What is ISO 9000? ISO 9000 is a set of international standards for operational systems
which was conceived by the International Standards Organization in 1986. The ISO
9000 standards were subsequently published in 1987. The ISO 9000 standards from
1987 were further revised in 1994. For manufacturers which desire to import from
China or export to China, having a full understanding of ISO 9000 and receiving ISO
9000 certification will accelerate product acceptance.
The ISO 9000: 1994 Changes
The update of the ISO standards in 1994 included the streamlining of the numbering
system. There are about 250 changes. Most of the changes were done to make the
standards easier to read. The ISO 9000 standards from 1994 did not change significantly
from the 1987 version. So what are the ISO 9000 key changes in 1994?
Requirement of all members of the organization down to at least the supervisory level
to have job descriptions that outline their responsibilities and authority.
Compulsory design reviews throughout the Work Package lifetime.
Ensure data was kept up to date through document control.
The ISO 9000: 2005 Changes and Impact
The ISO 9000 standards were again updated in 2005. The words and definitions within
the ISO 9000: 2005 became the source for the ISO 9001: 2008. ISO 9001 is the international
standard that identifies the requirements for establishing a system to manage your
organization and processes to better serve your customers.
The ISO 9000: 2005 Definitions
Here are some examples of ISO 9000: 2005 definitions:
Defect - Non-fulfillment of a requirement related to an intended use or specific
Corrective Action - Action to eliminate the cause of detected nonconformity or other
Preventive Action - Action to eliminate the cause of a potential nonconformity or
other potential situation.
Process - Set of interrelated interacting activities which transform inputs into
Procedure - Specific way to carry out a process.
The ISO 9000: 2005 Quality Management Principles
There are eight quality management principles with the ISO 9000: 2005. These became
the key input for ISO 9001: 2008.
Customer Focus. Understand and meet customer requirements and exceed customer expectations.
Leadership. Leaders within the organization create an environment to involve the
employees in achieving company objectives.
Employee Involvement. All levels of the company are involved for the organization's
Process Management. All activities and tasks are managed as a process to achieve
Systems Approach. Understand and manage the interactions between different processes.
Continuous Improvement. Constantly improving the company's overall performance.
Fact Based Decision Making. Data and information are used to make company decisions.
Supplier Relations. Suppliers are an integral part of an organization's ability to
create customer value.
The ISO 9000: 2005 General Requirements
The following are the general requirements of ISO 9000: 2005:
The company must establish, document and implement a quality management system.
The processes, sequences and interactions must be fully understood and captured.
The criteria (standards) for monitoring and managing the processes must be clearly
The appropriate resources needed to monitor and manage the processes must also be
Outsourced processes must also be monitored and controlled.
Benefits of ISO 9000: 2005
Once the ISO 9000 standards have been implemented, there are a number of benefits
to the organization:
The company delivers products that meet customer requirements.
Processes and resources are effectively managed.
Quality management is improved by improving the processes.
By now, you should have a full understanding of what is ISO 9000.
Steps to Implementing ISO 9000
If your company is interested in exporting to China or importing from China, below
are the key steps to implementing the ISO 9000 standards:
Processes are identified.
Inputs and outputs are clearly identified for each process.
Decide how to measure inputs and outputs.
Utilize process maps for key processes.
Relationship diagrams are used to show process interactions.