Quality beyond compliance
For companies handling critical materials, quality goes beyond compliance. It means being able to rely on consistent products, controlled processes, traceable documentation and carefully managed change.
For more than 30 years, quality thinking has shaped how CurTec develops products, improves processes and supports customers. Our approach is based on Total Quality Management (TQM), brought into daily practice through an integrated Quality Management System that combines Quality, GMP, Food Safety, Environmental and Energy Management within one controlled framework.
What our approach to quality means for you
Consistency
Reliable packaging quality across products, production runs and locations helps support predictable performance in your processes.
Control
Clear, structured management of risks, changes and compliance requirements helps you maintain control over factors that may affect your products or operations.
Confidence
Recognized standards, certifications and independent audits provide external assurance that our quality systems are implemented, maintained and continually improved.
Support
Access to regulatory documentation, qualification support and quality expertise helps you manage supplier compliance more efficiently.
Total Quality Management in practice
Total Quality Management involves employees across CurTec in continuously evaluating and improving how we work. Eight principles guide this approach.
1. Customer satisfaction – our quality benchmark
We regularly measure customer experiences across ordering, delivery, products, service and added value. We use that feedback to identify improvement opportunities, anticipate changing needs and strengthen the way we support customers.
2. Employees at the core of quality
We make quality a shared responsibility. Through training, dialogue, audits and cross-functional collaboration, we give employees the knowledge and ownership they need to improve both processes and outcomes.
3. Quality in every process
We standardize, control and continuously improve the processes that shape our performance. Automation, digitalization, clear procedures and documented controls help us increase consistency, traceability and reliability across production and supporting activities.
4. Quality through an integrated management system
We bring Quality, GMP, Food Safety, Environmental and Energy Management together within one integrated management system. Procedures, instructions and workflows translate these requirements into daily practice and keep responsibilities, controls and improvement activities connected.
5. Quality with a long-term perspective
We look beyond today's performance. Through strategic planning, business reviews, SWOT analysis and operational risk management, we assess changing customer needs, regulatory developments, opportunities and potential threats and prepare our organization accordingly.
6. Continual improvement
We use internal audits, customer feedback, KPIs and management reviews to evaluate performance and identify opportunities to improve. We turn lessons learned into actions that strengthen processes, reduce risk and improve the effectiveness of our management system.
7. Fact-based decision making
We base decisions on data, performance indicators and structured risk assessment. This helps us understand issues objectively, compare options and set priorities based on evidence rather than assumption.
8. Quality through communication
We keep objectives, responsibilities, risks, changes and progress visible across the organization. Regular dialogue, multidisciplinary collaboration and knowledge sharing connect teams and help ensure that relevant information leads to coordinated action.
Certifications and independent assurance
Our integrated management systems are supported by internationally recognized certifications and external assessments.
Management system certifications
- ISO 9001 - Quality Management
- ISO 14001 - Environmental Management
- ISO 15378 - Primary packaging materials for medicinal products, including GMP requirements
- ISO 50001 - Energy Management
- FSSC 22000 - Food safety
Additional authorizations and schemes
- ADR authorization by BVI for the transport of dangerous goods
- Operation Clean Sweep Europe certification
Our management systems are regularly assessed through independent audits. These external evaluations provide additional assurance that requirements are implemented and that our systems remain effective.
Supporting your supplier qualification process
Customer audits
We regularly welcome customers who want to audit our management systems and manufacturing processes, often with a particular focus on GMP.
These audits provide first-hand insight into how requirements are implemented, controlled and documented within CurTec.
We also value customer audits as an additional source of feedback. External perspectives help us identify opportunities for improvement and keep our organization focused on the expectations of the industries we serve.
Would you like to conduct a customer audit?
Contact us
An alternative through Qualifyze
Conducting individual supplier audits can require significant time and resources, particularly for organizations managing large supplier networks.
CurTec therefore participates in the Qualifyze shared-audit program. Qualifyze conducts independent third-party supplier audits against recognized quality and GMP standards.
Instead of arranging a separate on-site audit at CurTec, customers can obtain access to an existing CurTec audit report through the Qualifyze platform, helping support supplier qualification while reducing the resources required for individual audits.
Regulatory support
Regulatory requirements continue to evolve. Our Regulatory Affairs team monitors relevant developments and supports the organization in translating applicable requirements into products, processes and compliance documentation.
Our current regulatory compliance information is summarized in the Regulatory Affairs Data Sheet (RADS).
Download the current RADS
Product-specific Declarations of Conformity are also available for our product ranges upon request.
Do you need product-specific compliance documentation?
Contact us
Managing risk
Risk-based thinking is embedded throughout our management system and forms an important part of our GMP approach.
Depending on the application, structured methodologies such as HACCP, TACCP, VACCP, Fine & Kinney and Bow Tie analysis help us identify, assess and manage risks across products, processes and operations.
By evaluating risks systematically, we can define appropriate preventive and control measures before potential issues affect performance or compliance.
Managing change
Changes to packaging, materials or manufacturing processes can also affect our customers' own processes, qualification status or regulatory requirements.
Our change-control process ensures that relevant changes are assessed, qualified and validated in a controlled and coordinated manner before implementation.
Potential impacts are evaluated in advance and, where applicable, affected customers are informed or their approval is requested.
This provides transparency and helps customers maintain control over changes that may be relevant to their products, processes or compliance obligations.
Quality you can rely on
Quality at CurTec is not a separate activity or a certificate on the wall. It is a way of working that connects people, processes, risk management and continual improvement throughout our organization.
The result is packaging and support designed to give customers greater consistency, transparency and confidence throughout their supply chain.
Need support with quality, qualification or compliance?
Contact us
