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

Our mission is to provide outstanding service quality by our operations, in full compliance with the relevant technical, regulatory and quality requirements applied in the European Union.

Our aim is to earn our customers’ trust in and satisfaction with our services. We are confident that we can achieve our goals through the transparency and traceability of our expert consultancy activities and the retraceability of our analytical and testing procedures.

We are committed to maintaining the exceptionally high standards and professionalism of our work and practices and to the highest possible quality of the analyses, tests, sampling and other expert/consultancy services performed for our customers, while observing, and complying with, the requirements prescribed by the competent regulatory authorities and the accrediting authority. We aim to perform our assignments with highly trained and experienced professional staff and cutting edge technical facilities, equipment and materials.

lt is to achieve the above objectives that we operate, improve and develop our management system to assure the quality of our services, as expected by our customers.

We provide for the availability of the conditions and requisites demanded by the management system in place at our company and make sure that they are up to the requirements of what is known as Good Manufacturing Practice (GMPl, set forth in the standards MSZ EN ISO/IEC 17025:2018, MSZ EN ISO/IEC 17065:2013 and MSZ EN ISO 9001:2015.

We provide the following far the operation of the management system:

  • the general conditions and requisites for the operation and continuous development of the management system,
  • the required environmental conditions,
  • the necessary optimised number of technicians and professionals,
  • continued training of our employees and their acquisition of the necessary skills in the work processes,
  • up-to-date operating machines and equipment as required for meeting the technical and professional standards applying to our work, together with their regular maintenance, checks and development,
  • the application of the most appropriate analytical and testing procedures, with a focus on precision, repeatability and reliability,
  • the traceability of the applied analytical methods and tests,
  • participation in the development of new analytical methods and sampling techniques and in
  • skill testing programmes, as well as
  • participation in research programmes and opportunities for the preparation of theses and dissertations at the Company.

Based on the above we require:

  • confidentiality and impartiality in deating with cases as well as an obligation to report any and all situations that may involve conflicts of interests,
  • that the employees’ remuneration should be independent of the number of samples taken and analyses, tests, expert and certified activities carried out, as well as their results,
  • confidentiality in managing all details, data and information obtained or created during the activities,
  • that every one of our employees is fully familiar with the content of the Quality Management Manual and that they always observe and follow the quality policy and the procedures laid down in the Manual,
  • recording of the procedures in writing, their continuous updating,
  • regular checks of the instruments and devices in operation, together with the circumstances of the analyses,
  • assurance of the quality of the results produced by the services,
  • periodical reviews of the management system, in accordance with the applicable standard recommendations,  
  • maintenance of a customer service function.

We declare that WESSLING Hungary Kft. performs its operations to the best of its knowledge and conscience, as a business undertaking performing independent services, without any external influence, in full compliance with the requirements introduced by the competent regulatory and supervisory authorities.

Budapest, 15 August 2020

 

Dr. Zanathy László
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-1-1398/2019 up to 17 October 2024 and under the registration number NAH-1-1009/2019 up to 17 October 2024, 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.

Do you have any further question concerning quality issues?

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Accreditations