Quality & Certifications
ISO 9001 certified manufacturing with full material traceability, RoHS, REACH and FDA compliant compounds.
Our Commitment to Quality
Every O-ring we ship is backed by a comprehensive quality management system built specifically for industrial buyers who demand rigorous documentation, manufacturing repeatability, and regulatory compliance. In sectors such as aerospace, pharmaceutical, food processing, and oil & gas, a single seal failure can result in catastrophic equipment damage, production shutdowns, or safety incidents. Our quality system is designed to prevent these outcomes by enforcing strict controls at every stage of the manufacturing process, from raw material receipt through final shipment.
Our factory operates under ISO 9001:2015 certification, which provides the structural framework for continuous improvement, corrective action, and customer-focused quality management. This certification is not merely a certificate on the wall—it is a living system that drives daily decision-making on the production floor. Every batch of O-rings undergoes documented incoming material inspection, in-process monitoring, dimensional verification, and outgoing batch release. Our materials are validated for RoHS, REACH, and FDA food-contact requirements, with full certification packages available on request.
For pharmaceutical and medical device customers, we understand that biocompatibility is non-negotiable. We supply USP Class VI certificates and lot-specific test reports that document every aspect of material purity and performance. Our testing laboratory performs hardness testing, dimensional inspection, visual defect screening, and material certification for every production batch. Third-party laboratory verification is available for customers who require independent validation of material properties or compliance declarations.
Documentation and traceability are core pillars of our quality promise. We maintain batch-level records that link every finished O-ring back to its raw material compound, cure press, operator shift, and inspection data. In the event of a quality concern or audit request, we can retrieve complete manufacturing history within hours, not days. This level of transparency is essential for regulated industries and provides peace of mind for procurement teams managing supplier qualification programs and annual vendor audits.
Certifications & Compliance
ISO 9001:2015
Our quality management system covers incoming material inspection, in-process monitoring, dimensional verification, and outgoing batch release. The certification is maintained through annual surveillance audits by an accredited third-party registrar, ensuring that our processes remain aligned with international best practices. Our quality manual defines responsibilities, procedures, and performance metrics for every department, from production to logistics, creating a culture where quality is everyone's responsibility.
RoHS Compliant
All standard compounds are restricted-substance compliant per EU RoHS directives, suitable for electrical and electronic equipment markets. We maintain material declarations for all base polymers and additives, confirming that cadmium, lead, mercury, hexavalent chromium, and restricted phthalates are below regulatory thresholds. Customers in the electronics, automotive, and consumer appliance sectors rely on this compliance for CE marking and market access.
REACH Compliant
Full SVHC disclosure and REACH registration documentation available on request for European import requirements. Our supply chain team monitors the ECHA candidate list updates quarterly to ensure that no new substances of very high concern are introduced into our compounds. For European customers, we provide SCIP database declarations and downstream user communication as required by the Waste Framework Directive.
FDA 21 CFR 177.2600
Food-grade EPDM, VMQ (Silicone), and PTFE compounds meet FDA requirements for repeated food-contact applications. These materials are formulated with FDA-approved ingredients and processed in a controlled environment to prevent cross-contamination with non-food-grade compounds. Compliance letters and material test reports are available for food equipment OEMs, beverage system manufacturers, and pharmaceutical packaging companies.
USP Class VI
Pharmaceutical-grade Silicone and EPDM are available with USP Class VI biocompatibility certification. These materials undergo rigorous biological testing including systemic toxicity, intracutaneous reactivity, and implantation studies per United States Pharmacopeia standards. Lot-specific USP Class VI test reports are provided with every shipment for medical device, diagnostic equipment, and biopharmaceutical processing applications.
NSF 61 / WRAS
Potable water grades available for EPDM O-rings used in drinking water, beverage, and plumbing systems. NSF 61 certification confirms that materials do not leach harmful contaminants into drinking water at levels exceeding EPA safety thresholds. WRAS approval is recognized throughout the UK and Commonwealth countries for water fittings and plumbing products, simplifying market access for our customers in these regions.
Testing & Inspection Capabilities
Hardness Testing (Shore A / D)
Every batch is checked for hardness to confirm compound consistency and specification compliance. We use calibrated digital Shore A durometers for elastomeric compounds and Shore D for harder PTFE-filled materials, with instruments traceable to national standards. Hardness readings are recorded on the batch inspection report and compared against the approved material specification range, typically plus or minus 5 Shore A points. Deviations trigger automatic material review and corrective action.
Dimensional Inspection
Inside diameter and cross-section are measured with calibrated instruments against AS568 or ISO 3601 tolerances. Our 2D optical measuring systems and digital contact micrometers provide resolution to 0.01 millimeters, ensuring that even tight-tolerance seals meet specification. Dimensional data is recorded statistically to monitor process capability indices (Cp and Cpk), and out-of-tolerance trends trigger preventive maintenance on molding equipment before defects occur.
Visual & Defect Screening
100% visual inspection for flash, voids, cracks, contamination, and surface defects before packing. Trained inspectors follow documented acceptance criteria based on ASTM visual quality standards, with periodic inter-laboratory comparison to maintain consistency. Critical applications such as aerospace and semiconductor manufacturing receive enhanced inspection protocols including magnification and automated optical detection for sub-surface defects.
Material Certificates
Standard supply includes a material test certificate confirming compound identity and basic physical properties. Lot-specific reports and third-party test data are available on request, including tensile strength, elongation at break, compression set, and chemical compatibility verification. For regulated industries, we provide comprehensive certification packages that satisfy FDA, USP, and ISO material documentation requirements for supplier qualification files.
Batch Traceability
We maintain batch-level traceability from raw compound through molding, trimming, and inspection. Each production lot is assigned a unique batch number at the material mixing stage, and this identifier follows the parts through every manufacturing step. If a quality issue arises, we can trace the affected lot back to the cure press, operator shift, and material batch within hours.
Our traceability system captures key process parameters including cure temperature, cure time, press pressure, and ambient conditions for each batch. This data is retained for a minimum of ten years and is available for customer audit or regulatory inspection at any time. For aerospace and defense customers, we can provide additional serialization and documentation per AS9100 or customer-specific quality agreements.
Traceability extends to our supply chain as well. Every raw material shipment is received with a certificate of analysis from the polymer manufacturer, and we verify critical properties through incoming inspection before releasing materials to production. This closed-loop system ensures that any quality concern can be investigated comprehensively, whether the root cause lies in our manufacturing process or upstream in the raw material supply chain.
Regional Compliance
European Union
REACH (EC 1907/2006) SVHC disclosure, RoHS (2011/65/EU) restricted substances, CE marking support for pressure equipment, and EU Food Contact Framework Regulation (EC) 1935/2004 for food-grade compounds.
United States
FDA 21 CFR 177.2600 for food contact, USP Class VI for pharmaceutical and medical devices, NSF 61 for potable water applications, and compliance with EPA and OSHA material safety requirements.
China
GB standards for rubber products including GB/T 3452.1 (O-ring dimensions), GB/T 5720 (rubber quality), and GB 4806 food contact material standards for domestic market applications.
United Kingdom
WRAS approval for drinking water contact, UKCA marking support post-Brexit, and continued recognition of BS 1806 O-ring dimensional standards.
Japan
JIS B 2401 dimensional compliance, Food Sanitation Law compliance for food-contact applications, and industrial material standards for automotive and machinery sectors.
Canada
NSF 61 for drinking water systems, Canadian Food Inspection Agency (CFIA) acceptance for food-grade materials, and CSA standard alignment for pressure equipment applications.
Available Documentation
Standard document confirming compound composition, hardness, and conformance to specification. Provided with every order at no additional cost.
Formal declaration that the supplied parts conform to the stated standards, dimensions, and material specifications. Available on request for quality systems and audit files.
Measured values for inside diameter, cross-section, and visual inspection results. Available for critical applications and first article inspection requirements.
Formal statement confirming REACH compliance and SVHC status for the supplied material. Required for European market access and supplier qualification.
Document confirming restriction of hazardous substances compliance per EU directives. Essential for electronics and electrical equipment supply chains.
Letter confirming that the supplied compound meets FDA 21 CFR 177.2600 requirements for repeated food-contact applications. Required for food and beverage equipment.
Lot-specific biological testing documentation for pharmaceutical and medical device applications. Includes systemic toxicity, intracutaneous, and implantation test results.
Complete manufacturing history linking finished parts to raw material batch, cure press, operator, and inspection data. Available for regulated industries and quality investigations.
How to Read Our Certificates
Our certificates follow international standards for format and content. A Material Test Certificate (MTC) confirms compound identity, hardness, and basic physical properties measured on the specific batch. A Certificate of Conformity (COC) declares that the parts meet the stated dimensional and material specifications. REACH and RoHS declarations confirm regulatory compliance at the material level, not the finished-part level. For pharmaceutical applications, the USP Class VI report includes biological test data specific to the production lot.
- MTC = measured data for your batch; COC = formal declaration of conformance.
- REACH declaration covers SVHC status as of the date of issue; quarterly updates available.
- FDA compliance letters reference the specific 21 CFR paragraph and compound grade.
- USP Class VI reports are lot-specific, not generic, and include test methodology references.
Applicable Industries
| Industry | Typical Certifications |
|---|---|
| Aerospace & Defense | ISO 9001, material batch traceability, first-article inspection, AS9102 FAIR |
| Automotive | ISO 9001, PPAP levels 1-5, IMDS material declarations, REACH/RoHS |
| Food & Beverage | FDA 21 CFR 177.2600, EU 1935/2004, NSF 61, WRAS |
| Pharmaceutical & Medical | USP Class VI, FDA 21 CFR, ISO 10993 biocompatibility support |
| Oil & Gas | NACE TM0297 (sour gas), material traceability, batch hardness reports |
| Semiconductor | Ultra-high purity material verification, particle testing, metallic ion analysis |
Inspection Flow
Incoming Inspection
Verify supplier COA, check packaging integrity, spot-test hardness, record lot numbers. Reject non-conforming materials before they enter production.
Sample rate: 100% of lots
In-Process Inspection
Monitor molding temperature, pressure and cure time. Perform dimensional spot-checks at defined intervals. Plot SPC data to detect trends before out-of-spec parts are produced.
Sample rate: Every production batch
Final Inspection
100% visual screening for flash, voids, cracks and contamination. Batch hardness testing. Statistical dimensional sampling with calibrated instruments. Record all data on batch report.
Sample rate: 100% visual + statistical dimensional
Outgoing Inspection
Verify batch report completeness, confirm documentation matches order requirements, check label accuracy and packaging integrity. Release only after all checks pass.
Sample rate: 100% of batches
Report & Certificate List
| Report | Content | Lead Time |
|---|---|---|
| Material Test Certificate (MTC) | Compound identity, hardness, tensile strength, elongation, compression set | Included with shipment |
| Certificate of Conformity (COC) | Formal declaration of dimensional and material conformance to specification | Included on request |
| Dimensional Inspection Report | Measured ID, CS, visual acceptance, inspection method, instrument calibration dates | 1–2 days after shipment |
| REACH Declaration | SVHC status, SCIP database reference, downstream user communication | Included on request |
| RoHS Declaration | Restricted substances compliance per EU directive, material-level test data | Included on request |
| FDA Compliance Letter | 21 CFR 177.2600 paragraph reference, compound grade, intended use statement | Included on request |
| USP Class VI Test Report | Systemic toxicity, intracutaneous reactivity, implantation study results per lot | Included with pharmaceutical orders |
| Lot Traceability Record | Complete manufacturing history: raw material → compound → molding → inspection → ship | Included on request |
Frequently Asked Questions
Can you provide a certificate of conformity with my order?
Yes. A material test certificate (MTC) and dimensional inspection report are provided as standard with every shipment. For regulated industries, we can also supply REACH/RoHS declarations, FDA compliance letters, USP Class VI documentation, and certificates of conformity on request. Simply specify your documentation requirements when requesting a quote or placing your order, and we will include the appropriate certificates with your shipment at no additional charge.
Do you offer USP Class VI silicone O-rings?
Yes. We supply USP Class VI certified VMQ (Silicone) and EPDM grades specifically for pharmaceutical and medical device applications. These materials are manufactured in a controlled environment to prevent cross-contamination, and every lot is supported by batch-specific USP Class VI test reports covering systemic toxicity, intracutaneous reactivity, and implantation studies. Certificates are never generic—they are tied to the specific production batch you receive.
Is your FDA grade suitable for drinking water?
FDA 21 CFR 177.2600 covers food contact applications including food processing, packaging, and handling equipment. For direct drinking water contact, we recommend NSF 61 or WRAS certified EPDM grades, which undergo additional extraction and leachate testing to confirm they do not introduce harmful contaminants into potable water. We supply both FDA and NSF 61/WRAS grades, and our engineering team can recommend the appropriate certification based on your specific application.
How do I request lot traceability documentation?
Mention the requirement in your purchase order or quote request. We will include the lot number, cure date, compound batch reference, operator shift record, and process parameters with your shipment. For customers with ongoing quality agreements, we can provide electronic traceability data in your preferred format for direct import into your ERP or quality management system.
What is the difference between a Material Test Certificate and a Certificate of Conformity?
A Material Test Certificate (MTC) provides actual test data for the specific batch, such as hardness readings, tensile strength, and elongation values. A Certificate of Conformity (COC) is a formal declaration that the parts conform to the specified standards and requirements, but it does not necessarily include measured test data. Many customers request both documents for their supplier qualification files and incoming inspection records.
Do you perform third-party testing for material compliance?
Yes. While we perform all standard testing in-house with calibrated equipment, we also engage accredited third-party laboratories for independent verification upon customer request. Third-party testing is commonly requested for initial supplier qualification, annual audits, and critical applications where independent validation provides additional assurance. Common third-party tests include FTIR material identification, compression set per ASTM D395, and chemical compatibility immersion testing.
How do you handle corrective actions when a quality issue is identified?
Our ISO 9001:2015 system requires documented corrective action for all nonconformities. When a quality issue is reported, we initiate an 8D problem-solving process that includes immediate containment, root cause analysis, corrective and preventive action implementation, and effectiveness verification. The customer receives a full corrective action report with timelines, responsibilities, and evidence of closure. For serious issues, we conduct a management review to determine whether systemic changes are needed.
Can you support PPAP or first article inspection requirements?
Yes. For automotive, aerospace, and medical device customers, we provide full Production Part Approval Process (PPAP) documentation packages including dimensional results, material test reports, process flow diagrams, control plans, and appearance approval reports. First article inspection reports (FAIR) are available for all new parts and are formatted to AS9102 or customer-specific templates. Please discuss your PPAP level requirements during the quoting phase.
Are your quality certifications current and how can I verify them?
All certifications are current and maintained through regular surveillance audits. You can request copies of our ISO 9001:2015 certificate, test reports, and compliance declarations at any time. Certificate numbers and issuing body details are provided on request for independent verification through the registrar's online database. We also welcome customer audits and quality system reviews at our manufacturing facility.
Do you have experience supplying to regulated industries such as aerospace or medical devices?
Yes. We supply O-rings to aerospace subcontractors, medical device manufacturers, pharmaceutical processing equipment builders, and food equipment OEMs. Our quality system is designed to meet the documentation, traceability, and testing requirements of these industries. We understand the importance of lot control, change notification, and long-term record retention for regulated applications, and our processes are structured to satisfy these stringent requirements consistently.
Need Documentation for Your Order?
Contact us to confirm certificate requirements before production.