Laboratory Quality Manual

    The Sections below are part of a laboratory quality manual that need to be completed. I have already started each section and need you to finish it. If you can please just improve what has been done and add the missing information to each section by following the structure below. Also for each section a document may need to be created to show the procedure for the following section, these documents are to be placed in the appendix. This part of the manual has to be made sure that every section is to be made sure that they abide by the NATA accreted checklist which I will upload with all documentations that apply to this section. If any other documents need to be upload please notify me and I will upload them asap. Also any further questions please don’t hesitate to ask me as I will be checking my email regularly for notifications and will reply as sooon as I can.

    5. TECHNICAL REQUIREMENTS

    5.2 Personnel

    CLAUSE AND REQUIREMENTS:

    5.2.1 Competence
    ensure personnel performing specific tasks are qualified on the basis of education, training, experience and/or demonstrated skills and that when staff are being trained appropriate supervision is provided,

    5.2.2 Training policy
    policy and procedures must be implemented for identifying training needs, providing training and evaluating its effectiveness

    5.2.3 Employees
    ensure personnel are employed or contracted by the laboratory, and ensure contracted personnel are supervised, competent and work in accordance with the management system

    5.2.4 Job descriptions
    maintain current job descriptions for managerial, technical and key support staff,

    5.2.5 Authorised personnel
    >ensure management has authorised specific personnel to:
    -perform specific sampling, testing and/or calibration activities
    -issue test reports and/or calibration certificates and that NATA signatory approval has been taken into consideration
    -give opinions and interpretations (these are only permitted on test reports in the fields of Medical, Veterinary and Forensic testing)
    -operate particular types of equipment and that records for all technical personnel (including contracted personnel) are maintained for:
    =relevant authorisation(s) including date on which authorisation and/or competence is confirmed
    =competence
    =educational and professional qualifications
    =training, skills and experience

    5.3 Accommodation and environmental conditions

    CLAUSE AND REQUIREMENTS

    5.3.1 Facility
    ensure the laboratory or off-site facility(ies) and environmental conditions do not compromise the quality of results and that the technical requirements for critical accommodation and environmental conditions are documented

    5.3.2 Monitoring
    ensure the laboratory monitors, controls and records environmental conditions, where applicable and that tests and/or calibrations are stopped when results are jeopardised by the environmental conditions

    5.3.3 Incompatible activities
    ensure there is effective separation between areas of incompatible activity

    5.3.4 Access
    ensure access to office and laboratory areas is controlled

    5.3.4 Housekeeping
    ensure housekeeping measures are adequate

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