Quality Management

We work with a wide range of companies from start-ups developing innovative new consumer products to large, global companies already in the highly regulated medical device industry.

We provide the flexibility to work within our client’s Quality Management Systems (QMS). This approach provides the assurance of familiar processes aligned with our client’s own project work and systems. In addition, for medical devices, this approach allows our documents and records to be delivered into our client’s Design History File and vaulting system for regulatory and compliance inspections.

We also offer the capabilities to work within the Andrews-Cooper QMS. It complies with ISO 9001 for the development of commercial products and manufacturing automation systems. It also complies with ISO 13485 for the development of medical devices.

Our QMS also incorporates best practices from the following sources:

  • Capability Maturity Model Integrated (CMMI) from Carnegie Mellon University’s Software Engineering Institute.
  • The Project Management Body of Knowledge (PMBOK) from the Project Management Institute (PMI).
  • Good Automated Manufacturing Practices (GAMP-5) from the International Society for Pharmaceutical Engineering (ISPE).
  • Applicable process standards from the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) including ISO 14971 for Safety Risk Management, IEC 60601-1-8 for Alarms, and IEC 62304 for Software Development.