Quality Management System Services

High quality and quality assurance systems based on it are essential for the subsistence, for keeping already existing clients and generating new ones. Knowing this AdWare Research applies the national and international regulations for its own activites as well.

AdWare Research with its experienced team provides tailor made, holistic quality assurance and quality control services to producer, and service provider companies especially in the field of pharmaceutical and health industry. AdWare put high emphasis on the continuous relationship management with the clients so that the systems could be a help to the clients and not a barrier.

Quality systems we develop

  • ISO (International Organization for Standardization) standards
  • ISO 9001 Quality Management Systems
  • ISO 14001 Environmental Management Standard
  • ISO 13485 Medical Device Standard (CE sign’s user guidance)
  • ISO / IEC 17799 – Information Security Management Standard
  • ISO 17025 – General Requirements for the Competence of Calibration and Testing Laboratories
  • ISO 15189 – Medical Laboratories
  • ISO 15189 – Medical Laboratories
  • Hungarian Healthcare Management Standards (MEES) – including Hospitalization, Outpatient, Family, Physicians and District Nurse Manaement Standards
  • GLP (Good Laboratory Practice)
  • GCP (Good Clinical Practice)
  • HACCP (Hazard Analysis on Critical Control Points)
  • Another systems like: IFS

AdWare Research develops and implements

  • SOP systems and instructions
  • Document and data control systems
  • Employee training programme
  • Training and process management
  • Subcontractor assessment systems
  • Mock inspections

Quality systems and compliance checklist

In order to achieve the highest quality the following steps are necessary:

  • Define relevand quality standards and regulations
  • Preparing missing documents
  • Training of employees on the new documentation
  • Continous monitoring of the efficacy of the quality assurance system
  • Summarize experience, progress for the management
  • Consultation with experts

Setting up and initiating a new system always requires supervision and needs internal audit, accreditation.

With a more than 10 years past in this area AdWare Research has relevant experience, thus the business set up is already done according to the needs and instructions of the Authorities saving time and energy for the clients.