.
(8) quality management system has been effective for more than 3 months to prove the material.
(9) other documents related to the certification audit.
4.1.3 certification application review and confirmation
The certification body shall examine the application materials submitted by the applicant organization and confirm that:
(1) complete application information.
(2) The activities of the applicant organization comply with the relevant laws and regulations.
(3) the application organization to achieve the quality objectives and the establishment of a documented quality management system.
4.1.4 Based on the scope of application, the place of production and operation, the number of employees, the time required to complete the audit and other factors that affect the certification activities, the organization shall determine whether it is capable of accepting the application for certification.
4.1.5 The certification body may decide to accept the application for certification in accordance with the requirements of 4.1.3 and 4.1.4. If the application does not meet the above requirements, the certification body shall notify the applicant organization to complete and perfect, or not accept the certification application.
4.1.6 The certification body shall keep a record of the examination and verification of the certification application.
4.1.7 Signed a certification contract
Prior to the implementation of the certification audit, the certification body shall enter into a legally binding written certification contract with the applicant organization. The contract shall contain at least the following contents:
(1) Commitment to the continuous and effective operation of the quality management system after certification by the applicant organization.
(2) The applicant organization shall abide by the relevant laws and regulations of certification and accreditation, assist the supervision and inspection of the certification supervision department, and provide relevant materials and information truthfully to the inquiry and investigation of relevant matters.
(3) the application organization commitment to obtain certification after the following circumstances should promptly notify the certification body:
① customers and relevant parties have major complaints.
② products or services produced by law enforcement authorities that do not meet the statutory requirements.
③ the occurrence of product or service quality and safety incidents.
④ changes in the relevant circumstances, including: legal status, production and operation status, organizational status or ownership changes; obtained administrative license qualification, compulsory certification or other qualification certificate change; legal representative, top management, management representative changes; Changes in the workplace of operations or services, changes in the scope of activities covered by the quality management system, major changes in the quality management system and in important processes.
⑤ There are other important situations that affect the operation of the quality management system.
(4) the application organization commitment to obtain certification after the correct use of certification, certification mark and the relevant information; not unauthorized use of quality management system certification and related text, symbols misleading the public that their products or services through certification.
(5) the scope of activities of the production or service covered by the proposed quality management system.
(6) Responsibilities, rights and obligations of the certification body and the applicant organization in each supervision audit during the certification audit and the validity period of the certification certificate.
(7) the cost of certification services, payment methods and default terms.
4.2 to develop audit plans
4.2.1 Audit Time
4.2.1.1 In order to ensure the integrity and validity of the certification audit, the certification body shall, on the basis of the audit time specified in Appendix A, determine the scope, characteristics, technical complexity, quality and safety risk level, certification requirements and requirements of the applicant organization’s quality management system. The number of employees, etc., accounting and preparation of the completion of the audit time required. In exceptional cases, the audit time may be reduced by no more than 30% of the time specified in Appendix A.
4.2.1.2 The on-site audit time shall not be less than 80% of the total audit time.
4.2.2 Audit Team
4.2.2.1 The certification body shall select auditors and technical experts with relevant competencies to form an audit team in accordance with the technical areas of the activities covered by the quality management system. Auditors in the audit team shall be responsible for the audit.
4.2.2.2 Technical experts are mainly responsible for providing technical support for certification audit. They are not audited as auditors. They are not included in the audit time. Their activities in the audit process are the responsibility of the auditors in the audit team.
4.2.2.3 The audit team may have an internship auditor, who will participate in the audit under the guidance of the auditor and not be included in the audit time. The auditors in the audit team shall be responsible for the activities during the audit.
4.2.3 Audit Plan
4.2.3.1 The certification body shall prepare a written audit plan and submit it to the audit team for implementation. The audit plan shall include at least the following contents: the purpose of the audit, the scope of the audit, the audit process, the departments and sites involved in the audit, the audit time, the members of the audit team (of which: the auditor shall indicate the registration certificate number and professional code; technical experts should indicate the professional code, Technical titles or positions, if the service should be marked with its service units).
4.2.3.2 Normally, the initial certification audit, supervision audit and re-certification audit shall be carried out at each site involved in the scope of application for certification.
If the quality management system includes the same or similar activities in multiple locations and the sites are under the authority and control of the requesting organization, the certification body may sample these sites during the audit, but a reasonable sampling plan shall be established to ensure that On the site quality management system of the correct audit. If there is a fundamental difference in activities at different sites or regional factors that may have a significant impact on quality management in different locations, sampling audits should not be used and should be reviewed on a field-by-site basis.
4.2.3.3 In order to enable the on-site audit activities to observe the production or service activities, the on-site audit shall be arranged in the normal operation of the production or service activities covered by the certification scope.
4.2.3.4 Before the audit activity begins, the audit team shall submit the written audit plan to the applicant organization for confirmation. In case of special temporary change plan, it shall promptly notify the audited applicant organization of the change in written form and reach a consensus through consultation.
4.3 Implementation audit
4.3.1 The audit team shall complete all the work of the audit plan. Except for unforeseen special circumstances, auditors (other than technical experts and trainee auditors) identified in the audit plan may not be replaced during the audit.
4.3.2 The audit team shall, in conjunction with the applicant organization, convene the first and last meetings in the order of procedure. The audit team shall provide the check-in form for the first and last meetings, and the attendees shall sign-in.
4.3.3 audit process and links
4.3.3.1 initial certification audit, divided into the first and second stage of implementation of the audit.
4.3.3.2 The first stage audit shall cover at least the following:
(1) Confirm the consistency between the actual situation of the applicant organization and the description of the quality management system documents, especially the products or services described in the system documents, whether the departments are set up and the person in charge of the production or service process and the actual organization The situation is consistent.
(2) In accordance with the requirements of the GB / T 19001 / ISO 9001 standard, the applicant shall examine whether the application organization has conducted internal audit and management review to confirm whether the quality management system is effective. Run and more than 3 months.
If the quality management system documents do not conform to the actual conditions of the site and the relevant system has not been operated for more than 3 months or can not be proved for more than 3 months, the audit shall be terminated in a timely manner.
(3) to confirm the application of the organization to establish the quality management system coverage of the activities and scope of the number of employees of the organization, activities and places, comply with relevant laws and regulations and technical standards.
(4) Combining the characteristics of the coverage activities of the quality management system Identify the key points that have important impact on the achievement of the quality objectives, and scientifically identify important audit points in combination with other factors.
(5) to discuss with the applicant organization to determine the second stage of the audit arrangements.
4.3.3.3 Phase 1 audits may not be conducted at the applicant organization’s site in the following cases:
(1) The applicant organization has been other certification issued by the certification body, the certification body has a good understanding of the applicant organization’s quality management system.
(2) the certification body has sufficient grounds to prove that the organization of the production and operation or service of the technical characteristics of the process is simple, through the submission of documents and information review can achieve the purpose and requirements of the first phase of the audit.
(3) The applicant organization has obtained the certificate issued by other accredited certification bodies, which can meet the purpose and requirements of the first stage audit by reviewing the documents and materials.
In addition to the above, the first stage of the audit should be in the organization of the production or operation or service site.
4.3.3.4 The audit team shall inform the applicant organization of the written documentation of the first stage audit. In the second stage of the audit may be judged to be non-conformance of the important key points, to remind the applicant organization to pay special attention.
4.3.3.5 Appropriate intervals should be set for the first and second phases of the audit so that the applicant organization has sufficient time to resolve the problems identified in the first phase.
4.3.3.6 The second stage audit shall be conducted at the applicant organization’s site. The focus is on auditing the quality management system to meet the requirements of GB / T 19001 / ISO 9001 and the effective operation, and should cover at least the following contents:

(1) The name and address of the applicant organization.
(2) review the scope and location of the organization’s activities.
(3) audit team leader, audit team members and their personal registration information.
(4) the date and place of the audit.
(5) Describe the review of the procedures and requirements specified in 4.3, in which the audit requirements for 4.3.3.6 shall be described in detail on the audit evidence, audit findings and audit findings; The evaluation of the achievement of the objectives shall be accompanied by a description of the measurement method.
(6) the identified non-conformities. The expression of nonconformity should be based on objective evidence and audit basis, with accurate, specific and clear description, and easy to be understood by application organization. Nonconformities shall not be expressed in a conceptual, uncertain, vague language.
(7) The audit team’s recommendation on whether or not to pass the certification.
4.4.2 The audit report shall be accompanied by such evidence or records as may be necessary to prove the facts in question, including audiovisual material such as text or photograph.
4.4.3 The certification body shall submit the audit report to the applicant organization and retain the evidence of receipt or submission.
4.4.4 The audit team shall report on the work carried out, and the certification body shall submit the report and the reasons for the termination of the audit to the applicant organization and shall retain the evidence of receipt or submission.
4.5 Verification of corrective and corrective actions and results of nonconformities
4.5.1 For the non-conformities found in the audit, the certification body shall request the applicant organization to analyze the reasons and request the applicant organization to take measures to rectify within the prescribed time limit.
4.5.2 The certification body shall verify the corrective and corrective actions taken by the applicant organization and the validity of the results thereof.
4.6 Certification decision
4.6.1 The certification body shall make a certification decision on the basis of a comprehensive evaluation of the audit report, the corrective actions and corrective actions of the nonconformities, and the results thereof.
4.6.2 The audit team members shall not participate in the certification decision of the audit project.
4.6.3 The certification body shall, before making the certification decision, confirm the following:
(1) The audit report complies with the requirements of Rule 4.4 to meet the information required to make the certification decision.
(2) The certification body has reviewed, accepted and verified the effectiveness of the corrective and corrective actions and their results, reflecting the nonconformities of the following issues.
① failed to meet the requirements of quality management system standards.
② the development of quality objectives can not be measured, or the measurement method is not clear.
(3) Monitoring and measurement of key points that have a significant impact on the achievement of quality objectives are not operating effectively or the reporting or review of these key points is incomplete or ineffective.
④ In the continuous improvement of the effectiveness of quality management system deficiencies, to achieve quality objectives of major doubt.
(3) The certification body has reviewed other nonconformities and accepted the corrective and corrective actions taken by the applicant organization.
4.6.4 On the basis of satisfying the requirements of Clause 4.6.3, the certification body has sufficient objective evidence to prove that the applicant organization satisfies the following requirements and assesses the applicant organization to meet the certification requirements and issue the certificate to the applicant organization.
(1) the applicant organization’s quality management system in line with standard requirements and effective operation.
(2) the scope of certification products or services covered by the relevant laws and regulations.
(3) the application organization in accordance with the provisions of the certification contract to fulfill the relevant obligations.
4.6.5 If the applicant organization can not meet the above requirements, it will assess the applicant organization’s non-compliance with the certification requirements, inform the applicant organization in writing and explain why it has not passed the certification.
4.6.6 certification body in the issuance of certification, it should be within 30 working days in accordance with the requirements of the relevant information submitted to the national commission.
National Certification and Accreditation Administration in its website (www.cnca.gov.cn) set up a column to the public disclosure of the certification body of the certificate and other information.
4.6.7 The certification body shall not link the certification of the applicant organization to the auditors and other personnel involved in the certification audit.

5 supervision and audit procedures
5.1 The certification body shall keep track of the organization (hereinafter referred to as the certifying organization) holding the quality management system certification issued by it, and supervise the certified quality management system of the certified organization to continue to meet the requirements.
5.2 In order to ensure compliance with Article 5.1, the certification body shall determine the frequency of surveillance audits of the certified organization, based on the quality risk level or other characteristics of the product or service of the certified organization.
5.2.1 As a minimum, a surveillance audit shall be carried out at least 12 months after the second phase of the initial certification. Thereafter, the time interval for each surveillance audit shall not exceed 12 months.
5.2.2 When the supervision and audit period is reached and there is evidence that the organization is not qualified for the supervision and auditing, the supervision examination period may be extended as appropriate, but the maximum interval can not exceed 15 months.
5.2.3 Failure to carry out supervision and auditing beyond the time limit shall be dealt with in accordance with Article 7.2 or 7.3.
5.3 The time for the supervision audit shall not be less than 30% of the number of days of the audit according to 4.2.1.
5.4 The audit team to be audited shall meet the requirements of 4.2.2 and 4.3.1.
5.5 The supervisory audit shall be carried out at the site of the certified organization and shall meet the conditions specified in Article 4.2.3.3. Due to the seasonal reasons of product production, it is difficult to cover all the products in every supervision audit. All the products within the scope of certification should be covered by the supervision and auditing within the validity period of the certification certificate.
5.6 At least the following shall be audited by the Supervisory Authority:
(1) whether the resources covered by the quality management system and the operating system have changed since the last audit.
(2) Whether the critical key points identified in accordance with 4.3.3.2 are operating normally and efficiently according to the requirements of the quality management system.
(3) whether the corrective and corrective actions taken on the nonconformities identified in the previous audit are continuing.
(4) Quality management system covers activities related to laws and regulations, and whether consistent with the relevant provisions.
(5) whether the overall quality objectives and quality objectives at all levels are met. If the target has not been achieved, whether the certified organization has timely investigated and taken the improvement measures during the internal management review.
(6) the certification organization’s use of the certification mark or the eligibility of the certification is consistent with the relevant provisions.
(7) whether the internal audit and management review is normative and effective.
(8) whether timely acceptance and processing of complaints.
(9) The timely development and implementation of effective continuous improvement for problems identified by internal audit or complaints.
5.7 The auditing report of the supervisory audit shall describe the audit evidence, audit findings and audit conclusions one by one according to the audit requirements set out in 5.6. The audit team shall provide advice on whether or not to continue to maintain the certificate.
5.8 The certification body shall make a decision to continue or suspend or revoke the certificate according to the audit report and other relevant information.

6 Re-certification procedures
6.1 Before the expiration of the certification certificate, the certification body shall implement the re-certification audit to decide whether to renew the certificate if the organization applying for the certificate continues to hold the certificate.
6.2 The certification body shall constitute an audit team as required by 4.2.2. In accordance with the requirements of 4.2.3 and with the previous supervision and audit situation, re-certification plan developed and submitted to the audit team to implement. The audit team conducts re-certification audits as required.
In the absence of significant changes in the quality management system and the internal and external environment of the certified organization, the re-certification audit may omit the first stage audit, but the audit time shall not be less than 70% of the number of days counted in accordance with 4.2.1.
6.3 The non-conformities found in the re-certification audit shall be subject to the corrective and corrective actions described in 4.5 and verified and verified prior to the expiry of the original certificate.
6.4 The certification body shall make a re-certification decision with reference to Article 4.6. If the certification organization continues to meet the certification requirements and fulfill the obligations of the certification contract, the certification body shall be renewed.

7 Pause or revoke the certificate
7.1 The certification body shall formulate rules for suspending or revoking the certification or narrowing the scope of certification and formulate a documented management system.
7.2 Suspension of the certificate
7.2.1 The certification body shall suspend its certification within 5 working days after the investigation and verification after one of the following circumstances.
(1) The quality management system continues or seriously fails to meet the certification requirements, including the quality management system operational effectiveness requirements.
(2) does not assume, fulfill the contract and agreed responsibilities and obligations.
(3) by the relevant law enforcement supervision department ordered to suspend business for rectification.
(4) by the local regulatory authorities found that the system is running problems, the need to suspend the certificate.
(5) the holder of the administrative license, qualification certificates, mandatory certification certificate expired, re-submitted applications have been accepted but not yet replaced.
(6) the initiative to request the suspension.
(7) other should suspend the certificate.
7.2.2 The certificate shall not be suspended for more than 6 months. However, the suspension period under item (5) of 7.2.1 may be the date on which the licensing decision is made by the relevant entity.
7.2.3 The certification body shall suspend the information of the certificate. The certification body shall specify the starting date and the suspension period of the suspension and declare that the organization shall not use the certification certificate, certification mark or reference certification information in any way during the suspension period.
7.3 Revoke the certificate
7.3.1 In one of the following circumstances, the certification body shall revoke its certification certificate within 5 working days after obtaining relevant information and investigation and verification.
(1) written off or revoke the legal status of the document.
(2) refuses to cooperate with the supervision and inspection of the implementation of regulatory authorities, or inquiries and investigations related to the provision of false materials or information.
(3) the emergence of major products or services such as quality and safety incidents, the law enforcement regulatory authorities confirmed that the organization is caused by irregularities.
(4) there are other serious violations of laws and regulations.
(5) The period of suspension of the certificate has expired, but the problem that caused the suspension has not been solved or corrected (including the holder of the administrative license certificate, qualification certificate, compulsory certification certificate, etc.) which have expired but the application has not been approved.
(6) there is no operation of the quality management system or do not have the operating conditions.
(7) Failure to properly cite and publicize the information obtained from the certification in accordance with the relevant provisions has serious consequences or consequences, or the CB has requested corrections but has not been corrected for more than six months.
(8) other should revoke the certificate.
7.3.2 revocation of certification, the certification body shall revoke the revocation of the certificate. If it can not be recovered, the certification body shall promptly publish or declare the revocation decision in the relevant media and website.
7.4 Certification body suspend or revoke the certificate should be published on its Web site related information, at the same time in accordance with the prescribed procedures and requirements reported to the National Certification and Accreditation Administration.
7.5 The certification body has the obligation and responsibility to take effective measures to avoid the various types of invalid certification and certification mark is to continue to use.

8 certification certificate requirements
8.1 The certificate shall contain at least the following information:
(1) The name, address and organization code of the certified organization. This information should be consistent with the information in the legal status document.
(2) the quality management system covering the production and operation or service address and scope of business. If the certified quality management system covers multiple sites, the names and address information of the relevant sites covered by the statement shall be consistent with the corresponding legal status document information.
(3) quality management system in line with the GB / T 19001 / ISO 9001 standard expression.
(4) the certificate number.
(5) the name of the certification body.
(6) the date of issuance of the certificate and the date of expiry date.
For a re-certification that has not been interrupted since the initial certification, the date of the certification organization’s first certification date may be stated.
(7) the relevant recognition mark and recognized registration number (where applicable).
(8) certificate inquiry way. In addition to the issuance of the certificate on the website, the certification body should also indicate on the certificate: “This certificate information can be found on the website of the National Certification and Accreditation Administration (www.cnca.gov.cn) , In order to facilitate social supervision.
8.2 The certificate is valid for a maximum of three years.
8.3 The certification body shall establish a system for the disclosure of certificates. In addition to the application organization, regulatory authorities and other regulatory authorities to provide certification certificate information, should also be based on the request of the relevant parties to provide the certificate information to accept social supervision.

9 combined with other management systems audit
9.1 General and common requirements shall be met for the quality management system and other management systems to be audited. The requirements of 4.4 shall be clearly reflected in the audit report and shall be easily identifiable.
9.2 The number of audit days in combination with auditing shall not be less than 80% of the sum of the audit times required for multiple individual systems.

10 Accept the conversion certificate
10.1 The certification body shall fulfill its social responsibility. It is forbidden to apply for the conversion of the certificate of the organization that does not conform to the GB / T 19001 / ISO 9001 standard and can not effectively carry out the quality management system.
10.2 Acceptance of Certification Body The organization applying for conversion of the certificate of this organization shall know in detail the reasons for the application and make the necessary on-site audit.
10.3 Conversion is limited to valid certificates currently in force. Suspension or suspension of certification, revocation of the certificate and the invalidation of the certificate, may not accept the conversion request.
10.4 If the certification authority revokes the certificate (eg Article 7.3) by the enforcement authorities, it shall be ordered to suspend business for rectification or to be included in the “blacklist” (eg Article 7.2 [3]), unless the organization conducts thorough rectification, resulting in Suspend or revoke the certification certificate has been eliminated, or should not accept its certification application.

11 Appeal from the receiving organization
If the certification organization disagrees with the certification decision, the certification body shall accept the complaint from the certified organization and handle it in a timely manner. The certification organization shall send the written result to the certified organization within 60 days.
The written notice shall inform the certification organization, if that certification body does not comply with the relevant laws and regulations or certification rules and lead to their legitimate rights and interests of serious violations, Institutional Complaints.

12 Management of certification records
12.1 The certification body shall establish a certification record keeping system to record the whole process of certification activities and keep them properly.
12.2 Records should be true and accurate to demonstrate that certification activities are being effectively implemented. The records shall be in Chinese and shall be kept at least as long as the validity period of the certificate.
12.3 When electronic records are used to record records, they shall be in a non-editable electronic document format.

13 Others
13.1 The reference to GB / T 19001 / ISO 9001 in this Code refers to a valid version of the standard at the time the certification activity takes place. Certification activities and the certificate described in the standard number, the effective version should be used at the time of the complete standard number.
13.2 Copies of the types of supporting documents referred to in these Rules shall be photocopied on the original and shall be endorsed and signed by the supplier of the photocopies in accordance with the original.
13.3 The certification body may take the necessary measures to help the organization to carry out quality management system and relevant technical standards of publicizing training, to promote the understanding of all employees of the organization and the implementation of quality management system standards.