Quality assurance procedures
Level: Core
A quality management system is required to ensure that production is monitored and that products included in the tender are of the desired quality. A quality management system is also required to ensure traceability.
Details
- Type:
- Qualification requirement
- ID:
- 11087
- Group:
- Disposable gloves for medical use
- Swedish:
Criterion text
The tenderer of the tendered products shall report procedures for systematic quality management, and shall have documented procedures and instructions in place for ensuring:
- That the requirements for tendered products are checked and fulfilled during the contract period
- That documentation to verify fulfilment of the requirements is available
- That there is a contact person with respect to the contracting authority
To ensure compliance with the points above, the procedures and instructions shall cover at least the following:
- Monitoring and record-keeping (e.g., regular checks of raw material- and product quality)
- Reporting and correcting deviations from the requirements that have been set
- Reporting and documenting production changes for the tendered products
- Reporting, documenting, and handling claims and complaints regarding the tendered products
- Traceability throughout the entire supply chain
Verification
- The tenderer's valid EN ISO 9001 certificate (Quality management systems — Requirements (ISO 9001:2015)).
- Applies only to medical gloves for single use: The tenderer's and/or manufacturer's valid EN ISO 13485 certificate (Medical devices — Quality management systems — Requirements for regulatory purposes)
- Self-documented quality assurance systems that cover at least the requirements under points 1-5 above, including an audit report for the quality assurance system. The audit report shall not be more than one year old and shall be signed by both the tenderer and the auditor who reviewed the quality assurance system. If the quality assurance system covers both the tenderer and manufacturer (assuming they are not identical), the report shall also be signed by the manufacturer.
- The supplier’s self-declaration, including technical documentation of compliance, shall be verified by an accredited verification body that is accredited for the task in accordance with ISO/IEC 17029 or equivalent standard.
Proposed follow-up
Check that submitted certificates are valid prior to awarding the contract. One of the ways this can be done is to contact the accredited independent organisation that issued the certificate or the auditor.
Check and ensure that new certificates and audit reports have been submitted and that they are valid for the contract period. It is the duty of the certified tenderer to check its own supply chain that is covered by the certificate. This requirement should be handled together with other requirements for quality assurance systems and procedures.
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
ISO 13485:12 is based on 9001 but contains some special requirements for medical devices and excludes certain requirements in ISO 9001 that are not appropriate as procurement requirements.
ISO 13485 has more stringent requirements regarding formal documentation, and special requirements regarding product safety but does not contain obligations regarding continuous improvements to the same extent as ISO 9001. Rather, it only contains requirements that new certificates and audit reports shall be submitted and valid for the contract period.
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
- 11087
- Version date
- 2018-06-05
- Review date
- 2022-03-31