Quality Policy | Jagiellońskie Centrum Innowacji

Quality Policy

The mission of the Jagiellonian Center of Innovation is to provide the highest quality comprehensive services, dedicated for organizations operating in the life science sector. This service offering is designed to build and continuously expand a life science client portfolio as well as create conditions conducive to the establishment and development of enterprises engaged in research and development or innovative activities.

 

The highest quality level means:

  • provision of reliable research findings;
  • provision of reliable information as part of consulting services;
  • carrying out project work based on applicable guidelines and knowledge updated on an ongoing basis;
  • production of products in accordance with applicable standards and legal regulations;
  • completing works undertaken within the agreed time limit.

 

The mission of the Jagiellonian Center of Innovation is fulfilled in particular by:

  • activities in accordance with the principles resulting from the implemented quality management system based on the requirements of international standards: PN-EN ISO 9001, PN-EN ISO 13485, PN-EN ISO 22716 and GMP requirements specified in the Regulation of the Minister of Health on Good Manufacturing Practice
  • employing specialists with appropriate knowledge and qualifications
  • increasing the knowledge and qualifications of employees through training and exchange of experiences
  • the use of test materials and production materials of appropriate quality
  • ensuring adequate infrastructure and working environment
  • selection of suppliers and subcontractors that meet specific requirements
  • implementation of a risk management procedure in the design, testing and manufacturing of medical devices and pharmaceutical products
  • analysis and fulfillment of legal and other customer requirements
  • implementation of an effective system for dealing with complaints
  • effective corrective actions

 

The Jagiellonian Center of Innovation is committed to:

  • compliance with the applicable requirements, including the requirements of PN-EN ISO 9001, PN-EN ISO 13485, PN-EN ISO 22716 and the GMP requirements specified in the Regulation of the Minister of Health on Good Manufacturing Practice, legal requirements and other requirements of interested parties regarding which our organization is committed to meeting;
  • continually improving the quality management system.

 

This Quality Policy is evaluated in terms of its purposefulness during management reviews and forms part of employee induction training.

Quality Management System – ISO 9001: 2015

The Jagiellonian Center of Innovation has implemented a Quality Management System compliant with the requirements of the ISO 9001: 2015 standard in selected areas of the center’s activity, i.e. provision of the service consisting of designing and conducting laboratory research and tests, including those of innovative nature. No exclusions have been applied to the Quality Management System.

 

 

In implementing the procedures required by ISO 9001: 2015 we set ourselves the goal of continuously improving the services which we offer to our business partners.

 

The Jagiellonian Center of Innovation boasts a certificate issued by the Tüv Rheinland certification body attesting that the center has implemented and applies ISO 9001 requirements.

 

For more information on our Quality Management System please contact:

 

Ms Jolanta Kaleta, Ph.D., Quality Assurance Department Manager

 

We look forward to doing business with you.

 

 

 

Quality Management System – ISO 13485:2016-04

The Jagiellonian Center of Innovation has implemented a Quality Management System compliant with the requirements of the ISO 13485:2016-04 standard in selected areas of the center’s activity, i.e. design and development, research, quality control and production of inactive medical devices to be applied to the skin and mucous membranes in solid, liquid and semi-liquid form, commissioned by other manufacturers of medical devices.

 

 

 

 

In implementing the procedures required by ISO 13485:2016-04 we set ourselves the goal of continuously improving the services which we offer to our business partners.

 

The Jagiellonian Center of Innovation boasts a certificate issued by the Polish Centre for Testing and Certification certification body attesting that the center has implemented and applies ISO 13485 requirements.

 

For more information on our Quality Management System please contact:

 

Ms Jolanta Kaleta, Ph.D., Quality Assurance Department Director

 

We look forward to doing business with you.

 

Cosmetics, GOOD MANUFACTURING PRACTICES (GMP) – ISO 22716: 2009

The Jagiellonian Center of Innovation has implemented the GMP requirements in the production of cosmetics in accordance with the ISO 22716 standard. The requirements of this standard have been introduced into the quality management system in order to ensure appropriate production standards, and thus ensure the appropriate quality and safety of manufactured cosmetic products.

 

The ISO 22716 standard covers: personnel, premises, equipment, raw materials and packaging materials, production, finished product, quality control laboratory, waste, subcontracting, complaint and recall, internal audits and documentation.

 

The Jagiellonian Center of Innovation meets the requirements of the Regulation of the European Parliament and of the Council (EC) No. 1223/2009 of 30 November 2009 on cosmetic products and the Act of 4 October 2018 on cosmetic products (Journal of Laws, item 2227).

Quality Department Director

PhD Jolanta Kaleta

Jolanta Kaleta completed PhD studies at the Faculty of Pharmacy at the Jagiellonian University Medical College. At the Jagiellonian Center of Innovation she is responsible, among others, for the quality management system, quality control of production process of the cosmetic products and operation of the quality control laboratory. She gained professional experience as a long-time employee of Beekeping-pharamceutical enterprise “Apipol-Farma” Sp. z o.o. working as a Quality Control Manager and as a Qualified Person.

 

Team:
Marta Łukasiak – Quality Assurance Specialist

Marta Kocurek – Quality Control Specialist

Natalia Cagara – Junior Quality Control Specialist

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