Quality Management System
At Logical Biological we operate an ISO 9001:2015 certified Quality Management System, so you can be confident of our commitment to Quality processes and products. Our Quality Management System covers:
- Product quality checks, documentation control, traceability, recalls and returns
- Customer complaints, Non-conformance, CAPA and audits
- Approved supplier program
- Document control, Training system, Safety, Equipment control, and Change control measures
- Environmental control
ISO 9001:2015 Certified
The benefits of purchasing human biological material from an ISO 9001:2015 certified organisation are clear:
- Systematic and logical response to issues – Reliable delivery is a key priority. Should issues occur, they are corrected promptly and are thoroughly investigated to find the root cause, and appropriate corrective/preventive actions implemented
- Change control for consistent delivery –Defined processes are followed and any changes are carefully assessed and controlled
- Customer satisfaction – Customer feedback is actively sought and assessed to enable continuous improvement
Quality Assurance
Human Tissue Authority License
Logical Biological are licensed to handle and store human tissue in accordance with Section 16 (2) (e) (ii) of the Human Tissue Act 2004. We follow strict ethical standards, safeguarding the dignity of donors and ensuring tissues are acquired, stored, handled and used appropriately for research.
Informed Consent/ IRB Collected Material
Logical Biological understand the importance of the Institutional Review Board (IRB) and informed consent processes when using patient samples for research and clinical trials. Both processes ensure the ethical, legal, and regulatory integrity of research involving human participants. We can collect samples with informed consent and/ or under IRB.
Donor information
Logical Biological ensure the integrity and privacy of our donors is respected. Data accompanying our biological materials is stripped of any personal identifiers to protect their identity and ensure compliance with ethical and legal standards, such as GDPR. Anonymized data also facilitates larger-scale studies by allowing the pooling of data across multiple sources without compromising donor identities.
