Quality Management System

Competence, commitment and improvement

Capricorn Scientific is committed to being a well-trusted partner for our customers in every Life Science sector. We are regularly audited and certified by an independent organization to continuously improve our quality system and our standards, processes and products.

Our ISO 9001:2015 Certification

  • Customer focus through commitment and flexibility
  • Highest standard of production, quality and documentation
  • Permanent improvement of process and efficiency

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Our Quality Policy (DIN EN ISO 9001:2015) Includes:

The customer is the focus

We want to ensure and continuously improve the satisfaction of our customers. The customer's judgement is decisive for the product quality.

Every employee contributes to securing our quality standards; the commitment of employees at all levels is essential to increasing the quality of our products.

We ensure that all quality- and safety-relevant activities are planned, controlled and monitored in compliance with legal and official regulations.

We follow the zero-error principle. We attach particular importance to the avoidance rather than detection of error.

The company fulfills the requirements of the QM system (standard ISO 9001:2015) and the continuous improvement process.

Our structures include:


1. Policies and Procedures

  • Adverse incidents policy and procedures
  • Compliants policy and procedures
  • Safety policy and procedures
  • Waste policy

2. Supporting Documentation

  • Standard operating procedures
  • Staff training manual
  • Data management system
  • Document management system

3. Operational Procedures

  • Management procedures
  • Business continuity plan
  • Manufacturing protocols
  • Batch release protocols

 


4. Legal Framework

  • Distribution contracts
  • Material transfer documents
  • Supply agreements
  • Confidentiality agreements

5. Compliance and Improvement

  • Compliance management system
  • Internal and external audit programs
  • Inspection programs
  • Quality and change notification