ISO 9001:2008 Principles and Implementation
Principles of Customer-Focused Organizations
1. Customer Focus: Organizations depend on their customers and therefore should understand their present and future needs, meet their requirements, and strive to exceed their expectations.
2. Leadership: Leaders establish unity of purpose and direction for the organization. They must create and maintain an internal environment in which people can become fully involved in achieving the organization’s goals.
3. Engagement of People: People at all levels are the essence of an organization, and their full involvement enables their abilities to be used for the organization’s benefit.
4. Process Approach: Desired results are achieved more efficiently when related resources and activities are managed as a process.
5. System Approach to Management: Identifying, understanding, and managing a system of interrelated processes for a given objective improves an organization’s efficiency and effectiveness.
6. Continuous Improvement: Continuous improvement should be a permanent objective of the organization.
7. Fact-Based Decision Making: Effective decisions are based on the analysis of data and information.
8. Relationship Management: An organization and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value.
ISO 9001:2008 Structure and Implementation
ISO 9001:2008 is structured into eight clauses. The first three clauses cover the scope, references, terms, and definitions, and are introductory in nature. Clauses four to eight focus on processes and requirements for implementing a quality management system.
Clauses 1-3: Introduction
- Clause 1: Scope
- Clause 2: Normative References
- Clause 3: Terms and Definitions
Clause 4: Quality Management System
This clause contains the general requirements and documentation requirements for managing the quality management system.
- 4.1 General requirements
- 4.2 Documentation requirements
Clause 5: Management Responsibility
This clause contains the requirements to be met by the organization’s leadership, such as defining the quality policy, ensuring that responsibilities and authorities are defined, setting objectives, and demonstrating commitment to quality.
- 5.1 Management Commitment
- 5.2 Customer Focus
- 5.3 Quality Policy
- 5.4 Planning
- 5.5 Responsibility, Authority, and Communication
- 5.6 Management Review
Clause 6: Resource Management
The standard distinguishes three types of resources that must be managed: human resources, infrastructure, and work environment. This clause contains the requirements for their management.
- 6.1 Provision of Resources
- 6.2 Human Resources
- 6.3 Infrastructure
- 6.4 Work Environment
Clause 7: Product Realization
This clause contains the requirements related to the production of goods or services, from customer requirements to product delivery.
- 7.1 Planning of Product Realization
- 7.2 Customer-Related Processes
- 7.3 Design and Development
- 7.4 Purchasing
- 7.5 Production and Service Provision
- 7.6 Control of Monitoring and Measuring Equipment
Clause 8: Measurement, Analysis, and Improvement
This clause outlines the requirements for processes that collect and analyze information and take appropriate action. The objective is to continuously improve the organization’s ability to provide products that meet requirements and enhance customer satisfaction.
- 8.1 General
- 8.2 Monitoring and Measurement
- 8.3 Control of Nonconforming Output
- 8.4 Analysis of Data
- 8.5 Improvement
The objective stated in the Standard is that the organization relentlessly seeks customer satisfaction through the fulfillment of requirements.