ISO 9001:2008 Quality Management System Model for Manufacturing Organizations, Documentation Development and Compliance with Requirements

This Quality Management System Model for ISO 9001:2008 for General Manufacturing provides an overview of a quality management system (QMS), detailed information about the requirements of ISO 9001:2008, as well as a detailed documentation model for the development of documentation. The CD-ROM includes a quality manual, 55 procedures and work instructions, 70 templates and control forms, and a detailed checklist of ISO 9001 requirements. All documents are available in Ms Word (.doc) format for easy editing.
The quality manual references procedures, contains the quality policy, defines responsibilities and activities related to the quality management system, and a flowchart shows the interaction of processes that are necessary to meet the requirements of ISO 9001:2008. In addition to the 6 mandatory documented procedures that are also available in optional flowchart format, 49 detailed procedures and work instructions are referenced and available, describing quality related responsibilities and activities of the departments of QMS Administration, Quality Assurance, Manufacturing, Engineering, Purchasing, Sales/Customer Service and Warehouse. After development of the six mandatory documented procedures it is up to the criteria of the organization to document the other procedures, or just to implement these activities in order to meet the requirements of ISO 9001:2008.
The following procedures are included: Engineering: Design Activities - Coordination and Control , Document and Data Control, Quality Planning Process, Request for Design Initiation and Design Change. Manufacturing: Health and Safety Training, Cycle Counts ,Traceability of Manufactured Product, Production Scheduling, Material Resource Planning, Manufacturing Process Control, Set-Up Procedure, Preventive Maintenance of Equipment, Regulatory Requirements compliance. Purchasing: Purchase Orders - processing and follow-up, Supplier Database- set-up and maintenance, Purchasing Product-Database, Assessment - Eval. -Appr. - Rating of Suppliers, Suppliers Performance Rating System. Quality Assurance: Control of Nonconforming Product, Receiving Inspection, In-Process Inspection, Inspection and Testing of Finished Product, Control of Monitoring and Measuring Equipment, Out Of Calibration Report, Measurement Equipment Analysis, Customer Return Analysis, Positive Recall Control, Customer Approval of Production Parts. QMS Administration: Document Review, Training, Document and Data Control, Operational Performance, Evaluation of Customer Satisfaction, Customer Complaints, Customer Satisfaction Survey, Internal Quality Audits, Preventive Action, Corrective Action, Continual Improvement, Control of Records, Corrective Action Request, Problem Analysis, Quality Improvement Proposal, Document Identification. Sales/Customer Service: Warranty Control, Review of Quotations and Contracts, Product/Price File and Customer File, Order Taking and Processing, Delivery Performance - order entry, Customer Returns, Service Requirements. Warehouse: Shipping of Product, Receiving of Product, Handling and Storage of Product, Temperature Control.
If you want to know more about ISO 9001:2008, to get a general overview or to look at specific requirements and their compliance such as management responsibilities, resource management, quality planning, customer satisfaction, product and/or service realization, monitoring and measurement of system performance, continual improvement, internal audits, etc., or if you need assistance with the development of documentation or how to plan the implementation of ISO 9001:2008 in your organization, this hands-on and result oriented work tool certainly helps to get the job done. The program can easily be installed to a computer. System requirements: Windows and MSWord.