5.0 - Technical Requirements

  • 5.1.1

    Factors contributing to the correctness and reliability of the tests (calibrations) are:

    human factors [5.2]

    accomodations and environment [5.3]

    test (calibration) methods and method validations [5.4]

    equipment (assets) [5.5]

    measurement traceability [5.6 and Appendix B]

    sampling [5.7]

    handling of test (calibration) items [5.8]

    5.1.2

    The laboratory considers the above factors when developing test (calibration) methods and procedures, training, and the selection of equipment (assets).

  • 5.2.1

    The General Manager and Technical Manager are responsible for the technical competence of the laboratory staff.

    5.2.2

    The laboratory has a policy and procedure for identifying and providing training for lab staff.

    5.2.3

    The General Manager and Quality Manager are responsible for all lab staff, whether employed by the laboratory or contractors to the laboratory, are acting in accordance with the quality system of the laboratory.

    5.2.4

    Job descriptions for all lab staff are maintained and include a list of designated, deputy, or associate staff who fulfill that job description.

    5.2.5

    The Technical Manager authorizes staff to perform particular tests, calibrations, or sampling. Additional authorization is provided for reviewing and approving reports. Training records and employee skills are maintained in the online personnel folders.

  • 5.3.1

    The laboratory facilities provide adequate conditions to facilitate testing (calibration). The Lab Manager is responsible for ensuring that environmental conditions do not invalidate any test (calibration) results. The procedure for performing tests (calibrations) outside the laboratory includes a caution about environmental conditions. Section 5.10 of this quality manual, Reporting the results, states the requirements for documenting environmental conditions.

    5.3.2

    A procedure has been implemented to control, monitor, and record relevant environmental conditions.

    5.3.3

    This laboratory does not have any activities requiring separation, therefore, no measures to prevent cross-contamination have been implemented.

    5.3.4

    Laboratory access is controlled via a policy.

    5.3.5

    Good housekeeping measures are identified in a policy.

  • 5.4.1 General

    Test (calibration) methods within the scope of the laboratory are stored in documents. Sampling is covered under section 5.7 and the handling of test (calibration) items is in section 5.8 of this quality manual. An estimation of measurement uncertainty is found in section 5.4.6.

    User Manuals, containing instructions for use, of most equipment is found on the asset page of the equipment, the remaining hardcopy manuals are found on the engineering shelf in the laboratory library. A procedure for the preparation of test (calibration) items has been implemented. The document control procedure lists how the instructions, standards, manuals, and reference data are made available to the laboratory.

    Deviations from test (calibration) methods are allowed under section 5.10 of this quality manual.

    5.4.2 Selection of Methods

    Test (Calibration) methods used are chosen to meet the needs of the customer. The standards or methods used shall be the latest version, or the version specified by a regulation or by the customer. The laboratory will select the standards or methods to be used if not included in the customer's request and will also notify the customer if a requested standard or method is inappropriate or out of date. The standard(s) or method(s) selected will be communicated to the customer in the quote for services (See section 4.4).

    5.4.3 Laboratory-developed Methods

    For any laboratory-developed methods, the Technical Manager shall plan the implementation and assign adequate and appropriate resources to complete it.

    5.4.4 Non-standard Methods

    Non-standard customer requirements will be validated to section 5.4.5 below prior to use and should contain at least the following:

    identification

    purpose

    scope

    clear customer specifications

    description of the equipment to be tested (calibrated)

    parameters to be determined

    List of test (calibration) equipment including performance requirements

    reference standards or reference materials required (typically only needed for sampling and/or calibrations

    environmental conditions and stabilization period

    Procedure description

    Handling of test (calibration) items per section 5.8 of this quality manual

    checks to be made prior to commencing work

    test equipment checks according to section 5.5 of this quality manual

    method for recording results and observations

    safety measures to be observed

    approval/rejection criteria

    data to be recorded and the method of analysis and presentation according to section 5.10 of this quality manual

    measurement uncertainty

    5.4.5 Validation of methods

    The Technical Manager is responsible for validating non-standard methods or standard methods used outside their original scope. Records of method validations are kept that contain the results, procedure used for validation, and a statement that the method is fit for the intended use. The accuracy of the results from a validated method are relevant to the customer's needs.

    5.4.6 Estimation of Measurement Uncertainty

    The laboratory has a procedure for the calculation of measurement uncertainty

    5.4.7 Control of Data

    Any calculation of results are either applied directly from a standard method or are verified as part of the non-standard method validation of 5.4.5 above. The Technical Manager is responsible for sufficiently documenting any laboratory-developed software and the validation of its use. A procedure has been implemented for the protection of data.

  • 5.5.1

    The laboratory has the equipment needed to perform the tests (calibrations) within the scope of its accreditation. Rental equipment is subject to a procedure for ensuring that the requirements of this handbook are met.

    5.5.2

    A calibration program exists for all equipment.

    5.5.3

    The Technical Manager and Test (Calibration) Engineers are authorized to operate the equipment. Instructions on the use and/or maintenance of the equipment is available in the equipment database.

    5.5.4

    The equipment is identified by a unique asset tag and listed in the equipment database.

    5.5.5

    Records for each item of test equipment is found in the equipment database.

    5.5.6

    The laboratory uses a procedure for the safe handling, transport, storage, and use of test (calibration) equipment.

    5.5.7

    If an item of equipment gives suspect results, a "red tag" shall be attached to the equipment, marking it unfit for use until it is repaired or calibrated. Previous tests (calibrations) are considered and, if necessary, institue the procedure for non-conforming work acording to section 4.9.1 of this quality manual.

    5.5.8

    All equipment identified in the equipment database is appropriately identified to indicate the status of calibration in accordance with the calibration program.

    5.5.9

    For any equipment that goes outside the direct control of the laboratory, the functionality and calibration of the equipment is checked before returning it to service.

    5.5.10

    Intermediate checks needed to maintain confidence in the calibration are performed in accordance with a procedure.

    5.5.11

    A procedure for updating correction factors for use in the laboratory has been implemented.

    5.5.12

    Equipment, both hardware and software is safeguarded from adjustments that would invalidate the results according to the calibration program.

  • 5.6.1 General

    The laboratory has a calibration program for equipment that has a significant effect on the results. See Appendix B of this Quality Manual for the implementation of the traceability policy.

    5.6.2 Specific requirements

    Whenever possible, the laboratory operates a calibration program traceable to the International System of Units (SI). The use of external calibration services is limited to suppliers approved in accordance with Appendix B.

    and their calibration certificates contain the measurement results, the measurement uncertainty, and a statement of compliance with an identified meteorological standard, or an unamiguous reference to the specification (reference 5.10.4).

    5.6.3 Reference standards and reference materials

    A program and procedure exists for the calibration of the laboratory's reference standards. Intermediate checks of reference standards are carried out according to a procedure and schedule.

  • 5.7.1

    The laboratory has a plan and a procedure for the sampling of substances, materials, or products for subsequent testing (calibration) and are based on statistical methods whenever possible.

    5.7.2

    Any deviations, additions, or exclusions to the sampling procedure are recorded along with the sampling data.

    5.7.3

    The sampling procedure includes the relevant instructions for recording the relevant data.

  • 5.8.1

    The laboratory has a procedure for the transportation, receipt, handling, protection, storage, retention, and/or disposal of test (calibration) items.

    5.8.2

    The procedure of 5.8.1 above, includes the system for the identification of test (calibration) items.

    5.8.3

    The procedure of 5.8.1 above, includes the handling of abnormalities with the test (calibration) items.

    5.8.4

    The procedure of 5.8.1 above, describes appropriate facilities to avoid deterioration of and loss or damage to the test (calibration) items.

  • 5.9.1

    The laboratory has a procedure for assuring the quality of test (calibration) results. It involves inter-laboratory comparisons or proficiency testing programs that are planned and scheduled yearly.

    5.9.2

    The procedure in 5.9.1, above, has a deliverable that compares the data from all the laboratories and provides statistical analysis of the results. The results are reviewed and a corrective action is implemented if the laboratory's results are outside the statistically determined deviation.

  • 5.10.1 - General

    The laboratory reports the results in accordance with the test method required by the customer and includes all relevant information.

    5.10.2 - Test reports (Calibration certificates)

    The test report (calibration certificate) contains the following:

    title

    name and address of the laboratory and/or address of where testing (calibration) took place

    unique report (certificate) identifier appears on each page. the "page number" of "number of pages" also appears on each page

    Name and address of the customer

    identification of method

    identification of test (calibration) item per 5.8.2

    receive date and test (calibration) date of the test(calibration) item

    reference to the procedure (or sampling plan) used by the laboratory

    test (calibration) results, including units of measurement

    approved signatory (listed under the document(s)) authorizing the report (calibration)

    a statement that the results only pertain to the item(s) tested (calibrated)

    5.10.3 - Test Reports

    Additionally, the test report (calibration certificate) also contains:

    deviations from, additions to, or exclusions from the test method

    specific test conditions relevant to the results including environmental conditions according to 5.3.1.

    statement of the measurement uncertainty

    engineering judgement

    any other pertinent information required by the test method

    Sampling reports contain the following:

    date of sampling

    identification of substance, material, or product sampled

    sampling location

    reference to sampling plan used

    relevant environmental conditions

    5.10.4 - Calibration certificates

    In addition to 5.10.2 above, calibration certificates (including those from external suppliers) only include measurements that are traceable and do not recommend a calibration interval. If an instrument requires adjustment or repair, the calibration results before and after should be available.

    5.10.5 - Opinions and interpretations

    Opinions, interpretations, and engineering judgments are clearly marked and include the basis of the decision.

    5.10.6 - Testing and calibration results obtained from subcontractors

    Subcontracted results from approved suppliers are clearly documented to the customer.

    5.10.7 - Electronic transmission of results

    The procedure from 5.4.7 includes instructions regarding the electronic transmission of results.

    5.10.8 - Format of reports (certificates)

    Report and certificate templates are appropriate to the method(s) and are not misleading.

    5.10.9 - Amendments to test reports (certificates)

    Test reports are updated according to the document control procedure.