- Field of Application
- Rules for Application for a Laboratory Certificate of Accreditation
- Procedures to Obtain The Accreditation Certificate
- Procedures for Laboratory Assessment
- Responsibility of Laboratory after Accreditation
- General Rules
Requirements for the Technical Competence of Testing Laboratories
- General Requirements for the Technical
Competence of Testing Laboratories
The Saudi Arabian Standards Organization (SASO) has prepared this section
of Part 3 of the Regulations of Quality Mark, Certificate of Conformity
and Accreditation of Services. It is concerned with the permanent rules
for the assessment and accreditation of laboratories which carry out certain
tests. These regulations apply to both national and foreign laboratories
whether they are independent or part of a governmental or non-governmental
It is hoped these regulations will help ensure competence and quality
of services provided by accredited laboratories and to achieve the best
means for implementing the first and second parts of the regulations for
quality mark, certificate of conformity, and accreditation of services
as well as the implementation of the law for prohibition of commercial
adulteration issued by the Royal Decree No. M/11 dated 1404(H)-5-29 which
stipulates in its bylaws, Article 19: <<Specific quality control
laboratories affiliated to the Ministry of Commerce or any other laboratories
accredited by decision of the Minister of Commerce shall be responsible
for testing and analysis>>.
This will give an impetus to development wheel in the Kingdom and consolidate
advancement in all fields.
The following definitions shall indicate the following meaning wherever
it is mentioned in this section:
FIELD OF APPLICATION
- SASO: The Saudi Arabian Standards Organization (SASO) which
is responsible for accreditation of laboratories and grants, suspends or
- Laboratory: A laboratory which measures, inspects, tests, calibrates
or defines qualities of products or behavior of materials.
- Accreditation of Laboratory: Granting the laboratory a certificate
by SASO indicating its competence to carry out certain testing services
as mentioned in the certificate of accreditation.
- Testing Report: A document indicating test results and any other
information related to these results.
- Assessment of Laboratory: Inspection of laboratory to determine
its degree of compliance F4] with standards and requirements of technical
competence defined in this section or laid by SASO.
- Calibration: To determine the accuracy of a measuring instrument
or material measurement, by a standard measurement of a higher level of
RULES FOR APPLICATION FOR A LABORATORY CERTIFICATE OF ACCREDITATION
Article (22) The rules mentioned in this section apply to national or
foreign laboratories which request to obtain a SASO certificate of accreditation.
Such a laboratory, whether independent, affiliated to a university, a governmental
body, a technical authority, an organization or factory, will be granted
a certificate by SASO indicating its technical competence to carry out
certain testing services as defined in the certificate of accreditation.
PROCEDURES TO OBTAIN THE ACCREDITATION CERTIFICATE
SASO will grant the laboratory a certificate of accreditation when the
following requirements are met:
- The laboratory is legally licenced.
- To have an organizational structure conforming to its technical competence
and accuracy level in testing and measuring results and reports and their
- To have all general requirements of technical competence for laboratories
(annex 1) or any additional or substitute requirements deemed necessary
- To have technically competent, adequately qualified and suitably trained
employees to carry out their work duties and they shall meet the general
requirements for technical competence of laboratory staff.
- To have all suitable equipment required for carrying out tests to be
- To regularly calibrate its equipment and keep records in-cluding the
date of calibration for each item of equipment.
- To have the means of easily and effectively communicating with SASO
or other agencies which request testing services in its geographical region.
8- To 'have the competence to use required languages including translation
- To guarantee secrecy and security of the work assigned to it.
- To have adequate storehouses to keep samples in good condition without
spoil and in a manner which can be easily designated; and to keep part
of these samples for at least two weeks as from the date of issuing the
report, for reference purposes if necessary.
- To undertake to offer facilities to persons responsible for assessment
and to provide them with correct required in-formation.
PROCEDURES FOR LABORATORY ASSESSMENT
- The laboratory applies to SASO for a certificate of accreditation to
carry out certain tests, and fills the forms prepared by SASO for this
- The laboratory provides SASO with the following information:
- A brief account on previous experience in the field of tests for which
accreditation is requested.
- The geographical region covered by the laboratory services.
- Define customers who may use its services.
- Other technical services offered by the laboratory in the field where
accreditation certificate is requested especially studies for the development
of products or consultant services.
- Detailed information on any accreditation certificates the laboratory
obtained from other agencies.
- Information on the owner and the legal standing of the laboratory.
- The laboratory will pay the assessment expenses defined by SASO according
to volume and type of work requested in assessment.
In case the laboratory meets the conditions mentioned in this sec-tion,
SASO will carry the following:
RESPONSIBILITY OF LABORATORY AFTER ACCREDITATION
- Study information attached with the application to ensure that the
laboratory meets necessary conditions.
- Send one or more of its highly qualified technicians in the field of
tests to be accredited, to assess the laboratory. For this purpose, SASO
may seek the help of external experts.
- Prepare a report on this assessment and submit it to SASO.
- The certificate of accreditation for the laboratory to perform certain
tests shall be issued upon a decision by the Minister of Commerce/Chairman
of SASO Board of Directors, upon the recommendation of SASO Director General.
The accreditation is for 2 years period, and is revealed in writing
to the laboratory.
The laboratory may be re-assessed for renewal of the certificate of
accreditation upon a request presented 3 months at least before expiration
date of the previous certificate of accredita-tion.
- Responsible persons in SASO will pay regular visits twice a year at
least to the accredited laboratory to ensure conformity of the laboratory
with requirements and continuance of its technical competence to carry
out accredited tests. A report to this effect will be presented to SASO.
- SASO may, at any time, pay supervisory or re-assessment visits to the
accredited laboratory, if and when there is a liability of decrease in
the competence of this laboratory.
A) The laboratory will be responsible, after accreditation, for the
- To offer all necessary facilities to SASO inspectors during their regular
and sudden visits, such as allowing them into the areas where tests are
carried out to see by themselves, to carry out some of the tests requested
by inspectors to verify competence of the laboratory, to prepare samples
or any facilities requested by SASO for purposes of inspection, to allow
them to check results of tests carried out by the laboratory and to participate
in carrying out some tests such as blank tests, etc., whenever this is
deemed necessary ac-cording to SASO report.
- To abide by all requirements necessary to obtain certificate of tests
accreditation and any amendments or directives issued by SASO in this regard.
- To undertake to carry out testing services for which the laboratory
is accredited according to requirements and rules defined by SASO on accreditation
and to declare that accreditation by SASO is only confined to such services.
- Not to use the certificate of accreditation in a manner offending to
SASO directly or indirectly or to declare or an-nounce on certificate of
accreditation in a misleading or ambiguous manner.
- Laboratory contracts with clients will include a statement that its
certificate of accreditation from SASO to carry out some tests does not
mean acceptance by SASO of the tested commodity.
- Not to publish test reports or parts thereof by beneficiaries if considered
by SASO that they would result in fraudulence. Such reports shall not be
reprinted except after laboratory agreement.
- To keep records of test reports, original comments, calculations and
deduced information for a period not less than six years before disposing
of or destroying them.
- To obtain SASO agreement to any modifications or alterations which
may affect conformity of laboratory to all requirements and criterion's
laid by SASO, or which may af-fect its competence in the field of activity
accredited by SASO and to be granted a time period as deemed agreeable
to execute such modifications.
B) The laboratory will pay SASO, after accreditation, the necessary
expenses for regular visits by SASO inspectors during the accreditation
period. The minimum limit of these expenses shall be SR: 5000 at least
and SR: 50,000 at most to be defined in agreement with SASO. These amounts
are not refundable to laboratory after payment.
SUSPENSION OR CANCELLATION OF ACCREDITATION
- Accreditation granted to the laboratory may be suspended in case of
violating necessary requirements for obtaining it, or if found, during
one of the regular visits to the laboratory, that the standard of required
competence is low. The suspension decision is canceled after ensuring the
capability of laboratory to avoid reasons for this deterioration within
the period defined by SASO which shall not exceed 90 days.
- The accreditation granted to laboratory shall be canceled in case the
laboratory proves inability to regain requested competence within the assigned
period, or continues its violations. Accreditation may be regained upon
a new request according to conditions for obtaining accreditation.
- Suspension period does not affect the expiration date of accreditation.
- SASO may suspend or cancel the accreditation or reduce number of tests
for which the laboratory is accredited in case of reduction of manpower
or change in the equipment or field of activity, or in case of incompetence
or complete or partial halt for any reason to carry out its duties, or
in case of com-plaints or information indicating its incompetence to carry
- The laboratory may request cancellation of the accreditation granted
by SASO or part thereof, provided that it informs SASO in writing two months
- SASO shall notify the laboratory in writing of the reasons for refusal
to grant accreditation after assessment within a period not exceeding 60
days. The laboratory may present a new application for accreditation after
avoiding refusal reasons.
- The accreditation granted to the laboratory will not violate its contractual
responsibilities towards beneficiaries. It shall be responsible for results
of tests carried by it.
- The laboratory accredited by SASO has the right, within validity of
accreditation period, to refer in its documents and test reports to its
accreditation in a non-misleading way, as well as propagating this in the
various information media.
- The laboratory is not allowed to refer to its accreditation in any
of its documents or by any of the advertisement means after termination
of accreditation period and before its renewal.
- All data obtained by SASO through assessment and supervi-sion procedures
shall be considered as confidential between SASO and the laboratory.
- SASO will send the laboratory any information with regard to accreditation
by registered mail, telex, facsimile or any other suitable means to the
latest address of the laboratory known to it. This shall be considered
as a formal information after lapse of the regular period consumed for
Annex No. 1
for the technical Competence of
Testing laboratories with their vital and effective role, carry at present
testing and examination services for various commodities. Their reports
help decide conformity of such commodities to Saudi standards and determine
their quality level.
SASO issued the regulations for the Quality Mark, Certificate of Conformity
and Accreditation of Services, which stipulated in Section 1 of Part 3,
that testing laboratories shall meet SASO's general requirements for technical
SASO has thus set the general requirements for technical competence
of testing laboratories to be followed on accrediting these laboratories
and also on establishing new laboratories.
It is hoped that these rules would help laboratories achieve their vital
and effective role to protect consumer and assist the national economy
in the various fields.
GENERAL REQUIREMENTS FOR THE TECHNICAL COMPETENCE OF TESTING LABORATORY
Testing Laboratory:A laboratory which measures, examines, tests,
calibrates or otherwise determines the characteristics or performance of
materials or products.
Test Method:A defined technical procedure to determine one or
more specified characteristics of a material or product.
Test Report:A document which presents the test results and other
information relevant to the test.
The testing laboratory shall:
1. With regard to organization:
- Be legally identifiable.
- ave an organizational structure, including quality system, that enables
it to maintain the capability to perform satisfactorily the technical functions
for which accreditation is granted.
- Be able to demonstrate, on request from SASO or the persons assigned
by SASO to assess its competence, that it is capable of performing the
tests representative of those for which it is seeking accreditation.
- Be organized so as not to subject staff members to undue pressure or
inducement that might influence their judgment or results of their work.
- Be organized in such a way that each staff member is aware of both
the extent and the limitations of his area of responsibility.
- Have a technical manager who has overall responsibility for the technical
operations of the laboratory.
- Have adequate security rules and measures for protection of proprietary
rights and confidential information.
2. Quality System
- The laboratory shall operate an internal quality assurance programme
appropriate to the type, range and volume of work performed. The quality
assurance programme shall be documented in a quality manual which is available
for use by the laboratory staff. The quality manual shall b@ maintained
relevant and current by a responsible member of the laboratory staff.
A person or persons having responsibility for quality assurance within
the laboratory shall be designated by the laboratory management and have
direct access to top management.
- The quality manual shall contain information regarding:
- The structure of the laboratory (organizational charts)
- The operational and functional duties and services per-taining to quality,
so that each person concerned will know the extent and the limits of his
- General quality assurance procedures;
- Quality assurance procedures specific for each test, as appropriate;
- Where appropriate, proficiency testing, use of reference material,
- Satisfactory arrangements for feedback and corrective action whenever
testing discrepancies are detected;
- Procedures for dealing with technical complaints.
- The quality system shall be systematically and periodically reviewed
by or on behalf of management to ensure the continued effectiveness of
the arrangements, and corrective actions initiated. Such reviews shall
be recorded together with details of any corrective action taken.
- Staff shall have the necessary education, training, technical knowledge
and experience for their assigned functions.
- There shall be a job description for each senior technical position
category, which includes the necessary education, training, technical knowledge
- The proportion of supervisory to non-supervisory staff shall be such
as to ensure adequate supervision.
- Suitable staff shall be nominated to deputize for the senior technical
and quality system management staff in their absence.
- Information on the relevant qualifications, training and experience
of the technical staff shall be maintained by the laboratory.
4. Testing and Measuring Equipment
- The testing laboratory shall be furnished with all items of equipment
required for correct performance of the tests and measurements for which
it is accredited.
- All equipment shall be properly maintained to ensure pro-tection from
corrosion and deterioration. Instructions for a proper maintenance procedure
for those items of equipment which require periodical maintenance shall
- Any item of the equipment which has been subjected to overloading or
mishandling, or which gives suspect results, or has been shown by calibration
or otherwise to be defec-tive, shall be taken out of service and clearly
labelled until it has been repaired and then shown by test or calibration
to be performing its function satisfactorily.
- Records shall be maintained of each major item of equip-ment. Each
record shall include:
- - The name of the item of equipment.
- - The manufacturer's name and type identification and serial number.
- - Date received and date placed in service.
- - Current location, where appropriate.
- - Details of maintenance,
- - Date of last calibration and calibration reports in the case of measuring
- - The maximum period of time between successive calibrations of the
- A label or tag indicating the date of the last calibration and the
due date of the next calibration should be attached to equipment requiring
- Measuring and testing equipment used in the testing laboratory shall
be calibrated where appropriate before being put into service and thereafter
according to an established programme.
- The overall programme of calibration of equipment shall be designed
and operated so as to ensure that measurements made in the testing laboratory
are traceable to Saudi standards of measurement and, where available, to
international standards of measurement specified by the International Committee
of Weights and Measures in case no Saudi standards exist. Where the concept
of traceability to national or international standards of measurement is
not applicable, the testing laboratory shall provide satisfactory evidence
of correlation or accuracy of test results.
- Reference standards of measurement held by the laboratory shall be
used for calibration only and not for any other purpose.
- Reference standards of measurement shall be calibrated by a competent
body that can provide traceability to Saudi standards of measurement or
to international standards in case no Saudi standards exist. Where relevant,
in-service testing equipment shall be subjected to checks between regular
- Reference materials shall, where possible, be traceable to Saudi standards
or to international standard reference materials in case no Saudi standard
reference materials exist.
6. Test Methods and Procedures
- The testing laboratory shall have adequate documented in-structions
on the use and operation of all relevant equipment, on the handling and
preparation of test items (where applicable), and on standard testing techniques,
where the absence of such instructions could jeopardize the efficiency
of the testing process. All instructions, standards, manuals and reference
data relevant to the work of the testing laboratory shall be maintained
up-to-date and be readily available to the staff.
- The testing laboratory shall use methods and procedures required by
the specification against which the test items are to be tested. The specification
shall be permanently available to staff performing the test.
- Where it is necessary to employ test methods and pro-cedures other
than those mentioned in the standard, these shall be fully documented.
- All manual calculation and data transfers shall be subject to appropriate
- Where these results are derived by electronic data processing techniques,
the stability of the system shall be such that the accuracy of the results
is not affected. This generally implies an ability to detect malfunctions
in the hardware dur-ing programme execution and take appropriate action
- The environment in which the tests are undertaken shall not invalidate
the test results or adversely affect the required accuracy of measurement.
- The testing premises shall be protected as required from excessive
conditions such as excessive temperature, dust, moisture, steam, vibration,
electromagnetic disturbance and interference.
- The premises shall be sufficiently spacious to limit the risk of damage
or danger and to allow operators to make practical and precise movements.
They shall have the equipment and energy sources needed for the testing.
When the testing so requires, they shall be equipped with devices to monitor
the environmental conditions.
- Access to and use of all test areas shall be controlled in a manner
appropriate to their designated purpose and entry by persons external to
the laboratory shall be defined.
- Adequate measures shall be taken to ensure good housekeeping in the
8. Handling of Items to be Tested
- A system for identifying the samples or items to be tested or calibrated
shall be applied, either through documents or through marking, to ensure
that there can be no confusion regarding the identity of the samples or
test items and the results of the measurements made.
- A procedure shall exist for retention of items where necessary.
- At all stages of storing, handling and preparation for test, precautions
shall be taken to prevent damage to the items, for example contamination,
corrosion or the application of stresses, any of which would invalidate
the results. Any relevant instructions provided with the item shall be
- There shall be clear rules for the receipt, retention and disposal
- The testing laboratory shall maintain a record system to suit its particular
circumstances and comply with any existing regulations. It shall retain
on record all original observa-tions, calculations and derived data, calibration
records and the final test report for six years at least.
- All records and test reports shall be held secure and in con-fidence
to the client.
10. Test Reports
- The work carried out by the testing laboratory shall be covered by
a report which accurately, clearly and unambiguously presents the test
results and all other relevant information.
- Each test report shall include at least the following information:
- Name and address of testing laboratory;
- Unique identification of report (such as serial number), and of each
page of the report;
- Name and address of client;
- Description and identification of the test item;
- Date of receipt of test item and date(s) of performance of test, as
- A statement to the effect that the test results relate only to the
- Identification of the test specification, method and procedures;
- Description of sampling procedure, where relevant;
- Any deviations, additions to or exclusions from the test specification,
and any other information relevant to a specific test;
- Disclosure of any non-standard test method or procedure utilized;
- Measurements, examinations and derived results, supported by tables,
graphs, sketches and photographs as appropriate, and any failures identified;
- A statement on measurement uncertainty (where relevant);
-A signature and title of person(s) accepting technical responsibility
for the test report and date of issue;
-A statement that the report shall not be reproduced except in full.
- Particular care and attention shall be paid to the arrangement of the
test report, especially with regard to presentation of the test data and
ease of assimilation by the reader. The format shall be carefully and specifically
designed for each type of test carried out, but the headings shall be standardized
as far as possible.
- Corrections or additions to a test report after issue shall be made
only by a further document suitably marked, e.g. (<Supplement to test
report serial number ... (or as otherwise identified)>), and shall meet
the relevant requirements of the preceding paragraphs.
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