Services
QMS Development
QMS Success can help you design and develop your quality management system with flexible support that meets your needs.
Our Approach
Quality system development begins with defining the requirements needed for your business. Quality planning is performed as part of the overall management process and includes the identification of infrastructure, regulatory requirements, process requirements, and resources. During planning, resources are allocated and responsibilities are assigned. These details are captured in a quality plan document to facilitate the development and implementation stages. Process and procedure development begin during planning after requirements definition. Using our pre-configured templates and guidance can accelerate this process saving you time and money. Draft procedures are then validated with one or more dry runs. Gap analysis or traceability matrices are used to keep track of the requirements to ensure accountability of all quality system requirements.
QMS Implementation
QMS Success can help you implement all aspects of
your quality management system.
Our Approach
Implementation typically begins with training the process owners and personnel responsible for executing the processes and procedures. The evolution of processes and procedures continues from the QMS development stage through multiple iterations of execution. This is achieved using the Plan-Do-Check-Act (PDCA) methodology. During implementation, several cycles of process and procedure refinement and training may be necessary to ensure that everything functions smoothly and proper records are generated. Auditing is essential to ensuring a robust implementation. Auditing may be performed more frequently early in the QMS lifecycle and will change over time as the system evolves and becomes more stable.
QMS Maintenance
QMS Success can help you operate and maintain your quality management system.
Our Approach
You need to operate and maintain your quality management system to build your products, generate requisite records, and maintain customer satisfaction. This requires significant resources. Processes and procedures change driven by measurement, analysis, and improvement activities. Personnel are trained and audits are conducted. Products are developed, manufactured, and installed. Customers need support. Feedback and complaints must be processed, and QMS performance reported to management. Our turnkey services can facilitate your QMS operations.
- Ongoing quality planning
- Training program management
- Audit program management
- Documents and records management
- Product lifecycle management
- Clinical development support operations
- Measurement, analysis, and improvement activities
- Complaint handling process management
- Medical device reporting
Auditing Services
QMS Success can provide auditing services to fit your needs using qualified and experienced auditors.
Our Approach
Processes, procedures, standards, and regulations change over time making compliance a moving target. Auditing is the key to maintaining a successful quality management system. We create audit plans that define the audit scope and requirements. Audits are conducted by verifying that the QMS meets all requirements and conforms with your processes and procedures. Audit findings are confirmed with the stakeholders and detailed reports are created.
- Quality management system audits for compliance with standards and regulations including: MDSAP, QSR, ISO 13485, process, and MDR/IVDR audits
- Supplier audits to ensure compliance with supplier contracts
- Clinical study audits
- Gap analysis and assessments