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8.

0 ISO SERIES

8.1 Describe ISO 9000 Series for quality system management


8.1.1 Describe the needs for a quality system
8.1.2 Explain the basic concept and main terms in ISO 9000 series
8.1.3 Describe the Quality Management Principles
8.1.4 Explain the ISO 9000 series standard
8.1.5 Determine the advantages and disadvantages of practicing ISO 9000
8.1 Describe ISO 9000 Series for quality system management

8.1.1 Describe the needs for a quality system


A quality management system (QMS) can be expressed as the organizational structure,
procedures, processes and resources needed to implement quality management. Early
systems emphasized predictable outcomes of an industrial product production line, using
simple statistics and random sampling. In today's global economy the barriers of trade have
been knocked down. Companies have increased their level of performance in order to
survive today’s aggressive environment. In order to stay competitive, companies must apply
effective and efficient plans. The most accepted plan today is the ISO 9000. It is a set of
standards that help companies achieve cost effective and quality assurance methods. This
paper will explain what ISO 9000 is and what it means to a company to be ISO 9000
certified.

8.1.2 Explain the basic concept and main terms in ISO 9000 series

What is ISO?
ISO is an International Organization for Standards that was formed by technical committees.
They provide user-friendly guidelines for a wide range of organizations. Examples of these
organizations include manufacturing, processing, servicing, printing, forestry, and
electronics ISO was established in 1947, in Switzerland, with the purpose of developing
intellectual, scientific, technological, and economic corporation between member countries
(Bureau of Business Practice).

Approach to ISO 9000


ISO 9000 provides a starting place for all-encompassing quality efforts. The standards
merely stipulate where organizations need documentation to validate processes and
approaches but never dictate how much they require.
ISO 9000 is not a product registration standard; it in no way measures or recognizes the
quality of a company's product, nor does it mean that two companies with ISO 9000
registrations are equivalent.

ISO 9000 requires:


Management that is committed, involved, focused and responsive.
People who are organized, responsible, authorized, competent, empowered and
knowledgeable.
Processes that are visible, traceable, consistent, repeatable, measurable and documentable.
Documents that are appropriate, relevant, simple, understandable and consistent with
processes in use.

The ISO 9000 standards basically have three requirements. First, the company must
document the quality system and business process in detail. Second, the company must
make sure each employee understands and follows the guidelines put forth by the
documentation. And third, the documented quality system must be constantly monitored
through internal and external audits, and changed or updated when necessary.

A three-step process to ISO 9000 registration includes:


Management involvement and organizational commitment, along with team spirit.
The preparation process, which entails understanding the requirements, developing a good
assessment of current compliance (gap analysis), establishing an internal audit system and
documenting the processes.
Audit preparation, which includes undergoing a simulation, everyone understanding the
quality policy and showing a professional attitude, and fostering a good working
relationship with external auditors.
The ISO 9000 audit system includes a first-party audit and a third-party audit. The first-
party audit is performed internally by trained persons according to the established standards
and documentation. The third-party audit involves independent reviews and registration by
an external organization. Second-party audits, which are performed by the customer at a
supplier's location, can be easily eliminated if the supplier is ISO 9000 registered.

ISO 9000 registration ensures that organizations take time to understand what their key
quality processes are, that the processes are implemented and followed by everyone in the
organization and that the processes are documented and maintained to a degree that they can
be demonstrated to an outside agency.

Registration road map


ISO 9000 registration steps include the following:
Know what you are doing.
Involve management and make them understand the concepts and obtain their
commitment.
Establish a quality steering committee with empowerment.
Train management and employees.
Communicate a registration plan.
Develop an implementation plan.
Create self-assessment questions.
Establish a quality manual and procedures.
Establish an internal auditing system.
Measure compliance to the procedures.
Review results and act appropriately.
Call independent assessors in to audit.

8.1.3 Describe the Quality Management Principles

Definition of Quality Management Principle:

"A quality management principle is a comprehensive and fundamental rule / belief, for
leading and operating an organisation, aimed at continually improving performance over the
long term by focusing on customers while addressing the needs of all other stake holders".

The eight principles are ...

1. Customer-Focused Organisation

2. Leadership

3. Involvement of People

4. Process Approach

5. System Approach to Management

6. Continual Improvement

7. Factual Approach to Decision Making and

8. Mutually Beneficial Supplier Relationships.

Principle 1 - Customer-Focused Organisation : "Organisations depend on their customers


and therefore should understand current and future customer needs, meet customer
requirements and strive to exceed customer expectations".
Principle 2 - Leadership : "Leaders establish unity of purpose and direction of the
organisation. They should create and maintain the internal environment in which people can
become fully involved in achieving the organisation's objectives."

Principle 3 - Involvement of People : "People at all levels are the essence of an


organisation and their full involvement enables their abilities to be used for the
organisation's benefit".

Principle 4 - Process Approach : "A desired result is achieved more efficiently when
related resources and activities are managed as a process."

Principle 5 - System Approach to Management : "Identifying, understanding and


managing a system of interrelated processes for a given objective improves the
organisation's effectiveness and efficiency."

Principle 6 - Continual Improvement : "Continual improvement should be a permanent


objective of the organisation."

Principle 7 - Factual Approach to Decision Making : "Effective decisions are based on the
analysis of data and information."

Principle 8 - Mutually Beneficial Supplier Relationships : "An organisation and its


suppliers are interdependent, and a mutually beneficial relationship enhances the ability of
both to create value." .

8.1.4 Explain the ISO 9000 series standard

What is ISO 9000?

ISO 9000 is a set of five International Standards for Quality Assurance.

· •ISO 9001- sets out the requirements of a quality management system


•ISO 9000- covers the basic concepts and language

•ISO 9004- focuses on how to make a quality management system more efficient
and effective.

8.1.5 Determine the advantages and disadvantages of practicing ISO 9000

What are the disadvantages of ISO 9000?


1. Many companies are ISO 9000, but there are some companies that choose not to be
certified. As previously stated, ISO 9000 is a stead of guidelines. These guidelines
are implemented into companies operations. However, there are reasons why
companies would not be ISO. ·
2. The actual change of operations can be very expensive. Usually designated people
have to take classes and be trained as the company’s liaison for ISO 9000. These
people, as part of their full time jobs, train fellow employees how to implement and
use ISO 9000 procedures. As is well known in business and industry, it is difficult to
change the habits of longtime employees. New procedures are rarely welcomed with
open arms. In fact, new ways are usually resisted by everyone. This resistance cuts
into profits and also decreases company morale.
3. There are times when companies feel that the existing set of operational procedures
is already working well and they do not feel a change is necessary. Frequently,
companies will have a customer who demands that they be ISO 9000 certified to
continue doing business. Now the company has the choice of losing a customer or
implementing ISO 9000. Either way money is lost in the short term.
4. Even though there may be an initial implementing cost, ISO 9000 has been proven to
reduce cost and improve the total quality in the long run. The implementation of ISO
9000 benefits far out weight any disadvantages.
What are the advantages to having a quality system?
Companies strive for a total quality systems because quality is what the customer demands.
There are other reasons why a company may seek a quality system.
 Ensure that products and services provided meet customer requirements.
 Ensure consistency in the day to day operations.
 Ensure that processes are repeatable and predictable.
 Allow the company to create and retain satisfied customers
 Improve the efficiency, reduce operating cost and minimize unproductive time.
.