By Abe Stears
In the previous issue we addressed the accreditation process. The articles that follow will cover the certification process from application to the continual surveillance of the manufacturer’s product quality.
In writing these we strive to keep the information generic as per the relevant requirements. In some instances, we may use examples as per SATAS procedures to make certain aspects clear to the reader. If you have any specific questions you are welcome to contact us at firstname.lastname@example.org
Product certification process
In general, product certification on a global level follows very similar processes as the certification bodies offering these services all need to comply with the requirements of the international ISO/IEC 17065:2012 Conformity assessment — Requirements for bodies certifying products, processes and services document. All certification bodies operating in the world do, however, have subtle differences in the manner in which product certification is managed – with the South African market being no different. Typically, the product certification process in South Africa follows the process described below:
- Selection of Product Certification Body (CB)
Once a manufacturer decides to become product certified to a specific National Standard (SANS) or International Standard (such as EN or IEC) a choice needs to be made as to which product certification body is preferred. The choices available to the manufacturer are generally determined by establishing the certification body’s SANAS accreditation status by visiting the SANAS website (www.sanas.co.za) where a very specific scope of accreditation (product specifications) is listed. Further considerations such as levels of service, technical competency and track records play a role in choices being made by the manufacturer with costing inevitably being a significant factor.
- Application Process
- The CB (Certification Body) is required to process the applicant’s request for product certification in accordance with their documented procedures which should incorporate:
- A non-binding application form completed by the applicant clearly defining the product standard/s certification is required. Additional documentation may be requested by the CB such as tax clearance certificates, company registration, and VAT registration.
- On receipt of the application documentation the CB is required to first establish if the application for certification can be accepted or rejected based on their scope of accreditation or at least within their area of expertise, competency, and capability.
- The CB formulates and submits the necessary quotations for certification in accordance with documented costing models to ensure impartiality.
- The CB includes within the quotation documentation their certification conditions which the applicant is required to comply with. The certification conditions detail the necessary controls required for the applicant to achieve and maintain product certification, frequencies of surveillance audit, sampling and testing. It must be noted that these certification conditions formulated by the CB are standardised for each product specification and thereby require all applicants to comply with the identical requirements.
- The application for certification is then either accepted or rejected by the applicant. Negotiations between the applicant and CB pertaining to the certification conditions, including costing should not be considered to maintain impartiality and fairness to all.
The assessment of conformity for product certification includes four main activities, each of which are to be the cornerstone of any reputable product certification scheme. The manufacturer is subjected to all four these activities prior to product certification being granted.
- Assessment of the applicant’s quality management system
- The assessment of the manufacturer’s quality management system is performed on the premises where manufacturing takes place. These premises may be at the applicant’s physical address or at a manufacturing facility specifically nominated by the applicant as their subcontracted manufacturer. Examples of such being that of a South African based applicant making use of a European manufacturer.
- The assessment is performed in accordance with the requirements defined in the CB certification conditions. Generally, these requirements are based on ISO 9001 quality management system principles but tend to concentrate more on manufacturing/process/quality control systems.
- Product testing
- Product testing to the full requirements of the product specification(s) is either performed prior to, during, or after the assessment is performed at the manufacturing facility.
- Product testing to the full requirements of the specification should be performed at independent SANAS Accredited (or ILAC) test facility. The use of independent test facilities is critical to ensure unbiased test results where no external influences are possible.
- In the event where no accredited test facilities are available, it is permissible that the CB perform an assessment of the test facility in accordance with the requirements defined in ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories and based on the outcomes (emphasis placed on test methods, available equipment), approve or reject the use of the test facility to perform the product testing.
- In exceptional cases where the CB can demonstrate a high level of technical expertise in laboratory testing for the specific standard certification is desired, it is permissible that the product testing may be witnessed at the manufacturer’s laboratory. The manufacturer’s laboratory will however be subject to a similar audit as an external laboratory and if accepted, witness testing may be performed by the CB in accordance with the full requirements of the specification.
- Clearance of non-conformances
- Non-conformances recorded during the assessment of the manufacturer’s quality control system and more critically any product failures are required to be verified as being effectively addressed by a CB auditor. Non-conformances issued to the manufacturer need to be closed out within the time frames defined on the relevant non-conformance report.
- The process of granting product certification to the manufacturer may only commence if all non-conformances are closed out.
- Granting product certification
- This critical process in granting product certification is generally not understood in that, the submission of all assessment documentation by the CB is required to be considered by a certification advisory committee, headed by an independent chairman with the commensurate technical expertise. The independent chairman scrutinises the submission and makes recommendations whether, the submission may be accepted or rejected.
- The granting of product certification may only proceed following the recommendation received from the independent certification committee. Ultimately the final decision lays with the CB’s CEO to award product certification.
- The product certificate is issued to the manufacturer clearly displaying the CB’s Certification logo/mark and whether the specific standard is accredited by SANAS, shall also display the SANAS Logo.
|Detailed information can be accessed at:|
|SANAS Accredited Certification Bodies||:||www.sanas.co.za|
|SATAS Certified Manufacturers||:||www.satas.co.za|