CNAS-RC01. Rules for Accreditation of Certification Bodies

Transcription

1 CNAS-RC01 Rules for Accreditation of Certification Bodies CNAS

2 CNAS-RC01:2014 Page 1 of 25 Foreword Scope Reference Documents Terms and Definitions General Accreditation Procedures Initial Accreditation Application Preparation for Assessment Assessment Verification of Nonconformity Assessment Report Accreditation Decision and Accreditation Certificate Periodic Surveillance Assessments Interval of Surveillance Assessment Procedures for Surveillance Assessment Specific Surveillance Assessment and Audit Determination Principle of Sampling in Specific Surveillance Assessment Specific Surveillance Assessment Audit Determination Re-assessment Accreditation of Certification Scope Post-accreditation Information Notification Annex A (Normative Annex Classification of Certification Scope... 24

3 CNAS-RC01:2014 Page 2 of 25 Foreword This document is developed by CNAS. This document specifies the CNAS accreditation rules of certification body and the requirements formed the CNAS accreditation requirements of certification bodies in combination with other needed accreditation rules and criteria. This document is substitution of CNAS-RC01:2013.

4 CNAS-RC01:2014 Page 3 of 25 1 Scope Rules for Accreditation of Certification Bodies 1.1 This document is prepared to ensure that impartiality and effectiveness of the accreditation of certification bodies and to meet the requirements of relevant national laws and regulations associated International Standards and Guidance. 1.2 This document specifies the policy and procedures for the accreditation of certification bodies. It applies to the accreditation of certification bodies by CNAS. 1.3 CNAS may specify supplementary requirements for special fields and industries as necessary. 2 Normative Documents The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. CNAS-R01 Rules for Accreditation Symbols and References to Accreditation CNAS-R03 Rules for Dealing with Appeals, Complaints and Disputes CNAS-RC02 Rules for Sanctions against the Accreditation of Certification Bodies CNAS-RC03 Rules for Certification Bodies to Report Information CNAS-RC04 Rules for Fees on the Accreditation of Certification Bodies CNAS-RC05 Rules for the Accreditation of Certification Bodies with Multi-premises CNAS-RC07 Rules for the Accreditation of Certification Bodies with Foreign Locations 3 Terms and Definitions 3.1 Accreditation Specifications Policies, procedures, criteria, their explanatory and application guidance with regard to the implementation of accreditation activities by CNAS, including accreditation rules, accreditation criteria, accreditation guidance and accreditation schemes, etc. 1) Accreditation rules (R and RC series) are policy and procedures for the implementation of accreditation activities by CNAS, including generic rules and specific rules,etc. 2) Accreditation criteria (CC series) are basic requirements that certification bodies accredited by CNAS shall meet, including documents identical to relevant ISO/IEC standards, guides and IAF guidance on the application of relevant ISO/IEC standards and guides, as well as specific requirements for special industries.

5 CNAS-RC01:2014 Page 4 of 25 3) Accreditation guidance (GC series) is explanatory or application guidance of accreditation criteria of CNAS, including generic and special explanatory or application guidance. 4) Accreditation schemes (SC series) are complementary with regard to special fields or industries, to accreditation rules, criteria and guidance. 3.2 Certification Fields Specific types of certification activities, for example, quality management system certification, environmental management system certification, occupational health & safety management system certification, food safety management system and product certification, etc. 3.3 Certification Scope Specific technical fields in a certification field, which certification activities are involved in. Note: Categories of certification scope are classified in accordance with different characteristics of industries or activities (such as primary production, manufacture and service industries.), various processes of product or service realization (such as machinery, electronics, food, finance and medical industries), different natures of activities(e.g. quality, safety and environment) and product standards. Certification scope may be divided by a variety of methods on the basis of certification purposes. 3.4 Accreditation Scope Specific certification services for which accreditation is applied or has been granted, such as premises, certification fields and specific certification scope in a certification field which are covered by accreditation. 3.5 Major Nonconformity The absence of,or failure to implement and maintain one or more requirements of applicable accreditation rules, accreditation criteria and quality management system documentation of certification bodies; or the assessment findings that are enough to raise any doubts of the credibility of the certificate issued by certification bodies on the basis of available objective evidence. Note: Certification bodies establish management system for management and control certification processes based on accreditation criteria of CNAS-CC01 (ISO/IEC17021), CNAS-CC02 (ISO/IEC17065) and CNAS-CC03 (ISO/IEC17024), which is called quality management system of certification bodies. 3.6 Minor Nonconformity Assessment findings which may lead to major nonconformity, such as: 1) The absence of, or failure to implement and maintain one or more requirements of accreditation rules and accreditation criteria in a single or isolated way, its consequences do not lead to significant influences on quality management system of certification bodies, or 2) Failure to implement or deviation from the requirements of accreditation rules and accreditation criteria, which does not lead to serious consequences or serious

6 CNAS-RC01:2014 Page 5 of 25 influences on the credibility of the certification results, or 3) Breach of relevant document requirements of certification bodies and failure to meet requirements of any clause of accreditation specifications. 3.7 Observation Assessment findings do not lead to nonconformity, but should be paid attention to or improved by certification bodies. 3.8 Document Review Reviews for documentation or materials of quality management system submitted by certification bodies. 3.9 Office Assessment Assessment performed in the certification bodies office Witness Assessment Assessment of audit/inspection activities of the certification bodies performed at the auditee s premises Initial Assessment Assessment performed to certification bodies for initial application for accreditation or extending accreditation fields Surveillance Assessment Assessment performed to determine whether the certification bodies continually meet the requirements of accreditation specifications during the period of validity of the accreditation certificate, including periodic and notification surveillance assessment prior to short time, such as specific surveillance assessment and audit determination Specific Surveillance Assessment Surveillance assessment performed to certification bodies for some aspects of relevant certification activities Audit Determination Evaluation performed for conformity and effectiveness of certification activities of certification bodies by on-site verification of multiple system operations and auditee s processes of certified organizations. Note: On-site verification of certified organizations is verification of key points of conformity and effectiveness of management system of certified organizations instead of repeated certification audit of certification bodies Re-assessment Assessment performed to certification bodies who apply for renew accreditation prior to the expiry date of the accreditation certificate. 4 General

7 CNAS-RC01:2014 Page 6 of In according to the requirements of applicable laws and regulations, and the requirements of relevant ISO/IEC standards and IAF guidance, CNAS develops and implements relevant documents for the accreditation of certification bodies, and performs accreditation of certification bodies. 4.2 Accreditation activities of certification bodies by CNAS comply with the principles of non-discrimination and impartiality. 4.3 CNAS shall not provide any consultation or other services that may compromise the impartiality to certification bodies who apply for accreditation. 4.4 CNAS implements the accreditation of certification bodies which promise to meet the requirements of law and regulations. 4.5 CNAS shall safeguard the confidentiality of application documents, accreditation assessment information and other confidential information with regard to the certification bodies who apply for accreditation. CNAS has a responsibility to report relevant information of certification bodies to relevant authorities if so required by laws and regulations. 4.6 Accreditation of certification bodies by CNAS only means that the accredited certification bodies are competent to perform certification services of in the accredited certification scopes, does not indicate the certificates issued by the certification bodies are approved by CNAS. 4.7 CNAS charges certification bodies for accreditation services according to CNAS-RC04: Rules for Fees on the Accreditation of Certification Bodies and CNAS does not obtain the financial support from any certification bodies or any other interested parties of accreditation activities. 4.8 CNAS accepts and handles appeals, complaints and disputes of CNAS according to CNAS-R03: Rules for Dealing with Appeals, Complaints and Disputes. 4.9 For the accreditation of certification bodies with multi-premises, besides this document, complementary accreditation rules are provided by CNAS-RC05: Rules for the Accreditation of Certification Bodies with Multi-premises and CNAS-RC07 Rules for the Accreditation of Certification Bodies with Foreign Locations For certification bodies accredited by the accreditation bodies who are the signatories to IAF or PAC multilateral recognition arrangements (MLA), in accordance with relevant MLA and associated arrangements, CNAS evaluates the suitability of assessment results of such accreditation bodies and may take account of relevant assessment results. 5 Accreditation Procedures 5.1 Initial Accreditation Application The certification bodies who apply for accreditation (hereinafter cited as the applicant) shall meet the following basic requirements: 1) The applicant who performs certification activities in People s Republic of China shall be approved by Certification and Accreditation Administration of People s

8 CNAS-RC01:2014 Page 7 of 25 Republic of China. NOTE: CNAS will not accept the application of the certification body if one of situations exits: a) The applicant failed to submit approved documentation issued by Accreditation Administration of People s Republic of China, excluding foreign institutions. b) The applicant failed to meet establishment requirements specified in relevant certification accreditation rules and the application has been suspended by Accreditation Administration of People s Republic of China. c) The period of having withdrawn the applicant accreditation qualification is less than two years in accreditation scope. 2) The applicant is a legal entity. If the applicant is a part of a larger legal entity, then the accreditation application shall be submitted to CNAS by such larger legal entity. NOTE: CNAS will not accept the application of the certification body if one of situations exits: a) The applicant does not submit proven documents that demonstrate the status of applicant s legal entity, e.g. business license. b) The actual business address and address registered on the business license or registered address are not consistent with the address in the documents approved by Accreditation Administration of People s Republic of China. 3) The applicant has established and operated quality management system in accordance with accreditation specifications for relevant accreditation fields, and has implemented internal audit and management review covering all procedures. In general, the applicant shall have already conducted complete certification of at least three organizations in the requested accreditation fields, and the applicant has operated quality management system effectively in relevant fields for six months. Bodies operating certification of persons shall develop the certification scheme of certification scope applying for accreditation and implement certain number of certification activities in accordance with certification scheme. NOTE: CNAS will not accept the application of the certification body if one of situations exits: a) The applicant has not implemented internal audit (including internal audit of branches by its headquarters) and management review. b) The applicant has not submitted the proven documents that demonstrate three organizations have been conducted certification in the requested accreditation fields. c) The applicant s quality management system has not been operated effectively in relevant fields for six months. 4) The applicant has made arrangements for the legal obligations arise from the certification activities that the applicant shall undertake.

9 CNAS-RC01:2014 Page 8 of 25 NOTE: CNAS will not accept the application if the applicant has not made arrangements for the legal obligations arise from the certification activities. 5) The applicant has not used accreditation symbols in a misleading way before its application. NOTE: CNAS will not accept the application of the certification body if the applicant has used accreditation symbols in a misleading way before its application and has not taken any corrective actions Documents to be submitted by the applicant: 1) Accreditation application form. 2) The applicant who performs certification activities in People s Republic of China shall submit the approval documents issued by CNCA, which approves the establishment of the applicant and its scopes of certification services. 3) Registration documents that demonstrate the status of applicant s legal entity, e.g. business license. 4) Quality management system documentation of the applicant. 5) Analysis of interest conflicts (the applicant s various relationships that compromise the certification impartiality) between applicant s related bodies business activities and certification activities of the applicant and related control explanation. NOTE: CNAS will not accept the application of the certification body if the applicant cannot submit the analysis of interest conflicts between applicant s related bodies business activities and certification activities of the applicant and related control explanation or the analysis of the applicant s various relationships that compromise the certification impartiality and related control explanation. 6) Evidence of arrangements for the legal obligations arising from the certification activities that the applicant shall undertake. If necessary, the applicant shall submit further documents to enable CNAS to acquire sufficient information of certification bodies. See Accreditation Application From in detail. Note: The applicant may have access to accreditation specifications, Accreditation Application Form and other relevant documents either by log on CNAS website ( from CNAS secretariat The applicants shall pay for the application fees according to CNAS-RC04: Rules for Fees on the Accreditation of Certification Bodies when submitting Accreditation Application Form Generally, CNAS will review the application material in 30 working days after receiving Accreditation Application Form is received and resolve any differences of understanding between both sides. If necessary, a pre-visit to the applicant can be arranged. 1) If application review passed, CNAS will send notification of acceptance to the applicant, and sign an Accreditation Contract with the applicant.

10 CNAS-RC01:2014 Page 9 of 25 2) If the applicant cannot meet the application requirements, CNAS will send notification of rejection to the applicant and explain the reasons for rejection. 3) If the applicant does not agree with rejection, the applicant can submit an appeal according to rules specified in CNAS-R03: Rules for Dealing with Appeals, Complaints and Disputes When the applicant who has been accredited in one or more certification fields by CNAS applies for accreditation of new certification fields, it shall still submit accreditation application to CNAS for extending certification fields together with relevant application documents and material in accordance with the requirements of clause to clause in this document. CNAS accepts the application of extending certification fields according to the procedures referred to above If the accredited certification body applies for extending its accreditation to include specific sector certification schemes (e.g. TL9000 for telecommunication sector in the field of QMS), the applicant shall still submit accreditation application to CNAS for extending accreditation to specific sector certification scheme together with relevant application documents and material in accordance with the requirements of clause to clause in this document. CNAS accepts such application for extending accreditation according to the procedures referred to above. 5.2 Preparation for Assessment CNAS reviews the applicant s accreditation application, determines the scope of accreditation assessment and plans accreditation assessment program based on the applicant s condition. 5.3 Assessment CNAS conducts assessment to the applicant in accordance with accreditation specifications, and evaluates certification competence and conformity and effectiveness of its operation. The assessment includes document review, office assessment and witness assessment if necessary Document Review CNAS appoints accreditation assessment team leader or the assessor to take the responsibility of reviewing quality management system document and other documents related to certification activities in accordance with accreditation assessment plan for the assessment program. CNAS determines whether to conduct subsequent office assessment according to the results of the document review. In the cases of the corrective actions to nonconformity confirmed by CNAS document review are considered as failed to meet requirements for twice or the corrective actions exceed 3 months, CNAS will draw the conclusion of not completing the document review. The applicants need to submit the accreditation application again Office Assessment CNAS proposes man-day of office assessment and the name list of the assessment team according to accreditation assessment program and determine the exact assessment date and team members with the applicants. If the applicants have

11 CNAS-RC01:2014 Page 10 of 25 any objections, they may forward the objections to CNAS Office Assessment Plan The assessment team leader is responsible for establishing office assessment plan and informing the applicant in advance According to office assessment plan, the assessment team carries out assessment of the applicant based on the applicable accreditation specifications and within the specified assessment scopes. The assessment team shall hold the opening meeting on-site with the presence of representatives of the applicant in order to confirm the requirements and arrangements of office assessment. The assessment team conducts comprehensive evaluation of certification competence and the conformity and effectiveness of operation of the applicant. Any nonconformity shall be confirmed by the applicant and the report of nonconformity shall be submitted to the applicant. The assessment team holds the closing meeting on-site with the presence of the applicant representatives, reports the situations of assessment, assessment findings, assessment conclusions, and state the requirements and methods for verifying the corrective actions on nonconformity to the applicant and confirms the arrangements for witness assessment with the applicant Witness Assessment CNAS appoints assessment team to implement witness assessment of certification audit/inspection of the certification bodies in order to determine the certification bodies competence to perform audit/inspection (including the audit/inspection skills, technical competence, management and coordination abilities of audit/inspection team) and the effectiveness of audit/inspection management The Number of Witness Assessment 1) Initial application of accreditation in a single field a) Management system certification: the number of witness assessment projects shall normally not be less than 2. For the witness assessment projects which involved two stages audits, at least one of the witness assessment projects shall be witness a full two stages audit. b) Product certification: by considering the characteristics of product certification, witness assessment projects and the number of them shall be determined by such factors as product characteristics (e.g. safety, quality, etc.), product categories and the standards that product certification shall comply with. 2) Initial application of accreditation in more than one field a) Management system certification: the number of witness assessment for each field shall normally not be less than 1. For the witness assessment projects which involved two stages audits, at least one of the witness assessment projects shall be witness a full two stages audit. b) Product certification: witness assessment for product certification field may be

12 CNAS-RC01:2014 Page 11 of 25 increased appropriately by considering the characteristics of product certification. For combined audit involving more than one certification field, the number of witness assessment shall be increased accordingly. 3) Application of accreditation of extending certification fields a) Management system certification: the number of witness assessment for each field or specific sector shall normally not be less than 1. For the witness assessment projects which involved two stages audits, at least one of the witness assessment projects shall be witness a full two stages audit. b) Product certification: witness assessment for product certification field may be increased appropriately by considering the characteristics of product certification. For combined audit involving more than one certification field, the number of witness assessment shall be increased accordingly. 4) Application of accreditation of bodies operating certification of persons CNAS shall implement witness assessment for each certification scheme Selection of Certification audit/inspection/evaluation of Witness Assessment 1) In accordance with the requirements of accreditation specification, if the witness assessment projects involved two stages audits, then at least one of the witness assessment projects shall be witness a full two stages audit. For other two stages audits, the second stage audit must be witnessed if the first stage has not been arranged to witness. The implementation of the first stage audit is verified during the second stage audit is witnessed. Whether the first stage audit needs to be witnessed is depending on such factors as the complexity of audit, risk level and the operation maturity of certification bodies. 2) The certification audits to be witnessed are mainly selected from certification audits/inspections involving high risk, high level of technical difficulty, complexity in the process of product realization, complicated environment and safety aspects or large-scaled organization needed to be certified (e.g. the number of personnel, sites, products or service categories). 3) Different auditors/inspectors of the applicant shall be witnessed as many as possible. 4) The initial audits/inspections/evaluation and re-audit projects are priority options of as witness assessment projects. 5) The sampling of witness assessment of bodies operating certification of persons will be considered according to the content of and evaluation method in certification scheme by CNAS. 6) In general, witness assessment is arranged after completion of office assessment. At the stage of planning of accreditation assessment program, CNAS shall communicate with the applicant regarding selection of certification scope to be witnessed. The applicant shall submit the plans of audits/inspections in a time range

13 CNAS-RC01:2014 Page 12 of 25 to CNAS on the basis of CNAS specific requirements, in order to preliminarily select witness projects. During the period of office assessment, the team leader may propose to adjust witness assessment projects in accordance with the situations of assessment and report to CNAS. 7) The applicant shall submit certification audit/inspection plan to CNAS 15 days prior to implementation of audit/inspection item The applicant has the responsibility for requesting the organization pursuing the certification to accept CNAS witness assessment and provide necessary support. For those organizations that refuse CNAS to implement witness assessment activities without proper reasons, the applicant shall not issue the certificates with CNAS accreditation symbols. The applicant shall notify the name list of the witness assessment team to the organization pursuing the certification in advance Witness assessment team will witness the on-site audit/inspection activities of the audit/inspection team assigned by the applicant. After witness assessment, the witness assessment team shall inform the audit/inspection team of the applicant on the status of witness assessment, assessment findings and assessment conclusions. If any nonconformity is found, it must be confirmed by the applicant s representative and reported Accreditation assessment for the applicant who undertakes product certification includes the assessment of their own laboratories according to relevant requirements of ISO/IEC For those applicants whose laboratories have been accredited, CNAS shall consider their accreditation results in accordance with their specific situations. Accreditation assessment for the applicant s own inspection competence includes the assessment according the relevant requirements of ISO/IEC For those applicants who have been accredited by inspection bodies, CNAS shall consider their accreditation results according to their specific situations In general, CNAS shall assess certification bodies management of subcontracted body. When necessary, CNAS shall assess the subcontracted body in order to check whether the certification bodies management of their subcontract body meets the requirements of relevant accreditation specifications. 5.4 Verification of Nonconformity Time Limit of Verification 1) For initial assessment, the applicant shall take effective corrective actions on the nonconformities and submit necessary demonstrative documents to the assessment team for verification within three months after the nonconformities identified. 2) For surveillance assessment and re-assessment, the applicant shall correct nonconformities in time according to the grading of the nonconformities. In general, the correction of major nonconformities shall not exceed 15 days. For minor nonconformity, the applicant shall take necessary corrective actions and submit necessary demonstrative documents to the assessment team and get accepted within one month after the nonconformities identified,. 3) In other types assessment or assessment for other purposes, the applicant shall

14 CNAS-RC01:2014 Page 13 of 25 take or plan to take necessary corrective actions against the nonconformities within one month time after the assessment, and submit necessary demonstrative documents to the assessment team for acceptance verification For the applicant of initial assessment, if corrective actions or the plan of which against the nonconformities are not taken on schedule or the further corrective action proposed by the applicant could not meet the requirements of accreditation specifications CNAS ceases the accreditation activities of the applicant. For the applicant accepts surveillance, re-assessment and other assessment, if it cannot take corrective actions against the nonconformities on schedule, or as verified by the assessment team, the corrective actions it provided within specified time limit still cannot meet the requirements of accreditation specifications, CNAS shall take relevant actions according to the rules of CNAS-RC02: Rules for Sanctions against the Accreditation of Certification Bodies Method of Verification The assessment team determines the methods and scopes of verification according to the natures of the nonconformities and corrective actions taken or planned to be taken by the applicant. The forms of verification of corrective actions taken against the nonconformities include verification of document, verification at the applicant s office and/or verification by witness assessment. 5.5 Assessment Report At the closing meeting of office assessment, the team leader makes a summary reports to the applicant on the overall situation of the assessment, assessment findings and assessment conclusions and listen to the feedback of the applicant.. Based on the assessment results, the team leader composes the accreditation assessment report and submits it to CNAS. CNAS submits formal assessment report to the applicant after making accreditation decision. If there is any difference between the assessment report and the conclusions proposed by the assessment team at the closing meeting of the office assessment, CNAS will communicates with the applicant beforehand. 6 Accreditation Decision and Accreditation Certificate 6.1 CNAS reviews the assessment report, assessment record, the documents submitted by the applicant and related information acquired and makes accreditation decisions. If necessary, CNAS may request further supplementary information from the applicant. 6.2 CNAS issues the accreditation certificate with the signature of CNAS authorized person to the applicant. The annex of the certificate indicates the accreditation criteria, the accredited fields and certification scope (including specific product categories subject to certification) and the applicable certification criteria (including the certification scheme, standard and other normative documents). The validity period of the accreditation certificate is four years. For accreditation certificate of certification bodies with multi-premises, please refer to the rules of CNAS-RC05: Rules for the Accreditation of Certification Bodies with Multi-premises.

15 CNAS-RC01:2014 Page 14 of CNAS publishes an accreditation announcement to the public and list the accredited certification bodies in the accreditation directory of CNAS. NOTE: Relevant accreditation information is available on the website of CNAS. 6.4 The accredited certification bodies shall announce accredited certification scope by CNAS in open documents or other suitable way, and issue the certificates with CNAS accreditation symbols within its accredited certification scope according to CNAS-R01: Rules for Accreditation Symbols and References to Accreditation, including international multilateral recognition logo if applicable. 7 Periodic Surveillance Assessments During the validity of the certificate, CNAS carries out periodic surveillance assessment of accredited certification bodies in order to determine whether the certification bodies continuously conform with the accreditation specifications of CNAS. 7.1 Interval of Surveillance Assessment In general, CNAS conducts the first on-site surveillance assessment of accredited certification bodies within 12 months after initial accreditation date. The interval of the subsequent surveillance assessment should not exceed 12 months. For the certification body who is able to maintains a good management system, implement active self-discipline and achieve distinct results in continuous improvement, and receives a low accreditation risk grading, CNAS may prolong the interval of on-site surveillance assessment, to a period not exceeding two years.. CNAS can increase surveillance assessment on certification bodies in necessity. 7.2 Procedures for Surveillance Assessment In general, CNAS should confirm the exact assessment date with the accredited certification bodies in advance. For those organizations that refuse CNAS to implement on-site surveillance assessment without proper reasons, CNAS will take necessary actions according to the rules of CNAS-RC02: Rules for Sanctions against the Accreditation of Certification Bodies Surveillance assessment is conducted by means of office assessment plus necessary witness assessment. When major changes in quality management system document of accredited certification bodies occurred, document review of these changes shall be included. Other means of surveillance assessment may be adopted as necessary, such as conducting specific evaluation of relevant personnel of the accredited certification bodies, checking the documents related to certification activities, requesting advice of other interested parties of certification activities or verifying relevant situations The procedures for the office assessment for surveillance assessment are the same as the procedures for the office assessment for initial accreditation as specified in this document In surveillance assessment, the necessity, number and audit projects of witness assessment are determined based on accredited certification fields, the number of

16 CNAS-RC01:2014 Page 15 of 25 certification scopes, complexity in the process of product realization, complicated environment and safety aspects, the number of certificates issued and risk grade of certification body, etc(when applicable). At the surveillance assessment of bodies operating certification of personnel, at least one witness assessment will be implemented for each certification scheme, considering the content of certification system, the certification category of personnel and/or the grade of personnel who work in the certification body, the number of issued certificates, the number of evaluation personnel, the kinds of evaluation method and effectiveness of the internal audit of the certification body, etc. The initial assessment audits/inspections/evaluation and re-audit projects are priority options of witness assessment projects. If there are no projects described as above, CNAS may choose surveillance audit as witness assessment projects. The certification body shall submit monthly audit plan (including name of audit item, the type of audit, time, EA code and the name list of audit team) to CNAS in advance before on-site assessment of CNAS. CNAS chooses witness assessment projects and/or auditors in accordance with this plan. When witness assessment items have been chosen, the certification body has the responsibility for requesting the auditing organization to accept CNAS witness assessment and provide necessary support. For those organizations refuse CNAS to implement witness assessment activities without proper reasons, the certification body shall not issue the certificates with CNAS accreditation symbols. Otherwise, CNAS will take necessary measures according to the rules of CNAS-RC02: Rules for Sanctions against the Accreditation of Certification Bodies. Once auditors have been chosen for witness, the certification body cannot change auditors without proper reasons. Otherwise, CNAS will increase the amount of sampling. In cases of certification bodies cannot provide witness assessment project (no project could be witnessed by CNAS in 3 months after on-site assessment), generally the certification bodies shall submit the subsequently first audit project to CNAS for witness assessment. CNAS will take necessary measures on the certification body who conceal or purposely understate the actual amount of audit projects according to the rules of CNAS-RC02: Rules for Sanctions against the Accreditation of Certification Bodies when such violation has been proved t Decision on Surveillance Assessment After completion of each surveillance assessment, CNAS makes a decision on maintaining, suspending or withdrawing the accreditation of accredited certification bodies on the basis of assessment results, and submits formal surveillance assessment report to certification bodies. 8 Specific Surveillance Assessment and Audit Determination 8.1 Principle of Sampling in Specific Surveillance Assessment and Audit Determination CNAS considers (but not limited to) following factors while taking sample from the accredited certification bodies:

17 CNAS-RC01:2014 Page 16 of 25 1) Major problems or multiple violations found in national or industry sampling inspection. 2) Certification bodies with management classification of accreditation risk at C level ranking. 3) Multiple problems discovered in previous accreditation reviews. 4) Major changes in the operation of the certification bodies or other changes that may influence accreditation qualification. 5) Major complaints or multiple complaints against certification bodies reported. 6) Multiple accidents in quality, safety and environmental pollution occurred to the organizations certified by the body. 7) The number of certification increased abruptly. 8) With a substantial number of certified organizations operating in high risk level industry. 9) Taking in many certification transferred clients. 10) Clear mismatch between CB s certification resource and client base / workload. 11) Grant certification to multiple organizations which failed to obtain, or being suspended or withdrawn the certification by other certification bodies. 12) High risk in certification and management reflected by other source 13) Random sampling. 8.2 Specific Surveillance Assessment Preparation of Specific Surveillance Assessment CNAS identifies certification bodies to implement the specific surveillance assessment by analyzing relevant information. CNAS notifies certification bodies in short time prior to on-site specific surveillance assessment. Assessment time is determined by scale and risk level of certification bodies and scope of specific surveillance assessment. Assessment time can be adjusted by situation of on-site audit Procedure of Specific Surveillance Assessment Office assessment is adopted in specific surveillance assessment and other assessment methods can be adopted if necessary, such as an interview with relevant personnel of certification bodies, check on the files of certification activities, and take advice from interested parties or reference checking for verification Procedure of office assessment of initial accreditation in this document applies to that of specific surveillance assessment, except for the process in determination of the nature of nonconformity and the conclusion recommended by the audit team After conclusion of the on-site specific surveillance assessment, CNAS shall

18 CNAS-RC01:2014 Page 17 of 25 assign a panel to review the report submitted by the audit team and listen to the debriefs of the auditors involved to determine the nature of nonconformity and make recommendation on final conclusion Decision on Specific Surveillance Assessment CNAS makes Specific Surveillance Assessment decision for accredited certification bodies in accordance with the final assessment conclusion of the specific surveillance assessment. 8.3 Audit Determination Selection of Certified Organizations CNAS identifies certification bodies to implement the audit determination by analyzing relevant information. CNAS considers (but not limited to) the following factors while selecting certified organizations among those with valid certification certificate marked with CNAS accreditation symbol: 1) Problems found in national and administrative sampling inspection. 2) Accidents occurred in relation to quality, safety and environmental pollution. 3) Complaints or media exposure concerning certification. 4) Organizations which failed to obtain, being suspended of or withdrawn of certification previously from certain certification body and later on being granted certification by other certification body; 5) Certified organizations in the type of business, industry or regions which are highly risky or problematic in consideration of history data or reports. 6) Existence of possible risk as reflected by other source 7) Random sampling Preparation of Audit Determination Audit Determination of a certification body will be conducted by implementing on-site verification to at least two certified organizations per certification body base on sampling. CNAS notifies certified organizations to be verified and the certification bodies in short time prior to on-site verification. In general, on-site verification of certified organizations is conducted by a team of two or more auditors and the time of on-site verification is 1-2 man-days Procedure for Audit Determination Audit determination team implements on-site verification by checking on documents, communicating with relevant personnel and on-site observation, etc For problems found in on-site verification, audit determination team should communicate with the certified organizations and get confirmation Problems are confirmed by audit determination team with certified organizations and follow-up review be implemented if necessary. The nonconformity

19 CNAS-RC01:2014 Page 18 of 25 report is issued against certification bodies if any nonconformity has been concluded after completion of on-site verification After the completion of the on-site verification of audit determination CNAS shall assign a panel to review the report submitted by the audit team and listen to the debrief of the auditors involved to determine the nature of nonconformity and make recommendation on final conclusion Conclusion of Audit Determination CNAS makes Audit Determination decision for accredited certification bodies in accordance with the final assessment conclusion of the audit determination Suspension of On-site Verification of Audit Determination 1) Audit determination team can suspend on-site verification activity if any force majeure occurred to the certified organizations. 2) On-site verification can be suspended by audit determination team due to reasons other than force majeure on the side of the certified organization that prevent the on-site verification from effective implementation.. CNAS shall take relevant measures according to CNAS-RC02: Rules for Sanctions against the Accreditation of Certification Bodies 3) CNAS will conduct complementary sampling in case that previously arranged on-site verification of audit determination being suspended. 9 Re-assessment 9.1 Before the expiry of the accreditation certificate, for those certification bodies who apply to maintain the accreditation, CNAS conducts re-assessments within the validity of the certificate. 9.2 If the validity of the accreditation certificate needs to be extended for some special reasons, CNAS shall arrange to add one surveillance assessment or uses other methods to conduct assessment before the expiry of the certificate. The extension period shall not exceed one year at maximum. 9.3 Procedure for Re-assessment Application for Re-assessment The certification bodies shall submit the application to CNAS 4 months before the expiry of the accreditation certificate. When the applicant applies for the re-assessment, it shall submit necessary application documents in accordance with application procedures for initial accreditation. If the applicant could not submit all necessary application documents for re-assessment on time and caused assessment overdue or lead to the accreditation decision overdue, the accreditation certificate will expire Assessment The assessment procedures are the same as the procedures for initial accreditation assessment specified in this document Witness Assessment At least one certification audit/inspection/evaluation project shall be witnessed in each

20 CNAS-RC01:2014 Page 19 of 25 field, and the witness projects in product certification field may increase considering the characteristics of product certification. For combined certification audit involving multi-fields, the number of witness assessment may increase accordingly. At the re-assessment of bodies operating certification of personnel, at least one witness will be implemented for each of certification schemes considering the content of certification scheme, the certification category of personnel and/or the grade of personnel who work in the certification body, the number of certificates issued, the number of evaluation personnel, the type of evaluation method, the effectiveness of the internal audit of the certification body and the results of surveillance assessment during accreditation period, etc. The initial assessment audits/inspections/evaluation and re-audit projects are priority options of witness assessment items. If there are no items described as above, CNAS may choose surveillance audits as witness assessment projects. The certification body shall submit monthly audit plan (including name of audit item, the type of audit, time, EA code and the name list of audit team) to CNAS in advance before on-site assessment of CNAS. CNAS chooses witness assessment projects and/or auditors in accordance with this plan. When witness assessment items have been chosen, the certification body has the responsibility for requesting the auditing organization to accept CNAS witness assessment and provide necessary support. For those organizations that refuse CNAS to implement witness assessment activities without proper reasons, the certification body shall not issue the certificates with CNAS accreditation symbols. Otherwise, CNAS will take necessary measures according to the rules of CNAS-RC02: Rules for Sanctions against the Accreditation of Certification Bodies. Once auditors have been chosen for witness, the certification body cannot change auditors without proper reasons. Otherwise, CNAS will increase the amount of sampling. If the certification body cannot provide new project for witnessed audit, CNAS may accept the witness audit to be conducted to previously witnessed audit project CNAS will take necessary measures on the certification body who conceal or purposely understate the actual amount of audit projects according to the rules of CNAS-RC02: Rules for Sanctions against the Accreditation of Certification Bodies when such violation has been proved Decision on Re-assessment After completion of each re-assessment, CNAS makes a decision on renewal of the accreditation of accredited certification bodies on the basis of assessment results, issues renewed certificate and submits formal assessment report to certification bodies. 10 Accreditation of Certification Scope 10.1 Accreditation of Certification Scope The classification (39 scopes) in Annex 1 of this document or specific

21 CNAS-RC01:2014 Page 20 of 25 accreditation normative specification can be applied to CNAS accreditation of certification scope of certification bodies. When necessary, special classification or additional instruction may be adopted for special fields or industries. CNAS provide further division of the 39 scopes of Annex 1 into sub scopes and sub-sub scopes in CNAS implementation guidance for the management of certification scopes CNAS accreditation of product certification body s certification scope will adopt classification based on the product name, product standard and certification type The certification scope of bodies operating personnel certification is classified according to the type of personnel involved, such as auditors for management system audit, inspectors for product certification, specific professionals and other types of personnel in accordance with the natures and types of business. When necessary, the certification body may further classify the certification scope for certain type of personnel or may classify different grades of personnel in a certification scheme. For instance, in the certification of management system auditors, the sub scope includes QMS auditor, EMS auditor, OHSMS auditor and corresponding grades. For the accreditation of bodies operating certification of personnel, CNAS specifies the scope to the detail level of specific certification system and the exact field concerned Procedures for Certification Scope Accreditation Certification bodies applying for accreditation of certification scope shall meet the requirements of CNAS accreditation specifications. In general, the certification bodies shall have competent auditors/inspectors for the certification scope applying for accreditation, and have developed relevant instruction documents for auditing in the certification scope with high risk. NOTE: the auditors shall meet the relevant requirements of accreditation specifications and /or the requirements of auditors specified in GB/T Application The applicant shall fill in application form for accreditation of certification scope according to the instruction of Accreditation Application Form with relevant materials attached Assessment Based on the characteristics of accreditation fields and industries, CNAS may implement accreditation assessment of certification scope by means of classification. The assessment may involve (alone or in combination) document review, office assessment (applicable for initial assessment, surveillance assessment and re-assessment.), review of certification audit records, witness assessment and specific assessment of relevant personnel of certification bodies. NOTE: The certification body applying for extending certification scope (including mandatory or first/high risk certification scope) shall submit the application to CNAS for conducting witness assessment one month in advance after the document review