DOCUMENTED PROCEDURE SAMPLING OF CERTIFICATION BODIES DP SM

Transcription

1 REPUBLICAN UNITARY ENTERPRISE «BELARUSIAN STATE CENTRE FOR ACCREDITATION» DOCUMENTED PROCEDURE SAMPLING OF CERTIFICATION BODIES DP SM Developed Department for certification bodies accreditation Responsible for updating Department for certification bodies accreditation Checked Quality manager Approved by the Order from Implemented from Issue No 02 Copy No 1 Modification No from Minsk 2016

2 1 SCOPE OF APPLICATION This documented procedure (hereinafter referred to as the procedure) is a document of the management system of State Enterprise "BSCA" (hereinafter referred to as BSCA) developed in accordance with Section 7 of STB ISO/IEC 17011, IAF/ILAC-A5: 11/2013 and RK SM BSCA. The procedure establishes the order of sampling for certification bodies accreditation process. This documented procedure is mandatory for the staff of BSCA, which takes part in accreditation process. 2 REFERENCES This procedure refers to the following technical normative legal acts, BSCA management system documents: STB ISO 9000 Quality management systems. Fundamentals and Vocabulary. STB ISO/IEC Conformity assessment.vocabulary and general principles. STB ISO/IEC Conformity assessment. General requirements for accreditation bodies accrediting conformity assessment bodies. RK SM BSCA Quality manual. DP SM 7-04 Documented procedure. On-site assessment. DP SM 7-05 Documented procedure. Preparing documents to be considered at Technical Commission of Accreditation meetings. Decisions on accreditation, granting accreditation. IAF/ILAC-A5 IAF/ILAC Multi-Lateral Mutual Recognition Arrangements (Arrangements): Application of ISO/IEC 17011:2004 IAF GD5:2006 IAF Guidance on the Application of ISO/IEC Guide 65:1996. General Requirements for Bodies operating Product Certification Systems. 3 TERMS AND DEFINITIONS This procedure uses terms and definitions defined in STB ISO 9000, STB ISO/IEC 17000, STB ISO/IEC 17011, as well as: representative sampling sampling performed to reflect the total specificity referring the composition as well as individual characteristics included as representative units. reassessment assessment, performed by BSCA to maintain accreditation. extending accreditation accreditation in a supplementary area, including the organization of new areas to perform activities. 4 DESIGNATIONS AND ACRONYMS This procedure uses the following acronyms: BSCA State Enterprise BSCA; ТКА Technical Commission for Accreditation; ОАL Department for Laboratory Accreditation; ОАОS Department for Certification Bodies Accreditation; CAB Conformity Assessment Body ЕА European Cooperation on Accreditation IAF International Accreditation Forum ILAC International Laboratory Accreditation Cooperation Редакция 02 от Согласовано Менеджер по качеству Е.В. Морозова лист 2 из 10

3 5 RESPONSIBILITIES AND POWERS Responsibility distribution matrix is provided in Annex 1 to DP SM 7. 6 SAMPLING 6.1 General provisions BSCA evaluates a representative number of items of accredited activity carried out by a certification body, covering the whole scope of competence between initial accreditation and the first reaccreditation or between two subsequent surveillance assessments. 6.2 Planning When carrying out surveillance at a certain accreditation cycle all types of activities are assessed according to the scope of accreditation, including all offices, branches (if any) where certification bodies carried out their core activities. Surveillance includes assessments performed with a fixed interval (12-18 months) at head offices of certification bodies, as well as in offices, branches (if any) where certification bodies carried out their core activities. BSCA conducts surveillance of certification bodies activities, which includes on-site assessment and witnessing. BSCA develops a program of surveillance for the entire accreditation cycle (3 years), covering all the elements of the management system and the whole scope of accreditation, as well as by means of witnessing. The program of surveillance is developed for: - all the elements of accredited certification body MS; - technical competence of an accredited certification body on the basis of a representative number of elements of the whole accredited scope. The program should cover the activities to be evaluated, including all elements of management system and technical competence of an accredited certification body between primary accreditation and the first extension of accreditation or between two subsequent reaccreditations. Witnessing of the activities of a certification body in real conditions is an integral part of an surveillance assessment for all types of certification bodies. If necessary, witnessing of certification body on-site activities can be performed not within the period established for on-site assessment. It is recommended that such witnessing within surveillance takes place two months before or after the planned on-site assessment. The program should be regularly reviewed and updated (if necessary) taking into account the results of the previous assessment. 6.3 Responsibilities of an assessment team Prior to each assessment, BSCA forms an assessment team competent in this area of accreditation. To increase effectiveness, the members of the assessment team should work independently according to the received technical specifications developed by the lead assessor in accordance with the assessment plan. The lead assessor evaluates the certification body management system based on the quality manual and other documents, by means of discussion (interview) with the persons responsible for the certification body management system and with other employees of the certification body (if necessary). Редакция 02 от Согласовано Менеджер по качеству Е.В. Морозова лист 3 из 10

4 Technical assessors should evaluate the management system in operation, as well the processes of conformity compliances in the fields within their competency. A technical assessor should be competent and should be able to bring technical arguments for the representative units chosen for a particular assessment from all the groups of certification processes. The assessment includes witnessing of the activities carried out and other mechanisms. BSCA forms an evaluation team (for re-accreditation) based on rotating principle. 6.4 Mechanisms of implementation When carrying out initial accreditation, surveillance and reassessment, BSCA performs an onsite assessment and witnessing of the certification body activity. When carrying out on-site assessment both management system elements and operational elements (certification process) are performed. In order to cover the whole certification body scope of accreditation, BSCA applies a balanced combination of various mechanisms, including - management system assessment (compulsory); - vertical audit of certification process, including records review (compulsory); - assessment of personnel management (compulsory); - witnessing (compulsory): assessment of certification process, performed by management system certification bodies, personnel competency; assessment of certification process, performed by products/services certification bodies, personnel competency; exam carried out by the staff of personnel certification bodies, personnel competency. The aim of witnessing is to assess the performance of activities carried out by authorized certification body personnel (certified auditors). When performing witnessing BSCA assessment team members: - do not interfere in the activity assessed by the personnel of the certification body; - have the right to ask questions for further clarification; - do not express their own opinion concerning the certification body under assessment or concerning the certification body s client in the presence of the representative of the certification body s client. In such a situation, all discussions between the BSCA assessment team member and the personnel of the evaluated certification body should be taken in a private manner in order to preserve the confidentiality of evaluation results. 6.5 Sampling of management system elements During initial accreditation and reaccreditation of a certification body all elements of the following standards are to be assessed: - GOST ISO/IEC (for CABs performing certification of products services and processes); - STB ISO/IEC (for management system certification bodies); - GOST ISO/IEC (for personnel certification bodies). While the extending of the CAB accreditation, the assessment is carried out on those elements of the CAB management system that have been modified as a result of the extension and all the additional accreditation scope declared by the CAB (all directions of the additionally declared certification scope, all personnel conducting the certification work for the additionally declared scope, implementation of activities for an additional accreditation scope). Редакция 02 от Согласовано Менеджер по качеству Е.В. Морозова лист 5 из 10

5 Generally the surveillance of a certification body is less thorough than the initial assessment or the reassessment, but at each periodic inspection of all types of certification bodies it is necessary to evaluate the functioning of the following elements of the management system using the horizontal assessment technique: - the mechanism for ensuring impartiality; - personnel of the certification body; - requirements for the process; - management review; - internal audits. Also the following elements shall be assessed in a mandatory manner: - all changes in the certification body; - analysis of the implementation of corrective actions ( as well assessment their effectiveness) undertaken following the non-conformities, remarks and observations from the previous assessment - use of the accreditation symbol; - other elements that cause concerns and disclosed during the previous assessment. All other elements of the Standards GOST ISO/IEC 17065/ STB ISO/IEC / GOST ISO/IEC are assessed to ensure that all the elements are assessed at least once during the period between the initial assessment and the first reaccreditation, or between two subsequent surveillance assessments. 6.6 Conformity assessment bodies certifying products, processes and services. Sampling of technical aspects (scope of accreditation) Witnessing During the initial assessment all representative processes are to be witnessed (if possible): - products groups (sections), processes identified in accordance with the OKRB 007, - the number of the groups (section) of products, processes within the scope of accreditation; - the number of the types services (code) within the scope of accreditation. The minimum number of witnesses for products/processes certification are determined as follows: Number of types (code) of activity ОКРБ 015 Minimum number of witnessing 1 to to to 13 3 In case there is no possibility to perform witness (initial accreditation, extending accreditation): the first inspection of the certification process conducted by the products certification body within the product group (section) after granting accreditation by BSCA; the first witnessing of the certification process conducted by the products certification body within the types of activity (code) after granting accreditation by BSCA Редакция 02 от Согласовано Менеджер по качеству Е.В. Морозова лист 5 из 10

6 All representative certification/surveillance/recertification process of products groups (section)/services should be witnessed at least once between the initial assessment and reaccreditation. Important factors to be taken into account when sampling the number of units are the following: -number of certificates issued in this product group; - changes in the personnel of certification body; - the results of the previous observation; - the complexity of this group of products (section); - the risks of consequences during the adoption of the CAB of an incorrect decision based on the results of the certification work. During each surveillance assessment BSCA witnesses at least one certification procedure carried out by CB on the premises of the CB s clients under different product group/sector (if possible) and in selected locations, if relevant (or for the process of registration of declarations of compliance) On-site assessment - Vertical audit During the reassessment and each surveillance assessment a vertical audit of certification/surveillance/reassessment shall be performed. The number of vertical audits depends on the scope of accreditation granted. Vertical audit is a comprehensive assessment of all the aspects related to one of the processes: certification/ surveillance/reassessment. 6.7 Management system certification body. Sampling of technical aspects (scope of accreditation) Witnessing Initial certification, recertification and surveillance audits are subject to witnessing. During initial assessment of certification, process each certification scheme should be witnessed if possible (STB ISO 9001, STB ISO 14001, STB 18001, STB ISO 22000, STB ISO 13485, STB ISO/IEC 27001, STB ISO/TS 16949, STB ISO 50001, STB 1470). The number of witnessing visits depends on the number of the management system certification schemes within the scope of accreditation of the certification body. In case when there is no possibility to perform witness during initial assessment BSCA shall witness the first audit of the certification process conducted by the management system certification body after the accreditation is granted. Редакция 02 от Согласовано Менеджер по качеству Е.В. Морозова лист 6 из 10

7 All technical fields of all management system certification schemes should be witnessed at least once between the initial assessment and reaccreditation or between the two subsequent reaccreditations. Important factors should be taken into account when sampling: - number of issued certificates in this type of management system; - results of the previous witnessing; - number of auditors; - risks of consequences during the adoption of the CAB the wrong decision based on the results of the certification work; - types of audits (stage 1, stage 2, surveillance and recertification); BSCA performs witnessing of each type of management system within the accreditation cycle and if possible for difference codes (code OKRB 005). The number of witnessing visits depends on the number of codes to be accredited. The minimum number of witness are determined as follows: Number of codes OKRB 005, included in the scope of accreditation Minimum number of witnessing in the accreditation cycle With reference to ISO certification scheme BSCA carries out witnessing at least - at least one audit in Cluster 2, identified in accordance with the EA 3/11 (if it is included in the management system certification body s scope of accreditation) in each surveillance assessment or reassessment, - at least one audit in other clusters within the accreditation cycle, - at least one witnessing visit shall cover stage 1 of the audit within the accreditation cycle. Single witnessing visits may cover different food chain categories (different categories of food products) where it is justified. Редакция 02 от Согласовано Менеджер по качеству Е.В. Морозова лист 7 из 10

8 The minimum number of witness are determined as follows: Minimum number of EA cluster 3/11, included in the Code OKRB 005 witnessing within the scope of accreditation (categories ЕА 3\11) accreditation cycle 1. Agriculture A + B once in each accreditation cycle 2. Food and Feed Processing 3. Distribution, Transport and Storage C + D + E + F H + J once in each surveillance or reassessment once in each accreditation cycle 4. Catering G once in each accreditation cycle 5. (Bio) Chemicals L once in each accreditation cycle 6. Auxiliary Industries I + K + M once in each accreditation cycle With reference to: ISO 13485, ISO 27001, ISO/TS 16949, STB 50001, STB 1470 BSCA conducts witnessing not less than once every two years for each of the schemes On-site assessment - Vertical audit During the reassessment and each surveillance assessment vertical audit of certification/surveillance/reassessment process shall be performed. The number of vertical audit depends on the scope of accreditation granted. Each certification scheme is subject to on-site assessment not less than once every two years. Vertical audit is a comprehensive assessment of all the aspects of one certification/ surveillance/reassessment process. 6.8 Personell certification body. Sampling of technical aspects (scope of accreditation) Witnessing During initial assessment certification, persons of each type of activity should be witnessed if possible. In case there is no possibility to perform witness during initial assessment BSCA witnesses the first exam of the certification process conducted by the personnel certification body in the type of person after granting accreditation. During each surveillance and reassessment, apart of on-site assessment, BSCA conducts witnessing of the exams organized by the body. During the whole accreditation cycle including reassessment, for each accredited type of persons, BSCA conducts witnessing of at least one exam organized by the personnel certification body On-site assessment - Vertical audit Each accredited type of personnel is subject to on-site assessment not less than once every two years. Редакция 02 от Согласовано Менеджер по качеству Е.В. Морозова лист 8 из 10

9 During reassessment and each surveillance assessment vertical audit certification/surveillance/reassessment process shall be performed. The number of vertical audit depends on the scope of accreditation granted. Vertical audit is a comprehensive assessment of all the aspects of one certification/ surveillance/reassessment process. 6.9 Sampling of locations When certification activities are performed at different locations, all locations shall be assessed during initial assessment and reaccreditation. The surveillance assessment of the certification activity, located at multiple locations, is always performed at the main location and at least at one or more locations so that all locations are assessed at least once during the accreditation period. If the CB performs its key activities in several locations, the BSCA conducts the abovementioned witnessing to provide at least one witnessing visit in a given location 6.10 Cross frontier accreditation In case a certification body conducts its certification activity outside Belarus BSCA conducts witnessing not less than once within each accreditation cycle in each country where the certification body conducts its accredited certification activity. 7. RECORDS CONTROL The AB ensures that records on witnessed accredited activities of certification are kept in the file of accredited certification body according to RI SM Редакция 02 от Согласовано Менеджер по качеству Е.В. Морозова лист 9 из 10

10 Acknowledgment list on MS document DP SM 7-02 No Name Position, subdivision Signature Date Редакция 02 от Согласовано Менеджер по качеству Е.В. Морозова лист 10 из 10