UNIT – 5

QUALITY MANAGEMENT SYSTEM

Introduction - Benefits of ISO Registration - ISO 9000
Series of Standards - Sector-Specific Standards - AS
9100, TS16949 and TL 9000 - ISO 9001 Requirements –
Implementation – Documentation - Internal Audits –
Registration - ENVIRONMENTAL MANAGEMENT
SYSTEM: Introduction - ISO 14000 Series Standards -
Concepts of ISO 14001- Requirements of ISO 14001-
Benefits of EMS.
COURSE OBJECTIVES:
Illustrate and apply QMS and EMS in any organization.
COURSE OUTCOMES:
CO5: Ability to apply QMS and EMS in any organization.
 Introduction
• The International Organization for Standardization (ISO)
was founded in 1946 in Geneva, Switzerland, where it is
still based.
• Its mandate is to promote the development of
international standards to facilitate the exchange of goods
and services worldwide.
• ISO is composed of more than 90 member countries. The
United States representative is the American National
Standards Institute (ANSI).
 Introduction
• The ISO Technical Committee (TC) 176 developed a series of
international standards for quality systems, which were first
published in 1987.
• The standards (ISO 9000, 9001, and 9004) were intended to be
advisory and were developed for use in two-party contractual
situations and internal auditing.
• However, with their adoption by the European Community
(EC) and a worldwide emphasis on quality and economic
competitiveness, the standards have become universally
accepted.
• The fourth edition of ISO 9001 was released in the year 2008
and it replaces the third edition (IS 9001:2000), which had
been amended to clarify the points in the text and also to
enhance the compatibility with ISO 14001:2004.
 Introduction
• Most countries have adopted the ISO 9000 series as their
national standards. Likewise, thousands of organizations
throughout the world have quality systems registered to
the standard.
• In the United States, the national standards are published
by the American National Institute/American Society for
Quality (ANSI/ASQ) as the ANSI/ASQ Q9000 series.
Government bodies throughout the world, including the
United States, are also using the standards. U.S.
government agencies using the series are the Department
of Defense (DOD) and the Food and Drug Administration
(FDA).
 Introduction
• In India, Bureau of Indian Standards (BIS) adopts ISO
certification standards under the dual numbering scheme.
• In a two-party system, the supplier of a product or
service would develop a quality system that conformed to
the standards. The customers would then audit the system
for acceptability. This two-party system results in both the
supplier and customer having to participate in multiple
audits, which can be extremely costly. This practice is
replaced by a third-party registration system.
 Introduction
• A quality system registration involves the assessment and
periodic surveillance audit of the adequacy of a supplier’s
quality system by a third party, who is a registrar.
• When a system conforms to the registrar’s interpretation
of the standard, the registrar issues a certificate of
registration to the supplier.
• This registration ensures customers or potential customers
that a supplier has a quality system in place and it is being
monitored.
 Benefits of ISO Registration
There are various reasons for implementing a quality system that
conforms to an ISO standard.
• The primary reason is that customers or marketing are
suggesting or demanding compliance to a quality system.
• Other reasons are needed improvement in processes or
systems and a desire for global deployment of products and
services.
• As more and more organizations become registered, they are
requiring their subcontractors or suppliers to be registered,
creating a snowball effect.
• Consequently, in order to maintain or increase market share,
many organizations are finding they must be in conformance
with an ISO standard.
• Internal benefits that can be received from developing and
implementing a well-documented quality system can far
 Benefits of ISO Registration
A study of 100 Italian manufacturing firms was undertaken to
determine if there was any improvement in performance after
registration. Significant improvement was noted in:
The primary reason is that customers or marketing are suggesting
or demanding compliance to a quality system.
• Internal quality as measured by the percent of scrap, rework,
and nonconformities at final inspection.
• Production reliability as measured by the number of
breakdowns per month, percent of time dedicated to
emergencies, and percent of downtime per shift.
• External quality as measured by product accepted by
customers without inspection, claims of nonconforming
product, and returned product.
 Benefits of ISO Registration
• Time performance as measured by time to market, on-time
delivery, and throughput time.
• Cost of poor quality as measured by external nonconformities,
scrap, and rework.

On the negative side, prevention and appraisal costs

increased

The American Institute of Certified Public Accountants (AICPA)

now has a quality system that works, and there was a 4%
improvement in gross margins, which was the largest
improvement in their history.
 Benefits of ISO Registration
A study of 100 Italian manufacturing firms was undertaken to
determine if there was any improvement in performance after
registration. Significant improvement was noted in:
The primary reason is that customers or marketing are suggesting
or demanding compliance to a quality system.
• Internal quality as measured by the percent of scrap, rework,
and nonconformities at final inspection.
• Production reliability as measured by the number of
breakdowns per month, percent of time dedicated to
emergencies, and percent of downtime per shift.
• External quality as measured by product accepted by
customers without inspection, claims of nonconforming
product, and returned product.
 ISO 9000 Series of Standards
The ISO 9000 Series of Standards is generic in scope. By design,
the series can be tailored to fit any organization’s needs, whether
it is large or small, a manufacturer or a service organization.
It can be applied to construction, engineering, health care, legal,
and other professional services as well as the manufacturing of
anything from nuts and bolts to spacecraft.
Its purpose is to unify quality terms and definitions used by
industrialized nations and use those terms to demonstrate a
supplier’s capability of controlling its processes.
In very simplified terms, the standards require an organization to
say what it is doing to ensure quality, then do what it says, and,
finally, document or prove that it has done what it said.
 ISO 9000 Series of Standards
• ISO 9000:2005 Quality Management Systems (QMS) -
fundamentals and vocabulary discusses the fundamental
concepts related to the QMS and provides the terminology
used in the other two standards.
• ISO 9001:2008 Quality Management Systems (QMS) -
requirements is the standard used for registration by
demonstrating conformity of the QMS to customers,
regulatory, and the organization’s own requirements.
• ISO 9004:2000 Quality Management Systems (QMS)
guidelines for performance improvement provides guidelines
that an organization can use to establish a QMS focused on
improving performance.
 Sector Specific Standards
• The ISO 9000 system is designed as a simple system
that could be used by any industry.
• Other systems have been developed that are specific to a
particular industry such as automotive or aerospace.
• These systems use the ISO 9001 as the basic framework
and modify it to their needs. There are currently three
other quality systems:
1. AS9100,
2. ISO/TS 16949
3. TL 9000.
 Sector Specific Standards
One of the problems with sector-specific standards is the
need for suppliers with customers in different industries to
set up quality systems to meet each sector’s requirements.
Example:
A packaging supplier that services the aerospace,
automobile, and telecommunications industries would need
to set up its system to accommodate not only ISO 9001 but
three other standards.
In addition, the Registration Accreditation Board (RAB)
points out that sector-specific standards have created a need
for specialized auditors and training courses.
On the positive side, the standardization of requirements
beyond ISO 9001 makes compliance by key suppliers
and implementation by major customers much easier.
 AS9100
• This aerospace industry quality system was officially
released by the Society of Automotive Engineers in May
1997.
• Its development and release represents the first attempt to
unify the requirements of NASA, DOD, and FAA, while
satisfying the aerospace industry’s business needs.
• In March 2001, the International Aerospace Quality
Group (IAQG) aligned AS9100 with ISO 9001:2000.
• Industry-specific interpretations and methodologies are
identified in italics and bold type.
• These additions are accepted aerospace approaches to
quality practices and general requirements. Aerospace
organizations in Europe, Japan, and the U.S. will certify
registrars and auditors. AS 9100 Revision C is released in
January 2009.
ISO/TS 16949
• This standard is entitled Quality Systems Automotive
Suppliers—Particular Requirements for the Application
of ISO 9001.
• It harmonizes the supplier quality requirements of the
U.S. big three as provided in QS 9000 Third Edition with
the French, German and Italian automakers.
• The standard has been approved by Asian automakers.
• The goal of this technical specification is the
development of fundamental quality systems that provide
for continuous improvement, emphasizing defect
prevention, and the reduction of variation and waste
in the supply chain.
ISO/TS 16949
• There are three basic levels:
1. ISO 9001,
2. sector-specific requirements, and
3. company-specific requirements, and if appropriate levels
for division-specific, commodity-specific, and part
specific requirements.
• Registrars will need to be certified to the standard and
their number will be limited.
• It is assumed that this standard will show the same rate of
improvement as QS 9000.
• GM reported that supplier parts-per-million defect rate
improved about 85% for the first five years of the use
of QS 9000.
TL 9000
• The Quality Excellence for Suppliers of
Telecommunications Forum (QuEST) wrote TL 9000 to
consolidate the various quality system requirements
within the telecommunications industry.
• This forum was created to develop the standard wherein
suppliers such as Motorola and Lucent, and telecom
service providers such as Verizon, Southwestern Bell, and
AT&T would have an equal vote in developing the new
strategy.
TL 9000
• It is a specific set of requirements based on ISO 9001 that
defines the design, development, production, delivery,
installation, and maintenance of telecommunications
products and services.
• Customers and suppliers receive a number of benefits
including continuous improvement, enhanced
customer/supplier relationships, efficient management
of external audits, worldwide standards, increased
competitiveness which results in overall cost reduction,
industry benchmarks for performance metrics, and a
platform for improvement initiatives.
Structure of the TL 9000 standard
 ISO 9001 Requirements
The standard has eight clauses:
1. Scope
2. Normative References
3. Definitions
4. Quality Management Systems
5. Management Responsibility
6. Resource Management
7. Product and/or Service Realization and
8. Measurement, Analysis, and Improvement.
The first three clauses are for information while the last
five are requirements that an organization must meet.
 ISO 9001 Requirements
The application of a system of processes within an
organization, together with their identification and
interactions and the managing of these processes, is referred
to as the process approach.
This approach emphasizes the importance of:
• Understanding and fulfilling the requirements.
• The need to consider processes in terms of value added.
• Obtaining results of process performance and
effectiveness.
• Continual improvement of processes based on objective
measure.
Model of a Process-Based Quality Management System
 1. Scope
• The purpose of the standard is for the organization to
demonstrate its ability to provide a product that meets
customer and regulatory requirements and to enhance
customer satisfaction.
• This purpose is accomplished by evaluating and
continually improving the system, rather than the
product.
• The requirements of the standard are intended to be
applicable to all types and sizes of organizations.
• Requirements in Clause 7, Product Realization, that are
not appropriate to the organization, can be excluded.
2. Normative Reference
ISO 9000:2005 Quality Management Systems -
Fundamentals and vocabulary are a normative reference that
provides applicable concepts and definitions.
3. Terms and Definitions
For the purposes of this standard, the terms and definitions
given in ISO 9000:2000 apply.
Throughout the text of this standard, the term “Product” also
means “Service.”
 4. Quality Management System (QMS)
4.1 GENERAL REQUIREMENTS
• The organization shall establish, document, implement, and
maintain a QMS and continually improve its effectiveness.
• The organization shall
(a) determine the processes needed for QMS and their applications
throughout the organization
(b) determine their sequence and interaction,
(c) determine criteria and methods for effective operation and
control of these processes,
(d) ensure the availability of resources and information necessary
to support and monitor these processes,
(e) monitor, measure wherever applicable, and analyze these
processes, and
 4. Quality Management System (QMS)
4.1 GENERAL REQUIREMENTS
(f ) implement actions to achieve planned results and continual
improvement of these processes.
Outsourced processes that affect the quality of the product shall
be identified and included in the system.
4.2 DOCUMENTATION
4.2.1 General Documentation shall include
(a) statements of a quality policy and quality objectives,
(b) a quality manual,
(c) required documented procedures and records,
(d) needed documents to ensure effective planning,
operation, and control of processes, and records.
(e) A procedure or work instruction is needed if its
 4. Quality Management System (QMS)
4.2 DOCUMENTATION
A procedure or work instruction is needed if its absence could
adversely affect the product quality.
The extent of the documentation will depend on the
organization’s size and type of activities; the complexity of the
processes and their interactions; and the competency of the
employees.
• For example: a small organization may verbally notify a
manager of an upcoming meeting, whereas a large organization
would need written notification.
• The standard should satisfy the contractual, statutory, and
regulatory requirements and the needs and expectations of
customers and other interested parties. Documentation may be
in any form or type of medium.
 4. Quality Management System (QMS)
4.2 DOCUMENTATION
4.2.2 Quality Manual
A quality manual shall be established and maintained that
includes
(a) the scope of the QMS with details and justification for any
exclusions,
(b) (b) the documented procedures or reference to them, and
(c) a description of the interaction among the QMS processes.
 4. Quality Management System (QMS)
4.2 DOCUMENTATION
4.2.3 Control of Documents
Documents required by the QMS shall be controlled. Records are
special type of documents.
A documented procedure shall be in place to define the controls
needed to
(a) approve documents prior to use,
(b) review, update, and re-approve as necessary,
(c) identify the current revision status,
(d) ensure that current versions are available at the point of use,
(e) ensure that documents are legible and readily identified,
(f ) identify and distribute documents of external origin, and
(g) provide for the prompt removal of obsolete documents and
suitably identify any that may be retained.
 4. Quality Management System (QMS)
4.2 DOCUMENTATION
4.2.3 Control of Documents
Documented procedure means that the procedure is established,
documented, implemented, and maintained.
4.2.4 Control of Records
• Records which are established to provide evidence of
conformity to requirements and the effective operation of QMS
shall be controlled.
• A documented procedure shall be established to define the
controls needed for the identification, storage, protection,
retrieval, retention and disposition of records.
• Records shall remain legible, readily identifiable and
retrievable. Records can be used to document traceability and
to provide evidence of verification, preventive action, and
corrective action.
 5. Management Responsibility
5.1 MANAGEMENT COMMITMENT
Top management shall provide evidence of its commitment to the
development, implementation, and continual improvement of the
QMS by
(a) communicating the need to meet customer, legal, and
regulatory requirements,
(b) establishing a quality policy,
(c) ensuring that quality objectives are established,
(d) Conducting management reviews, and
(e) ensuring the availability of resources.
Top management is defined as the person or group of people who
directs and controls an organization.
 5. Management Responsibility
5.2 CUSTOMER FOCUS
• Top management shall ensure that customer requirements are
determined and met with the aim of enhancing customer
satisfaction.
5.3 QUALITY POLICY
• Top management shall insure that the quality policy
• (a) is appropriate to the organization’s purpose or mission,
• (b) includes a commitment to comply with requirements and
continually improve the effectiveness of the QMS,
• (c) provides a framework for establishing and reviewing the
quality objectives,
• (d) is communicated and understood within the organization,
and
• (e) is reviewed for continuing stability.
 5. Management Responsibility
5.3 QUALITY POLICY
• The quality policy gives the overall intention and direction of
the organization related to quality.
5.4 PLANNING
5.4.1 Quality Objectives
Top management shall ensure that quality objectives are
established at relevant functions and levels within th organization
and include product requirements.
They shall be measurable and consistent with the quality policy.
In addition, they should ensure that customer expectations are
met.
Quality objectives are something sought or aimed for related to
quality. For example, finishing department scrap will be reduced
from 5.0% to 4.3% and the first line supervisor is the person
responsible.
 5. Management Responsibility
5.4.2 Quality Management System Planning
• Top management shall ensure that the planning of the QMS is
• accomplished in order to meet the requirements of the QMS as
stated in the General Requirements and Quality objectives.
• In addition, the integrity of the QMS is maintained when
changes are planned and implemented.
 5. Management Responsibility
5.5 RESPONSIBILITY, AUTHORITY, AND
COMMUNICATION
5.5.1 Responsibility and Authority
• Top management shall ensure that responsibilities and
authorities aredefined and communicated within the
organization.
• Responsibilities can be defined in job descriptions, procedures,
and work instructions.
• Authorities and interrelationships can be defined in an
organization chart.
 5. Management Responsibility
5.5 RESPONSIBILITY, AUTHORITY, AND
COMMUNICATION
5.5.2 Management Representative
Top management shall appoint a member of organization’s
management, regardless of his/her other duties, that shall have the
responsibility and authority that includes
(a) ensuring that processes needed for the QMS system are
established, implemented, and maintained,
(b) reporting to top management on the performance of the QMS
and any need for improvement, and
(c) ensuring the promotion of awareness of customer
requirements throughout the organization.
Appointment of a member of top management as the
representative can contribute to the effectiveness of the QMS.
 5. Management Responsibility
5.5 RESPONSIBILITY, AUTHORITY, AND
COMMUNICATION
5.5.3 Internal Communication
• Top management shall ensure that appropriate communication
channels are established within the organization and that
communication takes place regarding the QMS.
• Typical communication techniques are management workplace
briefing, recognition of achievement, bulletin boards, e-mail,
and in-house news brochures.
 5. Management Responsibility
• 5.6 MANAGEMENT REVIEW
5.6.1 General
• Top management shall review the QMS at planned intervals to
ensure its continuing suitability, adequacy, and effectiveness.
• This review shall include assessing opportunities for
improvement and the need for changes to the QMS including
the quality policy and quality objectives. Records from the
reviews shall be maintained.
• 5.6.2 Review Input The input to the review shall include
information on (a) results of audits,
• (b) customer feedback,
• (c) process performance and product conformity,
• (d) status of corrective and preventative performance,
• (e) follow-up actions from previous management reviews,
 5. Management Responsibility
• 5.6 MANAGEMENT REVIEW
5.6.2 Review Input The input to the review shall include
information on
(a) results of audits,
(b) customer feedback,
(c) process performance and product conformity,
(d) status of corrective and preventative performance,
(e) follow-up actions from previous management reviews,
(f ) changes that could affect the QMS,
(g) recommendations for improvement.
 5. Management Responsibility
5.6 MANAGEMENT REVIEW
5.6.3 Review Output
The output from the review shall include any decisions and
actions related to
(a) improvement of the effectiveness of the QMS and its
processes,
(b) improvement of the product related to customer requirements,
and
(c) resource needs. Top management can use the outputs as
inputs to improvement opportunities.
 6. Resource Management
• 6.1 PROVISION OF RESOURCES
• The organization shall determine and provide the resources
needed
(a) to implement and maintain the QMS and continually improve
its effectiveness, and
(b) to enhance customer satisfaction by meeting customer
requirements.
• Resources may be people, infrastructure, work environment,
information, suppliers, natural resources, and financial
resources. Resources can be aligned with quality objectives.
 6. Resource Management
6.2 HUMAN RESOURCES
6.2.1 General
• Personnel performing work that affects conformity to
product requirements shall be competent on the basis of
appropriate education, training, skills, and experience.
• Conformity to product requirements can be affected
directly or indirectly by personnel performing any task
within the QMS.
 6. Resource Management
6.2 HUMAN RESOURCES
• 6.2.2 Competence, Training, and Awareness
The organization shall
• (a) determine the necessary competence for personnel
performing work affecting conformity to product requirements,
• (b) where applicable, provide training or take other actions to
achieve the necessary competence,
• (c) evaluate the effectiveness of the actions taken,
• (d) ensure that its personnel are aware of the relevance and
importance of their activities and how they contribute to the
achievement of the quality objectives, and
• (e) maintain appropriate records of education, training, skills,
and experience. Competency is defined as the demonstrated
ability to apply knowledge and skills.
 6. Resource Management
6.2 HUMAN RESOURCES
• 6.2.2 Competence, Training, and Awareness
• It can be contained in the job description by function, group, or
specific position.
• Training effectiveness can be determined by before and after
tests, performance, or turnover. ISO 10015 Guidelines for
Training will help organizations comply with this standard
 6. Resource Management
6.3 INFRASTRUCTURE
• The organization shall determine, provide, and maintain the
infrastructure needed to achieve conformity to product
requirements.
• Infrastructure includes, as applicable
(a) buildings, workspace, and associated utilities,
(b) process equipment (both hardware and software), and
(c) supporting services (such as transport, communication or
information systems).
 6. Resource Management
6.4 WORK ENVIRONMENT
• The organization shall determine and manage the work
environment needed to achieve conformity to product
requirements.
• Creation of a suitable work environment can have a positive
influence on employee motivation, satisfaction, and
performance.
• The term “work environment” relates to those conditions under
which work is performed including physical, environmental
and other factors (such as noise, temperature, humidity,
lighting and weather).
 7. Product Realization
7.1 PLANNING OF PRODUCT REALIZATION
• The organization shall plan and develop the processes needed
for product realization.
• Planning of product realization shall be consistent with the
requirements of the other processes of QMS.
• In planning product realization, the organization shall
determine the following, as appropriate:
• (a) quality objectives and requirements for the product;
• (b) the need to establish processes and documents, and to
provide resources specific to the product;
(c) required verification, validation, monitoring, measurement
inspection, and tes activities specific to the product and the
criteria for product acceptance; and
• (d) records needed to provide evidence that the realization
processes and resulting product or service meet requirements.
 7. Product Realization
7.1 PLANNING OF PRODUCT REALIZATION
• The output of this planning shall be in a form suitable for the
organization’s method of operations.
• A document specifying the processes of the QMS (including
the product realization processes) and the resources to be
applied to a specific product, project or contract, can be
referred to as a quality plan..
 7. Product Realization
• 7.2 CUSTOMER-RELATED PROCESSES
7.2.1 Determination of Requirements Related to the Product The
organization shall determine
(a) Requirements specified by the customer, including the
requirements for delivery and post-delivery activities,
(b) Requirements not stated by the customer but necessary for
specified or intended use, where known, (c) statutory and
(c) regulatory requirements applicable to the product, and
(d) any additional requirements considered necessary by the
organization.
 7. Product Realization
• 7.2 CUSTOMER-RELATED PROCESSES
• 7.2.2 Review of Requirements Related to the Product
• The organization shall review the requirements related to the
product.
• This review shall be conducted prior to the organization’s
commitment to supply a product to the customer (for example,
submission of tenders, acceptance of contracts or orders,
acceptance of changes to contracts or orders) and shall ensure
that
(a) product requirements are defined,
(b) contract or order requirements differing from those previously
expressed are resolved, and
(c) the organization has the ability to meet the defined
requirements. Records of the results of the review and actions
arising from the review
 7. Product Realization
• 7.2 CUSTOMER-RELATED PROCESSES
• 7.2.2 Review of Requirements Related to the Product
• Records of the results of the review and actions arising from
the review shall be maintained.
• Where the customer provides no documented statement of
requirement, the customer requirements shall be confirmed by
the organization before acceptance.
• Where product requirements are changed, the organization
shall ensure that relevant documents are amended and that
relevant personnel are made aware of the changed
requirements.
• In some situations, such as Internet sales, a formal review is
impractical for each order. Instead, the review can cover
relevant product information such as catalogs or advertising
material.
 7. Product Realization
• 7.2 CUSTOMER-RELATED PROCESSES
7.2.3 Customer Communication
The organization shall determine and implement effective
arrangements for communicating with customers in relation
to
(a) product information,
(b) inquiries, contracts, or order handling, including
amendments, and
(c) customer feedback, including customer complaints.