Professional Documents
Culture Documents
Quality Standards
3.1Quality System Standards
3.2 International Organization for Standardization
3.3 Conformance to Specification
3.4 Types of Quality Audits
3.5 Quality assurance
3.6 ISO standards (ISO 9000, 14000 …)
3..7 Nepal Standard (NS)
What is a standard?
• A standard is a document that provides
requirements, specifications, guidelines or
characteristics that can be used consistently to
ensure that materials, products, processes and
services are fit for their purpose.
3.1 Quality System Standards
• 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.
• Standards provide organizations with the shared vision,
understanding, procedures, and vocabulary needed to
meet the expectations of their stakeholders. Because
standards present precise descriptions and
terminology, they offer an objective and authoritative
basis for organizations and consumers around the
world to communicate and conduct business.
WHO USES QUALITY STANDARDS?
2 Compliance Undetermined
The measurement result is within limits by a margin less than required to
state compliance by a 95% level of confidence. However the result
indicates that compliance is more probable than non-compliance.
3 Non-Compliance Undetermined
The measurement result is not within limits by a margin less than required to
state non-compliance by a 95% level of confidence. However the result
indicates that non-compliance is more probable than compliance.
4. Non-Compliance (Out-of-Tolerance)
The measurement result is not within limits,
even when the uncertainty in measurement is
taken into consideration. The result does not
comply with the specification.
3.4 Types of Quality Audits
Quality Audits
• Quality audits are reviews to ensure that a company or
product meets quality standards. Quality standards
used for audit purposes include those set by a
company or by the American Society for Quality or
ASQ, International Standards Organization or ISO,
American National Standards Institute or ANSI, six
sigma quality standards and military specifications or
milspec. Audits can also be divided by the type of
auditor. Audits can also be classified based on what is
being audited: the product, the process, the system.
Quality Audits
10. Inspection and test planning: Do inspection and test plans exist for all products and records
maintained on the results? Is all test equipments calibrated regularly?
11. Quality performance indicators: Are quality performance indicators regularly published throughout
the organization and made available to employees?
12. Employee involvement program: Are employees involved in quality improvement through some
process such as quality circle?
13. Multifunctional quality improvement team: Has a quality improvement team covering all functional
areas been established to monitor quality and to work to improve it?
14. Quality business plan: Has quality been inetegrated into the organization’s business plan and from
there into the overall
3.4 Types of Quality Audits
Internal Audits
Two types of auditing are required to become
registered to the standard:
o Auditing by an external certification body
(external audit)
o Audits by internal staff trained for this process
(internal audits).
The aim is a continual process of review and
assessment, to verify that the system is working as
it's supposed to, find out where it can improve and
to correct or prevent problems identified.
• Also called first party audits
• A first party audit is usually performed by the company
(or a department within the company) upon itself.
• It is an audit of those portions of (the) quality
assurance program that are "retained under its direct
control and within its organizational structure
• A first party audit is usually conducted by an internal
audit group. However, employees within the
department itself may also conduct an assessment
similar to a first party audit.."
Purpose of Internal Audit
• The purpose of a self assessment is to monitor and
analyze key intradepartmental processes which, if
left unattended, have the potential to degenerate
and negatively affect product quality, safety and
overall system integrity.
• Provide feedback to management that the quality
system is both implemented and effective
• Are excellent tools for gauging the continuous
improvement effort as well as measuring the
return on investment for sustaining that effort
Types of Quality Audits
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. External audits can be done by
quality consultants specializing in the quality
standards for those organizations. In all of these
cases, the audit is called an external audit
Types of Quality Audits
• Second Party Audits
External audits done by a company that has a contract with the
audited firm is called a second party audit. The second party quality
audit is done by the company holding the audit.
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
Types of Quality Audits
Process Audits
A process audit verifies that a documented process meets
quality standards. This process could be a
manufacturing process or service process.
Product Audits
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.
3.5 Quality assurance
ISO 9000
ISO 9003
ISO 9002
ISO 9001