The management system of SCHOTT Lighting and Imaging was reviewed according requirements of ISO 13485:2003
The quality and environmental system of the company is well implemented and is already certified by LRQA for several years. Specific requirements of the standard 13485 were added into the current system. Requirements of standard were reviewed and found to be fulfilled. One small deviation was found and is linked to practical application of identification and traceability. Corrective action plan was issued by clients at the end of the visit and remote follow up is planned for 01/2012. The client will send records from realisation of this action to the LRQA office.ISO 13485 Mainz_english ISO 13485 ValMez_english ISO 13485 ValMez_czech ISO 13485 Mainz_deutsch ISO 13485 ValMez_deutsch
The recommendation to issue certificate for production site Valašské Meziříčí is given.
System effectiveness and continual improvement The high level of the system was noticed. Risk management is well applied. Products are not intended for end user- OEM products only. The level of the system is characterised by low level of complaints, no incident or near incident reported to the company caused by their product during whole production.
Areas for management attention Future link and results gained from feedback from customers, complaints to risk management.
More visible transfer of risk assessment results to the site level (specifically for employees).