Upon understanding your needs (e.g., achieve ISO 9001, AS9100, AS9120, ISO 13485 certification) and timeline, we typically assign a Lead Quality Specialist to get to work performing tasks such as:

• Identifying the sequence and interaction of your processes;
• Working with Management to establish KPIs with Quality Objectives/Goals (indicating the effectiveness of each process in meeting quality requirements);*
• Reviewing any existing documentation you have relating to your Quality Management System (QMS);
• Developing a formal QMS, while implementing changes needed to comply with the Standard you've chosen;
• Develop and implement a Document Control/Knowledge Management System (KMS);*
• Train employees in their responsibilities relating to the QMS;*
• Developing a Supplier Management System for evaluating, qualifying, and managing suppliers;*
• Developing and implementing a formal calibration management system (for any measuring and monitoring equipment used);*
• Develop and implement an operational risk management system (e.g., utilizing Risk Matrices or Process FMEAs);
• Manage the Corrective Action process;*
• Maintain a quality management system that consistently produces measurable improvements (e.g., through implementing LEAN Six Sigma (LSS) management techniques/tools).

• Scheduling and Performing Internal Audits to verify compliance with the documented QMS;*
• Hosting Management Reviews of the QMS;*
• Scheduling and Hosting the 3rd Party Audits (e.g., ISO 9001, AS9100, AS9120);
• Addressing and Responding to any non-conformities identified during the CB Audit.

* required by ISO 9001 or AS91xx.