Private Laboratories - Law
Royal Decree No.M/3, 8 Safar 1423 [21 April, 2002]
The English version of this document is for guidance only.
The Arabic version is the governing text.
The following terms, wherever they occur within this Law, shall have the meanings given below:
- Ministry concerned: Ministry of Commerce, Ministry of Health, Ministry of Agriculture and Water, Ministry of Industry and Electricity, Ministry of Rural and Municipal Affairs, or any other ministry as may be determined by the Implementing Regulations as the context or text may dictate.
- Organization: Saudi Arabian Specifications and Standards Organization.
- Goods: Commercial items, whether produced locally or imported, in the form of materials, equipment, tools, or otherwise.
- Test: Any analysis, calibration or inspection performed to identify characteristics of performance, competence, effectiveness or conformity.
- Laboratory: Any site set up for testing goods.
Assistance of qualified and licensed private national laboratories may be sought, by a decision of the Minister concerned, for purposes of testing local and imported goods.
Preliminary licensing may be granted to laboratories subject to fulfillment of the following conditions:
- The applicant for a license should be Saudi, whether natural or juristic person.
- The applicant for a license undertakes to assign a Saudi to the position of laboratory technical manager.
- The applicant for a license undertakes to provide the necessary academically qualified specialists and the proper equipment and instruments necessary to carry out the volume and nature of the work, in accordance with the directives of the Ministry concerned and the Organization.
The Implementing Regulations shall determine the classes of laboratories and the conditions for each class as recommended by the Organization.
The Implementing Regulations shall determine the procedures for obtaining a license and the time required to review an application.
Licensee shall preliminarily be granted a grace period not exceeding six months to finalize the following:
- Laboratory organizational structure.
- Technical staff to operate the laboratory. Certified copies of their academic qualifications and training courses attended shall be submitted.
- Certification of the Organization in accordance with the regulations related to quality mark, certificate of conformity, and accreditation of services (laboratory accreditation). Failure to meet the above requirements within the grace period of six months shall render the preliminary license void.
- The Ministry concerned shall issue the private laboratory license, upon satisfying the following:
- Fulfillment of the requirements of Article 6; designation of the type of goods, tests and maximum fees for each test which requires a license.
- Payment of the licensing fees of five thousand (5000) riyals for the main laboratory and two thousand five hundred riyals for each branch.
- Validity of the license shall be five years, renewable by an application submitted by the interested party to the Ministry concerned, at least three months prior to the date of expiry. The renewal shall be effective as of the expiration date of the license.
The Ministry concerned shall issue a decision specifying the goods to be tested by the private laboratory sixty days prior to assigning the task to the same and after publication it in the Official Gazette. The Ministry of Finance and National Economy (Customs Authority) shall be notified accordingly.
The laboratory shall comply with the following:
(a) Limiting the tests to goods licensed for testing.
(b) Maintaining the level of performance and precision in accordance with the standards of the profession, in performing tests honestly, accurately, and impartially as well as observing job confidentiality and maintaining soundness of equipment.
(c) Keeping records of test results for a period not less than five years for reference, when needed.
(d) Displaying the license, organizational structure, technical divisions, test charges and the Organization's certificate of accreditation, in a visible place at the laboratory entrance. Changes thereof may not be effected without the Ministry's approval.
(e) Observing confidentiality in transporting samples and test results and not providing relevant information except to authorized persons.
- Technicians of the Ministry concerned shall be responsible for collecting and preparing samples in accordance with approved standard specifications.
- For imported goods, an undertaking shall be made by the owner of the goods to the effect that they shall not be put to use until the final test has been completed.
- For locally produced goods, an undertaking shall be made by the owner of the goods to the effect that they shall not be put to use until they have been approved by the competent authority.
- Following preparation by technicians, the sample shall be handed to the private laboratory office with a letter precisely describing the sample and the tests to be performed thereon in accordance with approved standard specifications.
- The laboratory shall return the results along with the remaining samples or, otherwise, proof of having used the same during testing, to their source, within fifteen days of the date of taking the samples. The Ministry concerned shall be notified of the test results within a period not exceeding twenty five days of the date of taking the samples.
- The owner of the samples to be tested shall bear the necessary charges thereof.
Without prejudice to a harsher punishment imposed by other laws, violators of the provisions of this Law shall be subject to one or more of the following punishments:
- A fine not less than five thousand riyals and not exceeding twenty thousand riyals.
- Suspension of license for a period not less than thirty days and not exceeding sixty days.
- Withdrawal of the license, in case of repeated violations.
Delay fine shall be applied in accordance with the following:
- One thousand riyals for each year of delay when renewing the license. Renewal shall start as of the license expiration date.
- A fine equivalent to the test charges of the tests in question, for failure of the laboratory to submit the test results within the period stipulated for in Paragraph 4 of Article 10.
Laboratory control and inspection, and records of violations of the provisions of this Law, regulations and decisions issued to implement them shall be handled by specialized officers. The Implementing Regulations shall determine the following:
- The authority, or authorities, nominating such officers.
- Powers of the officers authorized to enter and inspect laboratories, record violations, seize samples, documents, and equipment involved in the violation, conducting the necessary investigations as well as the justifications for seeking assistance of the security authorities.
- The authority which has the right of granting permission of entry into laboratories for inspection purposes.
- However, officers in charge of control, inspection, and recording [of violations] must exercise confidentiality and good conduct and present to the party concerned proof of their identity, their official status and the purpose of their visit.
The Implementing Regulations shall specify the investigation and prosecution procedures as well as the authority to implement such procedures.
The Board of Grievances shall have the jurisdiction to decide cases of violation of this Law and impose punishments.
The Minister of Commerce, in agreement with the Ministries of Interior, Health, Agriculture and Water, Industry and Electricity, and Rural and Municipal Affairs shall issue the Implementing Regulations of this Law.
This Law shall be published in the Official Gazette, and shall be effective one hundred and eighty days after publication.