Laboratories and organisations handling radioactive materials.
For laboratories and organisations that work with, store or dispatch radioactive materials. Do your licence, documentation and actual operations still match? WiseRay checks this and, where needed, develops a quality system and digital workflows. You receive findings with a prioritised action plan and work directly with the person responsible for the specialist work.
Laboratory contamination monitoringLicensing and operations, ready for inspection at any time.
Laboratories, operators and radioactive materials
For organisations handling unsealed or sealed sources, medical and pharmaceutical laboratories, and dispatch, logistics and transport operations.
- Source inventory, licensing and technical responsibility
- Radiation protection experts and quality system
- Training, ordering and release processes
- Waste, interim storage, incidents and documentation
- Supply chain and software workflows
- Audit readiness and traceable evidence
Related links: Radiation protection expert in the wiki (DE) · External radiation protection expert (DE) → · Quality manual in the wiki (DE)
It starts with one question.
Do the licence, activities, radionuclides, activity limits, premises, training, measuring equipment, dosimetry, waste and documentation still reflect actual operations?
Licensing and responsibilities
For organisations wishing to check whether their licence and documentation still match how they actually handle unsealed materials.
Services in detail
- Scope of the licence (DE) checked against actual activities and radionuclides
- Source and material inventory, work areas, measuring equipment, dosimetry (DE)
- Internal instructions, training, incident preparedness (DE), disposal
- Findings with a prioritised action plan
- Review and documentation to support the licence holder and the formally appointed radiation protection expert, who retain their responsibilities
QMS (DE) for unsealed radioactive materials
For organisations wishing to turn a collection of work instructions into an auditable system.
Services in detail
- Process map and matrix of roles and approvals
- Document control, training matrix, equipment status and inspection intervals
- Deviations, corrective actions and contamination incidents (DE)
- Annual management review
- Scope tailored to the size of the operation and its licence, not to a standard template
Radiopharmacy process and documented evidence
From ordering to traceability, as one continuous documented pathway.
Services in detail
- Supplier and licence checks, ordering, goods receipt
- Batch, activity and reference time, preparation (DE), quality control
- Formal release, use, residual activity, waste (DE)
- Interfaces with existing systems
- Model the workflow and make its documentation auditable, through to the formal release of a preparation by the appropriately qualified and designated person
Digital operational workflow (DE) for radioactive materials
For organisations currently entering the same data into several systems.
Services in detail
- Review of existing systems and their gaps
- Target process covering licensing, ordering, inventory, batches, release and waste
- Define required fields, checks and traceability
- Validation from the perspectives of radiation protection, medical physics and auditability
- Vendor-independent recommendation to inform the organisation’s decision to extend an existing system or introduce a new one
Explore the topic before we speak.
Licensing and handling radiation sources When a licence is required, the duties involved in working with radiation, and why unsealed and sealed sources are treated differently. (DE)
Hot lab and radiopharmacy Where radiopharmaceuticals are prepared: the shielded hot lab at the heart of radiation protection in nuclear medicine, with a generator, dose calibrator and rigorous quality control. (DE)
Transport of radioactive materials Where radiation protection meets dangerous goods regulations: how radiopharmaceuticals and sources are safely packaged, labelled and transported, and who is responsible. (DE)
Radioactive waste in nuclear medicine Radioactive decay does part of the work in nuclear medicine: how decay storage reduces the activity of short-lived waste, and what matters for storage, documentation and clearance. (DE)
The radiation protection expert Who provides radiation protection expertise within an organisation: the expert’s tasks, responsibilities and limits, and why an external professional can also fill this role. (DE)
Quality management system and manual for radiation protection Turning individual measures into a demonstrable system: what a quality manual for radiation applications contains and why it provides the basis for audit readiness. (DE)