EN ISO 9001 : 2015 for the preparation of compounded medication



The Company’s Quality Management System covers the preparation of compounded medication. It is designed in accordance with the needs and objectives of the Company and the Legal and Regulatory Requirements of the current Greek and Community Legislation.

Satisfying and ensuring customer confidence through the fulfillment of defined quality standards and consistency in deliveries are the company’s basic principles.

The general objective is to offer the company’s customers safe products of consistent quality. More specifically, the company seeks :

  • The production of safe galenic preparations.
  • The continuous expansion of the company’s market share while always ensuring the high quality of the products; and
  • the constant upgrading of the company’s human resources through training programs and the recruitment of qualified new employees.
  • The continuous improvement in the operation of the Company through the effective use of the following tools:
  • Definition and review of quality objectives.
  • Management review
  • Internal inspections
  • Corrective Actions
  • Identification of stakeholder requirements (customers, staff, the wider community, etc.) related to the Quality Management System.
  • Written documentation (documents – records) to maintain the history of the company’s activities to prevent risks of interpretation, loss of information, or confusion from verbal communication.

To achieve the above objectives faster and more effectively, the Management:

  • Commits to and implements its Quality Policy and Quality Management System principles.
  • Commits to comply with the applicable Greek and Community legislation.
  • It shall inform its human resources and motivate them to commit to the same principles.
  • It is committed to making available the infrastructure and equipment deemed necessary for implementing its activities and correctly applying the Quality Management System.

The documentation of the Quality Management System and compliance with CM/Res (1016)1 is achieved by providing all the required information.   The above objectives are achieved through systematic planning, process control, and continuous improvement of all activities.

Each employee is responsible for the quality of their work, and it is imperative that they contribute to quality management and achieving the defined objectives. For this reason, according to their responsibilities, all employees are informed about the Quality Management System and act demonstrably in accordance with the established rules. Staff also comply with documents related to their area of responsibility, and personal hygiene requirements and are encouraged to report irregularities/MS occurring at their level of commitment.

Process flows and actions, which do not guarantee the fulfillment of the objectives set, are immediately interrupted by those responsible, root cause analyses are carried out, and the necessary improvement measures are defined.

This Quality Policy is communicated to staff, available to all stakeholders, and periodically reviewed by the Company’s Management.

High quality standards

The company has been certified for the Management System according to the standard EN ISO 9001 : 2015 for the preparation of compounded medication by TUV AUSTRIA HELLAS and has been certified for the Management System according to the Resolution:


CM/Res (2016)1 on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients (1 June 2016) by TUV AUSTRIA HELLAS.

Other certifications