They key aspects of our QA/QC policy
To safeguard the right quality, we work as per a set of fixed steps which are described in summar here below:
- Fully certified contract manufacturers
All medical and diagnostic consumables in our product range are produced by our ISO- and CE-certified contract manufacturers. This concerns ISO 9001 and/or ISO 13485 certification, but more and more often also concerns ISO 14001 (sustainability), and CE-certification as per MDD or MDR.
- Complete product files
Of each product, a complete file is kept, meaning that all quality certificates, test reports, declarations and (technical) product information is at all times available and up to date. This enables us to swiftly and completely hand over all required documentation and information to our relations.
- Verification with independent authorities
For all products involving the involvement of independent bodies (such as Notified Bodies or accredited laboratories), we verify the validity and authenticity of certification or test results issued by them. In addition, we also check the authorization of Notified Bodies themselves, to determine whether they are authorized to issue certificates for the applicable product category. In this way we prevent fraudulent or meaningless certificates from being used when selecting products.
- Sampling
Before a product is included in our range, we have already extensively assessed and tested it internally, often in collaboration with independent test laboratories. But we always offer the opportunity to first receive samples of our products. Certain products automatically include an explanatory session with one of our Product Specialists from a safety perspective.
- Independent quality inspections during and after production
Quality inspections take place periodically at our contract manufacturers, both by the Notified Body and our own QA consultants. We also work with TUV Product Services and SGS, among others, to carry out so-called 'pre-shipment inspections', where productions are inspected prior to import. The practical quality of the product is again independently assessed, in addition to the manufacturer's own in-process checks.
- Periodical audits
Apart from ongoing productions, we also periodically carry out quality checks and audits at our manufacturers. These are alternately carried out by independent bodies or by our own quality department. Important aspects such as sustainability of production and Product Life Cycles are also taken into account.
As extra assurance and validation of our quality policy, we are EUDAMED (Europe) and FAGG/AFMPS (Belgium) registered, and operate on a daily basis as per ISO 9001:2015.
