Quality assurance procedures

The supplier of the products delivered according to the contract shall have routines for systematic quality work. The routines shall be documented, at least include the activities covered by the contract and shall be applied during the contract period. The systematic quality work shall include at least the following points:

• Routines for the requirements in the contract to be controlled and fulfilled during the contract period.
• Routines for the documentation that verifies fulfilment of the requirements are to be available.
• Routines for reporting and processing of deviations related to the set requirements.
• Routines for reporting, documentation and management of claims and complaints regarding the products
• Routines for traceability upstream in the supplier chain for the products covered by the contract.
• That there is a contact person with respect to the contracting authority.
• Routines for the contact person's annual reporting of the above points to the contracting authority

Upon request, the supplier shall be able to prove that the requirement has been met. If the supplier applies its own documented system, [The contracting organization] may request that the information is verified by an independent third party.

The supplier shall provide information on their systematic quality work in the tender, and upon request be able to present any of for example the following:

• The supplier's valid certificate according to ISO 9001 or equivalent standard, issued by an accredited certification body. When the supplier's activities include design, development and/or manufacture of products, the production unit shall be covered by the certificate.
• Documented routines for quality assurance that include at least what is stated in the requirement.

In announced procurements above the threshold values, contracting organizations have an obligation to accept a standardized form of self-declaration, ESPD (European Single Procurement Document) as preliminary proof that the supplier meets the qualification requirements and can submit requested proof of this.