26 Oct Product regulations in an ever-changing world
The task of meeting a wide range of global regulations also continues far beyond the final product design and the factory floor procedures. Products that have been tested and qualified for certification by various agencies and Notified Bodies for many years can be met with new regulations in our ever-changing world.
A good example is the SALEEM-SABER certification process for product and material shipments entering the Saudi Arabia market. Len Swantek – Victaulic’s Global Regulatory Compliance Director attempts to provide a sense of clarity for the manufacturers and exporters who often struggle in their understanding of these requirements. And takes us through the process with helpful guidance in each step.
For manufacturers exporting products and systems to Saudi Arabia, fully understanding the SALEEM-SABER certification process is critical to clearing shipments to meet customer requirements and build schedules on time in the region. The process is by no means easy or intuitive. However, advanced planning and close communication with all relevant stakeholders can greatly improve the success rate in achieving the documentation required for Customs clearance. It’s important to remember that the initial design qualification and agency certifications are only the beginning of a long-term commitment to compliance, quality and consistency.
In early 2018 the Saudi Standards, Metrology and Quality Organisation (SASO) initiated the SALEEM-SABER electronic certification and conformity assessment system as part of a mandatory requirement for all imported products entering Saudi Arabia effective in July of that year. The system is designed for issuing Certificates of Conformity for products entering Saudi Arabia in accordance with Saudi standards and specifications.
The product safety programme (SALEEM) utilises an electronic platform (SABER) which links the material importers, SASO-approved Conformity Assessment Bodies or CABs, and Saudi customs in a single online network. The objective is to improve product safety, streamline the customs clearance process, screen and track potential counterfeit products, and raise the standard of excellence for a wide range of both consumer and commercial/industrial products and systems entering the Saudi market.
Working with Regional Importers
While the SALEEM-SABER product safety programme has many interacting elements, procedures and requirements, one of the most important aspects involves the role of the product importer. As outlined below, the importer plays a very important role throughout the entire process and must register its company and all intended products to be imported within the SABER system. Through our own experiences with this process, we have become keenly aware that the importer must have a proper understanding and knowledge of the products and/or technologies they will be engaged with in the course of their daily communications with the CABs and manufacturers. If left unaddressed, this seemingly simple point can lead to confusion if the importer is struggling to understand how the product is designed and how it will be used in the end application for which it is intended. The process typically works as follows:
- Initiates the certification request;
- Registers the product in the SABER system with all relevant details;
- Then selects the product classification (HS) code;
- Assigns a SASO-approved CAB if the product is regulated.
- Conducts the conformity assessment;
- Issues a Product Certificate of Conformity (PCoC);
- Issues a Shipment Certificate of Conformity (SCoC) for each individual product shipment;
- Selects the Correct HS Code.
Harmonised System (HS) codes are part of a global product classification system that has been in use for many years in the import/export process. These six-digit codes translate into the classification or categorisation of thousands of products transported worldwide. In Saudi Arabia, the HS-Code is either linked to a specific Gulf Technical Regulation or, if there is no applicable regulation available, the product is not considered regulated. It is the Technical Regulation that establishes the product conformity assessment requirements and product certification type.
For US exporters, it is important to follow the US Census Bureau’s Schedule B commodity classifications (based on the Harmonised System) which uses a 10-digit classification code. With nearly 8,000 classification codes in this system, granularity is of the utmost importance in identifying the product description that most closely matches the product of interest. If the importer, for example, were to inadvertently select the wrong HS code, the CAB may mistakenly seek improper or irrelevant product performance data from the manufacturer; or the CAB may also request additional performance tests be conducted that may not be aligned with the actual performance capabilities for which the product was designed.
While this may seem like a very simple matter, once the HS code is selected, it can be quite difficult for the importer to make a change in the system. The resulting delays and complicated communications between the various stakeholders can greatly impact product delivery and production schedules for the end recipient awaiting their shipment in country.
Regulated vs. Non-Regulated Products
Both regulated and non-regulated products must be entered into the SABER system. HS Codes that correlate to regulated products are governed by a Saudi Arabia Technical Regulation that details the requirements, including technical documents and detailed product information along with testing protocols and auditing requirements. For example, regulated fire protection products are defined by the Technical Regulation for Fire Fighting Equipment and Materials as a ‘Type 3’ product certification type, meaning CABs require technical documentation, third-party test reports and factory inspection audits to fulfil the conformity assessment requirements. This is in contrast to other regulated product categories, defined by their governing Technical Regulations as a ‘Type 1a’ product certification type. In these cases, technical documentation and third-party test reports are required, but without the factory inspection audit requirement.
For non-regulated products, the importer can simply self-declare the product or if the product meets a voluntary standard the product can be readily imported into the Saudi market with no CAB oversight. To register a non-regulated product, the importer must enter the product details into SABER, attach any required technical files and the self-declaration document. The importer is then permitted to be issued a shipment certificate, and the non-regulated product can enter into the Saudi Arabia market.
Product Certification and Manufacturing Assessments
As previously stated, the product certification and manufacturing assessments are conducted by the conformity assessment body or CAB. The CAB is authorised (accredited) by the SASO to conduct the assessments in accordance with the Technical Regulations, SASO standards and other specifications based on the end-use application.
The extent of these assessments is determined by each individual Technical Regulation, which defines the certification type for all regulated products. This may include a review of existing product performance data supplied by the manufacturer. This data must be no more than three years old and must conform to the requirements of the Technical Regulation. Additionally, the CAB may request additional testing if the data does not include all of the required elements of the Regulation. While most Saudi standards are based on other international standards, SASO, at their discretion, may include additional requirements to address local codes, practices and even cultural aspects to ensure safety for the end-user. For fire protection products, the qualification standards may also include references to EN, UL, FM, NFPA and other regional fire codes and product standards.
A separate and equally critical step in this process involves the physical auditing of the manufacturing location by the CAB or their designated contractor. If for some reason, the manufacturer is utilising multiple production sites for the imported products, each site is required to be audited. These onsite audits, also known as factory inspections, are only mandatory for certain product categories (i.e. Type 3 certification). The CABs typically have a well-defined process for these factory audits and are well-organised in their approach. Many elements of the SALEEM-SABER factory audit are similar (if not identical) to an ISO-9001 quality management system (QMS) audit programme. As one would expect, the manufacturers who maintain a third-party certification of their quality system in accordance with ISO-9001 typically have very successful results with the audits conducted by the CAB. However, it is equally important to note that quality system certification is not a mandatory requirement of the factory inspection process. If there are any non-conformities raised during the audit, it is in the manufacturer’s best interest to resolve those non-conformities as quickly as possible to keep the overall process moving forward.
Product and Shipment Certificates of Conformity
Once all required elements of the product conformity assessment have been satisfactorily completed in SABER as defined by the Technical Regulation, the CAB is responsible for issuing a Product Certification of Conformity (PCoC) to the importer through the SABER system. This PCoC is valid for 1-year from the date of its issuance and provides full confirmation by the CAB that the product model meets the SALEEM-SABER and Saudi Technical Regulations.
Then, prior to importing the product into Saudi Arabia, a Shipment Certificate of Conformity (SCoC) is required to be issued by the same CAB to the importer. In contrast to the 1-year term of validity of the PCoC, the SCoC is required to be issued for each shipment of the SABER-qualified product. Shipment details in terms of quantities, weights, barcode traceability and Country of Origin are several of the critical elements required to facilitate a successful SCoC transaction. As of 2020, the SABER system is now linked directly with the Saudi online customs programme known as FASAH. This enables a further streamlined customs clearance process for qualified imported products into the Saudi Arabia marketplace.
Overall, the process may seem unnecessarily complicated and a bit intimidating at first. Research and self-education is an important step in understanding how all of the various steps come together in this comprehensive product compliance model. As with any new system, the process becomes much easier with frequent transactions and experience with its various elements.
Today, we can confidently say that the SALEEM-SABER certification process has satisfied its objectives in providing an added measure of product performance validation, as well as safety and compliance for the thousands of consumer and commercial products for which their users rely upon each day.