At the core of maintaining our high quality and regulatory standards is a robust Quality Management System, where all relevant quality and regulatory processes are described. Inspections from authorities, customer and internal audits, customer feedback, along with targeted quality improvement plans provide the input for maintaining these highest standards, as well as for continuously improving our systems, processes and products. This results in an active involvement and ownership of employees across all functions and lives the model that Quality is embedded in everything we do.
The Life Science Quality Management Systems & Audit team works to assess, govern and implement quality processes across our Life Science business with the aim of continuously improving our systems and performance.
The team is responsible for:
ISO 9001:2015 is the foundation of our Quality Management System for our products and services. Our ISO 9001 Quality Self-Assessment provides in-depth information about our Life Science Quality Management System. The table of content of this document is aligned to « Contents of ISO 9001:2015 Quality Management Systems ». The company profile is aligned to « RX-360 Supplier Assessment Questionnaire, Module 1 ».
The majority of our Life Science sites are certified to the ISO 9001:2015 standard.
Sites that manufacture medical devices are additionally certified to ISO 13485.
To cover higher requirements, we follow additional Quality standards, for example Good Manufacturing Practice (GMP) regulations:
Customer Quality Management is an integral part of our commitment to quality and encompasses all manufacturing sites. Our mission is to support our customers by providing accurate and value-added responses to customer concerns and issues in a timely manner. One of the key components of our Customer Quality Management program is addressing customer issues, experiences and complaints.
Quality Management Reviews are conducted at planned intervals to ensure the continued suitability, adequacy and effectiveness of the Quality Management Systems.
The Quality Manual describes the basic requirements for implementation, maintenance, and improvement of our Quality Management Systems at every level of our organization. The implementation of the Quality Manual ensures the ability to consistently provide products and services that meet or exceed customer, statutory and regulatory requirements.
For the management of all Quality Documents ManGo (based on CARA) is our electronic system. Besides using ManGo as storage for all GxP relevant documents it also enables thorough management over the entire document lifecycle such as draft, approved, effective and obsolete. A versioning history is available for all documents and notifications are sent in real time in case of periodic review and other tasks. Through a smart interface to our Learning Management System, latest approved documents are made available to the employees instantly.
Data integrity is fundamental to our Quality Management System which ensures the products released are of the required quality. Data integrity is considered a best practice and is applied to all facets of the business.
Training is conducted to ensure the qualification and the competencies of all employees to current and future responsibilities. Training is conducted by qualified individuals on a continuing basis.
We rely on the worldwide leading enterprise quality management solution TrackWise to utilize all core business processes, such as Complaint, Change, Deviation and Audit/CAPA management. By implementing TrackWise already in 2008 we have built up one fully validated and centralized database for all Quality Processes. Clear roles and responsibilities in streamline workflows optimize efficiency in the daily management of all quality aspects and guarantee full transparency of all current and past events.
Quality Risk Management is consistent with the process outlined in ICH Q9. Risk management is based on scientific knowledge. Continuous improvement is accomplished through the process of collection, monitoring and analysis of quality performance indicators, and is focused on product quality, regulatory compliance, customer satisfaction, resource allocation and subcontractor/supplier management.
Corporate audits, Internal audits and self-inspections are regularly performed across the company and our Life Science business to verify compliance with external and internal standards and procedures, identify areas for continuous improvement, and highlight best practices.