Procedures for quality management, control, and handling of information on hazardous chemicals
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.
Details
- Type:
- Qualification requirement
- ID:
- 11258
- Group:
- General criteria
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.
Information about the criterion
Having a quality management system is the basis for functioning quality management with the possibility to monitor the supply chain. The primary purpose of a quality management system is to facilitate the ability of organisations to meet the customer's needs whilst satisfying the statutory requirements for the manufacture of medical devices in accordance with Regulation (EU) 2017/745 on medical devices. ISO 13485-2016 is based on ISO 9001-2015, but sets other requirements with regards to formal documentation and contains specific requirements regarding product safety for medical devices. ISO 13485 does not include requirements regarding continuous improvements to the extent that ISO 9001 does; it contains only a requirement to maintain the quality management system.
The legislation referred to in the criterion limits the use of substances that are hazardous to the health or environment contained in consumables or requires that information about such substances shall be made available. Good routines for checking and managing information about chemicals that are hazardous to the health or environment facilitates compliance with these laws. In the long term, this results in a reduced risk that these substances will affect patients and healthcare personnel or are released into the environment.
The contracting authority should also work effectively with chemicals and have the resources for managing and following up on incoming information, which applies, for example, to the requirement to submit information about substances in the Candidate List (Article 59 of Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals, (Requirement ID 11256)).
There are currently a limited number of accredited verification bodies for ISO/IEC 17029 (Conformity assessment - General principles and requirements for validation and verification bodies) as it is a relatively new standard. This may change, especially if the demand for verifying compliance in this way increases. More information about the standard and accredited verification bodies can be found on Swedac's website.
Versions history
The version date indicates when the sustainability criterion was created or last updated. Last reviewed dated tells when we last checked that the sustainability criterion still is relevant.
- Current ID
- 11258
- Version date
- 2019-05-29
- Review date
- 2022-04-07