"Quality begins where norms end"

What is meant by Quality Management?

Quality Management designates the planning, governance and optimization of business processes and value chains by means of pre-defined requirements. The objective is to improve or maintain the quality of products or services at a consistently high level.

What I can offer to you:

• Establishment, implementation and maintenance of quality management systems according to standards ISO 9001 and ISO 13485
• Performance of internal audits according to standards ISO 9001 and ISO 13485
• Performance of supplier audits according to standards ISO 9001 and ISO 13485
• Adoption, Governance and Updating of your QM-System according to standards ISO 9001 and ISO 13485
• Support in quality management
• Coaching for internal audits and supplier audits according to standards ISO 9001 and ISO 13485

Quality, customer satisfaction and efficiency rank among the crucial factors for a company to succeed in a competitive environment. But how can you manage to improve the necessary processes, to optimize workflows and to organize organizational and management demands more efficiently? The answer is: By implementing a reliable quality management system (QMS).

I‘ll be at your disposal from consultation to implementation of a QMS that is customized for your company.

The standard conformity of a QMS must be verified periodically by an internal audit. It is not enough for a company to implement a quality management system - it also has to permanently maintain and evolve the system. Nonconformities must be intercepted and improvements as well as their potentials need to be determined and used. The process of self-testing of a management system is called an internal audit. Many companies neither have the necessary resources nor the time to perform this. For this I am also offering the performance of or the support for your internal audit according to standards DIN EN ISO 9001 and DIN EN ISO 13485.

Furthermore, the standard requires that externally provided processes like suppliers need to be monitored periodically. Generally, this is done by performance of supplier audits on-site (or remotely, where applicable). As this means a high expenditure of time for you and your staff I am offering to carry out the supplier audits for your company.

I‘ll gladly support you and your team in a competent and practical manner in achieving your goals, in performing your internal audits and supplier audits according to standards DIN EN ISO 9001 and DIN EN ISO 13485 or in establishing and implementing a quality management system.

Please just contact me about this!