Quality, documentation and regulatory requirements
Choosing a supplier of high-performance plastic components involves more than material properties and manufacturing capabilities. You also need confidence in quality management, material traceability, relevant regulatory requirements and the documentation needed to support your own quality processes.
At Acoplastic, we work with customers to clarify documentation requirements and identify the information relevant to their components and applications. Our approach includes certified management systems, production controls, material documentation and support for customer-specific quality requirements.
Whether you need documentation for supplier approval, a regulated application or an established quality process, our team can discuss your requirements and help identify the relevant documentation.
Need documentation for a specific application, or help with plastic component compliance?
Quality, documentation and regulatory requirements
Choosing a supplier of high-performance plastic components involves more than material properties and manufacturing capabilities. You also need confidence in quality management, material traceability, relevant regulatory requirements and the documentation needed to support your own quality processes.
At Acoplastic, we work with customers to clarify documentation requirements and identify the information relevant to their components and applications. Our approach includes certified management systems, production controls, material documentation and support for customer-specific quality requirements.
Whether you need documentation for supplier approval, a regulated application or an established quality process, our team can discuss your requirements and help identify the relevant documentation.
Need documentation for a specific application, or help with plastic component compliance?
Certified management systems
Our certified management systems provide a structured framework for quality management and environmental management within the scope of our certifications.
Both certificates state validity until 1 June 2028.
For an overview of our certifications and standards, visit Certifications and Standards.
ISO 9001 – Quality Management System
Acoplastic holds ISO 9001 certification for its quality management system. The certified scope covers the development, production, machining and sale of plastic components.
The system provides a framework for managing processes and supporting consistent quality in accordance with applicable requirements.
ISO 14001 – Environmental Management System
Acoplastic holds ISO 14001 certification for its environmental management system. The certification provides a framework for managing the environmental aspects of our operations within the scope of the certified system.
ISO 14001 certification relates to environmental management and provides us with the tools to control and improve our environmental impacts.
Material compliance and regulatory requirements
Selecting the right material is an important part of specifying plastic components for industrial applications, particularly where regulatory or industry-specific requirements apply.
Depending on the material grade, component design and intended application, relevant requirements may include:
Food contact: Regulation (EC) No 1935/2004 and Regulation (EU) No 10/2011 for applicable plastic materials intended to come into contact with food and Regulation (EC) No 2023/2006 on good manufacturing practice for material intended to come into contact with food.
FDA requirements: Relevant provisions of 21 CFR, including 21 CFR 177 for applicable plastic material intended to come into contact with food.
Pharmaceutical, sanitary and drinking water applications: Requirements such as USP Class VI, 3-A Sanitary Standards, KTW or WRAS, where relevant to the material and application.
Chemical and product requirements: REACH and RoHS, where applicable.
The relevance of each requirement depends on the specific material, its composition, the manufacturing process and the intended conditions of use. Compliance with a particular requirement must be established for the relevant material or component; it should not be assumed to apply to every product.
We can discuss your requirements and help identify the relevant supplier information, declarations and test documentation available for your application.
Explore our materials and manufacturing capabilities:
PTFE compounds: Understanding material properties and performance
Material compliance and regulatory requirements
Selecting the right material is an important part of specifying plastic components for industrial applications, particularly where regulatory or industry-specific requirements apply.
Depending on the material grade, component design and intended application, relevant requirements may include:
Food contact: Regulation (EC) No 1935/2004 and Regulation (EU) No 10/2011 for applicable plastic materials intended to come into contact with food and Regulation (EC) No 2023/2006 on good manufacturing practice for material intended to come into contact with food.
FDA requirements: Relevant provisions of 21 CFR, including 21 CFR 177 for applicable plastic material intended to come into contact with food.
Pharmaceutical, sanitary and drinking water applications: Requirements such as USP Class VI, 3-A Sanitary Standards, KTW or WRAS, where relevant to the material and application.
Chemical and product requirements: REACH and RoHS, where applicable.
The relevance of each requirement depends on the specific material, its composition, the manufacturing process and the intended conditions of use. Compliance with a particular requirement must be established for the relevant material or component; it should not be assumed to apply to every product.
We can discuss your requirements and help identify the relevant supplier information, declarations and test documentation available for your application.
Explore our materials and manufacturing capabilities:
PTFE compounds: Understanding material properties and performance
Quality control and traceability
Documented processes and appropriate inspection are important when manufacturing components to customer specifications.
Acoplastic’s quality management approach includes traceability from raw material through machining and final inspection. Production records support the identification of relevant production information, while inspection activities help assess components against specified requirements.
Our measurement and testing equipment supports activities such as:
Dimensional inspection and measurement.
Optical and coordinate measurement.
Density testing.
Tensile and compression testing.
Surface and roughness measurement.
Final inspection against relevant specifications.
The inspection methods used depend on the component, material, tolerances and customer requirements. Specific measurements, tests and reports can be discussed and agreed as part of the project.
Our aim is to provide relevant quality information to support customer requirements and component approval.
Read more about our Quality Documentation
Quality documentation and customer-specific requirements
Documentation requirements vary between customers, industries and applications. We work with customers to clarify these requirements and identify the documentation relevant to each project.
Depending on the material, component and agreed scope, documentation may include:
Material certificates and supplier documentation.
Declarations of compliance, where applicable.
Inspection and test reports.
Dimensional measurement results.
Documentation in accordance with relevant EN 10204 certificate types, where applicable.
Customer-specific quality documentation and approval formats.
Our quality processes can also support customer-specific requirements, including PPAP (Production Part Approval Process), where required and agreed for the project.
The availability and scope of documentation depend on the material, production process, customer specification and requirements agreed for the order. We recommend discussing documentation needs early in the project so they can be considered during material selection and production planning.
Planning a new component or supplier approval? Contact our team to discuss the required documentation.
Environmental Management
Acoplastic holds ISO 14001 certification for its environmental management system. The certification covers the environmental management system within the scope stated in the certificate.
Our environmental management activities include improvement of our significant environmental aspects and thereby reduce our environmental footprint.
For further information about the scope of our environmental management system, please refer to our certificate.
Download our ISO 14001 certificate (PDF)
Environmental Management
Acoplastic holds ISO 14001 certification for its environmental management system. The certification covers the environmental management system within the scope stated in the certificate.
Our environmental management activities include improvement of our significant environmental aspects and thereby reduce our environmental footprint.
For further information about the scope of our environmental management system, please refer to our certificate.
Download our ISO 14001 certificate (PDF)
Business ethics and responsible partnerships
Clear expectations and documented policies are important elements of business relationships.
As part of our plastic component compliance, Acoplastic’s Code of Conduct sets out expectations relating to applicable legislation, human rights, labour rights, environmental responsibility and anti-corruption. It also describes expectations for suppliers and the importance of responsible business practices throughout the supply chain.
Our Code of Conduct provides a reference for these expectations in our business relationships.
Business ethics and responsible partnerships
Clear expectations and documented policies are important elements of business relationships.
As part of our plastic component compliance, Acoplastic’s Code of Conduct sets out expectations relating to applicable legislation, human rights, labour rights, environmental responsibility and anti-corruption. It also describes expectations for suppliers and the importance of responsible business practices throughout the supply chain.
Our Code of Conduct provides a reference for these expectations in our business relationships.
Access our compliance and quality documentation
Use the following resources to find information about our certifications, quality processes and business policies.
ISO 9001 certificate – Quality Management (PDF)
ISO 14001 certificate – Environmental Management (PDF)
Certifications and Standards
Quality Documentation
Code of Conduct
Whistleblower Policy
Additional documentation, such as material declarations, inspection reports and customer-specific quality records, may be available depending on the component and project requirements.
Every application has its own requirements. Our team can discuss the relevant material, quality and documentation considerations for your plastic components.
Tell us about your application, the component you are sourcing and any standards or documentation specified by your organisation. We will help clarify the relevant requirements and the next steps.
Contact Acoplastic to discuss your requirements
Frequently Asked Questions
Which quality certifications does Acoplastic hold?
Acoplastic holds ISO 9001 certification for its quality management system and ISO 14001 certification for its environmental management system. The ISO 9001 certification covers the development, production, machining and sale of plastic components. Both certificates state validity until 1 June 2028.
What does ISO 9001 certification mean for Acoplastic customers?
ISO 9001 provides a structured framework for quality management. At Acoplastic, it supports the management of processes and helps ensure that our activities are carried out in accordance with applicable requirements and established quality procedures.
What does ISO 14001 certification cover?
ISO 14001 is an international standard for environmental management systems. Acoplastic’s certification provides a framework for managing the environmental aspects of our operations within the scope stated in the certificate, including work to improve significant environmental aspects and reduce our environmental footprint.
Can Acoplastic provide material compliance documentation for plastic components?
Yes. Depending on the material, component and application, relevant documentation may include material certificates, supplier documentation, declarations of compliance, inspection reports and test documentation. The availability and scope of documentation depend on the specific project and should be discussed when defining the requirements.
Can Acoplastic supply plastic materials for food-contact applications?
Acoplastic can discuss material requirements for food-contact applications, including relevant requirements under Regulation (EC) No 1935/2004, Regulation (EU) No 10/2011 and Regulation (EC) No 2023/2006. Suitability and plastic component compliance, must be established for the specific material grade, component and intended conditions of use.
Does Acoplastic work with FDA-compliant plastic materials?
Relevant FDA requirements may include provisions of 21 CFR, such as 21 CFR 177 for applicable plastics intended for food contact. Whether a specific material or component meets the relevant requirements must be verified based on its grade, composition and intended application.
Can Acoplastic provide documentation for pharmaceutical and sanitary applications?
Depending on the material and application, relevant requirements may include USP Class VI and 3-A Sanitary Standards. Acoplastic can discuss the requirements for your application and help identify available supplier information, declarations and test documentation.
Can Acoplastic provide documentation for drinking water applications?
Requirements such as KTW and WRAS may be relevant for plastic materials used in drinking water applications. The applicability of these requirements depends on the material, product and intended conditions of use. Contact Acoplastic to discuss the documentation available for your specific application.
Does Acoplastic comply with REACH and RoHS requirements?
REACH and RoHS may be relevant depending on the material, component and application. Compliance must be established for the specific material or component rather than assumed to apply to all products. Acoplastic can discuss relevant supplier documentation and declarations for your project. Talk to us about plastic component compliance.
How does Acoplastic ensure material traceability?
Acoplastic’s quality management approach includes traceability from raw material through machining and final inspection. Production records support the identification of relevant production information, while inspection activities help assess components against specified requirements.
What quality control and testing can Acoplastic perform?
Acoplastic’s measurement and testing equipment supports several inspection activities, including:
- Dimensional inspection and measurement.
- Optical and coordinate measurement.
- Density testing.
- Tensile and compression testing.
- Surface and roughness measurement.
- Final inspection against relevant specifications.
The inspection methods used depend on the component, material, tolerances and customer requirements. Specific measurements and reports can be agreed as part of the project.
Can Acoplastic provide dimensional inspection reports?
Yes. Dimensional measurement results and inspection reports may be included in the agreed quality documentation. The scope of inspection and reporting is defined according to the component specifications and customer requirements.
Can Acoplastic provide EN 10204 material certificates?
Documentation in accordance with relevant EN 10204 certificate types may be available, depending on the material, supplier documentation and project requirements. The required certificate type should be agreed when placing the order.
Can Acoplastic support PPAP requirements?
Yes. Acoplastic’s quality processes can support customer-specific requirements, including PPAP (Production Part Approval Process), where required and agreed for the project. The scope and documentation requirements should be clarified before production.
What quality documentation can Acoplastic provide?
Depending on the material, component and agreed project scope, documentation may include:
- Material certificates and supplier documentation.
- Declarations of compliance, where applicable.
- Inspection and test reports.
- Dimensional measurement results.
- Documentation in accordance with relevant EN 10204 certificate types.
- Customer-specific quality documentation and approval formats.
Can Acoplastic meet customer-specific quality requirements?
Acoplastic works with customers to clarify their quality and documentation requirements. This may include specific inspection methods, measurement reports, material documentation and customer-specific approval formats. Requirements should be discussed early so they can be considered during material selection and production planning. Contact us and hear more about plastic component compliance.
Does Acoplastic have a Code of Conduct and whistleblower policy?
Yes. Acoplastic has a Code of Conduct describing expectations relating to applicable legislation, human rights, labour rights, environmental responsibility and anti-corruption. Acoplastic also has a whistleblower policy providing a channel for reporting serious concerns about misconduct.
How can I request plastic component compliance and quality documentation from Acoplastic?
Contact Acoplastic with information about your component, material, application and any relevant standards or documentation requirements. Our team can help clarify which requirements apply and identify the relevant supplier information, declarations, certificates and inspection documentation available for your project.