Rev 5_section 1.5.07 ( Umesh)

7/31/2019 Rev 5_section 1.5.07 ( Umesh)

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5 TECHNICAL REQUIREMENTSPrinted 15.04.2012 Created 19.04.2012

5 Technical Requirements

5.1 General

5.1.1 Correctness and Reliability(Ref Procedure No. ARJ-P -14)(Ref Uncertainty Budget form ARJ-F-19)

Correctness and reliability of the tests performed by AREEJ many contributing factors. Thesefactors include:

Human factorsAccommodation and environmental conditionsTest methods and method validationEquipmentMeasurement trace abilitySamplingHandling of test items

5.1.2 Measurement UncertaintyThe above factors have an affect on measurement uncertainty. ARJ conscientiously takes thesefactors into account in executing/ developing test methods and procedures, training programs,

qualification of personnel, the selection and calibration of the equipment we uses.

This section discusses these factors and the programs that we have in place to address them toensure that the measurement uncertainty is acceptable to the tests being performed.

See section 5.4.6 for more details.

5.2 Laboratory Personnel (Competence, Awareness, Training)(Ref Procedure No. ARJ-P -08)(Ref Training Plan form ARJ-F-20)(Ref Preliminary Evaluation of Training form ARJ-F-19)(Ref Training Record ARJ-F-21)

5.2.1 Competence and QualificationARJ Management ensures the competency of all who operate specific equipment, who performtests and/or calibrations, evaluate results and sign test reports. When using staff that isundergoing training, adequate and appropriate supervision is provided. Personnel performingspecific tasks are qualified on the basis of appropriate education, training, experience, and/or demonstrated skills, as required.

The evaluation of personnel is a major part of laboratory assessments. This criterion is evaluated based on the range, complexity and frequency of performing of tests for which accreditation is

sought.

Document Name Ref / Document No. Sheet Rev

Technical Requirement 5 1 of 16 00


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Vision deficiencies may prevent some people from performing some work satisfactorily. It is theresponsibility of the laboratory management to ensure in such cases that vision problems shallnot affect validity of results.

Personnel responsible for giving opinions and interpretations shall have in-depth knowledge of the relevant technical discipline. They should comply with the additional aspects of thecompetence ISO/IEC 17025:2005.

5.2.2 Training Policies and ProceduresLaboratory Management shall formulate goals for the laboratory personnel with respect to their skills, education and training. Laboratory Management shall maintain current job descriptionsfor the laboratory manager, technical and key support personnel involved in testing andcalibration activities.

ARJ shall have proper procedures for training new technical personnel and for developing theexpertise of existing technical personnel in new or rarely used techniques. The criteria used toassess the competence of trainees shall form an integral part of the procedures. Records of training and assessments of competence shall be kept. These shall include or refer to records of test results performed during training and assessment of competence. The validity of results

produced by technical personnel, particularly in the early stages after completion of training innew techniques shall be monitored.

Training in the laboratory must include all methods or parts of methods and techniques that personnel are asked to perform. Minimally, the analyst must demonstrate competency through

observation by management and verification using replicate and/or check samples.

Training is designed to be relevant to the current and anticipated work of the Lab.

5.2.3 Employees

Testing must be either performed or supervised by experienced/competent personnel.

5.2.4 Job DescriptionsARJ maintains current job descriptions for all personnel (managerial, technical, and support

personnel) involved in tests and or calibrations are maintained centrally in the administrationarea of the laboratory.

Minimum contents of job description include:o The duty of performing tests and/or calibrationso The act of planning tests and/or calibrations and evaluation of resultso The responsibility of developing and validating new methods as/ when requestedExpertise and experience requiredQualifications and training programsManagerial duties

Job descriptions are dated and signed to demonstrate that each employee has read it and is inagreement. They are maintained current.

5.2.5 Competency of Lab Personnel The Lab qualifies personnel performing specific tasks through education, training, experience or




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demonstrated skills, as appropriate. The Lab maintains records of competency, educationalqualifications, training, skills, and experience for all lab personnel, as appropriate

The purpose of these records is to provide evidence that personnel have been adequately trainedand their competence to perform particular tests has been assessed. In some cases it may be

pertinent to state any particular limitations to competence. The records are maintained in aregistry of skills and include:

Academic and professional qualificationsExternal and internal courses attendedo Relevant on-the-job training and retraining as necessary

(i.e.; demonstration of competence)

Skills and experience (i.e.; resume)Relevant authorisations

Records are held centrally in the administration area.

5.3 Accommodation and Environmental Conditions (Infrastructure)

5.3.1 FacilityLaboratory management shall ensure that the environmental conditions shall not invalidate theresults of the analysis or adversely affect the required quality of any measurement.

It is important that the working environment of the laboratory is free from excessive draughts.

The temperature should be reasonably stable and uniform and any temperature gradientsmeasured vertically, horizontally should be small.

5.3.2 Monitoring Apart form above, due attention shall be paid, for example, to biological sterility, dust,electromagnetic disturbances, radiation, humidity, electrical supply, and sound and vibrationlevels, as appropriate to the technical activities concerned. Tests and internal calibrations shall

be stopped when the environmental conditions jeopardize the results of the test and /or calibration activities.

5.3.3 Separation of Incompatible ActivitiesAny areas considered as incompatible activities are effectively separated. This can include also a

proper sanitation facility to exclude the possibility of cross-contamination. Segregation of activities is achieved through time and space allocations.

5.3.4 Controlled AccessAccess to and use of areas affecting quality of testing is adequately defined and controlled.

Access to the laboratory is restricted to authorized personnel. The authorised personnel are madeaware of the following items;

o The intended use of the areao The restrictions imposed on working within such areaso The reasons for imposing the restrictions.

5.3.5 Good House Keeping Document Name Ref / Document No. Sheet Rev



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The Lab ensures good housekeeping. Special procedures are prepared when necessary.Controlled use of cleaning and pest control materials is ARJ. The laboratory complies with thelocal health and safety requirements.

5.4 Test and Calibration methods and method validation(Ref Procedure No. ARJ-P -11,12 )(Ref Calibration Equipment form ARJ-F-29)(Ref Calibration of Equipment ARJ-F-30)(Ref: Instrument List ARJ-F-28)

5.4.1 Policy for testing methodsA formalised system shall be in operation for issuing, reviewing and updating of methods andspecifications. The system shall enable the laboratory to be aware of any new editions of

published standards. Methods shall be reviewed regularly with respect to the publications of neweditions of standards, development in the testing technology and other relevant information.

Methods and procedures used for all tests and/or calibrations are appropriate as per:

o Sampling, handling, transport, storage, and preparation of items to be tested.o An estimation of the measurement of uncertainty as well as statistical techniques for

analysis of test data where appropriate.

Instructions on the use and operations of all relevant equipment and on the handling and preparation of items for testing are available. All Instructions, Standards, Manuals and reference

data relevant to the work of the laboratory are maintained current and readily available to personnel. Deviation from test methods must be documented, technically justified, authorized,and accepted by the customer.

5.4.2 Selection of methodsARJ selects test methods that meet the needs of the customer and are appropriate to the test

being performed.

The lab ensures the latest valid edition of the test method unless it is not appropriate or possible,or when the customer requests a certain earlier revision level to be executed.

Methods that have been published either in International, or ARJ by reputable technicalorganisation, or in relevant scientific texts or journals , or as specified by the manufacturer areselected when the customer does not specify the method to be used. These methods may beadopted from the AOCS & IUPAC Standards

The ability of the laboratory to achieve satisfactory performance against documented performance characteristics is verified before samples are analysed.

Laboratory-developed methods or methods adopted by the laboratory may also be used if theyare appropriate for the intended use and if they are validated. The customer is informed as to themethod chosen. The laboratory confirms that it can properly operate Standardized Methods

before introducing the tests. If the standardized method changes, the confirmation is repeated.

The customer is informed when the method proposed by the customer is considered to beinappropriate or out of date.




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5.4.3 Laboratory-developed methodsAt this moment ARJ does not develop any test methods only international standard test methodsused .(eg ACOS, IUPAC)

In case in future if laboratory want to develop its own test methods following procedure shallfollow. Laboratory developed test methods are planned and assigned to qualified personnelequipped with adequate resources. As the development of the test methods proceeds, plans areupdated and technical changes are duly communicated to all affected personnel

Methods developed in-house are validated and authorised before use where available. CertifiedReference Materials (CRM) are used to determine any systematic bias, or where possible resultsare compared with other techniques, preferably based on different principles of analysis.Determination of uncertainty must be part of this validation process, and is essential for ongoingquality control.

5.4.4 Non-Standard methodsDiscussion and agreement for the use of non-standard methods is recorded as part of contractreview procedures (See section 4.4).

When it is necessary for the Lab to select non-standardized test methods, the methods are subjectto agreement with the customer per the customers documented requirements and specifications,and are validated before use. Qualitative test methods must be validated to demonstrate

estimated sensitivity and specificity, relative accuracy to official methods (If appropriate) positive and negative deviation, limit of detection, matrix effect, repeatability, andreproducibility.

Quantitative test methods are validated to demonstrate specificity, sensitivity, and relativeaccuracy, positive and negative deviation, repeatability, reproducibility, and limit of determination.

5.4.5 Validation of methods

5.4.5.1 Performance CharacteristicsValidation of methodology is a value judgement in which the performance parameters of the

methods are compared with the requirements for the test data. A prerequisite for a valid methodis that data produced by the method must attain a state of statistical control. Inter-laboratoryComparison or proficiency testing must be carried out at least once in every year with anapproved laboratory to find out the accuracy of data and reports.

5.4.5.2 Fit for UseAll modified/extended/amplified standard methods as well as laboratory designed test methodsand non-standard test methods and procedures are validated to ensure that such methods and

procedures are fit for their intended use and are relevant to the requirements of ISO/IEC 17025Clause 5.4.5 as well as the customer.

All type of test methods, for example non-standard methods, laboratory-designed methods or standard methods used outside their intended scope, and amplifications and modifications of standard methods shall be examined in regular intervals to meet the given application or field of




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application.

Developments in methodology and techniques require methods to be changed from time to time.The difference in performance between revised and obsolete methods is established so that it is

possible to compare old and new data.

Where a change in method involves only minor adjustments such as sample size, or differentreagents, the amended method is validated and the changes brought to the attention of accreditation body at the time of next accreditation audit.

Records are kept on all validation activities. The Laboratory Manager or his deputy shall beresponsible for the validation and adoption of new test methods and amendments of existing testmethods.

5.4.5.3 Customers NeedsValidation includes the specification of the requirements, determination of the characteristics of the methods, the comparison of the requirements with the values of the characteristics of themethod, and a statement on the validity.

As method development proceeds, regular review is required to verify that the needs to thecustomer are still being fulfilled. Changing requirements requiring modifications to thedevelopment plan are approved and authorized.

Validation is always a balance between costs, risks, and technical possibilities.

5.4.6 Estimation of Measurement Uncertainty

5.4.6.1 CalibrationARJ shall develop procedures for estimating uncertainty of measurement when deemednecessary.

The uncertainty of test and calibration results are calculated and documented in accordance withthe requirements of ISO/EC 17025 clause 5.4.6.

Repeatability and reproducibility data are the components of measurement uncertainty and aredetermined as a first step towards producing estimates of this parameter.

5.4.6.2 Documented procedures detail the methods used for estimating uncertainty of measurement andinclude all uncertainty components, which are of importance in the given situation.

5.4.6.3 The data relevant to a particular test is presented on the test certificate or the test report. A detailof measurement uncertainty is shown in Figure 1.1 below




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FLOW DIAGRAM OF UNCERTAINTY ESTIMATION

Figure: 1.15.4.7 Control of data

5.4.7.1 Calculations and Data TransfersCalculations and data transfers are subject to appropriate checks in a systematic manner. TheLaboratory Manager validates test data through the following arrangements prior to release the



PrepareReport

Set Specification (If relevant)

NO

Quantify Uncertainty Sources

Do SignificantComponentsNeedRe-evaluation?

Re - evaluate theSignificantComponents

YES

Identify Uncertainty Sources

Estimate Standard Uncertainty byConverting to Standard Deviations

Calculate Combined Uncertainty


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final report to any external parties:

Checks to determine accuracy of calculations.Checks for transcription errors, omissions and mistakes.Checks to determine consistency with normal or expected values.

For those analyses where normal data calculation is required, it is performed according to theinstructions provided in the test method.

5.4.7.2 Computers and Automated Equipment Data generated using computer software programs that are interfaced directly to instruments

incorporates all dilutions and calculations, thereby eliminating the need for manual datareduction.

ARJ initially developed software in general use within its designed application range may beconsidered sufficiently validated. More details regarding Laboratory softwareconfiguration/modifications are validated and shown in the local level procedures.

Electronic records, electronic signatures, and handwritten signatures executed to electronicrecords must be equivalent to proper records and handwritten signatures to paper.

5.5 Equipment

5.5.1 Required Equipment ARJ is furnished with the necessary infrastructure, measurement, and test equipment requiredfor the correct performance of its testing. All equipments are used in an environment appropriateto its proper performance. All equipments required by a test are described in each method,including the equipments tolerance.

5.5.2 Required AccuracyThe equipment and related computer software are capable of achieving the accuracy requiredand suitable for the test specifications. Testing and verification programs are established for allitems of equipment having a significant effect on results. All Lab equipment is tested andcalibrated or checked to ensure it meets the equipment specification requirements and complieswith relevant standard specifications.

The procedures for checking newly received equipment are as determined by manufacturersspecification and /or those determined by the laboratory during procurement.

5.5.3 Authorized Personnel Access to laboratory equipment is controlled to ensure that only authorised personnel useequipment. Instructions on the operation and maintenance of equipment are readily available.

5.5.4 Identification of Equipment Each item of equipment and its software used for testing and measurement significant to thequality of the testing results is uniquely identified through an asset ( Number / Identification ).

Components that can be intARJhanged between various instruments are tracked in equipmentlogbooks, but are not assigned individual asset ( Number / Identification ).




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5.5.5 Inventory and Maintenance RecordsRecords are maintained of each item of equipment and its software significant to the calibrations

performed. The information related to service and maintenance is kept in individual equipmentfiles/and or binders or stored electronically. Other information kept in files include;

o Condition when received (eg; new, used, refurbished).o Dates and results of calibration and or verification and date of next calibration and or

verification.o Performance history when appropriate (eg; response time, drift, noise level)

5.5.6 Equipment Procedures

The Lab has a procedure for safe handling, transport, and storage of testing equipment to ensure proper functioning to prevent contamination or deterioration. Test equipment (both hardwareand software) is safeguarded from adjustments that would invalidate the test results. Proceduresfor each piece of measuring equipment are located in the appropriate room where the equipmentis located.

5.5.7 Out of Service Equipment All Lab equipment subjected to overloading or mishandling, or shown to be defective, outside of specified limits or giving suspect results is taken out of service. Such equipment is isolated or clearly marked as out-of-service until it has been repaired and shown to perform correctly. TheLab examines the effect of the equipment problem on previous calibrations and implements anynonconforming procedures, as required.

Out of service equipment is clearly marked as outlined in section 5.5.8The laboratory examines the effect of the defect or departure from specified limits on previoustest/and or calibrations and institutes the Control of Nonconforming Work procedure.

5.5.8 Calibration StatusCalibration labels have a write-on surface and a pressure sensitive adhesive (or a piece of paper with company logo on it). The areas that are filled out include the person who performed thecalibration, the date it was performed, the date it is due for re-calibration, and the equipmentsidentification number.

Measuring equipment that has failed calibration or is deemed out of service is labelled with Outof Service

5.5.9 Return to ServiceAll items of equipment that go outside the control of the laboratory for a period is checked toensure the function and calibration are satisfactory before being returned to service.

Any additional quality control checks are outlined in the Quality Control Plan section of theappropriate test method.

5.5.10 Periodic Checks

Periodic checks for equipment are carried out in a define procedure to maintain confidence incalibration status.

5.5.11 Correction Factors




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Calibrations that give rise to a set of correction factors are updated along with all copies of thisdata (eg; in computer software).

5.5.12 Safeguards and AdjustmentsTest and calibration equipment including hardware and software are safeguarded fromadjustments that invalidate test and/or calibration results/status.

1) Safeguards against adjustment for laboratory equipment (Hardware) include;

o Detailed Manufacturers manuals on the operation of the equipment.o Policies permitting only fully trained and competent personnel to operate equipment.

Access to the laboratory is restricted to authorised personnel.

2) Safeguards against adjustment of software includes;

Password protection for important files and packages.Access to laboratory is restricted to authorised personnel.

5.6 Measurement Trace ability

5.6.1 General The laboratory has an established programme and procedure (eg. Equipment instruction manual)for calibration of all equipment that are used for testing /calibration including equipment for subsidiary measurements that has a significant effect on the accuracy of the test result.

It is necessary to establish a program for the maintenance and calibration of equipment. The program includes a system for selecting, using, calibrating, checking, controlling andmaintaining:

Measurement StandardsReference standards used as measurement standards.Measuring and test equipment used to perform test and calibration.

Procedures are documented where appropriate. All measurements that contribute a defining rolein testing accuracy are based directly or indirectly on reference standards, reference materials,certified reference materials or other standards or materials having appropriate trace ability.

5.6.2 Specific requirements

5.6.2.1 Calibration (This part is applied only when we do calibration to external parties)All calibration work performed by the laboratory will be in accordance with the documented

procedure using equipment traceable to National/International Standards.

Calibration laboratories accredited to ISO/IEC 17025 are considered competent to provide theappropriate calibration services.

Traceability to SI units of measurement may be achieved by reference to an appropriate primary

standard or by reference to a natural constant, the value of which in terms of the relevant SI unitis know.




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The term identified metrological specification means that it must be clear from the calibrationcertificate against which specification the measurements have been compared with, by includingthe specification or by giving an unambiguous reference to the specification.

When the terms international standard or national standard are used in connection with traceability, it is assumed that these standards fulfil the properties of primary standards for therealisation of SI units.

Maintain certificates of all reference standards measuring equipment, or certified referencematerial used in ensuring traceability. Where trace ability to IKCL Standards of measurement isnot applicable, the laboratory provides satisfactory evidence of correlation of results, for example by participation in a suitable program of inter-laboratory comparisons or proficiencytesting.

Reference standards, such as thermometers and weights are traceable to a national or international standard

5.6.2.2 Testing

5.6.2.2.1 The extent to which the requirements in section 5.6.2.1 are followed depends on the relativecontribution of calibration uncertainty. If calibration is dominant factor, the requirements arestrictly followed. If, however, calibration is not one of the major contributors to the totaluncertainty, other ways for providing confidence may be used, as given in section 5.6.2.2.2

5.6.2.2.2 Where traceability of measurements to SI units is not possible or not relevant the laboratory shalluse certified reference material supplied by competent supplier to give a reliable physical or chemical characterisation of a material or use specified methods that are clearly described andagreed by all concerned parties.

The laboratory participates in proficiency testing and/or check sample programs. The LaboratoryManager maintains the list of programs.

5.6.3 Reference standards and reference materials

5.6.3.1 Reference standardsThe laboratory has programme and procedure for calibration of reference standard. The

reference standard shall be calibrated by approved bodies, which can provide trace ability to theInternational Standard. These reference standards are only used for calibration and not for regular testing purposes.

5.6.3.2 Reference materialsReference materials, used in the laboratory are traceable as defined in the above standard clause5.6.2.2.

5.6.3.3 Intermediate checksThe laboratory has performed checks on calibration status of reference, primary, transfer or working standards and reference materials in accordance with defined procedures and schedules.

5.6.3.4 Transport and StorageARJ uses a procedure for the safe handling, transport, storage and use of reference standards and




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reference materials to prevent contamination and in order to protect their integrity.

5.7 Sampling

5.7.1 Sampling Plan and ProceduresSampling is not the responsibility ARJ laboratory at this moment. The sample brought in andtaken for the testing

The sampling plan describes the allocation, withdrawal and preservation of a sample or samplesfrom a substance, matrix, material or product to yield the required information. For details pleaserefer the Sampling Procedures.

5.7.2 Deviations, Additions or ExclusionsAny deviations as per customer specific instructions from the documented standard procedureshall be communicated to all lab personnel and recorded in all test results.

5.7.3 RecordsAdequate sample identification upon receipt in the laboratory includes;

o Unique and unambiguous sample identification, usually a number or alphanumericidentification, retained throughout the testing life of the test item.

o Sampler Identification

o Sample source and date if availableo Identification number or description (from customer) if anyo Product descriptiono Tests desired and/or methods requestedo Date of receipto Delivery carrier o Sample condition, including temperature (if relevant)

5.8 Handling of test items

5.8.1 ProceduresThe Lab has procedures for the transportation, receipt, handling, protection, storage, retentionand disposal of test items to assure the integrity of the test and the interests of the laboratory andthe customer. Samples are stored so as to ensure their integrity by preventing againstdeterioration, contamination, and loss of identity. It is recognized that this is a general statement,

but details shall be elaborated in the relevant procedures/work instructions.

5.8.2 Identification of Test ItemsThe ARJ has an established system for identifying test items throughout the life of the item inthe Lab to ensure items cannot be confused physically. Sample labelling indicates the uniqueidentification and conforms to applicable legal requirements.

5.8.3 Receipt

The lab records abnormalities or departures of the test item from the normal or specifiedcondition required by the test method. The Lab consults the customer for further instructions before proceeding and records the discussion when there is doubt as to the suitability of a test




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item or when an item does not conform to the description provided, or when the test required isnot specified in sufficient detail.

Arrangements are in place to ensure that elapsed time between sampling and testing does notexceed test method specifications (holding time).

5.8.4 ProtectionThe Lab has a procedure and information on storage and transport of samples, includes allinformation that may influence the test result. This procedure has provided to those responsiblefor taking and transporting the samples.

The laboratory establishes whether the sample has received all necessary preparation or whether the customer requires preparation to be undertaken or arranged by the laboratory. Proper requirements for packaging, environmental conditions, and separation from incompatiblematerials are observed. Where samples have to be stored or conditioned under specificconditions, these conditions are maintained, monitored and recorded, where necessary.

Where a sample, or portion of sample, is to be held secure ( eg; for reasons of record, duediligence or to enable re-check analysis), the laboratory has storage and security arrangementsthat protect the condition and integrity of the sample.

5.9 Assuring the quality of test results (Internal Quality Control Checks IQC)ARJ has quality control procedures for monitoring the validity of tests undertaken. The resultingdata is recorded in such a way that trends are detectable and, where practicable, statistical

techniques shall be applied to the reviewing of the results.The validity of test results shall be monitored and reviewed by:

o Regular use of certified reference materials and/or internal quality control usingsecondary reference materials;

o Participation in inter laboratory comparison or proficiency-testing programmeso Replicate tests or calibrations using the same or different methodso Retesting of retained itemso Correlation of results of different characteristics of an item (if relevant)

5.10 Reporting the results

5.10.1 General ARJ provides test report to the customer accurately, clearly, unambiguously, objectively and inaccordance with any specific instructions in the test methods.

The results are reported in a standard test report format and include all the information requested by the customer and necessary for the interpretation of the test results and required by the testmethod.

The test report is designed so that its format minimizes the possibility of misunderstanding or misuse by the reader.

The test reports are issued as either hard copy or by electronic data transfer.

5.10.2 Analysis reports/Test CertificatesDocument Name Ref / Document No. Sheet Rev



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Signing authority for test reports is the responsibility of ARJ Manager or to the personnominated during his absence. Records of individuals with signing authority for test report areapproved by the Laboratory Manager and maintained by the ORC laboratory.

Hard copies of test reports include the page number and total number of pages.

Our test reports include the following information:

o A title - Test Reporto Name and address of our testing laboratory

o Unique identification of the test report and on each page an identification in order to

ensure that the page is recognized as part of the test report and a clear identification of theend of the test report.o The name and address of the customer o Identification of the method usedo A description of, the condition of, and unambiguous identification of the item(s) testedo The date of receipt of the test item (s) where this is critical to the validity and application

of the results, and the date (s) of performance of the testo Reference to the sampling plan and procedures used by the laboratory or other bodies

where these are relevant to the validity or application of the results.o The test results with, where appropriate, the units of measurementso The name (s), function (s) and signature (s) or equivalent identification of person(s)

authorizing the test report.o Where relevant, a statement to the effect that the results relate only to the items tested.

A statement is included specifying that the test report is not be reproduced except in full, withoutwritten approval of the Laboratory. Data reported to the customer contains the appropriatesignificant digits for each test method. Low-level data are identified as being below specifiedlimits.

5.10.3 Test Reports

5.10.3.1 In addition to the requirements of section 5.10.2, test reports include the following, wherenecessary for the interpretation of results:

o Deviations from, additions to, or exclusions from test method, and information onspecific test conditions, such as environmental conditions.

o Where relevant, a statement of compliance/non-compliance with requirements and/or specifications.

o Where applicable, a statement on the estimated uncertainty of measurement of the testresults; information on uncertainty is needed in test reports when it is relevant to thevalidity or application of the test results.

o Where appropriate and needed opinions and interpretations (see section 5.10.5)o Additional information required by specific methods, customers, or group of customers.

5.10.3.2 In addition to the requirements of section 5.10.2 and 5.10.3.1, test reports containing the result of sampling include the following, where necessary for the interpretation of results:




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o Date of samplingo Unambiguous identification of substances, matrix, material or product sampled (including

name of manufacturer, model or type of designation and serial numbers as appropriate).o Location of sampling, including any diagrams, sketches or photographs.o Reference to sampling plan and procedures used.o Details of any environmental conditions during sampling that may affect the

interpretation of the test resultso Any standard or other specification for the sampling method or procedure, and deviations,

additions to or exclusions from the specification concerned.

5.10.4 Calibration Certificates :

5.10.4.1 ARJ does not do any calibration activities hence this clause is not applicable..

5.10.4.2 This section is not applicable for ARJ

5.10.4.3 This section is not applicable for ARJ

5.10.5 Opinions and InterpretationsLaboratory shall document the basis upon which the opinions and interpretations have been

made. It would be appropriate to communicate the opinions and interpretations by direct dialogue with the customer. Records for all such communicationsshall be maintained.

Opinions and interpretations included in a test report may comprise, but not be limited to thefollowing:

Opinion on conformity of the results with requirementsFulfilment of contractual requirementsRecommendations on how to use the resultsGuidance to be used for improvements

In many cases it is appropriate to communicate the opinions and interpretations by directdialogue with the customer. This dialogue is written down.

5.10.6 Testing and Calibration results obtained from SubcontractorsIf subcontractors work is involved within the analysis report, It shall be clearly identified in thefinal report by the Laboratory Manager or his deputy or who ever releasing the final report to thecustomer. The subcontractor reports the results either in writing or electronically to our laboratory.

5.10.7 Electronic transmission of resultsIf the test results are transmitting to a customer via electronically (either by fax, telex, e-mail or through any other means), the requirements of ISO/IEC 17025 International standard shall be

met. (See 5.4.7). Reports to be protected before transmitting.




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5.10.8 Format of ReportsThe layout of the test report is such that the presentation of the test data facilitates ease of assimilation by the reader. The headings are standardized as far as possible.

5.10.9 Amendments to test reports and calibration certificatesWhen it is necessary to issue a complete new test report, it is uniquely identified and contains areference to the original that it replaces.

5.11 Occupational Health and Safety.

5.11 The health and safety management system is independent from, but closely aligned with theBusiness Management System. It is administrated by the QHSE Department of the ARJProcedures and Job Safety Analysis sheets in the Health and Safety manual address conditions

and activities encountered in the work environment such as exposure to hazardous materials,Use of personal protective equipment, and general safety. ARJ comply with Health and Safetyrequirements as specified in guideline provided by ARJ.



Rev 5_section 1.5.07 ( Umesh)

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