Our vision of Quality
We strive for excellence at every level, both internally and externally. We are committed to providing the best possible customer experience, through a responsible and structured Quality policy.
We have established a culture of quality, supported by a Quality Management System certified to ISO 13485: 2016.
“We believe that quality is fundamental for everyone at every level, whether in relation to our suppliers or all our employees.”
Quality Management System
We rely on processes and procedures that enable us to set and successfully achieve our quality objectives. As a result, we are committed to providing you with safe products and accessible, up-to-date product information.
Certification
ISO 13485 : 2016
We are ISO 13485 certified for the organisation of our quality system for the manufacture of custom single-use assemblies.
We guarantee that we comply with regulations, take your requirements into account, and control our activity and the associated risks.
Customer Support at your disposal
We have a range of tools at your disposal, including :
- our customer portal where you can find your certificates of conformity:
Log in to your Customer Area
- contact forms, for all your quality-related requests.
Access the contact forms
Our quality system
At Aseptic Group, we know that our customers have increasingly stringent regulatory requirements. For your critical and sensitive applications, we have a duty to guarantee compliance with your level of requirements. Our quality policy means compliance with all your requirements.
Regulatory requirements
- Guaranteed compliance
We work in compliance with the regulatory requirements of the pharmaceutical industry. All our single-use assemblies and components are delivered with all the necessary documentation and regulatory support.
Certificates of conformity are systematically enclosed with the product in your parcel. We provide you with a secure personal Customer Area. Once you have created your account, you can download all your certificates of conformity with a single click.
- Validation files & Complementary studies
When using Single-Use products in your production process, it is important to know which substances can be released and in what quantities.
We can provide you with validation files for most of our components and custom Single-Use assemblies, as well as various types of studies (extractables, leachables, etc.).
- Dedicated quality support
Our quality department will help you with any specific request and provide you with the documents you need.
Change notification management
- Change management
Change management is an essential pillar of our quality system and risk management process. The slightest change to a Single-Use component can have a potential impact on your finished product.
- Transparent communication
For each notification of change, we carefully examine the possible impacts and inform our customers as soon as possible. Detailed files are sent to you to help you make your own assessment.
- Rigour and proactivity
Our customers particularly appreciate our responsiveness and our rigorous approach to monitoring changes.
Subscribe to our mailing list to receive our notifications as soon as they are published.
Quality Assurance
Audits, questionnaires and quality agreements
You may have specific questions about the products we deliver. This may include a questionnaire to complete, a joint assessment of specifications – both User Requirement Specifications (URS) and Product Technical Specification (PTS) – or an audit of our premises and organisation.
We’ll be happy to help you. For more information, please contact our Quality department.
Supplier approvals
As part of our quality approach, we have set up a supplier qualification system, including Quality and Supply Chain audits. This enables us to guarantee you a selection of reliable, high-performance products, as well as the necessary documentary support.
Handling and monitoring complaints
- Commitment to quality
We do our utmost to guarantee you high-performance, safe products and impeccable service.
- Simplified complaints process
If you have a problem with one of our products, let us know as soon as possible by filling in this form. Your request will be recorded immediately and handled by our quality department.
- Rigorous monitoring and corrective action
Every complaint is managed as quickly as possible. Our teams carry out an in-depth investigation and take the necessary action to prevent any recurrence.
Discover Aseptic Group
Your Single-Use reference in Bioproduction to simplify your processes and optimise your production.
faq
Quality assurance and regulatory support
Yes, we only work with partners who share our values and respect our strict quality and ethical standards.
You can contact us by email, telephone or online form. Our team will be happy to help you solve any problem.
We take every return very seriously. If you have a problem, our quality department is there to help you and find a quick solution, whether it’s a replacement or a refund.
We encourage our customers to share their feedback via surveys or directly with our customer service department. All feedback is taken into account to improve our products/services.
At Aseptic Group, quality assurance is at the heart of our operations. We strictly adhere to ISO 13485:2016 certification for the manufacture of single-use systems. Key points include:
- Certified production environment: all products are assembled in ISO 7-compliant facilities.
- Regulatory support: full documentation and regulatory compliance to meet industry standards.
- For more details, visit our Quality Assurance page .
Quality is controlled at every stage: from the selection of raw materials through to production, packaging and distribution. This includes rigorous testing, internal and external audits, and full documentation.
Challenges include contamination management, the complexity of biological processes, compliance with ever-changing regulations and the need for complete traceability.
A notification of change contains information about changes associated with the manufacture of products, in accordance with our standards.
The most common standards include Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and ISO standards (such as ISO 9001). These standards guarantee rigorous processes and complete traceability.