Is ISO 9001:2000 similar with Quality Assurance?

Description

30 Oct 2009

Background and history of ISO 9000

ISO (the International Organization for Standardization), a non-governmental organization, is a worldwide federation of national standards bodies (ISO member bodies).

ISO 9000, was set up in 1987 in Geneva, is a unique standard that can be implemented in almost all business aspects because ISO 9000 can be used as a guideline for design, manufacturing, sales and service (Nugroho, 1997, p20). During Second World War (1939-1945), Alliances between America, England, and France faced difficulties when they tried to handle the attack from German, Italy and Japan. It was because of the language differences and also difference in standard measurement of their equipments that they used for war. From this situation, it created an idea to make standardization, but at that time they only focused on war equipments.

In the next few years, the idea of developing standard in other areas has emerged. Between 1970s and 1980s, Quality control has improved from its main characteristic from reactive (inspection-dominant) became proactive (system oriented) which results in the implementation by focusing from the end results to production process This changes based on the mind set that production process should be improved dan well maintain in order to create a quality products.

By having the effort to develop a standard that can be implemented internationally, it was a pioneer of ISO organization. For technical implementation, ISO established technical team that well known as Technical Committee 176 (TC176) or ISO/TC176.

The growth of ISO 9000 series.

In 1987, ISO/TC 176 has successfully managed a standard series that can be implemented internationally especially for Europe Economic society. The series, at that time, is called ISO 9000 series 1987 version. ISO 9000 that created in 1987 has been revised in 1994 that called as ISO 9000:1994 series. In this version, certification model can be obtained for 3 types which are ISO 9001, ISO 9002, and ISO 9003. ISO 9000 series has continued changing toward total quality management, this series was called ISO 9000:2000. For organization, that has implemented ISO 9000 series before, should followed the new version if they still wanted to hold ISO 9000 certification.

What are the changes from ISO 9001:1994 to ISO 9001:2000?

For the readers who already known ISO 9001:1994 should already had a description of the basic changes on ISO 9001:2000. ISO 9000:1994 series has 20 elements that can be grouped as the model below:

Correspondence between 20 elements and this quality system model can be seen in below table:

Clausal

Elements

ISO 9001

ISO 9002

ISO 9003

4.1

Management responsibility

ü

ü

ü

4.2

Quality System

ü

ü

ü

4.3

Contract review

ü

ü

ü

4.4

Design Control

ü

N/A

N/A

4.5

Document and data control

ü

ü

ü

4.6

Purchasing

ü

ü

N/A

4.7

Control of customer-supplied product

ü

ü

ü

4.8

Product identification and traceability

ü

ü

ü

4.9

Process control

ü

ü

N/A

4.10

Inspection and testing

ü

ü

ü

4.11

Control of inspection, measuring and test equipment

ü

ü

ü

4.12

Inspection and test status

ü

ü

ü

4.13

Control of nonconforming product

ü

ü

ü

4.14

Corrective and preventive action

ü

ü

ü

4.15

Handling, storage, packing, preservation and delivery

ü

ü

ü

4.16

Control of quality records

ü

ü

ü

4.17

Internal quality Audit

ü

ü

ü

4.18

Training

ü

ü

ü

4.19

Servicing

ü

ü

ü

4.20

Statistical technique

ü

ü

ü



For the 2000 series revisions, the ISO 9000 family of standards, consist of
  1. ISO 9000 which sets out the concepts, principles, fundamentals and vocabulary of quality management systems;
  2. ISO 9001 which sets out the requirements to be met;
  3. ISO 9004 which provide guidance for improving the performance of the quality management system
  4. ISO 19011 which provide guidelines on auditing quality management systems (and environmental management system as well)
For the model 9001:2000 shown in below figure:

This model takes the view that everything to do with quality starts and ends with the customer. So the model is customer driven. In the diagram, the customer is shown on both the left and right. Most often it will be the same customer, but it could be a different one.

The model picks up with the discussions and specification from our customer - what our customer wants. This becomes an input to your quality management system (shown in diagram as the circle). This input feeds into the product and/or service planning and into its production or service provision.

The main process flow that enables the product and/or service to emerge is shown across the lower part of the figure, as product realization.

This box covers various activities that your business needs to do to make your product an/or your service. It becomes the output from your business in the form of a product and/or service.

The model highlights the importance of obtaining information on customer satisfaction (the dotted arrow on the right points back to measurement, analysis, and improvement). This and other measurements and evaluations become vital feedback on your organization's performance. These measurement systems are shown as the box titled "measurement, analysis and improvement".

The model also depicts management activities that are fundamental to the smooth operation of your process of product and/or service realization.

We need to study these concepts and act on them. The results may be good but equally may be poor. Either way, we are in a stronger position with this information to know how our business is running. We can now act by adjusting its resources in the light of the information, which then improves the performance of the products an/or service realization.

The "management responsibility" box is there to emphasize the need for management to study the results of the feedback and other information.

Management responsibility also covers the need for managers to set policy, objectives and targets. Following from these there is a need for proper planning. Planning includes the study of our processes and ensuring that they are adequately documented. These documents need to spell out the standard way that we want our processes to be done.

Management need to evaluate resources, which is addressed as the resource management box in our quality management system. We need to ensure that we have adequate resources to assure the quality of our product and/or service. Resources include workspace, equipment, material and people. We need to ensure that people are trained and are competent to do the tasks that we ask of them.

The data and analysis activities, shown in the box on the right, title Measurement, analysis and improvement, may suggest improvements to the quality management system, indicated as the arrow pointing to the box at the top, titled Continual improvement of the quality system.

At the initiative of top management, potential improvements should also be investigated and appropriated implemented, and this is yet another example of feedback.

So there are two mechanisms for making improvements:

  • As part of the quality management system (depicted by the arrows of the inner loop). This includes nonconformity rectification, corrective action and preventive action.
  • Review processes, and in particular management review, which look critically at the whole quality management system and make improvements to it.
Hence the process model in Figure 1 ties together the concepts of quality assurance to continual improvement.

Quality Management principles

According chapter two of ISO 9000:2000 quality management system - fundamental and vocabulary, we can see that ISO 9001:2000 is based on eight principles of quality management.

To lead and operate an organization successfully, it is necessary to direct and control it in a systematic and transparent manner. Success can result from implementing and maintaining a management system that is designed to continually improve performance while addressing the needs of all interested parties. Managing an organization encompass quality management amongst other management disciplines. Eight quality management principles have been identified that can be used by top management in order to lead the organization towards improved performance.

  • 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.
  • 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
  • Involvement 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 benefit
  • Process approach
    A desired result is achieved more efficiently when activities and related resource are managed as a process
  • System approach to management
    Identifying, understanding, and managing interrelated processes as a sytem contributes to organization's effectiveness and efficiency in achieving its objective
  • Continual improvement
    Continual improvement to organization's overall performance should be a permanent objective of the organization.
  • Factual approach to decision making
    Effective decisions are based on the analysis of data and information
  • Mutually beneficial supplier relationships
    An organization and its suppliers are interdependent and mutually beneficial relationship enhances the ability of both to create value.

What is the difference between Quality Assurance and Quality management systems?

  • What is Quality Assurance?
    According ISO 9000:2000 Quality Management Systems - Fundamentals and vocabulary, Quality Assurance is a part of quality management that focuses on the all conformities.
    Another definition of Quality Assurance is an effort to make sure that the system, process, procedure run according the standard.
    So Quality Assurance is a systematic management and procedure that can be adopted by an organization or system in order to monitor performance and make sure the desired output.
  • What is Quality Management systems?
    To lead and operate an organization successfully, it is necessary to direct and control it in a systematic and transparent manner. Success can result from implementing and maintaining a management system that is designed to continually improve performance while addressing the needs of all interested parties. Managing an organization encompass quality management amongst other management disciplines.

ISO 9001:2000 as Quality Management System

From the comparison between ISO 9001:1994 and ISO 9001:2000, we see that ISO 9001:1994 is in QA scope, but ISO 9001:2000 has scope in QMS elements (leadership, human resource, communication/good relationship between departments, and use data analysis for decision making).

Conclusion

From the above explanation, we know that QMS has broader scope compare to QA. So if ISO 9001:2000 is QMS that means ISO 9001:2000 is more than QA. So organization that has ISO 9001:2000 certification can prove that they have one step ahead from QA.

Reference:

Ir. S. Nugroho, Pengendalian ISO 9000 series - series Penambahan wawasan pengusaha Indonesia. 1997. Abadi Tandur British Standard International ISO 9000 for small business - what to do - advice from ISO TC 176,2001, BSI Standard.

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Did You Know?


Malcolm Baldrige National Quality Award is the highest accolode an organization can receive as a demonstration of excellence in quality operations.

Quotes

Quality is never an accident; it is always the result of intelligent effort

- John Ruskin

"Quality means doing it right when no one is looking"
~ Henry Ford

Quality Is Not An Act, It Is A Habit

(Aristotle)

If You Want A Quality, Act As If You Already Had It

(Wiliam James)

“Quality means doing it right when no one is looking.”

- Henry Ford -

 

“Quality is more important than quantity. One home run is much better than two doubles”

- Steve Jobs -

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