Our diverse and practical expertise lies in the areas of traditional pharmaceuticals, APIs, medical devices, biotechnology, biomedicine, food and the cosmetics industry. 

We will be happy to support you in introducing a quality management system based on DIN EN ISO 9001 and, if necessary, in accordance with DIN EN ISO 13485 or the more far-reaching GMP regulations. 

Why
should you introduce a QM system? 

• Increasing the performance of the organization 
• Consistent quality through structured processes 
• Fulfilling customer requirements and consolidating market position
• Cost savings due to fewer errors or complaints  

And this is where our Passion on Point guarantee comes into play! We guarantee 100% commitment to the introduction of a QM system and preparation for an audit. 

What does this mean for you in practice? 

• Implementation of a workshop on the topic 
• If necessary, create a gap analysis for existing SOPs  
• Creation/review of SOPs 
• Preparation for audits 
• Creation/implementation of training courses  
• Etc....  

CONTACT
Bettina Ernst
Head of QMS
Phone: +49 (0) 6321 - 9 26 26-0
Mobile: +49 (0)151 - 146 112 93
Email: bettina.ernst@pitzek-consulting.de