Technical Requirements



The following are the list of items presented in this section.
1. General
2. Personnel
3. Accommodation and environmental conditions
4. Test and calibration methods and method validation
5. Equipment
6. Measurement traceability
7. Sampling
8. Handling of test and calibration items
9. Assuring the quality of test and calibration results
10. Reporting the results

5.1 General

Compliance statement for clause No. 5.1.1 of ISO requirements.

* The lab recognizes that the following factors may effect the correctness and reliability of the tests, and implements its policies and procedures to ensure their correctness and reliability:

- human factors # Reference : Section 5.2
- accommodation and environmental conditions # Reference : Section 5.3
- test and calibration methods and method validation # Reference : Section 5.4
- equipment # Reference : Section 5.5
- measurement traceability # Reference : Section 5.6
- sampling # Reference : Section 5.7
- the handling of test and calibration items # Reference : Section 5.8
Compliance statement for clause No. 5.1.2 of ISO requirements.
* These factors are considered in determining the total measurement uncertainty and in developing uncertainty budgets. Additionally, these factors are considered by the laboratory when developing test procedures, in the training and qualification of personnel and in the selection of the equipment utilized.
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5.2 Personnel


Compliance statement for clause No. 5.2.1 of ISO requirements.
* Laboratory management ensures that lab personnel have the knowledge, skills and abilities to perform their duties. Competence is based on education, experience, demonstrated skills and training. Staff records contain the documentation of personnel education, experience, skills and training for the position held.
* Reference: Policy on Personnel
Compliance statement for clause No. 5.2.2 of ISO requirements.
* The individual employee and management are jointly responsible for setting, pursuing and achieving educational goals for professional advancement. The annual performance evaluation process can be used by the individual to discuss career advancement and training possibilities. By using this process, individuals have the opportunity to identify areas of study and request training oriented towards the attainment of their goals. Procedures for employee career development are described separately in the SOP
* Training needs are identified by the analyst's discipline and the scope of the lab. In-house training is conducted according to the laboratory’s training procedure. Present and anticipated tasks of the laboratory are addressed in the planning of special training modules.
* The skills of personnel are based on the demonstration of competence. This demonstration is to be completed successfully before analysts generate data independently. The effectiveness of personnel training is documented in, but not limited to, management reviews, internal audits, external assessments, proficiency testing and performance evaluations.
* Reference: Annual training plan and training modules.
Compliance statement for clause No. 5.2.3 of ISO requirements.
* All personnel are employed by the lab. When contracted and additional technical and key support personnel are used, lab ensures that such personnel are competent and supervised and that their work is in accordance with the lab’s management system.
* Reference : Training modules.
Compliance statement for clause No. 5.2.4 of ISO requirements.
* Job description for managerial, technical and key personnel are maintained as current.
* Reference: Job description of personnel.
Compliance statement for clause No. 5.2.5 of ISO requirements.
* The management authorizes personnel to perform particular types of duties like testing, issuing test reports that give opinions and interpretations, and operating particular types of equipment.
* Records of relevant authorization(s), competence, educational and professional qualifications, training skills and experience of all technical personnel, including contracted personnel, are written up and maintained. This information is readily available as a controlled management system document along with the date of confirmation of authorization and / or competence.
* References: List of authorized signatories, personnel training records.
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5.3 Accommodation and environmental conditions
Compliance statement for clause No. 5.3.1 of ISO requirements.
* The laboratory’s environmental conditions facilitate the correct performance of analytical testing. Test methods used by the laboratory include instructions about applicable environmental conditions. Examples of environmental influence are energy sources, lighting, biological stability, dust, humidity and temperature. The laboratory monitors critical environmental conditions to ensure that the results and the quality of measurements are not adversely affected or invalidated.
* Reference: Floor Plan of the lab
Compliance statement for clause No. 5.3.2 of ISO requirements.
Tests shall be stopped when the environmental conditions jeopardize the results of the tests.
* Environment conditions that require monitoring include, but are not limited to, room temperature and humidity, airflow rates for chemical fume hoods, bio-safety hoods and laminar flow hoods, metal contamination on benches and hoods in the laboratory performing metal analysis, microbiological contamination on bench surfaces and hoods in the microbiology laboratory and air sampling for microbiological contamination in microbiology areas. Where environmental controls are needed, the environmental conditions are recorded.
* Tests are stopped when the environmental conditions jeopardize the results of the tests. After appropriate corrective action, the testing is allowed to proceed.
* Reference: Records of environmental conditions.
Compliance statement for clause No. 5.3.3 of ISO requirements.
* Separate areas are maintained for incompatible activities. Measures taken to prevent cross-contamination include, but are not limited to:
# Chemistry laboratory is separated from microbiology laboratory
# Sample receiving and storage are conducted in designated areas
# Separate storage for standards and reference materials and cultures
# Microbiology media preparation and sterilization are separated from work areas.
* Reference: Floor plan of the lab
Compliance statement for clause No. 5.3.4 of ISO requirements.
* Laboratories are limited access areas. Access is controlled, but not limited to:
# Those issued with entry keycards.
# Escorted visitors
# Those issued with identification badges
# Security guards.
Compliance statement for clause No. 5.3.5 of ISO requirements.
* The lab ensures good housekeeping practices in the laboratory. The lab space, ventilation, air-conditioning, lighting, power and water supply, cleanliness, and safety are maintained to facilitate the proper performance of personnel and equipments.
* The lab’s chemical plan and hazardous waste management plan include measures to ensure good house keeping in the lab.
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5.4 Test and calibration methods and method validation


Compliance statement for clause No. 5.4.1 of ISO requirements.
* The lab adopts appropriate methods and procedures for all tests within its scope. This covers the sampling, handling, transport, storage and preparation of items to be tested.
* Reference: National specifications, ISO specifications, Methods published in AOAC / EPA / Pesticide Analytical Manual – US Food and Drug department / SOP’s
* Where appropriate, the measurement of uncertainty is estimated. Statistical techniques for analysis are also used for the evaluation of test results/data.
* The estimation of uncertainty of measurement is addressed in subsection 5.4.6 of this document. Section 5.9 of this document, assuring the quality of test results, describes the quality control processes, including the application of statistical techniques to support test and calibration data.
* The laboratory instructions for the use and operation of equipment required for the laboratory methods is either a laboratory procedure identified on the master list or in the equipment manuals. Procedures for the handling of items for testing are addressed in section 5.8. Equipment manuals and standards for the laboratory’s scope of testing technologies are controlled as external documents according to section 4.3. Deviations from test methods are documented, technically justified, authorized and, where circumstances call for it, accepted by the customer.
* Reference: Equipment manuals offered by the manufacturers.
Compliance statement for clause No. 5.4.2 of ISO requirements.
* The lab has a policy of using sampling and test methods in compliance with the customer requirements, preferably the national, international or regional standards. Standards thus used shall be valid and up-to-date wherever possible. Standards are supplemented if there is a requirement to ensure consistency.
* Standard methods are those published by international, regional or national standards-writing bodies, and by reputable technical organizations. These methods include those in national specifications, ISO specifications, methods published in AOAC / EPA / Pesticide Analytical Manual – US Food and Drug department / Pharmacopeial compendia / SOP’s. A standard method may be supplemented with additional details in the form of a laboratory standard operating procedure to ensure consistent application. Those methods specified by the manufacturer are also considered as standard methods.
* Laboratory methods are selected to meet the customer’s need as addressed in the SOPs.
* When the customer does not specify the method to be used, a standard method is preferred for use. If a standard method is not found, the laboratory may use either a non-standard method or modify a method for use with the concurrence of the customer. The non-standard or modified method is validated according to the SOPs on the validation of methods.
* The laboratory informs the customer when the method proposed by the customer is considered to be the incorrect choice or the incorrect revision for the intended purpose. This is done as part of the contract review addressed in section 4.4 on Review of Requests, Tenders and contracts.
* Reference: National specifications, ISO specifications, Methods published in AOAC / EPA / Pesticide Analytical Manual – US Food and Drug department / SOP’s
5.4.3 Lab developed methods:
* If the laboratory develops methods for its own use, it has its own procedure for introducing them. This procedure provides the planned activities, identification of qualified personnel, and resources. Plans are revised as methods are developed; effective communications amongst all personnel involved is strongly encouraged. Laboratory-developed methods adopted by the lab are used if they are validated according to sub section 5.4.5 of this document.
* Reference: SOP on validation and test methods.
5.4.4 Non-standard methods:
Compliance statement for clause No. 5.4.4 of ISO requirements.
Non-standard methods are those methods not taken from authoritative, validated sources. A non standard method has not undergone validation, such as a collaborative study or process to evaluate the method’s performance capabilities. Non-standard methods are selected for use when a customer request cannot be addressed with a standard method. Such methods are subject to agreement with the customer and a clear specification is made of the customers work request including the purpose of the tests. This process is described for contract amendments in sub section 4.4.5. *
* Non-standard methods are validated according sub section 5.4.5 – Validation of methods.
5.4.5 Validation of Methods
Compliance statement for clause No. 5.4.5.1 of ISO requirements.
The lab shall adopt the meaning of validation as given in this clause.
Compliance statement for clause No. 5.4.5.2 of ISO requirements.
* All non-standard methods, lab-designed / -developed methods, and standard methods used outside their intended scope are validated, if they have not been validated elsewhere, to confirm that they are fit for the intended use. Extensive trials are conducted for validation in order to meet the needs of the given application
* The techniques used for validation of a method consist of one or more of the following:
a. Calibration using reference standards or reference materials.
b. Comparison of results achieved with other methods.
c. Inter-laboratory comparisons.
d. Systematic assessment of the factors influencing the result.
e. Assessment of the uncertainty of the results based on scientific understanding of the theoretical principle of the method and on practical experience.
* Procedures are documented along with statement on fitness for intended use.
* Validation is conducted to confirm that the methods are fit for the intended use. The validation is documented.
Compliance statement for clause No. 5.4.5.3 of ISO requirements.
* The validation process addresses the needs of the given application or field of application. The laboratory analysts records the results obtained according to the SOP on validation. The validation results include a statement of whether the method is fit for the intended use. The needs of the customer define the intended use of the method. The attributes and the data quality objectives include, but are not limited to,:
# Accuracy
# Precision
# Specificity
# Detection limit
# Limit of quantitation
# Linearity
# Range and
# Ruggedness / Robustness
* If all the data quality objectives are met as indicated by the data collected, the method is considered as validated.
5.4.6 Estimation of uncertainty of measurement
Compliance statement for clause No. 5.4.6.1 of ISO requirements.
* Procedures for estimating uncertainty of measurements are laid down, for performing its own calibrations.
* Reference: SOP on uncertainty measurement.

Compliance statement for clause No. 5.4.6.2 of ISO requirements.

 

* The laboratory has developed an SOP, “Estimation of uncertainty measurement”, to estimate the uncertainty of measurement for testing activities. The application of details in cases where the nature of the test method may preclude rigorous, metrologically and statistically valid calculation of uncertainty measurement is addressed in the procedure. An attempt is made to identify all the components of uncertainty and make a reasonable estimation of the measurement uncertainty. This estimation is based on knowledge, experience, and validation data of the performance of the method and on the measurement scope. If needed as a part of the laboratory data, the uncertainty measurement is reported according the SOP “Estimation of uncertainty measurement”.

 

* Reference : SOP on Estimation of Uncertainty Measurement.
Compliance statement for clause No. 5.4.6.3 of ISO requirements.

* When estimating the uncertainty of measurement, all important uncertainty components and all the factors that may have an affect on the quality of results are recorded in the uncertainty records for each determination and test technology as addressed in the SOP “Estimation of uncertainty measurement”.

 

* Reference : SOP on Estimation of Uncertainty Measurement.
Compliance statement for clause No. 5.4.7 of ISO requirements.
* Calculations and data transfers are reviewed before the data is reported. All changes are identified and verified where they occur. This process is detailed in section 5.9 and the SOP on assuring the quality of test results.
Compliance statement for clause No. 5.4.7.2 of ISO requirements.
* When computers or automated equipments are used for the acquisition, processing, reporting, storage or retrieval of test data, the laboratory follows the process in its data protection procedure.
a. Computer software developed by the user is documented in sufficient detail and is suitably validated as being adequate for use:

* If computer software is developed by the user, its development is documented in detail and algorithms are validated.

 

b. Procedures are established and implemented for protecting the data; such procedures shall include, but not be limited to, the integrity and confidentiality of data entry or collection, data storage, data transmission and data processing.

 

* The laboratory’s data protection procedures addresses the protection of data to include, but not be limited to, data integrity, data confidentiality, and data collection, storage, transmission and processing.

 

c. Computers and automated equipment are maintained to ensure their proper functioning and are provided with the environmental and operating conditions necessary to maintain the integrity of test and calibration data.

 

* Computers and automated equipment are maintained to ensure their proper functioning and are provided with environmental and operating conditions necessary to maintain the integrity of test and calibration data.
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5.5 Equipment


Compliance statement for clause No. 5.5.1 of ISO requirements.

* The lab is furnished with all the items for sampling, and the measurement and test equipment required for the correct performance of the tests. In those cases where the lab needs to use equipment outside its permanent control, it is ensured that the requirements of ISO 17025 standards are met.

 

Compliance statement for clause No. 5.5.2 of ISO requirements.

 

* The lab ensures that all equipment and software used for testing and sampling are capable of achieving the accuracy required and comply with the specifications relevant to the tests concerned. Calibration programs are established for major equipments where these properties have a significant effect on the results.

 

* Before being placed into service, equipment (including that used for sampling) is calibrated or checked to establish that it meets the lab’s specification requirements and ensure that it complies with the relevant standard specifications.

* Reference: Calibration Schedule of Equipment

 

Compliance statement for clause No. 5.5.3 of ISO requirements.

* Personnel are authorized to operate equipment according to sub section 5.2.5 - Management authorization. The authorization is based on work assignment, training, experience and demonstrated proficiency. Equipment manuals and maintenance procedures are maintained and supplied to laboratory personnel as described in sub-section 4.3.1.

 

Compliance statement for clause No. 5.5.4 of ISO requirements.

* All equipment and their software significant to the results of testing and / or calibration, are identified by a unique alphanumeric code number.

 

* Reference : SOP on Indexing and Numbering.
Compliance statement for clause No. 5.5.5 of ISO requirements.

There should be an introductory sentence such as "Records of all major items of equipment affecting tests and calibrations are maintained and include the following information:"

 

a. The identify of the item of equipment and its software.

b. The manufacturer’s name, type identification, and serial number or other unique identification.

 

c. Checks that the equipment complies with the specification (see 5.5.2)

d. The current location, where appropriate.

 

e. The manufacturer’s instructions, if available, or reference to their location.

f. Dates, results and copies of reports and certificates of all calibrations, adjustments, acceptance criteria, and the due date of the next calibration.

 

g. The maintenance plan, where appropriate, and maintenance carried out to date.

* Records are maintained of each item of equipment and its software significant to the tests and calibrations performed. These are kept according to the procedure on instrument and equipment documentation and records. They include at least the following items:

 

# Identity of the item of equipment and its software.

# Manufacturers’ name, type, identification and serial number or other unique identification.

 

# Performance checks that the equipment conforms to testing parameters and acceptance criteria.

 

# Location of the equipment.
# Location of the manufacturers instructions.
# Dates, results of copies of reports and Certificates of calibrations, adjustments, acceptance criteria and the due date of next calibration-
# Maintenance plan and maintenance carried out to date
# any damage , malfunction, modification or repair to the equipment.
* Reference: Equipment Log and Maintenance records.
Compliance statement for clause No. 5.5.6 of ISO requirements.
* There are use, calibration and maintenance of equipment instructions for all measuring equipments in order to prevent deterioration or contamination.
* Reference: SOP on calibration of equipment, SOP on handling of test items.

Compliance statement for clause No. 5.5.7 of ISO requirements.

 

* Nonconforming equipment: Any item of equipment which has been subjected to overloading or mishandling or which gives suspect results, or has been shown by verification or otherwise to be defective, is taken out of service, clearly identified, labeled and marked as being out of service, kept at a specified place until it has been repaired and shown by calibration or test to be performing satisfactorily.

 

* The procedures for examining the effect of the defect or departure from specified limits on previous tests are specified in the “Control of nonconforming work” procedure.

 

Compliance statement for clause No. 5.5.8 of ISO requirements.

* Labeling: wherever practicable, all equipment under the control of the lab and requiring calibration is labeled, to indicate the status of calibration. Labels include the date last calibrated and the recalibration date.

 

* Alternatively equipment calibration status may be identified in an associated record.
* Different coloured labels are used for different methods of maintenance and calibrations.
Compliance statement for clause No. 5.5.9 of ISO requirements.

* If for any reason, equipment leaves the control of the laboratory, the function and calibration status of the equipment is checked upon return and shown to be satisfactory before the equipment is returned to service.

 

Compliance statement for clause No. 5.5.10 of ISO requirements.

* Intermediate calibration conformation checks are performed to maintain confidence in the calibration status of the equipment. These checks are conducted according to the procedure in section 5.9: Assuring the Quality of Test Results.

 

Compliance statement for clause No. 5.5.11 of ISO requirements.

* Correction factors: The lab ensures that copies of software are correctly updated, and maintained to ensure that true correction factors are always put into use. When calibrations give rise to a set of correction factors, the lab ensures that the copies and computer software are correctly updated.

 

Compliance statement for clause No. 5.5.12 of ISO requirements.

* The test and calibration equipment including both hardware and software are safeguarded from adjustments that would invalidate the test or calibration results. Safeguards are provided in the control of access to the laboratory.

 

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5.6 Measurement traceability


Compliance statement for clause No. 5.6.1 of ISO requirements.
* The lab calibrates all equipment used for tests, including equipment used for subsidiary measurements (e.g. for environmental conditions) which have a significant effect on the accuracy or validity of the result of the test. The lab has an established program and procedure for calibrating its equipment, which is related to its scope of activities.
5.6.2 Specific Requirements
5.6.2.2 Testing
Compliance statement for clause No. 5.6.2.2.1 of ISO requirements.

* Calibration of measuring and test equipment is always ensured. When the calibration contributes little to the total uncertainty of the test result, and calibration is not needed, the lab ensures that the equipment used can provide the uncertainty of measurement needed.

 

Compliance statement for clause No. 5.6.2.2.2 of ISO requirements.

* If SI units are not applicable, traceability of measurements is ensured through certified reference materials from competent suppliers, agreed methods and / or consensus standards, and participation in inter-laboratory comparisons where possible.

 

5.6.3 Reference standards and reference materials.
Compliance statement for clause No. 5.6.3.1 of ISO requirements.

* The lab has a program and procedure for the use and maintenance of calibration standards. Reference standards are calibrated by bodies that provide traceability. These standards are used for calibration purposes only.

 

Compliance statement for clause No. 5.6.3.2 of ISO requirements.

* A reference material is a homogenous and well-characterized substance used for the standardization of equipment used in the testing process. Reference materials are traceable to national / international standard reference materials (SRMs) such as the National Institute of Standards and Technology (NIST) or certified reference materials (CRMs) from competent suppliers of reference materials. The measurement integrity of internal reference material generated by the laboratory is evaluated against either SRMs or CRMs from an independent source when this is technically and economically possible.

 

Compliance statement for clause No. 5.6.3.3 of ISO requirements.

* Intermediate checks to verify calibration status of standards, certified reference materials and working standards are as per defined procedures.

 

Compliance statement for clause No. 5.6.3.4 of ISO requirements.
* The lab has procedures for the safe handling, transport, storage and use of reference standards and reference materials.
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5.7 Sampling
Compliance statement for clause No. 5.7.1 of ISO requirements.
* Sampling procedures and plans based on statistical methods are made available to the personnel at the place of sampling. Defined sampling processes address the factors that need to be controlled to ensure the validity of tests.

* Reference: SOP on Sampling

 

Compliance statement for clause No. 5.7.2 of ISO requirements.

* Whenever the client requires deviations, additions or exclusions from the documented sampling procedures, these are recorded in detail with the appropriate sampling data and are included in all documents containing test results. These are communicated to the responsible personnel.

 

Compliance statement for clause No. 5.7.3 of ISO requirements.

* The lab has procedures for documenting sampling details that form part of testing undertaken. These records include the use of relevant sampling procedures, identification of the sampler, environmental conditions and diagrams or equivalent means of identifying the sampling location, as necessary, and statistics of the sampling procedures where appropriate.

 

* Sampling by the lab is done as per pre-determined procedures and SOPs and documented in the test requisition form and test report.
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5.8 Handling of test and calibration items
Compliance statement for clause No. 5.8.1 of ISO requirements.

* The lab has specially designated areas for the receipt, handling, protection, storage, retention and disposal of test items to protect the sample integrity, and the interests of clients and the laboratory.

 

* Disposal methods for samples and related materials are clearly laid down.
* Reference: SOP on Receipt, Handling, Storage and Disposal

Compliance statement for clause No. 5.8.2 of ISO requirements.

 

* The laboratory has a system for uniquely identifying the samples. The sample number is used to track its progress from the time it is collected / submitted until the analysis is completed and it is disposed of. The sample number is also used to provide traceability between the sample and data. The numbering system also provides traceability during the transfer of samples within the laboratory and between laboratories in the case of administratively transferred samples. The identification system is described in the SOP on registration of samples.

 

Compliance statement for clause No. 5.8.3 of ISO requirements.

* Upon receipt of the sample, abnormalities or departures from the normal / specified conditions (for example, contract specifications, analysis requested and chain of custody) are recorded according to the SOP on sample registration.

 

* When the samples received do not meet the established acceptance criteria as given in the SOP on sample registration, laboratory personnel seek further instructions from the customer before proceeding. Communication with the customer is documented in the “Customer Intimation Form”.

 

Compliance statement for clause No. 5.8.4 of ISO requirements.

* The lab has created facilities to prevent deterioration, loss or damage to the test items during storage, handling and preparation. Procedures and facilities are available to store the test items in the specified environmental conditions. Procedures facilitate monitoring and recording. Security arrangements are also made for the proper protection and security of the test items in order to protect their integrity.

 

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5.9 Assuring the quality of test and calibration results


Compliance statement for clause No. 5.9.1 of ISO requirements.
* The lab believes that assurance of the quality of test and validation results to the customer is of top priority. To fulfill this, management has designated an independent quality assurance manager, under the direct control of top management. All the original copies of MS documents are under the control of the quality manager. The lab adopts planned monitoring procedures which include the following steps:
a. Regular use of certified reference materials and / or internal quality control using secondary reference materials.
* Certified reference materials (CRMs) / secondary reference materials wherever required.
b. Participation in inter-lab comparison or proficiency-testing programmes.
* Participation in inter-laboratory proficiency testing programs conducted by national accreditation bodies or any other competent institutions.
c. Replicate tests or calibrations using the same or different methods.
* Conduct of replicate tests and calibration using different methods.
d. Retesting or recalibration of retained items.
* Retesting of retained items.
e. Correlation of results for different characteristics of an item.
* Correlation of results for different characteristics of an item.
* Quality assurance through QC samples.
* Routine process verification.
* Preparation of trend analysis.
Compliance statement for clause No. 5.9.2 of ISO requirements.
* The laboratory has defined the criteria for quality control data and performs analysis by such means as control charting. When data is found to be outside the established criteria, action is taken in accordance with the laboratory’s control of nonconforming work procedure.
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5.10 Reporting the results


Compliance statement for clause No. 5.10.1 of ISO requirements.
* Results of tests are reported accurately, clearly, unambiguously and objectively in accordance with the specification requirements.
* All test reports are issued in the format specified or as required by contract. Test reports contain information required by Cl.5.10.2 and 5.10.3.
* Results may be reported in brief with respect to internal customers and / or under certain specific contracts with customers.
* The lab maintains all the information/ raw data pertaining to the job, even though the test report contains simplified/condensed information about all the tests done.
* Reference: Test Report Format
Compliance statement for clause No. 5.10.2 of ISO requirements.
"The lab is required to fulfill the following requirements for its test reports: …"
a. A title (e.g.” Test Report” or "Calibration Certificate")
b. The name and address of the lab, and the location where the tests and / or calibrations were carried out, if different from the address of the lab.
c. Unique identification of the test report or calibration certificate (such as the serial number), and on each page an identification to ensure that the page is recognized as apart of the test report or calibration certificate, and a clear identification of the end of the test report or calibration certificate.
d. The name and address of the customer.
e. Identification of the method used.
f. A description of the condition of the item(s) tested or calibrated and their unambiguous identification.
g. The date of receipt of the test or calibration item(s) where this is critical to the validity and application of the results, and the date(s) of performance of the test or calibration.
h. Reference to the sampling plan and procedures used by the lab or other bodies where these are relevant to the validity or application of the results.
i. The test or calibration results with, where appropriate, the units of measurement.
j. The name(s) function(s) and signature(s) or equivalent identification of person(s) authorizing the test report or calibration certificate.
k. Where relevant, a statement to the effect that the results relate only to the items tested or calibrated.
* The lab’s test reports include the following information as a minimum unless otherwise agreed to:
a. Title
b. The name and address of the lab where tests are done.
c. Test report and page numbers with integrity.
d. Name and address of the customer.
e. Identification of the method used.
f. Description and condition of the sample.
g. Date of receipt of the sample and date(s) of performance of tests.
h. Reference to sampling plan and sampling procedure where appropriate and deviations if any, where relevant.
i. Test results with units of measurement where appropriate.
j. Name, function and signature or equivalent identification of authorized person.
* A statement to the effect that the results relate only to the sample tested.
5.10.3 Test Reports:
Compliance statement for clause No. 5.10.3.1 of ISO requirements.
a. Deviation from, additions to, or exclusions from the test method, and information on specific test conditions, such as environmental conditions.
b. Where relevant, a statement of compliance / non-compliance with requirements and / or specifications.
c. Where applicable, a statement on the estimated uncertainty of measurement. Information on uncertainty is needed in test reports when it is relevant to the validity or application of the test results, when a customer’s instruction so requires, or when the uncertainty affects compliance to a specification limit.
d. Where appropriate and needed, opinions and interpretations.
e. Additional information which may be required by specific methods, customers or groups of customers.
* In addition to the information given under Cl.5.10.2, test reports also contain the following wherever necessary and applicable.
a. Any deviations, additions or exclusions from the specification requirements (test methods) and environmental conditions.
b. A statement of compliance / non-compliance with reference to requirements.
c. A statement of uncertainty of measurement.
d. Opinions and interpretations.
e. Any other information required by specific methods or customers.
* If any amendments are to be made to an issued test report because of transcription errors or a written request by the customer, QA Unit verifies the request. Where substantial evidence is presented of the need to do so, the customer shall surrender the original and the copy of the test report to the lab. These will be cancelled and kept in the records. A new set of test reports to No…. (Original No.) will be issued in lieu of the cancelled report.
Compliance statement for clause No. 5.10.3.2 of ISO requirements.
a. The date of sampling.
b. Unambiguous identification of the substance, material or product sampled (including the name of the manufacturer, the model or type of designation and the serial numbers as appropriate).
c. The location of sampling, including any diagrams, sketches or photographs.
d. A reference to the sampling plan and procedures used.
e. Details of any environmental conditions during sampling that may affect the interpretation of the test results.
f. Any standard or other specification for the sampling method or procedure, and deviations additions to or exclusions from the specification concerned.
* Test reports containing the results of sampling include:
a. Sampling date / dates.
b. Unambiguous identification of the substance, material or product sampled (including the name of the manufacturer, the model or type of designation and the serial numbers as appropriate).
c. Location of sampling and its layout (diagrams, sketches, photographs)
d. Reference to the sampling plan and procedures used.
e. Significant environmental conditions during sampling.
f. Specification for the sampling method and deviations, additions etc., if any.
g. Details of sample drawn. Methods of storing, packing, handling and transportation of the sample, wherever relevant.
Compliance statement for clause No. 5.10.5 of ISO requirements.
* Laboratory management expresses its opinion and interpretation of the compliance or non-compliance of results through the laboratory classification assigned to each sample. These are clearly marked in the test reports.
Compliance statement for clause No. 5.10.6 of ISO requirements.
* Report of results from the sub-contractor are obtained in writing, print or electronically and such sub-contracted results are identified clearly in the reports.
Compliance statement for clause No. 5.10.7 of ISO requirements.
* Transmission of results through telephone, fax for advance information are followed by original print dispatch. Electronic reports wherever made, comply with cl. 5.4.7 of ISO 17025
Compliance statement for clause No. 5.10.8 of ISO requirements.
* Result report formats are made are such as to minimize ambiguity, misunderstanding and misuse.
Compliance statement for clause No. 5.10.9 of ISO requirements.
* Material amendments to test reports are made through addendums or supplements and as per cl.5.10.2 and 5.10.3.
* If it is necessary to issue a new test report, this will be uniquely identified and contain a reference to the original report that it replaces.
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