Quality audit is the process of systematic examination of
a quality system carried out by an internal or
external quality auditor or an audit team. It
is an important part of an
organization's quality management system and is a key
element in the ISO quality system standard, ISO
TYPES OF QUALITY AUDIT
1.Internal Audits Internal audits ensure that an organization is
meeting its own quality standards or contractually required
standards. This is also called a first party audit. Internal audits
may be done by auditors who work for the company being reviewed.
They may also be hired by the company to audit its own functions.
However, auditors must be independent of the function they are
2.External Audits External auditors are separate from the company
they are auditing because they are independent. They may be hired
by a supplier or customer to ensure that the audited company meets
their quality standards. They may be audited by the government to
verify that they meet military specifications.
3.Third Party Audits External quality audits done by an
organization that has no contract with the company it is auditing
is called a third party audit. A third party external audit can be
done to attain or maintain certification in a quality standard. A
third party audit by an independent auditor can also be mandated by
law to qualify for government contracts. A third party audit of a
company can also be done at the request of a supplier or customer
who would be considered a second party audit if they performed the
quality audit themselves.
4.Process Audits A process audit verifies that a documented process
meets quality standards. This process could be a manufacturing
process or service process.
A product quality audit verifies that a physical product meets
design specifications and other quality measurements. Product
audits may require measuring physical dimensions, product testing,
or destructive testing. A product audit can involve checking the
calibration and test equipment used to verify that the product
meets quality standards.
6.System Audits A system audit is a review of the quality system
used by a company. It is a review of how quality standards are
measured and met by the company. It verifies the procedures used to
measure the quality of the product, how defects are recorded, and
how the company ensures that failed product is not passed.
Quality standards are defined as documents that provide
requirements, specifications, guidelines, or characteristics that
can be used consistently to ensure that materials, products,
processes, and services are fit for their purpose.
Procedures of Quality Standards
Ensuring their products and services are safe
Complying with regulations
Meeting environmental objectives
Importance of Quality Standards
Standards are important to the bottom line of every
organization. Successful companies recognize standards as business
tools that should be managed alongside quality, safety,
intellectual property, and environmental policies. Standardization
leads to lower costs by reducing redundancy, minimizing errors
or recalls, and reducing time to market.
For the global economy:
Businesses and organizations complying to quality standards helps
products, services, and personnel cross borders and also ensures
that products manufactured in one country can be sold and used in
Many quality management standards provide safeguards for users of
products and services, but standardization can also make consumers’
lives simplier. A product or service based on an international
standard will be compatible with more products or services
worldwide, which increases the number of choices available across
The International Organization for Standardization is
an international standard-setting body composed of
representatives from various national standards organizations.
In contrast to many international organizations, which utilize
the British English form of spelling, the ISO uses
English with Oxford spelling as one of its official
languages along with French and Russian.
Founded on 23 February 1947, the organization promotes worldwide
proprietary, industrial, and commercial standards. It is
headquartered in Geneva, Switzerland, and works in 164
ISO 9000 is defined as a set of international standards on quality
management and quality assurance developed to help companies
effectively document the quality system elements needed to maintain
an efficient quality system. They are not specific to any one
industry and can be applied to organizations of any size.
ISO 9000 principles of Quality Management
1.Customer focus Understand the needs of existing and future
customers Align organizational objectives with customer needs and
expectations Meet customer requirements Measure customer
satisfaction Manage customer relationships Aim to exceed customer
expectations Learn more about the customer experience and
2.Leadership Establish a vision and direction for the organization
Set challenging goals Model organizational values Establish trust
Equip and empower employees Recognize employee contributions
Learn more about leadership
3.Engagement of people Ensure that people’s abilities are used and
Make people accountable
Evaluate individual performance
Enable open discussion of problems and constraints
Learn more about employee involvement
4.Process approach Manage activities as processes
Measure the capability of activities
Identify linkages between activities
Prioritize improvement opportunities
Deploy resources effectively
Learn more about a process view of work and
see process analysis tools
Align improvement activities
Measure improvement consistently
Learn more about approaches to continual improvement
6.Evidence-based decision making Ensure the accessibility of
accurate and reliable data Use appropriate methods to analyze data
Make decisions based on analysis Balance data analysis with
practical experience See tools for decision making
7.Relationship management Identify and select suppliers to manage
costs, optimize resources,
and create value Establish relationships considering both the short
and long term Share expertise, resources, information, and plans
with partners Collaborate on improvement and development activities
Recognize supplier successes
DISADVANTAGES OF ISO 9000
Owners and managers do not have an adequate understanding of the
ISO 9000 certification process or of the quality standards
Funding for establishing the quality system is inadequate.
Heavy emphasis on documentation.
Length of the process.
ISO 9000 series of quality management ISO 9000 Quality
management systems – Fundamentals and
Vocabulary, referenced in all ISO 9000 Standards.
ISO 9001 Quality management systems – Requirements, contains
the requirements an organization must comply with to
become ISO 9001 certified.
ISO 9002 – Guidelines for the application of ISO
ISO 9004 – Managing for the sustained success of an
organization, provides guidelines for sustaining QMS
success through evaluation and performance improvement.
ISO 9000 CERTIFICATION
RELIABILITY AND MAINTAINABILITY
Reliability and maintainability management is the management
of failure. Maintainability is related
to reliability because when a product or system fails,
there may be a process to restore the product or system to
The 80-20 rule maintains that 80% of outcomes (outputs) come from
20% of causes (inputs).
In the 80-20 rule, you prioritize the 20% of factors that will
produce the best results.
A principle of the 80-20 rule is to identify an entity's best
assets and use them efficiently to create maximum value.
ISO 9000 CERTIFICATION