Accreditations
Accreditation demonstrates that a laboratory meets both the technical competence requirements and the management system requirements necessary to produce accurate and reliable testing results.
Renolab is accredited by the Italian national accreditation body ACCREDIA in accordance with the requirements of UNI CEI EN ISO/IEC 17025:2018, the international reference standard for testing and calibration laboratories.
Renolab also operates in accordance with the principles of Good Laboratory Practice (GLP), within the national GLP compliance monitoring system coordinated by the Italian Ministry of Health, ensuring the quality, integrity and traceability of the data generated.
What does it mean to be an accredited laboratory?
Accreditation primarily represents formal recognition by an independent and impartial third-party body of a laboratory's competence, independence and impartiality in performing accredited tests.
Accreditation demonstrates that the laboratory meets both the technical and management system requirements necessary to provide accurate and technically valid data and results for specific testing activities.
Renolab is accredited by ACCREDIA in accordance with the requirements of UNI CEI EN ISO/IEC 17025:2018, Accreditation No. 02341 Testing.
Accreditation is formally granted through a specific agreement between ACCREDIA and the laboratory. By entering into this agreement, ACCREDIA confirms, following the successful completion of its assessment activities, the granting and validity period of the accreditation, as specified in the Accreditation Certificate and its annexes.
ACCREDIA is a signatory to the international mutual recognition agreements EA MLA and ILAC MRA, which extend the recognition of the laboratory's accreditation beyond national borders to all countries whose accreditation bodies are signatories to these agreements.
Use of the ACCREDIA Mark
The ACCREDIA document RG-09, "Regulations for the use of the ACCREDIA Mark", includes provisions that also apply to the customers of accredited laboratories.
The following provisions are particularly relevant:
- 6.4.5 Accredited bodies are required to report to ACCREDIA any misuse or abuse of the accreditation mark or logo of which they become aware.
- 6.5.2.5 The ACCREDIA Mark and any reference to accreditation must not be placed on a test sample or product (or any part thereof), or used in a way that implies product certification.
- 6.5.2.11 The ACCREDIA Mark or any reference to accreditation must not be used by customers of accredited laboratories, included in product-related documentation or displayed on a product. However, a copy of the test report may be attached. The laboratory must adequately inform its customers of the reasons for this restriction and monitor compliance.
- 6.5.2.12 Customers of accredited laboratories that commercially offer accredited testing services (e.g. consulting firms or intermediaries) and issue test reports containing results provided by accredited laboratories must not use the ACCREDIA Mark or refer to the accreditation of the laboratory that performed the tests. They must not use the ACCREDIA Mark in offers for accredited services under any circumstances. However, they may refer to the accreditation by stating the accreditation number and the registered company name of the accredited laboratory.
- 10.2 The ACCREDIA logo, as well as the IAF and ILAC marks, are legally protected. Any intentional or fraudulent use by accredited bodies and/or their customers, where applicable, will be prosecuted in accordance with the law.
Accredited Testing for Medical Devices
Renolab is an ACCREDIA-accredited laboratory (No. 02341) for the following tests:
- Sterility Testing
On medical devices
Standard: ISO 11737-2:2019 - In vitro cytotoxicity - XTT Test
On medical devices and raw materials used in medical devices
Standards: ISO 10993-12:2021, ISO 10993-5:2009 - annex D only - Skin irritation test by Reconstructed Human Epidermis (RhE)
On medical devices and raw materials used in medical devices
Standards: ISO 10993-12:2021, ISO 10993-23:2021/Amd1:2025 - paragraph 6 only - Bioburden – Enumeration of Microorganisms
On medical devices and raw materials used in medical devices
Aerobic bacteria, anaerobic bacteria, yeasts and moulds
Standard: ISO 11737-1:2018/A1:2021
Good Laboratory Practice (GLP)
The laboratory complies with the Italian Ministry of Health directives for chemical and physical characterisation and for residue studies on agrochemicals, biocides, cosmetics, drugs, additives and other industrial chemical products and for microbiological studies, in accordance with the OECD principles, European directives and Italian legislation.
GLP is recognised by the competent authorities of the European Community, the United States of America (FDA and EPA) and Japan (MHLW, MAFF and METI) under inter-governmental agreements.
Renolab is also one of the 16 Italian laboratories selected by the REACH Centre for the performance of the tests and analyses envisaged by European Union Regulation no. 1907/2006.