Documentation relating to procedures for quotations and pre-application activities, including: # description of the application procedure by manufacturers can obtain certification 4.1 (4.2(a)) fees charged and financial conditions (4.2(b)) 4.2 advertising of conformity assessment services (4.2(c)) 4.3 review of pre-application information (4.2(d)) 4.4 Documentation relating to contractual arrangements between the manufacturer and the # conformity assessment body, including template application form (4.3) 4.5 template contract specifying terms and conditions and obligations of the conformity 4.6 assessment body in relation to conformity assessment activities (4.3) Procedures relating to review of applications(4.3): 4.7 the verification of completeness of the application the verification of the qualification and classification of the product the applicability of the conformity assessment procedures chosen by the applicant the ability of the conformity assessment body to assess the application in accordance with the of designation applied for the availability of sufficient and appropriate resources Procedures to ensure that all contracts relating to the conformity assessment activities are 4.8 concluded directly between the manufacturer and the conformity assessment body (4.2(e)) Allocation of resources Procedures and forms to ensure that conformity assessment activities are conducted by 4.9 appropriately qualified and authorised personnel, including the identification of one individual responsible for each application, and that allocation of tasks and changes thereto are documented (4.4 and 4.5.1) Documentation relating to project planning (4.5.1), including # planning the conduct of each individual project and specifying the rationale for fixing 4.10 time limits for completion of the conformity assessment rotation of the members of the assessment team at appropriate intervals 4.11 Conformity assessment activities
# Documentation relating to procedures for quotations and pre-application activities, including: 4.1 description of the application procedure by manufacturers can obtain certification (4.2(a)) 4.2 fees charged and financial conditions (4.2(b)) 4.3 advertising of conformity assessment services (4.2(c)) 4.4 review of pre-application information (4.2(d)) # Documentation relating to contractual arrangements between the manufacturer and the conformity assessment body, including 4.5 template application form (4.3) 4.6 template contract specifying terms and conditions and obligations of the conformity assessment body in relation to conformity assessment activities (4.3) 4.7 Procedures relating to review of applications(4.3): the verification of completeness of the application the verification of the qualification and classification of the product the applicability of the conformity assessment procedures chosen by the applicant the ability of the conformity assessment body to assess the application in accordance with the of designation applied for the availability of sufficient and appropriate resources 4.8 Procedures to ensure that all contracts relating to the conformity assessment activities are concluded directly between the manufacturer and the conformity assessment body (4.2(e)) Allocation of resources 4.9 Procedures and forms to ensure that conformity assessment activities are conducted by appropriately qualified and authorised personnel, including the identification of one individual responsible for each application, and that allocation of tasks and changes thereto are documented (4.4 and 4.5.1) # Documentation relating to project planning (4.5.1), including 4.10 planning the conduct of each individual project and specifying the rationale for fixing time limits for completion of the conformity assessment 4.11 rotation of the members of the assessment team at appropriate intervals Conformity assessment activities
NBOG_F_2017_2_IVDR_rev2.docx