Quality assurance

In order to fulfil the requirements in the technical specification, the supplier shall have documented procedures and instructions for quality assurance.

Criterion ID

10223

Criterion level

Core

Criterion type

Qualification requirement

Criterion text

The supplier of the offered products shall itself, or through its sub-supplier, have documented routines and instructions in order to ensure:

  • that the requirements are checked and met during the contract period
  • that documentation which demonstrates requirement conformity is available
  • that there is a contact person in relation to the procuring authority

In order to ensure that the above items are observed in daily production, the routines and instructions at a minimum must include the following:

  1. organisation, quality supervisor, contact person and other supervisory personnel as well as their areas of responsibility,
  2. monitoring and record keeping (e.g. regular inspection of raw material and product quality),
  3. reporting and handling of deviations related to the set requirements,
  4. reporting and documentation of planned production changes to the product offered,
  5. contact person reporting on points 3 and 4 above to the procuring authority,
  6. reporting, documentation and handling of claims and complaints about the products offered,
  7. traceability upstream in the supply chain by means of batch coding of the product.