14. QUALITY ASSURANCE
• The Quality System ensures that all applicable standards are strictly
followed.These are ISO 9001/2000 (basic Q/A rules), ISO 13485
(special Q/A rules for the medical industry, EN 552 (rules for
irradiation), EN 556 (definition of the term sterility) and ISO 11137
(rules for a/o validation of products). In case of medicinal products,
the rules in the Pharmacopoeia are also applied.The system will also
be compatible with the FDA 21 CFR Part 820 QS Reg. GMP
• We have acquired a cerificate for ISO 13485 (special Q/A rules for the
medical industry that include basic Q/A rules of ISO 9001/2000) with
reference to ISO 11137 (rules for validation of products)
15. Pricing
• Prices are calculated per container (tote box) and they depend on
needed dose range, product density etc., typically in a range of 40 –
75 €/container (eg. 25 - 125 per m3)
• Dose mappings (product validations) are offered for free for serious
customers. For small volumes the list price is around 400 - 700 € per
product
• Irradiation of samples fee is 175 € per ”reasonable” dose for
"reasonable amount" of samples. "Reasonable" means that weight
must be below 120 kg and samples must fit into one container,
requested dose has usually been in between of 5 kGy and 50 kGy