Quality Management System Requirements

We implement comprehensive Quality Management System Requirements that are scaled to fit your individual business needs.

Quality Management System Requirements

Our unique approach blends assessment, planning, remediation, and implementation tools so you get the best possible outcome not only from a compliance perspective but also from a performance perspective.

Whether you are implementing quality management system requirements for the first time or are blending quality management system requirements as a result of a merger, we will provide you with a customized solution that fits your business, your products, and your culture.

We work closely with your team to develop and translate quality management system requirements into your own policies and procedures that reflect your products and your culture. Our solutions are as unique as your business.

Some Specific Quality Management System Requirements we will help you implement are:

  • Full Quality System design & deployment
  • Management Controls
  • Qaulity Audit Controls
  • Qualification & Training of Personnel
  • Complaint Handling & Failure Investigations
  • Corrective and Preventive Action (CAPA)
  • Regulatory Reporting (MDR, MDV, etc)
  • Recalls & Field Corrections
  • Design Controls & Risk Management
  • Design History Files (DHF) & Technical Files
  • Device Master Records (DMR)
  • Post Market Surveillance
  • Document and Change Control
  • Data & Records Management
  • Purchasing & Supplier Controls
  • Identification & Traceability
  • Labeling & Packaging Controls
  • Handling, Storage, & Distribution Controls
  • Installation Controls
  • Servicing Controls
  • Production & Process Controls
  • Nonconforming Product & Rework
  • Device History Records (DHR)
  • Acceptance Activities (incoming, in-process, and final release)
  • Process Validation
  • Software Design, Configuration, and Validation
  • Electronic Records & Electronic Signatures
  • Facility Moves & Validation