CNAS-RC07 Rules for the Accreditation of Certification Bodies with Foreign Locations CNAS
CNAS-RC07:2014 Page 1 of 7 Foreword This document is developed by CNAS. This document specifies the basic rules for certification bodies with foreign locations to handle accreditation qualification of the CB and the requirements formed with other relevant accreditation rules and criteria by CNAS. This document is substitution of CNAS-RC07:2011, Amendments including: 1. Adjusting title of this document, 2. Adding requirements of IAF MD 12:2003, 3. Adding informative annex A, 4. Adjusting sequence numbers and literary amendments.
CNAS-RC07:2014 Page 2 of 7 Rules for the Accreditation of Certification Bodies with Foreign Locations 1 Purpose and scope 1.1 China National Accreditation Service for Conformity Assessment (CNAS) developed this document to implement IAF/PAC Cross Frontier Policy so as to fulfill its membership obligations as the signatory to the IAF MLA and PAC MLA. 1.2 This document specifies the policies and procedures of CNAS to accredit certification body with foreign locations, which supplements CNAS-R01 Rules for Accreditation of Certification Bodies and is applicable to CNAS accreditation of certification bodies with foreign locations. 2 Reference 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-RC01 Rules for Accreditation of Certification Bodies CNAS-RC05 Rules for the Accreditation of Certification Bodies with Multi-premises 3 Terms and definitions The terms and definitions given in CNAS-RC01, CNAS-RC05 and the following apply. 3.1Foreign locations Locations in which certification and/or management of certification activities performed outside the country or region where the headquarters of the CB located. Note1: It can be either the headquarters of CB located in the People s Republic of China and other locations located in Hong Kong Special Administrative Area, Macau Special Administrative Area or Taiwan area or the headquarters of CB located outside of the People s Republic of China, or located in Hong Kong Special Administrative Area, Macau Special Administrative Area or Taiwan area and other locations located in the People s Republic of China. Note2: Whether a location of CB is a foreign location has no reference to the composition (office, personnel etc) or legal relationship (contractor, franchisee etc) of such premise. Annex A provides some examples of the type of relationships the CB may have with its foreign entities and subsidiaries 3.2 Remote Personnel The individuals who may be internal or external that perform certification activities for certification bodies and do not work at foreign location of certification bodies.
CNAS-RC07:2014 Page 3 of 7 3.3 Local Accreditation Body The signatory of IAF/ PAC MLA in the country or region where foreign locations located. 4 Procedures for Accreditation 4.1 Application for Initial Accreditation 4.1.1 When the CB applies for initial accreditation, it shall provide the documents and materials of CNAS-RC01: Rules for Accreditation of Certification Bodies and the following information. 1) Countries and regions into which accredited certificates are issued and the number of certificates issued in each country; 2) The number of foreign locations, the number of certificates issued by each foreign location and the relationship between the CB and its locations; 3) Countries and regions in which the CB has remote personnel that perform any certification activities; the number of remote personnel, undertaking certification activities in each country and region and the number of different countries and regions covered by remote personnel; 4) Foreign locations of CB are responsible for performing key activities or from where remote personnel perform key activities and be managed; 5) Actions taken on foreign locations and remote personnel of CB and management of the risks of certification activities performed; Note: these may be non-key activities. 6) Whether the CB holds accreditation from the local AB; 7) Situation of management of other locations and remote personnel outside its own country or region of the CB; 8) Whether the CB has been suspended or withdrawn qualification by the local AB or has been penalized by the local regulators. 4.1.2 After receiving the application for accreditation, CNAS confirms whether there is a LAB who can cover the foreign locations. If there is a LAB who can cover the foreign locations, CNAS enquires the CB in writing whether it has applied for or obtained local accreditation for the foreign locations, and (1) suggests that the accreditation could be more economically performed by the LAB (2) points out that the equivalence of the local accreditation has been verified by the MLA 4.1.3 After receiving the written enquiry described in 4.1.2, the CB shall reply to CNAS in written to confirm whether it chooses CNAS accreditation for the foreign locations. If the CB s headquarters itself is foreign locations, the CB shall apply to CNAS for assessment and accreditation of such headquarters when it applies for CNAS accreditation, otherwise CNAS will not accept the application for
CNAS-RC07:2014 Page 4 of 7 accreditation of its other foreign locations. If the foreign location is a sub-premise of CB and the CB does not choose CNAS accreditation for such foreign locations, then CNAS will exclude such foreign locations from the accreditation scope. 4.2 Assessment Preparation CNAS will review the application materials submitted by CB to determine accreditation assessment scope and the assessment plan. The management of assessment plan shall cover the current accreditation period to ensure that the locations where the certification activities performed in accreditation scope and remote personnel have met the requirements of relevant standard. 4.3 Assessment 4.3.1 When the CB chooses CNAS accreditation for the foreign locations, CNAS conducts assessment on such foreign locations according to CNAS-RC01 Rules for Accreditation of Certification Bodies and CNAS-RC05 Rules for the Accreditation of Certification Bodies with Multi-premises and this document. 4.3.1.1 When the CB has not obtained and has not applied for local accreditation for the foreign locations, CNAS (1) informs the LAB that CNAS will conduct the relevant accreditation activities and explains the relevant situations to the LAB after permission of the applicant CB (2) cooperates with the LAB during the assessment in either of the following ways as the actual situation may : a) invite LAB personnel to participate in the assessment as the member of CNAS assessment team b) subcontract the appropriate part of the assessment to the local AB (3) considers to transfer CNAS accreditation to the LAB within a reasonable timeframe with the agreement of the CB 4. 3.1.2 When the CB has obtained or applied for local accreditation for the foreign locations, CNAS (1) shares information gained from its accreditation activities with the LAB after obtaining written permission from the CB (2) cooperates with the LAB during the assessment in either of the following ways as the actual situation may: a) invite the local AB personnel to participate in the assessment as the member of CNAS assessment team b) conduct joint assessment with the local AB c) subcontract the appropriate part of the assessment to the local AB d) other means accepted by the CB. (3) when appropriate, takes adequate account of the assessment results of the local AB
CNAS-RC07:2014 Page 5 of 7 4.3.2 When CNAS cooperates with the local AB, it will be agreed by CB in advance. 4.3.3 As team members in CNAS assessment team, local assessors shall be appropriately trained, supervised and monitored by CNAS, and shall be normally assigned to team member responsibilities so that they can play a full part in the assessment team. In addition to the normal assessment team responsibilities, the local assessors may be assigned special responsibilities with regard to aspects of the assessment that are influenced by local issues and conditions, such as investigation of complaints and conflict of interest issues. 4.3.4 CNAS will perform the assessment in the following foreign locations in initial assessments: 1) locations where key activities performed and/or managed; 2) locations where the personnel who perform the key activities are managed; 3) locations where the records kept 4.3.5 When appropriate, CNAS will perform the assessment by sampling in foreign locations except for which described in Clause 4.3.4 in accordance with CNAS-RC05 Rules for the Accreditation of Certification Bodies with Multi-premises. 4.3.6 When necessary, CNAS will select the representative personnel of CB (internal and external) for interview 4.3.7CNAS will perform the remote assessment instead of on-site assessment when the results are the equivalent. 4.3.8CNAS will conduct the assessment of the effectiveness of the headquarters of CB s management controls of its certification activities performed in foreign locations and remote personnel except for foreign locations. 5 Accreditation Decision and Accreditation Certificate 5.1 CNAS makes accreditation decision after confirming the overall conformity of the CB (incl. the foreign locations) to CNAS accreditation specifications and has verified CB s corrective actions on all non-conformities. 5.2 When identified any problems related to the foreign locations through accreditation assessment, CNAS will evaluate such problems from a local perspective as well as the perspective of the whole geographical areas covered by CB s activities (see the NOTE below), so that effective actions can be taken by CB against such problems. When CNAS makes decisions on the foreign locations, it will adequately consider whether such foreign location is deemed as a local CB operating in that local market. NOTE: For example, if impartiality problems are found in just one country during a worldwide surveillance process, such problems may be minor from the global perspective of the CB s activities, but critical at the local level. 5.3 CNAS will determine the accreditation scope in some geographical regions or locations based on the assessment results and issue the certificate of CB and its foreign locations in accordance with CNAS-RC05 Rules for the Accreditation of Certification Bodies with Multi-premises and note the headquarters of CB and locations where the key activities performed in the certificate.
CNAS-RC07:2014 Page 6 of 7 6 Surveillance and Reassessment CNAS will perform the assessment in foreign locations described in Clause 4.3.4 in accordance with the assessment plan and the sampling method in CNAS-RC05 Rules for the Accreditation of Certification Bodies with Multi-premises. 6.1CNAS conduct at least one assessment in foreign locations described in Clause 4.3.4 in each accreditation period. 6.2 Except for locations described in Clause 4.3.4, CNAS conduct assessment to a certain amount of foreign locations by sampling in each accreditation period.6.3 CB shall identify the changes of information described in 4.1.1 and report to CNAS on time therefore CNAS could review the assessment plan annually. 7 Accreditation of New Foreign Locations CNAS will perform the accreditation of new foreign locations of CB according to CNAS-RC05 Rules for the Accreditation of Certification Bodies with Multi-premises. 8 Communications between CNAS and other MLA Signatory ABs CNAS will conduct well communications with other IAF/PAC MLA signatory ABs with respect to relevant information on foreign locations, such as handling of complaints, suspension or withdrawn, changes to accreditation scopes etc.
CNAS-RC07:2014 Page 7 of 7 ANNEX A INFORMATIVE This informative Annex provides some examples of the type of relationships the CB may have with its foreign entities and subsidiaries: (1) A wholly or majority (partly) owned regional subsidiary which controls and manages a number of subsidiaries; Note: This may be a separate entity which is wholly or majority (partly) owned by the CB. (2) A wholly or majority (partly) owned subsidiary or branch of certification bodies, either in its own country or in another country; Note: This may be a separate entity which is wholly or majority (partly) owned by the CB. (3) A joint venture company, in which the CB is a partner; (4) A wholly or majority (partly) owned subsidiary of a joint venture company; Note: This may be a separate entity which is wholly or majority (partly) owned by the joint venture company. (5) A representative, agency, franchisee or sales office of the CB, a wholly or majority (partly) owned subsidiary of the CB or a joint venture company; (6) Any separate entity that has contractual relationship with the CB for performing certification activities.