QUALITY MANAGEMENT SYSTEM
ACCORDING TO EN ISO 9001:2008
A lasting implementation of the SKAN Quality Management System required SKAN to face up to a structured process understanding in order to cope with the various requirements of our clients. This also had been viewed in combination with the demanding technologies and realisation targets. Performing like this was only possible by a sound measure of identification by all staff members of this company. There was to gain a vivid ground for pre set quality agreements to the inner SKAN sight as well as to the outer client related focus.
With the internationally accepted quality management standard according to EN ISO 9001:2008 are now fundamentally bound in all business units of the SKAN. Corresponding procedures are backed up by accurately designed processes. This basis has been laid down together with the SQS, the Swiss Association for Quality and Management Systems. This enables us to meet obligations towards the stakeholders in an optimised way.
Quality as a self evident expression of the SKAN company culture is regarded as an integral part of it's working activity. The enterprising's focus is mirrored by the integral quality management system that leads beyond the ISO 9001 requirement. To say, that the objectives of the machine directive according to 2006/42/EC, with consecutive CE compliance assessment, is a necessity, followed by binding additions, e.g. to the workplace safety according to EKAS 6508 up to the technological alignement with pharmaceutical industry processes and laboratory applications. With all of this go along criteria in regard to the European cGMP Good Manufacturing Practice, according to 2003/94/EC, Annex 1, and GAMP Good Automated Manufacturing Practice, according to the actual recommendation of ISPE.
Accordingly, this integrated quality system's approach is bound into the ISO 9001, which allows SKAN to create reliably complex isolator systems as well as small project based devices in a highly customized manner. This fosters SKAN to implement innovative products into the market
