Delivering high quality products and services at an acceptable cost while maintaining strong customer satisfaction and product reputation.
Quality Monitoring Service
We believe our quality assurance procedures are among the best in the industry. Adding the SIMULIA Quality Monitoring Service for the Abaqus Unified Finite Element Analysis (FEA) product suite is a cost-effective way to leverage our Quality Assurance work in achieving your own quality assurance objectives.
Increasingly, customers find that they are required to select, evaluate and re-evaluate suppliers' quality activities as a desirable or mandatory component of their own quality assurance work or a regulation requirement. To assist customers in meeting this requirement, SIMULIA offers the Quality Monitoring Service for Abaqus Unified FEA. The service has four components:
A controlled copy of the SIMULIA Quality Assurance Manual
Monthly Potentially Serious Error Reports emailed on the first business day of each month
A copy of the annual internal Quality Assurance Audit
The right to conduct the customer's own Quality Assurance Audit
Quality Monitoring Service customers receive controlled copies of the Quality Assurance Manual. This document defines the processes used at SIMULIA to ensure quality. It is designed to comply with the ISO 9001:2008 standard and applicable parts of industry-specific regulatory requirements. A "controlled" copy means that customers receive all revisions to the manual. In this way, such customers are informed in detail of the processes used at SIMULIA for quality assurance and are notified of any changes in those processes. Industry-specific supplements have been added to the Quality Assurance Manual to facilitate customers subject to regulatory requirements in accepting or dedicating Abaqus Unified FEA. The regulations addressed are listed below by industry.
Energy, Process and Utilities
ASME NQA-1-2008 Part 1, titled "Quality Assurance Requirements for Nuclear Facility Applications" and subsequent applicable addenda’s of NQA-1-2008
Subpart 2.7, titled "Quality Assurance Requirements for Computer Software"
Title 10, Chapter 1, Code of Federal Regulation (CFR), Appendix B to Part 50, titled, "Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants"
10 CFR Part 21, titled, "Reporting of Defects and Noncompliance" for commercial grade items.
A defect is potentially serious when one behavior should occur, but the software is providing a wrong result or behavior and this is not obvious to the user. An Abaqus Unified FEA bug is considered to be potentially serious if it may cause an experienced analyst to believe the behavior of Abaqus Unified FEA to be accurate when it may in fact be inaccurate in an engineering sense. Because SIMULIA cannot predict perfectly how Abaqus Unified FEA may be used, the likelihood of the conditions that trigger the bug is not considered when deciding if a bug is potentially serious. A defect may be classified as Potentially Serious without regard for the frequency at which it may occur.
Our SIMULIA Quality Management System is designed to meet the ISO 9001:2008 requirements and to facilitate customer compliance with the ASME NQA-1 requirements. NQA-1 discusses "conditions adverse to quality" under the section on corrective action. NQA-1 is consistent with 10 CFR Appendix B to Part 50 titled “Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants”. Recognizing our customers’ requirements under 10 CFR Part 21 titled “Reporting of Defects and Noncompliances” as applied to commercial grade items, SIMULIA provides customers with timely notification of all known defects to enable prompt identification and reporting. In addition, subscribers to the Quality Monitoring System receive monthly Potentially Serious Error Reports. All defects in the Abaqus Unified FEA product suites are conditions adverse to quality, but potentially serious bugs are clearly the most severe and hence receive special treatment.
An internal audit is conducted annually of the SIMULIA Quality Management System for Abaqus Unified FEA. The purpose of the audit is to ensure continuing compliance of the SIMULIA Quality Management System with the provisions of the ISO 9001:2008 standard. Quality Monitoring Service customers receive a copy of the annual internal audit report.
Quality Monitoring Service customers have the right to visit Dassault Systèmes Simulia Corp. to audit the SIMULIA Quality Management System for Abaqus Unified FEA themselves or to have their own contractors perform such quality audits. Dassault Systèmes Simulia Corp. covers its own costs for staffing, copying, etc. in cooperating with such audits. The customer is responsible for its auditor's costs.
We ask that reasonable notification of such audit visits be provided and that flexibility be shown in choosing dates so that the appropriate personnel are available to support the auditors.