ISO 9001 Software Suite
ISO 9000/9001 Software: Quality Management Software Makes Compliance Easy
More so than ever, quality is of paramount importance. A comprehensive quality management system (QMS) is one of the key attributes to the longevity and success of an organization. However, managing the quality management system (QMS) to ISO 9000/9001 is no easy task! ISO standards constantly change as new requirements emerge, and customers mandate more stringent compliance requirements. Compounding these challenges are the types of systems that are being used to manage the QMS:
- Email, Word, Excel, and Access (e.g., manual based systems) to complete tasks
- Human capital to action related data across the QMS (e.g., document change requests to training personnel, audit findings to CAPA, etc.)
- Manually generated, inaccurate, out of date reports to attempt provide enterprise visibility
CEBOS’ MQ1 quality management software – ISO solution is a completely automated, integrated, quality management system geared specifically to the requirements of all flavors of ISO. The software significantly reduces the time organizations spend to complete and maintain registration. It ensures that the organization’s QMS is in compliance with the applicable requirements and that staff know exactly what and when to complete required tasks.
ISO 9001 Quality Management Requirements Needs Matrix
| Attribute | Compliance Requirements Covered with MQ1 Software |
| Product Planning and Realization | Customer Requirements and Related Processes, Customer approved sources, Product Realization, Multi-disciplinary approach, Change Control, Engineering Specifications, Process Flow, FMEA, Acceptance Criteria, Special Characteristics, Control Plans, Error-Proofing, Personnel Safety, Work Instructions, Prototype and Product Approval Process (PPAP), and Preservation of Product |
| Risk Management | Risk management plan, risk analysis and risk analysis process, identification of hazards, estimation of risks, risk control, risk reduction, risk reporting, FMEA, control plans, and error-proofing |
| Audits | Internal Audits (Process, Product and System audits), Audit Planning, Internal Auditor Qualification, Management Review, Cleanliness of Premises, Work Environment, Storage and Inventory |
| Customer Management | Customer Focus, Customer Feedback and Satisfaction, Customer Communication, Customer Property, and Manufacturing Feasibility |
| Data Collection | Monitoring & Measuring of Products/Processes; Verification of Job-set-ups, Layout Inspection and Functional Testing, Identification and Traceability |
| Document Control and Management | Quality Policy, Quality Manual, Control of Documents/Drawings, Control of Records, Work Instructions, Process approval, Engineering Specifications, and Laboratory requirements |
| Employee Skill Management and Competency | Responsibility and Authority, Competence Awareness, Employee Motivation and Empowerment, Training Needs Analysis, Maintenance of Training Records, Knowledge of Statistical Processes, Contingency and Succession Planning |
| Gage | Control of Monitoring and Measurement Devices, Measurement System Analysis, Calibration Verification Records |
| Equipment Maintenance | Preventive and Predictive Maintenance, Infrastructure Maintenance, Plant, Facility and Equipment Planning, and Management of Production Tooling |
| Problem Solving | Control of Non-conforming and Reworked product, Corrective Action, Preventive Action, Problem Solving, Customer Review (Deviations), Identification and traceability and Corrective Action Impact, Pre-configured with MedWatch form 3500 |
| Supplier Performance Management | Supplier Evaluations and Performance Monitoring, Supplier Quality Management System Development, Verification of Purchased Product (Incoming Product Quality), Regulatory Conformity, Control of Purchasing Process, Customer Property |
| Program/Project Management | Product and Quality System Planning, Design and Development Planning, Design Verification and Validation, Continual Improvement, Confidentiality Protection, Multi-disciplinary Approach, Management Commitment, Management Monitoring and Review, Internal Communication, Action Plans |
| Key Performance Measurement and Reporting and effective process monitoring | Quality Objectives, Analysis of Data, Process Efficiency and Effectiveness, Performance Trends Measurement, Management Review (utilizing graphical scorecards), Continual Improvement, Employee Motivation and Empowerment |