ISO 17034 2016 pdf download – General requirements for the competence of reference material producers.
6 Resource requirements 6.1 Personnel 6.1.1 The RMP shall ensure that all personnel involved in RM production are supervised and competent and that they work in accordance with the RMP’s management system. 6.1.2 Personnel, including subcontractors, personnel of external bodies, or other individuals acting on the RMP’s behalf, shall comply with the policies and procedures for management of confidential information that are set by the RMP. 6.1.3 The RMP shall ensure the competence of all personnel, including technical management personnel, operating under its management system who undertake activities relating to the production of each particular type of RM. There shall be sufficient personnel having the necessary education, training, technical knowledge and experience for their assigned functions. 6.1.4 The RMP shall have procedures for identifying training needs and providing training of personnel. The training programme shall be relevant to the present and anticipated tasks of the RMP. 6.1.5 The RMP shall maintain records of job descriptions for its personnel involved in RM production activities. 6.1.6 The RMP shall authorize competent personnel to perform particular activities relating to RM production. The RMP shall maintain records of the authorizations, competence, educational and professional qualifications of those personnel. These records shall provide evidence that individuals have been adequately trained and that their competence to perform particular activities in the RM production has been assessed. This information shall be readily available and shall include the date on which the authorization and/or competence has been confirmed.
6.4 Facilities and environmental conditions 6.4.1 The RMP shall ensure that all laboratory facilities, calibration and testing areas (if applicable), . material handling, storage, processing and packaging areas, energy sources, lighting， humidity, temperature, pressure and ventilation are such as to facilitate proper material handling, storage, processing and packaging, as well as proper performance of calibration and testing activities (if applicable). 6.4.2 When the environmental conditions could have an adverse effect on the RM, the environmental conditions in which the RM production activities are undertaken shall be monitored with appropriately calibrated equipment, and shall be controlled and recorded, such that results and processes are not adversely affected. 6.4.3 All RM processing and calibration and testing areas, in addition to satisfying requirements for humidity and temperature, shall be protected, where appropriate, from other environmental factors such as incompatible activities, vibration, aerosols, airborne dust and microbiological contamination, magnetic fields, light and electromagnetic and/or ionising radiation. 6.4.4 Access to and use of areas shall be controlled as appropriate to maintain the quality of the RMs. 7 Technical and production requirements 7.1 General requirements The RMP shall address the requirements in this clause for the production of RMs, including CRMs. NOTE 1 A CRM has at least one certified value. NOTE 2 79 applies only to certified values. NOTE 3 72 to 7.18 contain requirements for certified values and other property values where necessary.