ISO 9000 Consulting Services

Founded in 1968, STAT-A-MATRIX is the world's leading consulting and training organization dedicated to the pursuit of business process improvement and the deployment of quality, regulatory, and environmental management systems. We offer ongoing consulting services as well as educational training in every aspect of business process design and management, from the theoretical foundations to the practical tools needed to assure both customer satisfaction and regulatory or standards compliance.

STAT-A-MATRIX can help you understand and apply management and quality system requirements while ensuring that your program proceeds smoothly, from executive commitment to ongoing process management.

The members of our team represent a broad range of industries and average over 25 years of practical experience, fully qualifying them to fulfill your needs at the corporate or division level, at multiple or single sites. Hundreds of organizations have already used our guidance to design, develop, and deploy cost-effective, profit-enhancing management systems.

STAT-A-MATRIX has a proven 14-step implementation process that is equally applicable to compliance and/or registration of any quality management system. Learn more about the STAT-A-MATRIX 14-Step Implementation Process below . STAT-A-MATRIX has been using our proprietary 14-step process since 1968 and has helped over 1,200 companies use this methodology to attain ISO 9000 registration since 1989.

The STAT-A-MATRIX 14-Step Implementation Process
SAM offers consulting services packaged in a process designed to take a client through quality management system (QMS) development and implementation process and registration in a most timely, effective, and efficient manner. The process is equally applicable to ISO 9001, TL 9000, ISO/TS 16949, AS9100, or the medical device GMP.

Description of the 14-Step Implementation Process
The chart below describes the STAT-A-MATRIX 14-step implementation process, and the bullet points hightlights SAM efforts and deliverables. SAM can participate in any or all of the steps, as required.

1. Management Orientation - Deliverable: Management Understanding of Registration Process

2. Baseline Evaluation - Deliverable: Baseline Evaluation Report

3. Management Planning - Deliverable: Action Plan

4. Responsibility Matrix - Deliverable: Responsibility Matrix

5. Macroflowcharting (Process Mapping) - Deliverable: Macroflowchart of Company Operations

6. Form and Train the Steering Committee - Deliverable: Steering Committee Selection and Training

7. Identify Specific System-Level Procedures - Deliverable: List of System-Level Procedures to Be Documented

8. Prepare System-Level Procedures (SLPs)

• Flowchart System-Level Procedures - Deliverable: Flowcharts of Required SLPs
• Walk Through, Document, and Validate SLPs - Deliverable: Completed System-Level Procedure

9. Write Quality Manual - Deliverable: Draft Quality Manual

10. Flowchart, Improve, Document Instructions - Deliverable: Instruction Writing and Training

11. Train Personnel and Conduct Internal Audits - Deliverable: Documented and Validated Internal Audit System

12. Perform Preassessment Evaluation - Deliverable: Audit Report

13. Take Corrective Action and Review Results - Deliverable: Corrective Action Review

14. Registration or Compliance Audit - SAM can remain on-site during the registration audit to help answer questions and correct nonconformances before the auditors leave the site. Deliverable: Assistance During Registration Audit