Outsource Technical Concepts - Comprehensive and Stringent Quality Management System


We recognise the intrinsic link between quality and the levels of service and product we offer. Our aim is to deliver a project right, first time, every time. Quality and Compliance is directly tangible in what we deliver. Our client base in the Medical, Orthopaedic and Pharmaceutical industries requires and deserves no less than us being an equal in terms of compliance.

In creating and expanding our business, we recognised at an early stage that significant investment in a robust Quality Management System would enable us to scale our business from a solid foundation and allow us to excel.

We integrate Lean Sigma in Our Quality Management System

By establishing Lean Sigma throughout our Quality Management System, we continuously look for Lean opportunities in our own processes. We operate a Continuous Improvement programme which both strengthens our Quality Management System and streamlines our operational efficiencies.

We believe that a Quality focused business and an operationally efficient business are one in the same

We have robust processes and systems in place to deliver a fully traceable product or service. We have structured our systems to enable us to use YOUR standards, procedures and work instructions for YOUR projects. This approach bolsters our partnership with you in terms of synchronised understanding of methodologies, reductions in transfer time and eliminating overlap of processes, which in turn reduces your total costs.

We have structured our IT systems using a Lean approach

We also apply  a Lean philosophy where our IT systems are concerned. We fully integrate Lean into our IT system by adhering to a number of stringent measures:

  • Version Control on electronic files and records
  • Data retention policies
  • Encrypted customer specific server segregation
  • The use of Intranet for Customer Standards
  • Quality Procedures and Work Instructions

We have completed a gap analysis from ISO9001 and incorporated relevant sections from ISO13485, ISO17025, 21 CFR Part 11 and 21 CFR Part 820.

We extend our robust quality standards to our Vendors

We maintain stringent controls on vendor selection and monitoring, with verification of materials and treatments and validation of inspection and critical to quality features. Our ability to complete the Validation elements of the project including Gauge R&R, FAT and SAT ensures we deliver a quality project to you. These elements are frontloaded to the Engineering Design and documented in the Functional Design Specification.