Our services:

Enhance Quality for added value with Haabio.

• What are your strategic and customers’ needs for your Quality System?
• Which standard, guidelines or regulations are obligatory for your organization to be followed?
• Do you want to achieve an excellent business model which covers all your activities?
• Do you want to full-fill just the basic requirements set by the authorities or your customers?

Our goal is to help you to build up a Quality System which fits your needs and maintains your quality system steering activities at an appropriate level.

You can choose a combination of consultancy services that best meets your needs.

Quality and organization management

• Quality system creation, maintenance and improvement
• Quality system reviews and recommendations
• Process, project and resource management
• Organizational development and team work
• Training

QA management and QA-managerial duties, e.g.

• Internal and external auditing, supplier auditing
• Quality system documentation and practices (Quality manual, SOPs, Procedures, work instructions
• Consultancy on Quality assurance practices
• Validation, qualification, verification
• Training

We are experienced specialists in the following standards, guidelines and models

• GMP
• GLP
• ISO 9001
• ISO 13485
• GCP
• FDA QSR (Quality System Regulations)
• EFQM Model (EFQM = European Foundation for Quality Management)
• Laboratory accreditation
• CE-labeling