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Technical requirements:

Technical requirements:. general (ISO 17025:2005, 5.1) personnel (ISO 17025:2005, 5.2) accommodation and environment (ISO 17025:2005, 5.31). Laboratory. Report. Sample. The Laboratory Process. Laboratory. Sample. Technical requirements. In general

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Technical requirements:

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  1. Technical requirements: • general (ISO 17025:2005, 5.1) • personnel (ISO 17025:2005, 5.2) • accommodation and environment(ISO 17025:2005, 5.31)

  2. Laboratory Report Sample The Laboratory Process

  3. Laboratory Sample Technical requirements In general • Factors influencing the correctness and reliability of the tests performed ?

  4. Factors determine correctness and reliability of the tests • Human factors • Acomodation and environmental conditions • Test and calibration methods, method validation • Equipment • Measurement traceability • Sampling • Handling test items

  5. Personnel(ISO 17025:2005, 5.2)

  6. Management requirements to personnel -1 (ISO 17025: 2005, 4.1) • Laboratory have managerial and technical personnel (irrespective of other responsibilities) who have the authority and resources needed to carry out their duties and to identify the occurrence of departures from the quality system and initiate actions if required • Free from any undue internal and external pressures and influences

  7. Management requirements to personnel -2 (ISO 17025 ; 2005,4.1) • Protection of the customers confidential information • Specify responsibilities, authority and interrelations of all personnel which activities can influence the quality of the result • Appropropriate supervision of testing staff and trainees

  8. Management requirements to personnel - 3 (ISO 17025:2005, 4.1) • Technical management which has overall responsibility for operations and provision of resources needed to ensure required quality of operations • Quality manager: irrespective of other duties has defined responsibility and authority ensuring the management system is implemented and followed at all times, has direct access to the highest level of management

  9. Management requirements to personnel - 4 (ISO 17025: 2005,4.1) • Appoint deputies for key managerial personnel • Ensure that personnel is aware of relevance and importance of their activities • Top management shall ensure proper communication processes are established regarding effectiveness of the management system

  10. Technical requirements to personnel -1 (ISO 17025:2005, 5.2) • Laboratory management shall ensure the competence of personnel for operation specific equipment, perform tests, evaluate results, sign test reports • Personnel responsible for opinions and interpretation at reports have relevant knowledge of technology including legislation, understanding significance of deviations • Training programme: Management formulates goals for education, training and skills of personnel. Needs are identified and training programme is evaluated.

  11. Personnel -2 (ISO 17025:2005, 5.2) Job descriptions • minimal responsibilities with respect to performing tests, planning and evaluation of tests, reporting opinions and interpretations, method modification and validation new methods. • Expertise and experience required • Qualification and training programmes • Managerial duties

  12. Personnel - 3 (ISO 17025:2005, 5.2) • Authorization to perform particular types of sampling, tests, issuing tests reports, to give opinions and interpretations, operation of particularly types of equipment • Authorization of specified tasks is done including date on which it is confirmed and registrated and readily available

  13. Requirements to personnel are registrated

  14. Accommodation and environmental conditions (ISO17025:2005, 5.3) • Laboratory facilities will facilitate correct performance of the tests and are documented • Monitor, control and record conditions as required by relevant specifications (biological sterility, dust, humidity temperature, electrical supply etc.) • Attention for access to certain test areas, good housekeeping and effective separation of incompatible activities

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