At Schematic Engineering Industries, we are committed to supplying high-quality products to clients in all industry sectors, with particular product specialisation for the pharmaceutical, chemical, food and beverage industries.

Schematic are ISO9001:2015 accredited and we understand the critical importance of quality, safety, and regulatory compliance in the pharmaceutical sector, and we strive to exceed industry standards in all aspects of our operations. This Quality Management Statement outlines our approach to ensure the quality of our products throughout the supply chain.

Regulatory Compliance: We strictly adhere to all applicable local and international regulations, including but not limited to Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and relevant guidelines set forth by regulatory bodies such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency). Our processes are designed to ensure compliance with these regulations, and we regularly review and update our procedures to reflect any changes in requirements.

Quality Assurance: We have established a robust quality assurance system to monitor and control every stage of our product supply chain. This includes comprehensive quality control measures during manufacturing, rigorous testing of raw materials and finished products, and ongoing monitoring and analysis to identify any potential quality issues. Our quality assurance team is equipped with the necessary expertise and resources to ensure that our products consistently meet the highest quality standards.

Supplier Management: We maintain strong relationships with our suppliers and partners, ensuring they share our commitment to quality. Our supplier selection process includes rigorous evaluations, assessing their capabilities, quality systems, and adherence to regulatory requirements. We work closely with our suppliers to establish clear quality specifications, and we conduct regular audits and inspections to monitor their performance and compliance.

Continuous Improvement: We believe in the pursuit of continuous improvement across all areas of our operations. We foster a culture of quality within our organization, encouraging all employees to contribute to quality enhancement initiatives. We regularly review our quality management system, gather feedback from customers and stakeholders, and implement necessary improvements to optimize our processes and ensure the highest level of quality in our products.

Training and Competence: We recognize that well-trained and competent employees are crucial to maintaining product quality. We provide comprehensive training programs to our staff, ensuring they have the necessary knowledge and skills to perform their roles effectively and in compliance with quality standards. We also promote a culture of individual responsibility and accountability for quality among all employees.

Documentation and Traceability: We maintain accurate and complete documentation of all processes, procedures, and quality-related activities. This includes detailed records of raw materials, manufacturing processes, quality testing results, and distribution activities. Through meticulous documentation and robust traceability systems, we can track and trace our products throughout the supply chain, facilitating effective quality control and regulatory compliance.

Customer Focus: Customer satisfaction is at the forefront of our quality management approach. We actively engage with our customers to understand their specific requirements and expectations. By incorporating customer feedback into our quality improvement initiatives, we aim to consistently deliver products that meet or exceed their needs, providing them with the utmost confidence in the quality and safety of our offerings.

By adhering to these principles, Schematic is committed to maintaining the highest standards of quality management in supplying products to our clients. We strive to be a trusted partner to our clients, contributing and supporting them in their operations.

Quality Policy

  • Achieve and maintain a level of workmanship which will be a guarantee to customers that the products manufactured will consistently conform to the quality standard demanded and conform to statutory and regulatory requirements.
  • Continually document, develop and improve the companies Quality System, which is designed to laydown procedures which will achieve this policy and is available to all employees and customers.
  • To provide a process of Internal Auditing, Quality Analysis and Management Review to document,prove, monitor and continually improve the effectiveness of the Quality system and objectives andenhance Customer satisfaction.
  • To hold an Annual Management Review Meeting which will be the framework that will determine Quality Objectives, their measurement and review and the setting of targets for future improvement of the system.
  • To ensure all personnel, at all levels, take on board the issue of ‘quality’ by performing their task correctly, conscious of the fact that they are making a vital contribution to this goal.

Barrier Isolator Quality Standards

We continually strive to meet and exceed our international client quality expectations. As such, we are continually improving our quality management practices to deliver safe, reliable, and high-quality products across all industry sectors, with specialisation on products for the pharmaceutical and healthcare sector that contribute to the well-being of patients and support the advancement of healthcare.
  • We operate a Quality Management System and are accredited to ISO9001:2015
  • Our clean room products are compliant with the European Standard EN ISO 14644 (Parts 1-8) and ISO 14698-1 standards.
  • We adhere to 21 CRF 211 cGMP and cGAMP across all our operations and delivered products.
  • Our Isolator products are Pressure Tested to International Standard ISO 10648-2 (Class 2)
  • We perform DQ, FAT/IQ, SAT/OQ and PQ acceptance testing in conformance with the clients requirements.
  • We are members of the American Glovebox Society (AGS)

Container (IBC/FLC) Quality Standards

Our Folding Large Containers (Model KF975) conform to:
- The general simulation performance test for packaging (ISTA-3E)
- The D4169-08 Performance Testing of Shipping Containers
- The Systems by the International Safe Transit Association (ISTA)
- The American Society for Testing and Materials (ASTM)

Why Partner With Us?

Logistics, API, Formulation & Injectable Equipment Solutions
Schematic and the wider Standard Group offer 95% of ALL products required for Pharmaceutical processing.