BS ISO 17034:2016 pdf free
BS ISO 17034:2016 pdf free.General requirements for the competence of reference material producers
The RMP shall:
a) have a description of its legal status, define the organizational and management structure of the RMP, its place in any parent organization and the relations between management, technical operations, support services and subcontractors;
b) define the parts of the organization covered by the management system for the production of RMs;specify the responsibility, authority and interrelationships of all personnel who manage, perform or verify work affecting the quality of RMs produced;
d) have managerial personnel, supported by technical personnel, with the authority and resources needed to discharge their duties and to identify the occurrence of departures from the management system or the procedures for the production of RMs and to initiate actions to prevent or minimize such departures;
e) have technical management with overall responsibility for the technical operations and the provision of the resources needed to ensure the required quality of each operation which forms part of the RM production;
f) appoint personnel (however named) who, irrespective of other duties and responsibilities, shall have defined responsibility and authority for ensuring that the requirements of this International Standard are implemented and followed at all times – these appointed personnel shall have direct access to the highest level of management at which decisions are taken on RM production policy or resources;
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).
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.
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.BS ISO 17034 pdf download.
