Introduction
Organizations - industrial, commercial, or governmental
- supply products intended to satisfy customers' needs
and/or requirements. Increased global competition has
led to increasingly more stringent customer expectations
with regard to quality. To be competitive and to maintain
good economic performance, organizations/suppliers need
to employ increasingly effective and efficient systems.
Such systems should result in continual improvements
in quality and increased satisfaction of the organization's
customers and other stakeholders (employees, owners,
subsuppliers, society).
Customer requirements often are incorporated in "specifications".
However, specifications may not in themselves guarantee
that a customer's requirements will be met consistently,
if there are any deficiencies in the organizational system
to supply and support the product. Consequently, these
concerns have led to the development of quality-system
standards and guidelines that complement relevant product
requirements given in the technical specifications. The
International Standards in the ISO 9000 family are intended
to provide a generic core of quality -system standards
applicable to a broad range of industry and economic
sectors.
The management system of the organization is influenced
by the objectives of the organization, by it's products,
and by the practices specific to the organization and,
therefore, quality systems also vary from one organization
to another. A major purpose of quality management is
to improve the systems and processes so that continual
improvement of quality can be achieved.
The ISO 9000 Family of Quality System Standards
The ISO 9000 family of quality system standards specify
quality system requirements. for use where a supplier's
capability to design and supply conforming product needs
to be demonstrated.
The requirements specified are aimed primarily at achieving
customer satisfaction by preventing nonconformity at
all stages from design through to servicing.
The family of ISO 9000 standards includes:
- ISO 9000 - Quality Management and Quality Assurance
Standards - Guidelines for Selection and Use
- ISO 9001 - Quality Systems - Model for Quality Assurance
in Design, Development, Production, Installation and
Servicing
- ISO 9002 - Quality Systems - Model for Quality Assurance
in Production, Installation and Servicing
- ISO 9003 - Quality Systems - Model for Quality Assurance
in Final Inspection and Test
- ISO 9004 - Quality Management and Quality System
Elements - Guidelines
ISO 9001, 9002 and 9003 are the standards which specify
the requirements. ISO 9000 provides the organization
with guidance to selecting the appropriate standard (9001,
9002 or 9003) and ISO 9004 is a guideline to the implementation
of a quality system.
The Quality System
A primary concern of any organization should be the
quality of it's products. However, quality also encompasses
the ability of an organization to provide support and
maintenance of the product and the quality system in
a consistent manner.
In order to be successful, an organization should offer
products that:
a) meet a well defined need, use, or purpose;
b) satisfy customers' expectations;
c) comply with applicable standards and specifications
d) comply with the requirements of society;
e) reflect environmental needs;
f) are made available at competitive prices;
g) are provided economically.
In order to meet its objectives, the organization should
ensure that the technical, administrative, and human
factors affecting the quality of its products will be
under control, whether hardware, software, processed
materials, or services. All such control should be oriented
towards the reduction, elimination, and, most importantly,
prevention of quality nonconformities.
A quality system should be developed and implemented
for the purpose of accomplishing the objectives set out
in the organization's quality policy.
In order to achieve maximum effectiveness and to satisfy
customer expectations, it is essential that the quality
system be appropriate to the type of activity and to
the product being offered.
A quality system has two interrelated aspects, as follows.
a) For the customer, there is a need for confidence
in the ability of the organization to deliver the desired
quality as well as the consistent maintenance of that
quality.
b) For the organization, there is a business need to
attain and to maintain the desired quality at an optimum
cost; the fulfillment of this aspect is related to the
planned and efficient utilization of the technological,
human, and material resources available to the organization.
Elements of a Quality System
The ISO 9000 standards describe the elements that a
quality system should encompass, but not how a specific
organization should implement these elements. Because
the needs of organizations vary, it is not the purpose
of the standards to enforce uniformity of quality systems.
The design and implementation of a quality system will
be influenced by the particular objectives, products,
processes, and individual practices of the organization.
A quality system as specified by a standard such as
ISO 9001 covers the following elements:
- Quality System - Documented Policies and Procedures
- Management Responsibilities
- Contract Review
- Design Control
- Document Control
- Procurement Control (includes Supplier Control)
- Purchaser Supplied Product
- Identification and Control of Items
- Control of Processes
- Inspection
- Control of Measuring and Test Equipment
- Inspection, Test and Operating Status
- Control of Nonconforming Items
- Corrective Action
- Preventive Action
- Handling, Storage and Shipping
- Quality Assurance Records
- Internal Audits
- Training and Personnel Qualifications
- Statistical Techniques
All elements must be adequately documented and controlled.
Documentation includes a written quality policy, a quality
policy manual, which specifies the basic methods as to
how the company will meet the requiremnts, and supplemental
documents such as written procedures, guidelines and
work instructions which document exactly how the policies
are implemented and controlled.
The standards do not specify any product requirements,
but they are designed to cover a four generic product
categories that fit nearly any organization:
- Hardware
- Software
- Processed Materials
- Services
These product categories encompass all the kinds of
product supplied by organizations, and the ISO 9000 family
are applicable to organizations supplying one or more
of the generic categories.
Application of ISO 9001
ISO 9001 is applicable when:
a) design is required and the product requirements are
stated principally in performance terms, or they need
to be established, and
b) confidence in product conformance can be attained
by adequate demonstration of a supplier's capabilities
in design, development, production, installation, and
servicing.
Once an organization decides to implement a quality
standard such as ISO 9001, its must also choose whether
or not to have the quality system "certified" (the
terms "registered" and "accredited" are
also used). This choice is largely market driven. The
adoption of such a standard to build a quality system
has many internal benefits. External benefits are largely
a customer requirements.
An independent (third party) evaluation of the quality
system provides the most benefit to both the customer
and the organization. An independent third party auditor
provides an evaluation of the quality system, which provides
customers and the organization with confidence that product
conformance can be attained because the supplier's capabilities
in design, development, production, installation, and
servicing have been adequately demonstrated to the third
party auditor. Once such adequate demonstration has been
provided, the third party auditor "certifies" that
the organizations quality system is effective and meets
all of the requirements of the specified quality system
standard.
Quality system certification is not to be confused with
product certifications. Product certifications work with
the resultant product directly and provide confidence
that the product meets all of its published specifications,
and most likely, other industry standard and accepted
safety standards. In the US., such certifications can
be obtained from such testing laboratories as UL, CSA,
MET Labs and ETL. Such labs are known as "nationally
recognized testing labs", and are specifically in
the business of providing product certifications.
Once quality system certification is obtained, the organization
must undergo surveillance audits every six months to
provide evidence that the system continues to be effective
and remain in compliance with the selected quality system
standard. If the organization does not maintain the system
adequately, it could be in jeopardy of loosing its certification.
CANBERRA's Implementation of ISO 9001
The process of implementing and certifying the quality
system varies by the organization, but all organizations
will follow the same general preparation:
- Select the Standard which best fits the organizations
activities
- Review the requirements
- Plan the implementation
- Assign responsibilities
- Document the system
- Train employees
- Select a registrar
- Undergo the audit
- Maintain the system
For many years, CANBERRA had complied with basic inspection
and quality control requirements. In the early 1980's,
CANBERRA adopted ASME NQA-1, Quality Assurance Standard
for Nuclear Facilities, due to domestic (US) customer
demands. NQA-1 requires documented procedures in certain
system elements, but is not as rigorous as the ISO 9000
family of standards. In addition, compliance to NQA -1
is measured by performance (the output of activities
meet the requirements), whereas ISO 9001 compliance is
measured by the process (if the process is controlled,
the output will be consistent).
When CANBERRA decided to implement an ISO 9001 program,
the majority of work was in the documentation arena.
Policies needed to updated to reflect ISO requirements,
and procedures, guidelines and work instructions needed
to be developed in those areas not previously developed
for NQA-1. Because CANBERRA had a well defined and well
documented quality system before adopting ISO 9001, the
implementation effort was much less than an organization
who was implementing a formal quality system for the
first time.
The Results
The result of the ISO 9001 compliance is a quality system
which fosters an environment of teamwork, trust and respect.
The organization is committed to quality, and bases the
system on it's people - the best and the brightest, working
within a framework of communication, cooperation, commitment
and leadership.
Team-based activities are encouraged at each level and
department of the organization. The quality system places
the responsibility for quality of work on each employee,
and does not rely on a traditional system of quality
control. An objective of the quality system is to minimize
all non-value added operations, such as inspection, repair,
and rework. All employees are empowered to stop work
or processes when, in their belief, quality is affected.
Each employee has the right (and are encouraged) to report
quality problems to the president, should they feel it
necessary.
The quality system elicits the involvement of every
employee at every level in an effective Corrective Action
Program. A corrective action system is in place for customer
complaints and process related problems requiring the
involvement of the Quality Assurance organization. Other
systems exist to handle product design discrepancies.
Each system is available for use by any employee of the
company.
The goal of this approach is 100% Customer Satisfaction.
By focusing on our quality system, continuously improving
our products and processes, and constantly innovating,
we believe we create the most value for our customers.
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