ISO 9000

Introduction: ISO, or the International Organization for Standardization, is “the

world’s largest developer of voluntary International Standards.” Organizations
can comply with these standards in order to increase efficiency and
productivity, as well as gain access to new and more diverse markets.

Origin: The roots of the ISO 9000 series date back to World War II, when the
Ministry of Defense in Britain decided to implement a set of standards to reduce
mistakes and the resulting accidents in the manufacturing of munitions. The
standards focused on the management of procedures rather than the actual
manufacturing. Focusing on management meant that the MoD would first
inspect the procedures used during manufacturing, and then inspect the
manufactured product to ensure consistency in quality.

Basic Principles:

 Customer focus

 Leadership

 Involvement of people

 Process approach

 System approach to management

 Continual improvement

 Factual approach to decision making

 Mutually beneficial supplier relationships

Series:

 ISO 9001:2015: Quality management systems - Requirements

 ISO 9000:2015: Quality management systems - Fundamentals and

vocabulary (definitions)

 ISO 9004:2009: Quality management systems – Managing for the sustained

success of an organization (continuous improvement)

 ISO 19011:2011: Guidelines for auditing management systems

Benefits of Registration:

Proper quality management can improve business, often having a positive

effect on investment, market share, sales growth, sales margins, competitive
advantage, and avoidance of litigation. According to ISO the 2015 version of
the standard brings the following benefits:

1. By assessing their context, organizations can define who is affected by

their work and what they expect. This enables clearly stated business
objectives and the identification of new business opportunities.
2. Organizations can identify and address the risks associated with their
organization.
3. By putting customers first organizations can make sure they consistently
meet customer needs and enhance customer satisfaction. This can lead
to more repeat custom, new clients and increased business for the
organization.
4. Organizations work in a more efficient way as all their processes are
aligned and understood by everyone. This increases productivity and
efficiency, bringing internal costs down.
5. Organizations will meet necessary statutory and regulatory requirements.
6. Organizations can expand into new markets, as some sectors and clients
require ISO 9001 before doing business
Requirements for ISO 9001:

ISO 9001:2008 “requires” only 7 documents:

1. Quality Manual

2. Control of Documents Procedure

3. Control of Records Procedure

4. Control of Non conformances Procedure

5. Internal Audit Procedure

6. Corrective Action Procedure

7. Preventive Action Procedure