ISO 9000

ISO 9000

ISO 9000 refers to a generic series of standards published by the ISO that provide quality assurance requirements and quality management guidance. ISO 9000 is a quality system standard, not a technical product standard. The ISO 9000 series currently contains four standards - ISO 9001, ISO 9002, ISO 9003 and ISO 9004. Firms select the standard that is most relevant to their business activities.

Evolution of ISO 9000 Standard-

Year	Edition of ISO 9001
1987	1st Edition
1994	2nd Edition
2000	3rd Edition
2008	4th Edition
2015	5th Edition

Quality Management Principle-

The ISO 9000 series are based on seven quality management principles (QMP)

The seven quality management principles are:

· QMP 1 – Customer focus

· QMP 2 – Leadership

· QMP 3 – Engagement of people

· QMP 4 – Process approach

· QMP 5 – Improvement

· QMP 6 – Evidence-based decision making

· QMP 7 – Relationship management

Principle 1 – Customer focus

Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.

Principle 2 – Leadership

Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives.

Principle 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.

Principle 4 – Process approach

A desired result is achieved more efficiently when activities and related resources are managed as a process.

Principle 5 – Improvement

Improvement of the organization's overall performance should be a permanent objective of the organization.

Principle 6 – Evidence-based decision making

Effective decisions are based on the analysis of data and information.

Principle 7 – Relationship management

An organization and its external providers (suppliers, contractors, service providers) are interdependent and a mutually beneficial relationship enhances the ability of both to create value.

Element of ISO 9000 Quality Management System

The standards of ISO 9000 detail 20 requirements for an organization's quality management system in the following areas:

• Management Responsibility
• Quality System
• Order Entry
• Design Control
• Document and Data Control
• Purchasing
• Control of Customer Supplied Products
• Product Identification and Tractability
• Process Control
• Inspection and Testing Control of Inspection, Measuring, and Test Equipment
• Inspection and Test Status
• Control of Nonconforming Products
• Corrective and Preventive Action
• Handling, Storage, Packaging, and Delivery
• Control of Quality Records
• Internal Quality Audits
• Training
• Servicing
• Statistical Techniques

Auditing

Two types of auditing are required to become registered to the standard:
1. Auditing by an external certification body (external audit)
2. Audits by internal staff trained for this process (internal audits).

Advantages of ISO 9000

1. The ISO 9000 registration reveal the weaknesses area in which final product quality can be improved.

2. Improved internal communication; The ISO 9000 certification process focus more on self-analysis and operations management.

3. Improved customer service

4. Reduction of product liability risks

5. Attractiveness to investors

Disadvantages of ISO 9000

1. Owners and managers do not have an adequate understanding of ISO 9000. 

2. Most of companies have less funding available, therefore companies are finding difficulties to adopt ISO system. 

3. ISO 9000 registration need heavy document workload. 

4. ISO 9000 registration process require long time.