SimpleQuE’s 4-Step Approach

Step 1: Gap Analysis

Our custom gap analysis is a useful tool to clearly identify the differences between your current practices and the standard requirements. Our consultant evaluates any current quality system procedures, documentation, and the overall identification and implementation of key processes against the requirements of the standard and other best practices. The objective is to establish a baseline and provide an analysis to determine the actions that will be necessary to meet the intent of these requirements.

Step 2: Proposal and Action Plan

Upon completion of step one, we provide a detailed action plan of everything required to achieve certification.  This is shared during a Management meeting with results of the gap analysis to establish an overall implementation strategy.

Step 3: Implementation

The next phase includes practical results and is based on training, developing or integrating any required documentation changes, creating or updating any existing documentation, completing or updating the quality manual and procedures to meet the standard’s requirements. All Step 3 activities are based on the results of the Step 1 Gap Analysis and utilize the assistance of your personnel in closing all identified gaps in the Action Item List (Step 2).

Implementation may include:

• Requirements and process owner training
• Key process development (process flow, process maps, turtle diagrams)
• Context of the organization and strategic direction
• Goal establishment and key performance indicators
• Risk management process
• Modify or develop the quality management system and procedures
• Update or create documented information
• Project management tracking with periodic management status to track each action
• Internal audit prior to certification to make sure you’re ready

Step 4: Registration Audit Support

Provide support during and/or after the Registration Audit to provide direction with regard to the most effective and efficient method of establishing corrective actions for nonconformances identified during the registration audit.  Assure root cause analysis and corrective action implementation to successfully close findings quickly to obtain certification.

After certification we can help you maintain it in a variety of ways.