Title Page
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Laboratory/Site
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Conducted on
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Prepared by
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Location
Internal Assessment
6. Resource Requirements
6.1 General
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6.1 Available resources<br>• laboratory to have available personnel, facilities, equipment, systems and support services necessary to manage and perform its laboratory activities
6.2 Personnel
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6.2.1 Competence and impartiality<br>• all personnel (internal or external) associated with the laboratory that could influence the laboratory activities to be competent and act impartially in accordance with the management system
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6.2.2 Documentation of competency requirements<br>• to include education, qualification, training, technical knowledge, skills and experience for each role which influence the laboratory activities
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6.2.3 Competency<br>• ensure personnel are competent to perform laboratory activities for which they are responsible and to evaluate the significance of deviations
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6.2.4 Duties, responsibilities and authorities<br>• ensure these are communicated
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6.2.5 Procedures and records<br>a) for the determination of the competence requirements<br>b) for the selection of personnel <br>c) for training<br>d) for supervision<br>e) for authorisations<br>f) for the monitoring of competence
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6.2.6 Authorisations to perform specific activities<br>a) develop, modify, verify and validate methods<br>b) analyse results, including statements of conformity or opinions and interpretations<br>c) report, review and authorise results
6.3 Facilities and Environmental Conditions
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6.3.1 Suitability of facilities and environmental conditions<br>• appropriate and not adversely affect the validity of results
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6.3.2 Document<br>• the requirements for facilities and environmental conditions to perform laboratory activities
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6.3.3 Monitor, control and record<br>• the environmental conditions in accordance with the relevant specifications, methods and procedures or when they influence the validity of results
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6.3.4 Measures to control facilities<br>• to be implemented, monitored and periodically reviewed, including but not limited to<br>a) access to and use of areas affecting laboratory activities<br>b) prevention of contamination, interference or adverse influences on laboratory activities<br>c) effective separation between areas with incompatible laboratory activities
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6.3.5 Sites outside laboratory’s permanent control<br>• ensure facilities and environmental conditions comply with requirements of the Standard
6.4 Equipment
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6.4.1 Availability of equipment<br>• laboratory has access to equipment for correct performance of laboratory activities
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6.4.2 Equipment outside control of laboratory<br>• the requirements of the Standard are met
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6.4.3 Procedure<br>• is available for handling, storage, use and planned maintenance to ensure proper functions and to prevent contamination or deterioration
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6.4.4 Verification<br>• ensure equipment conforms to specified requirements before being placed or returned into service
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6.4.5 Accuracy and/or measurement uncertainty (MU)<br>• to provide a valid result, equipment must be capable of achieving the required<br>- measurement accuracy; and/or<br>- MU
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6.4.6 Calibration<br>• equipment shall be calibrated when<br>• measurement accuracy or MU affects the validity of the results; and/or<br>• the equipment is necessary to establish metrological traceability of the results
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6.4.7 Calibration program<br>• shall be established and reviewed and adjusted as necessary in order to maintain confidence in the status of calibration
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6.4.8 Labelling<br>• all equipment which requires calibration or has a defined period of validity shall be labeled, coded or otherwise identified
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6.4.9 Out-of-service<br>• overloaded, mishandled or poorly functioning equipment shall be isolated and not reused until verified that it performs correctly<br>• the effect of such defective equipment<br>shall be investigated and the management of non-conforming work initiated
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6.4.10 Intermediate checks<br>• shall be carried out when necessary to confirm performance of the equipment<br>• in accordance with a procedure
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6.4.11 Correction factors<br>• when calibration and reference material data include reference values or correction factors, these are to be updated and implemented, as appropriate, to meet specified requirements
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6.4.12 Unintended adjustments<br>• practicable measures are taken to prevent these from occurring and invalidating results
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6.4.13 Records<br>• shall be retained for equipment which can influence laboratory activities, including:<br>- identity, including software/firmware version<br>- manufacturer’s name, type and serial number or other identification<br>- evidence of verification<br>- location<br>- calibration dates and results, results of adjustments, acceptance criteria, due date of next calibration or interval<br>- documentation of reference materials, results, acceptance criteria, relevant dates and the period of validity<br>- maintenance plan and maintenance performed;<br>- details of damage, malfunction, modifications or repair
6.5 Metrological Traceability
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6.5.1 Establish metrological traceability<br>• the laboratory shall establish and maintain metrological traceability of its measurement results by means of a documented unbroken chain of calibrations, each contributing to the measurement uncertainty, linking them to an appropriate reference
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6.5.2 Measurement results traceable to SI units<br>• to be established through<br>a) calibration provided by a competent laboratory; or<br>b) certified values of CRMs from a competent producer with stated traceability to SI units; or<br>c) direct realization of the SI units<br>ensured by comparison with national or international standards
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6.5.3 Traceability to SI not technically possible<br>• where this occurs, metrological traceability to an appropriate reference shall be demonstrated, for example<br>a) certified values of CRMs provided by a competent producer to non SI values<br>b) results of reference measurement procedures, specified methods or consensus standards that are accepted as providing measurement results fit for their intended use and ensured by suitable comparison
6.6 EXTERNALLY PROVIDED PRODUCTS AND SERVICES
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6.6.1 Use of externally provided products and services<br>• Only suitable products and services are used when<br>a) incorporated into the laboratory’s own activities<br>b) provided directly to the customer by the laboratory as received from the external provider<br>c) used to support the operation of the laboratory
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6.6.2 Procedure and records for<br>a) defining, reviewing and approving the laboratory’s requirements for externally provided products and services<br>b) defining criteria for evaluation, selection, monitoring of performance and re- evaluation of external providers<br>c) ensuring that prior to laboratory use or supply to customers, the products and services conform to the laboratory’s requirements or where relevant to the Standard<br>d) actions to take arising from evaluations, monitoring or re-evaluations of external providers
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6.6.3 Communication of requirements to external providers<br>• These include<br>a) the products and services to be provided<br>b) the acceptance criteria<br>c) competence, including any required qualification of personnel<br>d) activities that the laboratory, or its customer, intends to perform at the external provider’s premises
Completion
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Comments/Recommendations
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Conducted by: Name and Signature
