Quality Systems


Delivering Quality through a Certified Systems Approach

Most primary packaging, particularly packaging that is used to support highly critical applications including the packaging of pharmaceuticals and diagnostics, is subject to stringent quality criteria. DWK’s commitment to quality as well as our approach to quality assurance assures that we deliver products meeting the highest quality standards, on time, every time.

DWK Life Sciences’ tubular manufacturing lines operate within an ISO 15378 environment for the production of primary packaging using Cpk statistical tools to assure our customer's specifications are met every time. Each of our manufacturing entities utilize identical equipment, feed stock, manufacturing processes, quality controls, and inspections to meet Customer requirements at all of their geographic operations.

As your trusted partner, DWK Life Sciences is committed to manufacturing primary packaging solutions that achieve all required quality standards. Through our commitment to quality initiatives and conformity to standard accreditations, such as the International Organization for Standardization (ISO) and United Kingdom Accreditation Service (UKAS) certification, we seek to deliver the highest levels of safety and confidence through quality and competence. Our quality management system is registered and audited to the ISO 9001 Quality Management System (QMS) and certified to ISO standards for the manufacture of primary packaging products.

At DWK Life Sciences, quality is everyone’s responsibility! Employees and processes are governed by Acceptable Quality Limit (AQL) and Capability Indexes (Cpk) quality tests and inspections according to the latest defect evaluation criteria for the manufacture of products. Rely on DWK to provide product and process details including Device Master File (DMF) support. We adhere to the principles of continuous improvement with all processes subject to process-oriented risk analysis performed according to Failure Modes and Effects Analysis (FMEA). Together, ensuring delivery of products suitable for pharmaceutical and diagnostic packaging applications.


  • ISO 9001 A worldwide standard defining the requirements of a QMS that consistently provides products and services meeting its Customer’s expectations and industry requirements.
  • ISO 15378 Our quality management system commitment applicable to primary packaging materials for medicinal products.
  • Incoming Material Inspection Quality control and validation of raw material to prevent defective materials from entering the manufacturing line ensuring production of the highest quality of finished goods.
  • 100% Visual Camera Inspection Production level quality assurance applied to every vial to ensure delivery of the highest dimensional and cosmetic quality.
  • Process Control An essential element of our QMS, the use of continuous monitoring and refinement of critical process parameters.
  • Customization Meeting your unique needs through the delivery of products designed and controlled to your specifications.
  • Traceability Our quality system collects data on process and product throughout the manufacturing and supply flow.
  • Certificates Products purchased from DWK are supported by documentation packages to meet regulatory requirements during the validation and use.
  • ISO 14644-1 Clean Room Packaging Details the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and controlled environments. DWK vials are packed in ISO class 8 clean rooms.
  • ISO 45001 Occupational Health & Safety Management Implementation of practical solutions intended to improve the safety and health of our employees and other personnel.
  • ISO 14001 Environmental Management DWK is committed to advancing sustainability through the more efficient use of resources and reduction of waste.
  • ISO 50001 Energy Management Our commitment to improve energy-related performance and the continuous reduction in energy use and greenhouse emissions.