Many organizations can benefit from developing ISO 9001 Quality Management Systems (QMS) to improve the effectiveness and efficiency of their business operations. ISO 9001 Quality Management Systems: Implementation and Integration features the author’s patented Three Step Process – “Identify, Insure, Improve,” in use since 1995 and developed, tested, and applied in actual business situations. It also explains how to integrate ISO 9000, ISO 14000 and OHSAS 18000 programs. This guide is a valuable resource for companies wanting to update their QMS or become certified for the first time.
ISO 9001 Quality Management Systems: Implementation and Integration is used by Quality Assurance/Quality Control Managers, EHS Managers, Risk Managers, Consultants, Loss Control and Operations Managers within manufacturing and service organizations.
Benefits
- Discusses the purpose and features of a QMS system
- Clearly identifies and explains the requirements of the ISO 9001 Standard, as amended, and how to meet them
- Provides a gap analysis to establish a baseline for implementing a QMS
- Helps reduce the development time and energy needed to create a QMS and integrate it with other management systems
- Saves time and consulting fees
- Enhances an organization’s process controls and management of business system operations
- Offers examples of measurement, analysis, and improvement tools
- Includes a broad array of useful supplementary materials (see Features section below)
Topic Areas
- Areas to monitor
- Auditing a process system
- Certification to ISO 9001
- Communication
- Comparison between ISO 9001:2000 and 9001:1994
- Document requirements
- Eight principles of quality management
- Gap analysis
- Guidelines and technical specifications
- Implementing a quality management system
| - Quality Improvement
- Integrating other management systems with QMS: ISO 14001 and OHSAS 18001
- ISO 9001element requirements
- Management responsibility
- Measurement, analysis, and improvement
- New additions to ISO 9001
- Other management system standards: environment, health and safety
| - Pilot’s “Three Step Process – Identify, Insure, Improve”
- Planning
- Product realization
- QMS models
- Quality requirement(s) identification
- Resource management
- Self-declaration or registration
- Tools
- Training
- Updating your quality management system
|
Features
| Introduction
| Provides an overview of ISO 9001, why it is necessary, and how to use this guide |
| ISO 9001 Requirements
|
Details requirements and terminology, the process approach, and process mapping
|
| Implementation
| Describes Pilot’s “Three Step Process – Identify, Insure, Improve”; includes a Process Model |
| Integration
| Discusses other management systems such as ISO 14001 and OHSAS 18001, their benefits, and how they may be integrated with an ISO 9001 QMS; supplements include TS16949:2002, ISO 10006:2003, and ISO 13485:2003 |
| Q-and-A Section
| Answers frequently asked questions |
| Registrar’s Corner
| Offers additional insights, suggestions, and perspectives to assist readers in meeting registration criteria |
| Sample QMS Manual
| Provides a template outline of necessary documentation and serves as an example that can be customized to the user’s requirements |
| Automotive Industry TS
| Includes a section on the Automotive Industry Technical Specifications ISO/TS 16949:2002 and compares requirements of ISO 9001; includes a Gap Matrix |
| Graphics
| Explains complex processes and procedures with flowcharts, diagrams, and figures |
| Supplementary Materials
| Includes task lists, training, gap analysis, checklists, list of acronyms, and supplemental sections on Quality Management in Projects ISO 1006:2003 and Quality Management in Medical Devices ISO 13485:2003 |