Quality issues

You can find information about our management system and can download our certificates and licences on this page.

WESSLING ensures quality management

WESSLING Hungary Kft. has been operating a management system since March 1996 which was developed since that time into an integrated system covering the organisation as a whole in order to achieve and ensure compliance with the requirements of both the system standards No MSZ EN ISO 9001:2015 and No MSZ EN ISO/IEC 17025:2018, as well as of the requirements of the Good Pharmaceutical Manufacturing Practices (GMP).

Quality policy

WESSLING Hungary Kft. – The quality of our lives

The mission of our company is to provide such outstanding service standards in the course of its operations which fully meets the professional, statutory and quality requirements of the European Union.

Our goal is to win the trust and satisfaction of our Customers cast in our services. We firmly believe that this can be achieved by ensuring transparency, traceability of our services, professional expert activities and the follow-up on our procedures.

We commit ourselves towards the prominently demanding professional work and practices in place at our company, the first class quality of the testing, sampling and expert activities conducted in order to serve our Customers – beside adhering to the requirements set by the regulatory authorities and the accreditation bodies. We make all reasonable efforts to carry out our work by employing highly qualified, experienced personnel, modern technical equipment, tools and materials.

In order to implement the objectives referred to above, and to ensure the high standards expected by our clients from the services we provide, we operate and continuously improve our governance system.

We ensure the conditions required by the management system operated by the company, in order to achieve and ensure compliance with the requirements of both the system standards No MSZ EN ISO 9001:2015 and No MSZ EN ISO/IEC 17025:2018, as well as of the requirements of the Good Pharmaceutical Manufacturing Practices (GMP).

The following are provided in order to operate the management system:

  • overall conditions of the operations and continuous improvement of the management system,
  • appropriate environmental conditions,
  • the necessary and optimum number of staff,
  • further education of personnel and the acquisition of skills necessary for the work processes,
  • state of the art plant and equipment to meet the professional standards set for the work, their maintenance and regular periodical inspection, development,
  • the application of the most appropriate testing methods, having regard to the aspects of accuracy, repeatability and reliability,
  • follow up on the test methods and tests used,
  • involvement in the development of new test methods and sampling methods and
  • in the proficiency testing programmes, as well as
  • participation in research programmes, assistance to the preparation of theses and dissertations within the framework offered by our company.

On this basis, we require:

  • confidential treatment of issues and impartiality, reporting obligation in each case when conflict of interest may emerge,
  • remuneration of staff independent from the number and outcome of the sampling operations and testing accomplished,
  • confidential treatment of all information obtained or created in the course of the operations,
  • from all members of staff to get to know the contents of the Quality Management Manual and to follow the quality policy and procedures formulated therein all times,
  • recording of standard operating procedures in writing and their continuous updating,
  • ongoing monitoring of commissioned instruments and devices as well as the test conditions,
  • quality assurance to test results,
  • periodical review of the management system according to the recommendations of the relevant standard,
  • running the Customer Service Desk.

We represent and warrant that WESSLING Hungary Kft. conducts its activities according to its best knowledge and conscience as an independent economic operator providing services without any external influence or pressure, meeting all regulatory and statutory requirements.

Budapest, 1 March 2019

Dr. László Zanathy
Managing Director

Ensuring high standards in quality requirements

  • During the provision of our services we keep on providing quality assurance systems meeting both the regulatory requirements and Customer expectations.
  • Our accreditation, licences warrant high quality levels in laboratory tests and the efficiency of the quality assurance management system. The set of criteria laid down in the Hungarian standard MSZ EN ISO/IEC 17025 and in the GMP guidelines contain all requirements relevant for test laboratories. Among others, requirements are defined with respect to employee competence, introduction of test methods, validation of the methods already developed, and the handling and control of testing equipment.
  • All employees in the company hold appropriate qualifications, are familiar with the requirements laid down in the quality assurance system documents and carry out their respective works in accordance with these procedures.
  • The operation of our laboratories is regularly audited by the supervisory authorities.
  • Our accredited laboratories participate in all relevant skills assessment programmes in order to demonstrate our professional and technical competence.
  • Compliance with legal rules and quality requirements represent the foundations of the operation of our company.

Accredited laboratories

Based on the decisions made by the National Accreditation Authority (NAH) the Environmental Analytical Laboratory and the Food Testing Laboratory of WESSLING Hungary Kft. hold the certification of independent testing laboratory under the registration number of NAH-1-1398/2015 up to 7 December 2019 and under the registration number NAH-1-1009/2015 up to 1 December 2019, respectively.

Having regard to the fact that the National Accreditation Authority (NAH) is a signatory to the mutual multilateral recognition agreements of both the European Cooperation for Accreditation (EA) and International Laboratory Accreditation Cooperation (ILAC), the accredited tests made by the laboratories are accepted not only in this country but abroad just as well.

This recognition of European level strengthens the confidence of our Customers in our competence, the quality of the tests we make and the independence and impartiality of our laboratories.

Quality Management and Accreditation

WESSLING Hungary Kft. holds manufacturing / import licences to carry out quality control tests on human pharmaceutical products and pharmaceutical starting materials, as well as to release medical products.

Conformity with GMP requirements was certified by the National Institute of Pharmacy and Nutrition. – The laboratory, and the Product Release Department were granted to carry out quality control of pharmaceutical products and pharmaceutical starting materials and to test and to release production batches of pharmaceutical products originating from third countries with the number HU-M-WESS.

GMP compliance was demonstrated by the National Food Chain Safety Agency Veterinarian Medical Products Directorate. – The number of the manufacturing authorisation licence issued by the Directorate for quality control testing of veterinarian medical products is: MA-HU/17V/2006/M2.

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