Procedures for quality management, control, and handling of information on hazardous chemicals

Details

Type:
Qualification requirement
ID:
11258
Group:
General criteria

Level: Core

Having documented procedures and instructions for quality assurance of products and supply allow for the handling of information and establishing traceability along the supply chain in accordance with existing statutory requirements etcetera for the manufacture of medical consumables. This allows supplies to better be able to meet the requirements regarding technical specifications and to be able to fulfil the contract.

Criterion text

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.

Verification

Upon request, the supplier shall be able to present for example, one of the following to demonstrate that the supplier conducts systematic quality management work or has a quality management system and that this includes the points above or equivalent by the following:

  • Valid certificate in accordance with ISO 9001:15 or ISO 13485:16.
  • A self-documented system that covers what is stated in the requirement together with an audit report from a completed external audit. The audit report shall be no older than one year and shall be signed by both an authorised representative of the supplier and the auditor.
  • The supplier’s self-declaration including technical documentation of compliance verified by an accredited verification body, accredited for the task in accordance with ISO/IEC 17029 or equivalent standard. 

Proposed follow-up

Check that submitted certificate is valid. This can be done by contacting the accredited independent organisation that issued the certificate. Check and ensure that new certificates and audit reports are submitted and that they are valid for the contract period. The supplier's annual reports submitted to the contracting authority regarding the points in the requirement.

If a verified self-declaration is used to prove that the requirement is fulfilled, request the supplier’s self-declaration, including documentation showing that the requirement is met. The self-declaration shall be verified by a verification body accredited for the task in accordance with ISO / IEC 17029 or equivalent standard. 

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