To support international expansion and to cope with the increase in quality demands of its customers, Capsulution Nanoscience AG has introduced the international standard, the ISO 9001:2000 as the minimum standard for quality management. "With this process oriented, customer friendly approach, our company, which focuses on customer specific development, seeks to continuously improve its performance," states Alexander Herrmann, CFO. Capsulution is obtaining support from its external partner, the company QM-Consulting GmbH.
In the coming months, the QM team will be working on the introduction of a complete quality management system according to ISO standards. All working areas will be closely studied with regard to customer and process orientation including Research and Development, Business Development, from Sales to Secretarial Services. "The starting position is good" surmises the external QM consultant Göbel after taking stock of the existing situation. "Capsulution has at its disposal a solid base for a rapid and successful implementation because important QMS demands have been already met in recent years."
"As a developer, consistent customer orientation is a matter of course", explains the QM representative Claudia Aldenhoven. "We develop tailor-made products for the individual technological and market-specific demands of the most varied customers. Capsulution is proving to be on the right track also by its long-standing customer partnerships." These customers appreciate the nanocapsules, individualised to their specific needs or complexes, each endowed with the required pharmaceutical, biochemical, electrical, optical and magnetic properties.
The rocky road to quality assurance and management still needs official confirmation. "The certification audit should take place in the second half of this year", adds Aldenhoven. The certification is not the completion of the QM activities but rather the first step. In order to introduce own product developments in the field of drug delivery/medical products and diagnostic sensors onto the pharmaceutical market, we want to rely on a vital quality management which also puts the guidelines of the EC-GMP into action.
In the coming months, the QM team will be working on the introduction of a complete quality management system according to ISO standards. All working areas will be closely studied with regard to customer and process orientation including Research and Development, Business Development, from Sales to Secretarial Services. "The starting position is good" surmises the external QM consultant Göbel after taking stock of the existing situation. "Capsulution has at its disposal a solid base for a rapid and successful implementation because important QMS demands have been already met in recent years."
"As a developer, consistent customer orientation is a matter of course", explains the QM representative Claudia Aldenhoven. "We develop tailor-made products for the individual technological and market-specific demands of the most varied customers. Capsulution is proving to be on the right track also by its long-standing customer partnerships." These customers appreciate the nanocapsules, individualised to their specific needs or complexes, each endowed with the required pharmaceutical, biochemical, electrical, optical and magnetic properties.
The rocky road to quality assurance and management still needs official confirmation. "The certification audit should take place in the second half of this year", adds Aldenhoven. The certification is not the completion of the QM activities but rather the first step. In order to introduce own product developments in the field of drug delivery/medical products and diagnostic sensors onto the pharmaceutical market, we want to rely on a vital quality management which also puts the guidelines of the EC-GMP into action.
