Certification provisions product certification

Version: 2018-06-04

1. Introduction

This document constitutes SBSC’s provisions for certification of products. In addition to these provisions, SBSC’s General Terms and Conditions shall apply.

2. The customer’s obligations

2.1 General
The customer must at all times fulfil SBSC’s General Terms and Conditions and Certification Provisions and implement relevant amendments when so communicated by SBSC. The customer must be a legal person.

2.2 Application
The customer shall apply for certification via the client portal on SBSC’s website or in such other manner as instructed by SBSC. In addition to the application, the applicant shall provide complete and correct information required by SBSC for certification. In the event the applicant or a third party instructed by the applicant is in delay in providing the information or material or fails to take the steps necessary for certification, such delay or failure may give rise to delays and additional costs. SBSC shall not be responsible for such delays and additional costs. When certification occurs, SBSC assumes that the information and material is correct and complete. SBSC shall not be responsible for conclusions or recommendations based on erroneous or inadequate information provided by the applicant. The information and material must be in Swedish or English.

2.3 Documentation
The customer shall ensure that SBSC obtains the necessary documentation for certification. Submitted documentation will not be returned. The customer shall also ensure, to the appropriate extent, that:

  • the customer is entitled to use the documentation;
  • testing of the product is carried out by a testing laboratory accepted by SBSC for the task;
  • tested products are representative of the product to be certified in respect of all of its characteristics;
  • tested products conform to specifications, drawings and other documentation.

2.4 Production control
For certification which is covered by production control, the customer shall continuously ensure that relevant manufacturing sites fulfil SBSC’s requirements for manufacturing sites. The requirements for manufacturing sites are set forth in an appendix to these provisions. As regards certification which is covered by production control, the customer shall fully cooperate in ensuring that SBSC can regularly inspect the relevant manufacturing site. This shall include:

  • providing specifications and records for review;
  • providing access to relevant equipment, sites, areas, employees and sub-contractors;
  • documenting, investigating and responding to complaints;
  • accepting the participation of observers.

2.5 Duty to inform
The customer shall inform SBSC without delay regarding changes which may have an impact on the possibility to fulfil the requirements for certification or the conditions for conducting the operations. Changes may be comprised, for example, of the following:

  • changes to legal, commercial and organisational status or ownership;
  • changes to organisation or management;
  • changes to products or manufacturing methods;
  • changes to contact information or manufacturing sites;
  • major changes in quality management systems.

2.6 Obligations regarding the product
The customer shall ensure that the product continuously fulfils the product requirements. The customer shall ensure that no changes in the product design, materials or execution are implemented. In the event product changes are desired, SBSC must first accept the same.

3. SBSC’s obligations

3.1 Generally
SBSC undertakes to fulfil SBSC’s General Terms and Conditions and Certification Provisions.

3.2 The application
SBSC shall confirm for the customer the applications SBSC undertakes to process.

3.3 Documentation
SBSC shall inform the customer with respect to necessary documentation to be submitted in supplementation of the application. SBSC shall, upon request, provide information regarding the testing laboratories accepted by SBSC. In the event necessary documentation has not been received within 12 months following the application, SBSC reserves the right to terminate the application process. SBSC reserves the right to reject documentation which is older than three (3) years.

3.4 Production control
For certification which is covered by production control, SBSC shall conduct the inspections of the relevant
manufacturing sites.

3.5 Evaluation
SBSC shall evaluate conformity with the requirements in accordance with the applicable regulations. The result of the evaluation shall be notified to the customer.

3.6 Certification
Certification shall take place in accordance with SBSC’s General Terms and Conditions.

Appendix – Requirements for manufacturing sites
For the purpose of continuously ensuring the conformity of manufactured products with applicable requirements, the producer shall apply and maintain a quality system which fulfils the requirements set forth below.

1. Documents

  • Necessary documented information shall be provided.
  • Documented information shall be created and updated in a structured manner.
  • Documented information shall be controlled in order to ensure accessibility and suitability

2. Materials

  • The organisation shall ensure that purchased products fulfil specified requirements.
  • To the extent necessary, purchasing information shall specify the product to be purchased.
  • To the extent necessary, verification of purchased products shall be carried out.

3. Equipment

  • Necessary equipment for production and control shall be provided and used.
  • Equipment shall be suitable for the purpose and maintained in order to ensure continued suitability.
  • To the extent necessary, equipment shall be calibrated, identified and protected.

4. Controls

  • Controls shall be carried out on suitable occasions in order to verify conformity with acceptance criteria.
  • To the extent necessary, controls shall entail production controls and final controls.

5. Organisation

  • Necessary personnel shall be provided.
  • Relevant roles shall be allocated responsibilities and authority.
  • Personnel shall be competent.

6. Identification and traceability

  • Where so appropriate, the product and the status of the product shall be identified at all stages
  • Where traceability is a requirement, the unique identity of the product shall be controlled and documented.

7. Preservation

  • Product characteristics shall be preserved during internal processes and in conjunction with delivery.
  • Preservation shall entail, to the extent necessary, identification, handling, packing, storage and protection.

8. Nonconforming products

  • Products which do not fulfil the imposed requirements shall be identified and controlled such that unintentional use and delivery are prevented.
  • Suitable measures shall be taken on the basis of the nature of the nonconformity and its impact on the conformity of the product with requirements.

9. Corrective actions

  • Nonconformities, including complaints, shall be investigated and corrective actions shall be taken to prevent re-occurrence.
  • The effect of corrective actions carried out shall be reviewed.
  • Nonconformities, corrective actions and results shall be documented.

In addition to the aforementioned requirements, the quality system shall also fulfil other applicable requirements.

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