Together with its tender, the supplier shall submit a description of its procedures for systematic quality management (quality assurance) and the procedures that are used for checking and managing information relating to substances hazardous to the health or environment in the consumables covered by the contract. The description of procedures shall include at least the following points:
- Procedures for ensuring that information on the existence of substances hazardous to the health or environment in concentrations over 0.1% by weight are systematically requested from subcontractors. The substances referred to are those listed in:
- The Candidate List from the REACH regulation (Article 59 of Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals).
- Annex XVII to the REACH regulation (list of restrictions, Regulation (EC) No 1907/2006).
- Annex I to Regulation (EU) 2017/745 on medical devices, point 10.4.1.
- Monitoring and keeping records of chemical handling, and regular checks of the quality of raw materials and products.
- Information received about the products’ constituent substances shall be reviewed and filed to be accessible to the contracting authority.
- Correction of deviations from the requirements, reporting and documentation.
- Reporting, documenting, and handling claims and complaints regarding the products covered by the contract.
- Traceability of subcontractors in the supply chain.
Procedures shall be documented and apply for the duration of the contract period.
