• The terms and phrases below - when applying the provisions of this Regulation - shall have the meanings indicated next to them, unless the context of the text requires otherwise:

• The Kingdom: The Kingdom of Saudi Arabia.

• The Board of Directors: The Board of Directors of the Organization.

• The Organization (SASO): The Saudi Standards, Metrology and Quality Organization.

• The Competent Authority: The authorities responsible for market surveillance in accordance with the provisions of the Law and Regulations.

• Market Surveillance: Any task undertaken by the competent authorities to verify the compliance of products with the provisions of the Law and Regulations.

• Technical Regulations: Regulations approved by the Council that set the requirements and essential requirements applicable to a specific product or product category mandatorily in accordance with the provisions of the Law.

• The General Regulation for Conformity Models (the Regulation): A regulation issued by the Organization to define the approved conformity models in the technical regulations, based on international practices and guidelines for granting certifications, especially the international standard (ISO/IEC 17067) - Conformity Assessment - Fundamentals of Product Certification, and specific guidelines for product certification models.

• The Standard: An approved document that sets the rules, instructions, or characteristics for products or processes and related production methods, and compliance with it is not mandatory.

• The Saudi Standard: The standard approved by the Council, which is considered the national standard of the Kingdom.

• The National Standard: The standard adopted by a metrology body in one of the countries.

• The Regional Standard: The standard adopted by a regional metrology body.

• The International Standard: The standard adopted by an international metrology body.

• Accreditation: A certificate from a third party that officially certifies that a conformity assessment body is qualified to perform specific conformity assessment tasks.

• Conformity: Meeting the requirements of something, meaning that the product, service, process, system, entity, or person meets the specific requirements for each, which may include standard specifications, technical regulations, contract conditions, consumer requirements, etc.

• Conformity Assessment: Ensuring that the product, service, process, or procedure complies with the requirements and essential requirements.

• Conformity Assessment Bodies: The bodies that carry out conformity assessment procedures according to a specific model, including calibration, testing, certification, and inspection.

• Accepted Bodies: Conformity assessment bodies that have been accepted by the Organization in accordance with the provisions of the Law and Regulations.

• Granting Body: The Organization or any body accepted by the Organization that issues conformity certificates.

• Periodic Surveillance: A systematic repetition of conformity assessment activities as a basis for maintaining the validity of the conformity declaration.

• Conformity Model: A specific procedure for conformity, with defined limits, inputs, and outputs, used directly or indirectly to verify that the requirements stated in the technical regulation or standards have been met, including sampling and testing procedures, inspection, assessment, ensuring conformity, registration, declaration, and any other related procedures.

• Internal Control: A first-party conformity assessment procedure carried out by the manufacturer without the intervention of a conformity assessment body or any other interested party in the product.

• First Party: The manufacturer.

• Third Party: A neutral and accredited conformity assessment body according to its field of activity in testing, inspection, or granting conformity certificates, independent of the entity being assessed.

• Conformity Assessment Procedures: The procedures used for conformity assessment, which include calibration, testing, certification, and inspection activities.

• Supplier Declaration of Conformity: A document issued by the responsible party for placing the product in the market before it is placed, in which they declare under their responsibility that the product meets the requirements.

• The Saudi Quality Mark: A mark approved by the Organization indicating that the entity has an effective management system ensuring the production of a product that complies with the general technical regulation for the Saudi Quality Mark and the procedures for granting the product and its specific specifications and/or its technical regulations.

• Production Processes: A series of continuous sequential activities that transform inputs (raw materials, technology, knowledge, energy, procedures, data, etc.) into outputs (final product).

• Production Procedures: A specific method for executing production processes.

• Type: A category/design of a product that has the same physical properties (shape, capacity, size, etc.) and specific technical characteristics, and may include a range of models of the same product, where differences among them do not affect the level of safety and security, nor the other performance-related requirements.

• The Product: Any product placed or offered in the markets.

• Product Category: A group of industrial products that share common characteristics and features, allowing for the issuance of a technical regulation that encompasses them all.

• The Consumer: Any individual who obtains the product directly or through a service, using it for personal purposes or for the purposes of family members or their property.

• The Supplier: Refers to the following:

  • - The manufacturer of the product, if residing in the Kingdom, or any person presenting their identity as the manufacturer of the product by naming the product after them or any relevant commercial description, as well as any person involved in renewing the product.

  • - The manufacturer's agent in the Kingdom if the manufacturer resides outside the Kingdom, or the importer in the absence of an agent for the manufacturer in the Kingdom.

  • - Any person in the supply chain whose activity may affect the characteristics of the product.

  • - The authorized representative, which is any natural person or legal entity established in the Kingdom; who has been authorized by the manufacturer outside the Kingdom to act on their behalf in accordance with legal procedures.

• Market Placement: The placement of the product in the markets.

• Market Offering: Any supply or advertisement of a product for distribution or consumption within a commercial activity, whether for a fee or free of charge.

• Supply Chain: All stages that the product goes through until final use.

• Essential Requirements: The requirements and outcomes related to safety, health, and the environment that must be achieved, or related to hazards and risks that must be addressed.

• This regulation clarifies the approved conformity models for granting conformity certificates for products subject to technical regulations issued by the authority. The application of these models is the responsibility of the supplier and the granting entities, each according to their jurisdiction. Raw materials and semi-finished materials that are used in the manufacturing of final products are excluded from this regulation.

• The purpose of this Regulation is to ensure that the supplier and grant authorities comply with the approved conformity models in issuing conformity certificates for products covered by the technical regulations issued by the Authority, before they are placed in the market. This is to enable the competent authorities to verify the extent to which these products meet the requirements set forth in the relevant technical regulations, particularly concerning the health and safety of users and consumers, and the public interest.

• Principle One: The procedures for self-compliance assessment (internal monitoring) are applied by the manufacturer or their authorized representative - as the first party - who issues the supplier's declaration of conformity, as outlined in Appurtenance (1), in accordance with the best practices in the field, ensuring that the product meets the requirements specified in the relevant technical regulations, and the systems and conditions referred to therein, in order to ensure consumer safety when using the product.

• Principle Two: The process of granting conformity certificates for products is conducted by granting bodies - as the third party - where the granting body - according to its jurisdiction and area of activity - issues a conformity certificate for the products, as outlined in Appurtenance (2), ensuring that the product meets the requirements specified in the relevant technical regulations, and the systems and conditions referred to therein, in order to ensure consumer safety when using the product.

• Principle Three: Compliance assessment procedures are applied to products before they are placed in the market, without discrimination in terms of technical requirements and conformity models, whether they are of local or foreign origin.

• Principle Four: Granting bodies do not impose the application of any unnecessary conformity model/models that would create an additional burden not directly related to the objectives of the relevant technical regulation.

Appurtenance (1): General illustrative diagram for self-compliance models for production (First Party).