We have been successfully re-certified. The new certificates and documents have been issued. In our download centre, you can access the latest certificates for your files or inform yourself about them under "Quality" (last update: 04/2020).
Heinlein Plastik-Technik has successfully fulfilled the requirements of the standards (DIN EN ISO 9001 + HACCP),
DIN EN ISO 15378, parts of DIN EN ISO 13485, as well as the
Medical Device Directive 93/42/EEC MMD).
In February, after an on-site audit lasting several days, the responsible certifiers confirmed that all organisational and hygienic requirements of these stringent standard regulations had been implemented in accordance with standards, without any critical deviations. Instead, the new building/comprehensive ISO management system/structure and organisation of the company were viewed in a very positive light and assessed accordingly.
"It is evident that Heinlein has continued to evolve and constructively address these topics."
We thank all our employees for this success. It is only when each and every person does their job conscientiously and responsibly that the company is able to achieve the results that our customers and partners expect from us today.
But we do not wish to rest on our laurels. Instead, we continue to work on complying with the latest guidelines for the manufacture of pharmaceutical primary packaging and medical products and fulfilling the requirements of the relevant standards.