Quality

Our management system takes into account all the demands on and expectations faced by providers to the global pharmaceuticals and medical devices industries:

  • We are certified to the ISO 9001, ISO 13485 and ISO 14001 standards
  • We have CE mark certification under the Medical Device Directive (93/42/EEC) as amended by 2007/47/EEC
  • We comply with the Global Harmonization Task Force Guidelines
  • We have MSA accreditation
  • We build and maintain our cleanroom environments in accordance with ISO 14644 and ISO 14698

 

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    SP Medical is a highly modern technological company, continuously monitoring the state of excellence of our manufacturing and supporting processes by measuring and monitoring Key Performance Indexes in the relevant areas of our business. The KPI’s include product and process quality, as well the environmental responsibility.