[B] ISO 9000

ISO 9000

Companies today compete on a global scale. In order to remain competitive, organizations must be able to adapt to the corporate climate. One obstacle many companies are facing today is the ever-increasing standards of quality customers expect from their respective firms. To overcome this obstacle, many organizations have begun or completed the implementation of ISO 9000.

ISO 9000 is a quality system. It is a set of rules that can be followed by an organization in order for a company to understand the wants and needs of their customers. ISO 9000 is a generic system, allowing the standard to be applied in virtually any situation. ISO is not an acronym. Formed in 1947, in Geneva, Switzerland, ISO is a nickname used for the International Organization for Standardization. The word “isos” means, “equal” in Greek, and that is what ISO 9000 attempts to establish. The ISO 9000 standard is used in order to create organizations that are equal when it comes to customer service and meeting customer needs.

ISO 9000 is a European standard, however, it is being adapted throughout the world. The International Organization for Standardization believes there are two main points that should be understood in order to undertake ISO 9000 implementation. One is to promote development of standardization to facilitate international exchange of goods and services. Basically, this is to allow international companies to compete on the same level in regards to goods and services. The second is to promote cooperation in intellectual, scientific, technological, and economic activity. Sharing information allows companies to grow, and has been a key point in discussions from Robert C. Camp. His ideas of benchmarking are those of sharing information in order to allow both parties to benefit.

A commitment to ISO 9000 is necessary in order for it to be successful. Once a commitment is made, it is only a matter of time until the organization is compliant with ISO 9000. Once the commitment is made, the organization must come up with a plan in order to see what is feasible. Implementation of the plan will commence, and then, once completed, an ISO 9000 certificate can be issued.

Once ISO 9000 is implemented, it will benefit the organization in many ways. Customers will recognize the certification, as it holds an important place when most companies are looking to purchase from others. This will allow increased sales, while the actual implementation is contributing to higher quality and service. The organization on a whole will benefit, as it will allow the employees to operate in a more efficient way, and has shown to increase morale and team work efficiency.

ISO 9000 has a series of parts in which guidelines and rules are presented in order to achieve ISO 9000 certification. Specifically, ISO 9000 and 9004 are the guidelines, while ISO 9001, 9002, and 9003 are the categories in which an organization can apply in order to achieve ISO 9000 certification.

In part one of ISO 9000 documentation, ISO 9000 is the “Quality Management and Quality Assurance Standards – Guidelines for Selection and Use” section. This section is an overview of ISO 9000 certification and allows a company to decide which category they can apply for in order to achieve ISO 9000 certification.

ISO 9001 is the “Quality Systems – Model for Quality Assurance in Design/Development, Production, Installation, and Servicing” category within ISO 9000. This category is for use by companies within the manufacturing sector or organizations involved in the creation and delivery of a service.

ISO 9002, “Quality Systems – Model for Quality Assurance in Production and Installation” is the category for companies who perform many functions, with the exception of design and development, to implement. A job shop would be an example of a company who would apply for ISO 9002.

ISO 9003, “Quality Systems – Model for Quality Assurance in Final Inspection and Test” is used by non-manufacturing firms, such as distributors and warehouses. This standard is not being used as much as it was in the past, as more quality is now being built directly into a product. ISO 9003 is expected to be dropped from the ISO 9000 certification sometime in the future.

ISO 9004, “Quality Management and Quality System Elements – Guidelines” are the guidelines a company use to implement and interpret what category to apply for within ISO 9000. It helps the company seek direction and achieve what ISO 9000 has set out to create: quality and unity.
ISO 9000:2000 is an ISO 9000 update. Some of the changes include the integration of ISO 9001, 9002, and 9003, and important issues within ISO 9000 being clarified. Another related standard is ISO 14000, which is an extension of ISO 9000 into environmental certification. The support for ISO 14000 is not as great as ISO 9000, as integrating ISO 14000 can cause conflicting interests within an organization, due to opinions over environmental issues.

ISO 9000, as stated previously, can be implemented virtually anywhere. An organization just needs to determine which section of ISO 9000 implementation to proceed with, and from there is it simply a matter of following through with the standard. Companies such as IBM, Motorola, Exxon-Mobil, and Fed-Ex have all implemented some type of ISO 9000 standards. Once a company’s basic structure and goals have been identified, the implementation can begin. Taking a small manufacturing business as an example, the following paragraph describes the process involved in ISO 9000 implementation.

ISO 9001 would be the choice of the small manufacturing business, as ISO 9001 is the category for which manufacturing operations should choose to implement. Costs would break down into two parts: implementation and registration. The implementation costs include: Multiple Locations, Design, Non-existence of a Quality Program, and Significant Corporate Changes. The registering costs include: Design Responsibility, Number of Locations, and Size of Facility in Terms of Employment (Employees). There can also be additional costs, which do not register in dollars and cents, such as employee morale.

ISO 9000 is an important standard in the industry today. When companies choose to implement ISO 9000, they must think of not only the short-term transition period, but also the long-term future of the organization. Too often, companies do not see this, and implement ISO 9000 simply to remain competitive due to outside pressure. This can lead to failure of the implementation, and even to the point of failure of the company due to the loss in quality that may have existed before the implementation.

For additional information, many sources can be utilized. The Internet is a place that can be very helpful in learning more about ISO 9000. A good site to visit would be the International Organization for Standardization (http://www.iso.ch/). Also, the resources in the library or a specialized engineering library will be very helpful in obtaining ISO 9000 information. Finally, contacting a company directly to see a first-hand account of ISO 9000 implementation can be very informative.

ISO 9000:2000

What is ISO 9000:2000?

The International Organization for Standardization (ISO) was founded in 1946 “to develop a common set of manufacturing, common trade, and communications standards.” Based in Geneva, Switzerland, ISO is composed of more than 100 member nations that are represented by national organizations charged with creating standards (the US-based organization is called the American National Standards Institute).

[1]

ISO 9000 was first published in 1987, revised in 1994, and updated in 2000; hence the name ISO 9000:2000, the latter number referring to the last revision. The main reasons for 2000 revision were to improve user-friendliness; to give more attention to the process approach, continual improvement, and resource management; and to improve integration of quality management systems with other management systems.
The ISO 9000 family is composed of the 9000 series of two documents, ISO 9001:2000, Quality management systems—Requirements and ISO 9004:2000, Quality management systems—Guidelines for performance improvements, which outline specific requirements; ISO 19011, Guidelines for quality and/or environmental management systems auditing; and ISO 9000:2000, Quality management systems—Fundamentals and vocabulary.

[2]

ISO 9000:2000 is a set of general guidelines that organizations can adopt to improve their quality management systems; the guidelines are broad enough to apply to Fortune 500 companies as well as not-for-profit organizations. The guidelines are separated into eight quality management principles:
(1) Customer Focus,
(2) Leadership,
(3) Involvement of People,
(4) Process Approach,
(5) Systems Approach to Management,
(6) Continual Improvement,
(7) Factual Approach to Decision Making, and
(8) Mutually Beneficial Supplier Relationships.

How to Use the Concept?

In order to fully utilize the ISO 9000 family of principles, an organization must:
(1) Understand why it should use ISO 9000,
(2) How to implement ISO 9000, and
(3) How to obtain certification.

Why ISO 9000?

Many companies want to focus on continual process improvement in order to improve internal processes, decrease costs, and increase customer satisfaction and retention. “ISO 9001 is a vehicle to educate management about systems thinking, the process approach, and process improvement tools and techniques.”

[3]

The international acceptance of these standards makes them even more appealing to many businesses and organizations.

How to Implement ISO 9000?

ISO 9000 implementation responsibilities rest on management, employees, and internal and external auditors. Management responsibilities can be summarized in ten basic points:

• Communicate importance of meeting customer requirements.
• Develop an integrated overall plan.
• Ensure that quality starts at design stage to prevent problems.
• Monitor process capability.
• Measure key product and service characteristics.
• Continually improve processes.
• Create constancy of purpose.
• Demonstrate leadership. Work on the system to support the employee.
• Commit to ongoing training.Promote continual improvement rather than management by numbers.

[4]

Employee responsibilities include:

• Follow the most current work instruction.
• Identify problems and inaccuracies in work instructions and inform management.
• Make recommendations for process improvement.
• Identify and report to management all service or product nonconformity.
  

Auditors responsibilities include:

• Ensuring complete conformity to ISO standards.
• Monitor and review quality management system activity at appropriate intervals.
• Suggest corrective or preventive action as needed. (Scott)
  

How to Obtain Certification

After management, employees, and internal auditors have adopted and ensured ISO quality standards, the organization can then contact a accredited registrar (an approved auditor) that can issue official certifications.

Palmetto GBA—A Working Example of ISO 9000 in Service
Palmetto GBA, a Medicare and Medicaid claims processing contractor, has been focused on qualitative process improvement for 12 years. In 1998, The Centers for Medicare and Madicaid Services, one of Palmetto’s largest customers began requiring ISO 9001 certification for its business contracts. Palmetto decided to become 9001 certified to retain and satisfy its largest customers. Palmetto implemented a 4-phase program in order to comply with customer demands.

In the planning phase Palmetto read and understood the ISO 9001 standard and attended proper training. After receiving the training they were able to implement the second phase by performing GAP analysis between their existing system and the new Quality Management System. They identified problems in their current business processes by creating a flowchart of the sequence and interaction of all business processes, which allowed Palmetto to implement the third phase by analyzing problems and implementing new procedures. In the fourth and final phase Palmetto hired two certified auditors to audit processes full-time. They continually provided new ideas on improving quality management systems.

Palmetto gave a great example of qualitative improvements by utilizing ISO 9001 standards. Examples of quantitative improvements are evident with DuPont. DuPont used ISO 9000 to “increase on-time delivery from 70 percent to 90 percent, decreasing cycle time from 15 days to 1.5 days, increasing first-pass yields from 72 percent to 92 percent, and reducing the number of test procedures to one-third.”

[5]

Conclusion

The family of ISO 9000 including specifics found within 9001 and 9004 provide a way for companies to improve their business processes in order to accomplish the ultimate goal of pleasing their customers.