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Implementation of “INTERNATIONAL STANDARD –ISO/IEC 17025” –

General requirements for the competence of testing and calibration

laboratories-summary Chandran.udumbasseri, Technical consultant

cudumbasseri@yahoo.co.in.

1. Scope

For competence to carryout test and calibration, it covers calibration performed, using

standards, non standards and laboratory developed

The scope explains the competency of the laboratory to carry out tests and calibrations.

There are two types of laboratory. Some laboratory does only testing and analysis and

gives calibration of instruments for external calibration agency or laboratory. This

definitely adds expense to the laboratory. This may be due to the fact that laboratory

personnel are not competent enough to carry out calibration themselves. Sometimes NIT

traceable standards are not available for such laboratory. Nations importing international

standards are regularized by the government and in such countries laboratories have to

give the calibration work to external agencies.

If the laboratory has the capability to carry out both testing and calibration and have

laboratory personnel having required competency then such laboratory can go for

registration to ISO17025

Here the calibration standards are those procured from international agencies and NIT

traceable standards.

The scope explains calibration using non standards meaning these standards need not be

traceable to NIT standards, but may be a secondary type whose traceability can be

achieved through secondary standards.

The scope also explains developing new calibration methods in the laboratory. Sometime

it is necessary to develop new calibration methods suitable for the laboratory. In such

cases method development, statistical method application to get repeatability and

reproducibility data for the new methods should be documented

So requirements are:

Well equipped laboratory that can conduct testing and calibration

Qualified laboratory personnel having competency in developing new methods of testing

and standardization

Check list

Document all calibration evidences and certificates

Document new method developments, statistical results and evidence that can support

Document the trainings given to the laboratory personnel with an objective to improve

their efficiency

Applicable to all organizations performing tests and calibration

Scope of applying this standard is wider with respect to testing laboratories. It can be a

part of an organization or independent

Applicable to all laboratories regardless of number of employees

There is no restriction on the number of laboratory personnel to get registered to his

standard

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For use by laboratories in developing their management system for quality,

administrative and technical operations

The scope is to develop as a quality management system for the laboratory both

administrative and technical operations.

Laboratory customers, regulatory authorities and accreditation bodies may use this to

confirm and recognize competence of the laboratories.

A laboratory accredited to this standard is a bench mark to recognize as competent

laboratory. Customers of the laboratory and other regulatory bodies both government and

non government organization can recognize the laboratory as competent

Compliance with regulatory and safety requirements are not covered by this standard

The scope of this standard should not be considered as an approval for compliance to

regulatory requirements of local government bodies and safety requirements of

international safety organizations (OSHA, etc..)

This standard covers the requirements of ISO 9001 quality management system. This

standard also covers technical competence that are not covered by ISO 9001

This standard encompasses the requirements of ISO9001 QMS. So separate accreditation

from ISO9001 is not insisted

Additionally this standard necessitates the requirement of technical competency of

laboratory and laboratory personnel.

4. Management requirements

4.1. Organization

Laboratory should carry out testing and calibration to meet the requirements of this

standard

Evidences should be documented on the work conducted by the laboratory to ensure that

the requirements of the standard is properly followed

The management system shall cover work carried out in its permanent facilities, at sites

and or at associated temporary facilities

The works to be included and audited are the one carried out in the laboratory itself. The

work done in a customer’s site is also included for auditing. If it is necessary to conduct

work in some other type of temporary facilities then such work will also be audited as per

the compliances requirements.

Laboratory as a part of an organization should have a responsible person at key position

to avoid any influence or conflict from the organizations other sections

The laboratory is considered as independent in its management from the rest of the

organization. Its decision should not be jeopardized from the bias of the rest of the

organization. Laboratory should have a responsible person at the key position whose

decision is the final one regarding the work and management of the laboratory.

The laboratory shall have managerial and technical personnel who have authority and

resources to carry out their duties (testing and calibration activities, modification,

rectification, improvement of these areas of work)

This emphasizes above requirements. The organization should delegate authority along

with responsibility to the key person of the laboratory.

The personnel should not be influenced by pressure like internal and external commercial

and financial which affect the work adversely

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The decision on work to be carried out in the laboratory should not be influenced by the

pressure from any person internal and external to the laboratory which may not be useful

and fruitful to the laboratory.

Should have policies and procedures to protect the customer’s interest and proprietary

rights

The laboratory needs a separate policy statement and should be exhibited to the public to

understand the priorities of the professionals and laboratory personnel to follow in their

work. The policy should imply customer’s interest and their proprietary rights

Should have policies and procedures to avoid situation that diminish confidence of the

customer

The content of the policy should be to boost customer confidence in the work

accomplishment of the laboratory

Should have defined organizational and structural relationship with the rest of the

organization-quality management, technical operation and support services

The organizational chart showing relationship of laboratory with the rest of the

organization, hierarchical relationship of laboratory personnel, transformation of

customer needs and requirements in to product and services that satisfies the customer

and enhance customer to supplier relationship

Should specify the responsibility, authority and inter relationships of all personnel who

manage, perform, and verify the quality of tests and /or calibration

Job description of each laboratory personnel should be documented. It should specify

responsibility, authority, inter relationship of each designated levels with the rest of the

organization. The relationship should indicate the work flow, quality testing/ calibration

work and assurance of quality that satisfy the customer needs and requirements.

Should provide adequate supervision of testing and calibration and training by a person

familiar with methods and procedures, purpose of each test or calibration and assessment

of the test and or calibration results

Should have technical management for supervising technical operation and the provision

of resources

Should appoint a quality manager, with defined responsibility and authority for ensuring

the management of quality that are followed at all times, he should have direct access to

higher level of management where decision are made relating to laboratory policies and

resources

Should appoint deputies for key managerial personnel

Should have awareness of their activities and ability to contribute for achieving

management objectivities.

4.2. Management system

The laboratory shall

Establish, implement and maintain a management system appropriate to the scope of

its activities

Document its policies, system, programs, procedures and instructions to the extent

necessary to assure the quality in testing and calibration

Communicate Documentation which should be understood and implemented

Define management system policies (statement) with quality manual

Establish overall objectives

Review during management review

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Issue Quality Policy Management under the authority of top management

The policy statement should include:

Commitment of laboratory to good professional practice and to its customer to serve

with quality in testing and calibration

Management’s statement of the laboratory’s standard of service

Purpose of management system related to quality

Requirement that all personnel concerned with testing and calibration should

familiarize quality documentation and implement policies and procedures in their

work

The laboratory management’s commitment to comply with this international standard

and to continually improve the effectiveness of the management system

Top management shall provide evidence of commitment to development and

implementation of management system

Top management shall communicate to the organization the importance of meeting

customer requirements government regulations

The quality manual shall include or make reference to the supporting procedures

including technical procedures. It shall outline the structure of documentation used in the

management system

The roles of technical management and quality manager should be defined in the quality

manual so as to comply with this international standard.

Top management should ensure integrity of management system and maintained while

changes in the system are planned and implemented

4.3. Document control

All laboratory documents shall be established, maintained and controlled

4.3.2. Document approval and issue

☼ All the documents used in the laboratory should be reviewed and approved by

authorized personnel. A list of all documents controlled with their revision status and

distribution shall be established and available

Ensure that

Appropriate controlled documents are available at all locations where operations are

essential

Documents are periodically reviewed and revised wherever necessary for suitability

and compliance

Obsolete documents should be removed from all locations of use

Any obsolete document retained for any legal or knowledge preservation shall be

marked

Documents generated by laboratory shall include, the date of issue, revision number,

page number, total number of pages or a mark to identify the end of document and the

issuing authority

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4.3.3. Document changes

o Changes in document shall be reviewed and approved by the same function that

performed original review. Otherwise specify the new designation to have access to and

ability for review

o If possible, altered text should be identified in the document

o If document amendment is allowed by hand, the required procedure with authorities shall

be defined (amendments shall be clearly marked, initialed and dated)

o A proper procedure for controlling documents stored in the computer shall be maintained

4.4. Review of requests, tenders and contracts

₤ The laboratory shall establish and maintain procedures for the review of requests, tenders

and contacts. The policies and procedures ensure that:

₤ The requirements including methods to be used should be defined, documented and

understood

₤ The laboratory has the capability and resources to meet the requirements

₤ The appropriate method is selected and is capable of meeting the customer’s

requirements

₤ Records of reviews shall be maintained including discussions with customer

₤ Subcontracted work review should also be maintained

₤ Deviation from the contract should be informed to the customer

₤ If any amendment needed to contract, then the process of preparation of contract should

be repeated and any amendment shall be communicated to all affected personnel

4.5. Subcontracting of tests and calibrations

◙ When subcontracting a work, then ensure that sub contractor is competent so that the

subcontractor complies with this international standard.

◙ The laboratory shall inform in writing to the customer about the new subcontractor and if

possible get approval for the customer

◙ The laboratory is responsible for the work of the subcontractor unless specified by the

customer for a specific subcontractor.

◙ The laboratory should keep a register for all subcontractors with their compliance to

international standard as evidence

4.6. Purchasing services and supplies

∆ Laboratory should have policy and procedure for the selection and purchasing of services

and supplies. Procedures for reception and storage of reagents and consumable materials

shall be documented

∆ The purchased items shall be inspected /verified to comply with the specification

requirements. The records of action shall be maintained

∆ Purchase order documents should be accompanied with data and specification to which

the purchased material should comply. These documents should be properly reviewed

before realizing to supplier.

∆ Laboratory should conduct suppliers’ evaluation (auditing) and maintain records of

evaluation

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4.7. Service to the customer

◘ The laboratory shall be willing to cooperate with the customer in clarifying customer’s

request and monitoring laboratory performance in relation to the job work executed

◘ The laboratory shall seek feedback from the customer. This feedback should be used to

improve management system

4.8. Complaints

♦ Laboratory shall have a policy and procedure to resolve customer complaints. Records of

such complaints and their corrective/preventive action records should be maintained.

4.9. Control of non conforming testing and /or calibration work

☼ The laboratory should have policy and procedure to control non conformance work. the

policy and procedure should ensure that:

□ The responsibilities and authorities for managing non conformance work shall be

defined and implemented when a non conformance work was identified

□ The non conformance work should be evaluated

□ Correction should be taken immediately

□ Customer should be notified about non conformance work and work should be

recalled

□ The responsibility for authorizing the resumption of work should be defined

☼ If the recurrence of non conformance work is doubted, then a corrective action as per

section 4.11 should be followed.

4.10. Improvement

► The laboratory should continually improve the effectiveness of management system

through the use of quality policy, quality objectives, auditing, analysis of data, corrective

and preventive action and management reviews

4.11. Corrective action

◊ The laboratory shall establish policies and procedures and designate personnel with

appropriate authorities to implement corrective action for non-conforming works (non

conformance to policies and procedures of management system or technical operations)

4.11.2. Cause analysis

♦ The procedure for corrective action should start with investigation for root causes of the

problem

4.11.3. Selection and implementation of corrective action

♀ The laboratory shall identify the potential corrective actions that can prevent recurrence

of the same problem. Corrective action report shall be documented with evidence of

follow up of actions for changes

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4.11.4. Monitoring corrective action

♯ The effectiveness of corrective action shall be monitored

4.11.5. Additional audits

◌ If the non conformities are non compliance with laboratory’s policies and procedures, an

audit should be conducted as given in 4.14 as soon as possible

4.12. Preventive action

→ If the non conformities concerning either technical operation or management system are

for the preventive action or improvement opportunities the actions should be planned,

implemented and monitored. The result shall show reduction in occurrence of such non

conformities and advantage from the opportunities for improvement

4.13. Control of records

╨ Laboratory shall establish and maintain procedures (for identification, collection,

indexing, access, filing, storage, maintenance and records disposal). Quality records

include internal audit reports and management reviews and corrective &preventive

actions

╨ All records should be stored, preserved and easily retrievable as and when required and

prevented from losing throughout the period of retention time established.

╨ All records should be secured and in confidence

╨ Electronically stored records should be protected and backed up and prevent from

unauthorized access

4.13.2. Technical records

♠ The laboratory shall retain records of original observations, data and information,

calibration records, staff records, a copy of each test report, calibration certificates issued,

for a definite period. The records should have sufficient information that affects

uncertainty to enable repeating tests if required. The records should have information of

personnel responsible for sampling and testing and result validation.

♠ Observations, data and calculations shall be recorded at the time they are made

♠ When mistakes occur in records, each mistake should be crossed and not erased. The

correct value should be entered alongside. Any alteration in records should be signed or

initialized by the person making the correction

4.14. Internal audits

♂ The laboratory shall conduct internal audits periodically to ascertain compliance with

management system and this international standard. The internal audit program shall

address all elements of the management system. The quality manager plans and organizes

audits as required by the schedule and requested by the management. This audit shall be

carried out by trained and qualified personnel and shall audit independent of the activity

to be audited.

♂ All audit findings that shows doubt on any results should be followed by corrective

action. The customers shall be notified about the non conformities of results

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♂ The area of activity audited, the audit findings, and corrective actions shall be recorded

♂ The implementation and effectiveness of corrective actions shall be followed and

verified.

4.15. Management reviews

ằ The laboratory management shall conduct a periodic review of the management

system at regular scheduled time to ensure the effectiveness and suitability of

management system and introduce necessary changes or improvements

ằ The review shall include:

ᾀ Suitability of policies and procedures

ᾀ Reports from managerial and supervisory personnel

ᾀ Outcome of recent internal audits

ᾀ Corrective and preventive actions

ᾀ Assessment of external bodies

ᾀ The results of inter-laboratory comparisons or proficiency tests

ᾀ Changes in the volume and type of work

ᾀ Customer feedback

ᾀ Complaints

ᾀ Recommendations for improvement

ᾀ Other relevant factors, such as quality control activities, resources and staff

training

ằ Findings from management reviews and actions that arise shall be recorded; the

action should be carried out within appropriate and agreed timescale

5. Technical requirements

ṱ The factors that determine the correctness of tests and calibration are:

ẹ Human factors

ẹ Accommodation and environmental conditions

ẹ Test and calibration methods and method of validation

ẹ Equipment

ẹ Measurement traceability

ẹ Sampling

ẹ The handling of test and calibration items

ṱ The factors contributing to the total uncertainty measurement differs between tests

and between calibrations. These factors should be accounted during developing test

and calibration methods, during training personnel and during selecting calibration of

equipments

5.2. Personnel

ṩ The laboratory management shall ensure the competence of all who operate specific

equipment, perform tests and calibration, result evaluation and authorizing the test

reports and calibration certificates. Staff under training shall be supervised. Specific

tasks should be performed by qualified personnel with appropriate education,

training, experience and skills

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ṩ The management shall formulate the goals with respect to education, training and

skills of the laboratory personnel. Laboratory should have policies and procedures for

identifying and training needs and providing training to personnel. These trainings

shall be relevant to the present and anticipated tasks of the laboratory. The

effectiveness shall be evaluated.

ṩ The laboratory shall use personnel who are employed or can use personnel hired

through contract. But hired personnel should be supervised and competency at work

in accordance to the laboratory management system should be evaluated.

ṩ Laboratory shall maintain job descriptions for managerial, technical and key support

personnel involved in tests and calibrations

ṩ The management shall authorize specific personnel to perform sampling, test and

calibration, to issue test reports and calibration certificates, to give opinions and

interpretations and operate particular type of equipments. The laboratory shall

maintain records of the relevant authorizations, competence, educational and

professional qualifications, training and skills and experience of all technical

personnel, including contracted personnel. This information shall be readily available

and shall include the date on which authorization and competence is confirmed.

5.3. Accommodation and environmental conditions

ṙ The laboratory facilities including lighting and environmental conditions shall be to

facilitate correct performance

ṙ The laboratory should ensure that the environmental conditions do not invalidate the

results or adversely affect the required quality of any measurement. Particular care

should be taken when testing and calibration are conducted at site other than

permanent laboratory. Technical requirements for accommodation and environmental

conditions that can affect the results shall be documented

ṙ The laboratory shall monitor, control and record environmental conditions as required

by the relevant specifications, methods and procedures or where they influence the

quality of the results. Due attention shall be paid to biological sterility, dust,

electromagnetic disturbances, radiation, humidity, electrical supply, temperature and

sound and vibration levels. The tests and calibration should be stopped when the

environmental conditions jeopardize the results

ṙ There shall be separation between incompatible conditions. Cross contamination

should be avoided

ṙ The area affecting the quality of the test and calibration shall be controlled. The

laboratory decides the extent of control

ṙ Measures shall be taken to ensure good housekeeping in the laboratory. Special

procedures shall be prepared if necessary

5.4. Test and calibration methods and method validation

The laboratory shall use appropriate procedures for sampling, handling, transport, storage

and preparation wherever applicable. An estimation of measurement uncertainty and

statistical techniques for analysis of test and calibration data can be applied.

The laboratory shall have instructions on the use and operation of all equipments. All

instructions, standards, manuals and reference data relevant to the work of the laboratory

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shall be kept up to date and shall be made available to personnel. Deviations from test

and calibration methods shall occur only if the deviation has been documented,

technically justified, authorized and accepted by the customer.

5.4.2. Selection of methods

The laboratory shall use test and calibration methods, including sampling methods which

meet the needs of the customer and which are appropriate for the tests and calibrations.

Methods published in international, regional or national standards (or reputed

organizations/relevant scientific texts/journals, or specified by the manufacturer of the

equipment) shall be used. Methods developed by the laboratory may also be used. The

customer shall be informed of the method chosen. The laboratory shall confirm that it can

properly operate standard methods

The laboratory shall inform the customer when the method proposed by the customer is

considered to be inappropriate.

5.4.3. Laboratory developed methods

The laboratory developed methods shall be a planned activity and shall be assigned to

qualified personnel equipped with adequate resources

All the development stage of the method shall be communicated to all personnel involved

in the method development

5.4.4. Non-standard methods

If standard methods are not available, non standard methods may be used by an

agreement with the customer for particular specification measurement.

5.4.5. Validation of methods

Validation is the confirmation by examination for objective evidence as the requirement

fulfillment for specific intended use.

The laboratory shall validate non-standard methods, laboratory developed methods,

standard methods used outside their intended use and any amplification and modification

of standard methods. The validation shall be extensive to meet the needs of the given

application. The laboratory shall record the results obtained and the procedure used for

validation

When some changes are made in the non-standard methods, the influence of such

changes should be documented

The range and accuracy of the values obtainable from validated methods shall be relevant

to the customer’s needs.

5.4.6. Estimation of uncertainty measurement

A calibration/testing laboratory performing its own calibrations shall have and shall apply

a procedure to estimate the uncertainty of measurement for all calibrations and types of

calibrations

Testing laboratories shall have and shall apply procedures for estimating uncertainty of

measurement. In certain cases valid statistical data may preclude in the calculation of

uncertainty measurement. In such identify the components of uncertainty and make more

reasonably acceptable calculation. Such reasonable estimation should be based on the

performance of method and must use previous experience and validation data.

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When calculating the uncertainty all components should be taken into account (Sources

of uncertainty include, the reference standards and materials, methods used, equipments

used, environmental conditions, properties and condition of tests).

5.4.7. Control of data

Calculation and data transfers shall be subjected to appropriate checks in a systematic

manner

When computers are used for processing, then ensure that:

◘ The computer software is documented in sufficient detail and suitably validated

◘ Procedures are established and implemented for protecting the data

◘ Computers are maintained to ensure proper functioning

5.5. Equipment

The laboratory shall be furnished with all items of sampling, measurement, and test

equipment for correct performance of tests and calibration

Equipment and its software used for testing, calibration and sampling shall be capable of

achieving the accuracy required and shall comply with specification relevant to tests. The

equipment shall be calibrated before placed for regular service. It shall be calibrated

before use.

Equipment shall be operated by authorized personnel. Up to date on the use and

maintanance of equipment shall be readily performed by appropriate personnel

Each item of equipment and its software used for testing and calibration shall be uniquely

identified.

Records shall be maintained of each item of equipment and its software The records shall

include:

Identity of the equipment and its software

Manufacturer’s name, type identification and serial number

Checks that the equipment complies with the specification

The current location

The manufacturer’s instructions

Dates, results and copies of reports and certificates of all calibrations, adjustments,

acceptance criteria and the due date of next calibration

Maintenance plan and maintenance carried out date

Any damage, malfunction, modification or repair to the equipment

The laboratory shall have procedures for safe handling, transport, storage use and planned

maintenance of measuring equipment to ensure proper function

Malfunctioning equipments shall be taken out of service. It should be labeled or marked

out of service

All equipments under control of the laboratory and requiring calibration shall be labeled,

coded or otherwise identified to indicate status of calibration with last and next

calibration dates

When equipment goes out of the control of laboratory, the calibration status of the

equipment are checked and shown to be satisfactory before the equipment is returned to

service

When intermediate checks are needed to maintain confidence in the calibration status

such checks shall be carried using defined procedure

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When calibrations give rise to correction factors the updating procedure should be carried

out.

The calibrated equipments shall be safeguarded against adjustments

5.6. Measurement traceability

All equipments used for the measurement should be calibrated before putting in to

service to keep the accuracy and reliability of results.

5.6.2. Specific requirements

5.6.2.1. Calibration

For calibration laboratories, the program for calibration shall be designed and operated.

The calibration and measurement should be traceable to the International System of Units

A calibration laboratory establishes to its own measurement standards and the measuring

instruments to the SI by means of unbroken chain of calibrations or comparison to

primary standards of the SI units of measurement. The link to SI units may be achieved

by reference to national measurement standards. National measurement standards may be

primary standards (primary realization of SI units based on fundamental physical

constants) or may be secondary standards which are standards calibrated by another

national metrology institute. When using external calibration services traceability of

measurement shall be assured by the use of calibration services of laboratories that can

demonstrate competence, measurement capability and traceability. That calibration

certificates issued by these laboratories shall contain the measurement results including

uncertainty measurement and statement of compliance with an identified metrological

specification.

Calibrations that cannot be made in SI units shall provide confidence in measurements by

establishing traceability to appropriate measurement standards

The use of certified reference materials provided by a competent supplier

The use of specified methods and standards

5.6.2.2. Testing

For testing laboratories, the requirements given in 5.6.2.1 apply for measuring and test

equipment with measuring functions used if the associated contribution from the

calibration contributes little to the total uncertainty of the test results. In such situation,

the laboratory shall ensure that the equipment used can provide the uncertainty of

measurement needed.

Where traceability of measurements to SI units is not possible, the same requirements for

traceability to certified reference materials, agreed methods and consensus standards are

required as for calibration laboratories.

5.6.3. Reference standards and reference materials

5.6.3.1. Reference standards

The laboratory shall have a program and procedure for the calibration of its reference

standards. Reference standards shall be calibrated by a body that can provide traceability

(5.6.2.1). These reference standards should be preserved exclusively for calibration only.

Reference standards shall be calibrated before and after any adjustment.

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5.6.3.2. Reference materials

Reference materials shall be traceable to SI units of measurement or to certified reference

materials. Internal reference materials shall be checked if economically feasible.

5.6.3.3. Intermediate checks

Intermediate checks are needed for all standards and reference materials to maintain

confidence.

5.6.3.4. Transport and storage

The laboratory should have safe handling procedures (handling, transport, storage and

use) for reference standards and materials to prevent contamination and deterioration.

5.7. Sampling

The laboratory shall have a sampling plan and procedures for sampling of materials for

testing and calibration. The sampling plan and procedures should be available at the

location from where the samples are collected. The sampling procedure should be based

on statistical methods. The sampling process shall specify factors to be controlled to

ensure validity of test and calibration.

If the customer requires deviations, additions or exclusions from the documented

sampling procedure, these shall be recorded in detail with the appropriate data and shall

be included in all documents of testing and calibration

The sampling procedure for recording data should include identification of sampler,

environmental conditions and diagram or equivalent means to identify the sampling

location, also sampling statistics to be used.

5.8. Handling of test and calibration items

The laboratory shall have procedures for transportation, receipt, handling, protection,

storage, retention and disposal of test and calibration items. It should include provisions

to protect the interest of laboratory and customer

The laboratory shall have a system for identifying test and calibration items. The

identification shall be retained throughout the life of the item in the laboratory. The

system shall be operated to ensure that items cannot be confused physically.

When the test or calibration item is received, departure from normal conditions shall be

recorded. When there is doubt about the suitability of this type of received item, the

matter may be discussed with the customer and take a decision to proceed with the same

damaged item. The discussion shall be recorded.

The laboratory shall have procedures and appropriate facilities for avoiding deterioration,

loss or damage to the test or calibration item during storage, handling and preparation.

Instructions forwarded with the item shall be followed in handling, storage and these

conditions should be maintained, monitored and recorded throughout the item storage

with the laboratory.

5.9. Assuring the quality of test and calibration results

The laboratory shall have quality control procedures for monitoring the validity of tests

and calibrations undertaken. The resulting data shall be recorded to understand trends and

if possible statistical techniques shall be applied to review the results. The monitoring

may include:

Regular use of certified materials, internal quality control using secondary reference

materials

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Participation in inter-laboratory comparison or proficiency testing program

Replicate test or calibration using the same or different methods

Retesting or recalibration of retained items

Correlation of results for different characteristics of an item

Quality control data shall be analyzed and outliers are found planned action shall be taken

to correct the problem and to prevent incorrect results from being reported.

5.10. Reporting the results

The results of tests or calibration carried out by the laboratory shall be reported

accurately, clearly, unambiguously and objectively and in accordance with any specific

instruction in the test or calibration methods.

The result shall be reported in a test report or a calibration certificate and shall include all

information requested by the customer and necessary for the interpretation of the results

and all results required by the method used (5.10.2, 5.10.3 or 5.10.4)

If the test or calibration is performed for an internal customer the report may be in a

simplified way. But any information (not reported to customer) as given in section 5.10.2

to 5.10.4 shall be with laboratory

5.10.2. Test reports and calibration certificates

o Each test report and calibration certificate shall include:

♦ The title

♦ The name and address of the laboratory and the location where the tests and

calibrations were carried out

♦ Unique identification of the report or certificate (serial number), page identification a

clear identification of the end of the report or certificate

♦ The name and address of the customer

♦ Identification of the method used

♦ A description of, the condition of, and unambiguous identification of the item tested

or calibrated

♦ The date of receipt of the test or calibration item where this is critical to the validity

and application of the results, and the date of performance of the test or calibration

♦ Reference to the sampling plan and procedures used by the laboratory

♦ The test or calibration results with units of measurement

♦ The name, function and signature or equivalent identification of person authorizing

the test reports or calibration certificates

♦ A statement to the effect that the results relate only to the items tested or calibrated.

5.10.3. Test Reports

In addition to the requirements listed in 5.10.2, the test report shall include:

◘ Deviation from, addition to or exclusion from the test method, and information on

specific test conditions, such as environmental conditions

◘ A statement of compliance /non compliance with requirements and specification

◘ If applicable, a statement on the estimated uncertainty of measurement (information

on uncertainty is needed when there is relevant to validity or customer requires or

compliance to specification needs justification from uncertainty)

◘ If needed opinions and interpretations

◘ Additional information required by specific methods, or customers

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In addition to requirements listed in 5.10.2 and above (5.10.3) reports on sampling shall

include:

◘ Date of sampling

◘ Unambiguous identification of the substance

◘ The location of sampling (may be with diagram, photographs)

◘ Reference to sampling plan and procedures

◘ Details of any environmental conditions during sampling that can help the result

interpretation

◘ Any standard specification for the sampling methods, deviations additions to,

exclusions from the specification concerned

5.10.6. Opinions and interpretations

When opinions and interpretations are included the basis of such writings should be

included in the document and the opinions and interpretations shall be clearly marked.

5.10.6. Testing and calibration results obtained from subcontractors

♦ If the final document (report/certificate) contains results performed by the subcontractors,

these results shall be clearly identified

♦ When the calibration is conducted by subcontracted laboratory, it should issue calibration

certificate to the main contracting laboratory

5.10.7. Electronic transmission of results

☼ If the results are transmitted electronically (phone, fax, any electronic medium) this

should meet the requirements of this international standard section 5.4.7.

5.10.8. Format of reports and certificates

→ The format shall be designed to accommodate each type of test/certificate to minimize

misunderstanding/misuse.

5.10.9. Amendments to test reports and calibration certificates

◙ Amendments to a report or certificate after its issue to the customer shall be made only in

the form of a further document which include the below statement

“Supplement to test report (calibration certificate), serial number….”

Such amendments should be subjected to this international standard.

◙ When a new report or certificate has to be issued, this shall be uniquely identified and

shall contain a reference to the original one that it replaces.