Second Semester 2025-2026
CBMEC 1
TOTAL QUALITY
MANAGEMENT
Second Semester 2025-2026
MODULE 4
ISO 9000
▪ Total Quality Management
QUALITY STANDARDS
QUALITY SYSTEM
A framework for quality management.
Embraces the organizational structure, procedure, and processes needed to implement a quality
management system (QMS).
Quality system should address everything in the organization related to the quality of
• Product
• Services
• Processes
• Projects
• Operations
The adequacy of quality system and the quality of products, services, processes, projects, operations
and customer satisfaction are judged by their compliance to specified/relevant standards.
▪ Total Quality Management
QUALITY STANDARDS
STANDARDS
They have important economic and social repercussions.
Useful to industrial and business organizations of all types, to the
• government and other regulatory bodies,
• conformity assessment professionals
• to suppliers
• customers of products, projects, and services in both the public and private sectors
• people in general, in their role as customers and users.
Standards provide the government with a technical base for health, safety, and environmental
legislation.
▪ Total Quality Management
QUALITY STANDARDS
STANDARDS
Standards are documents used to define acceptable conditions or behaviors and to provide a
baseline for assuring that conditions or behaviors meet the acceptable criteria.
In most cases, they define the minimum criteria, which could be:
• Written or unwritten,
• Voluntary or mandatory
Unwritten quality standards are generally not acceptable.
▪ Total Quality Management
QUALITY STANDARDS
IMPORTANCE OF STANDARDS
The International Organization for Standardization has given importance to standards:
“Standards make an enormous contribution to most aspects of our lives. Standards ensure desirable
characteristics of products and services, such as quality, environmental fitness, safety, reliability,
efficiency, and interchangeability at an economical cost.”
Standard setting is one of the first issues in developing a quality assurance system, and increasingly,
organizations are relying on readily available standards rather than developing their own.
▪ Total Quality Management
QUALITY STANDARDS
IMPORTANCE OF STANDARDS
The International Organization for Standardization has given importance to standards:
“Standards make an enormous contribution to most aspects of our lives. Standards ensure desirable
characteristics of products and services, such as quality, environmental fitness, safety, reliability,
efficiency, and interchangeability at an economical cost.”
When standards are absent, we soon notice. We soon care when products turn out to be of poor
quality, do not fit, are incompatible with equipment that we already have, are unreliable, or are
dangerous. When products, systems, machinery, and devices work well and safely, it is often because
they meet standards.
▪ Total Quality Management
QUALITY STANDARDS
IMPORTANCE OF STANDARDS
Standard setting is one of the first issues in developing a quality assurance system, and increasingly,
organizations are relying on readily available standards rather than developing their own.
Each standard should be:
• Clearly written in simple, unambiguous language
• Convenient in understanding
• Specific in setting out precisely what is expected
• Measurable so that the organization can know whether the standard is being met
• Achievable, the organization must have resources available to meet the standard
• Constructible
▪ Total Quality Management
QUALITY STANDARDS
IMPORTANCE OF STANDARDS
Standards are published documents that establish
• Specifications
• Guidelines
• Procedures
Designed to ensure the reliability of materials, products, systems, processes, and services people use
every day to satisfy their requirements.
Standards are used to ensure that a product, system, or service measures up to its specifications and
is safe for use. Standards are the key to any conformity assessment activity.
▪ Total Quality Management
QUALITY STANDARDS
STANDARDS ORGANIZATIONS
• American Concrete Institute (ACI)
• American Institute of Steel Construction (AISC)
• American National Standards Institute (ANSI)
• American Petroleum Institute (API)
• American Society of Mechanical Engineers (ASME)
• American Society for Heating, Refrigerating, and Air- Conditioning Engineers
(ASHRAE)
• American Society for Quality (ASQ)
• American Society for Testing and Materials (ASTM)
• American Welding Society (AWS)
• British Standards Institution (BSI)
• European Committee for Electrotechnical Standardization (CENELEC)
• International Association of Plumbing and Mechanical Officials (IAPMO)
• International Electrotechnical Commission (IEC)
• International Organization for Standardization (ISO)
• Engineering Equipment and Material Users Association (EEMUA)
• Expansion Joint Manufacturers Association (EJMA)
▪ Total Quality Management
QUALITY STANDARDS
IMPORTANCE OF STANDARDS
Standards produced by these organizations/ institutes are recognized worldwide.
The designers refer to these standards in the contract documents to specify the products, systems,
or services to be used in a project.
Apart from these, there have been many other national and international quality system standards:
these various standards share commonalities and a historical link.
The new organization, International Organization for Standardization (ISO), officially began
operation on February 23, 1947.
The objective of this organization was to facilitate international coordination and unification of
industrial standards.
▪ Total Quality Management
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (ISO)
ISO is an independent nongovernmental organization with 168 members (as of December 2023)/
institutes formed based on one per country, and a Central Secretariat in Geneva, Switzerland, that
coordinates the system.
ISO is the world’s largest developer and publisher of international standards.
It is a nongovernmental organization that forms a bridge between the public and private sectors.
ISO has more than 21,000 international standards. Of all the ISO standards, the most widely known are
the ISO 9000 and ISO 14000 series.
ISO 9000 has become an international reference for quality requirements in business- to- business
dealings
ISO 14000 looks to achieve at least as much, if not more, in helping organizations to meet their
environmental changes.
ISO 9000 and ISO 14000 families are known as “generic management system standards.”
▪ Total Quality Management
ISO 9000
The ISO 9000 is a series, or family of standards, primarily concerned with “quality management.”
This means what the organization does to fulfill
• The customer’s quality requirements
• Applicable regulatory requirements, while aiming to enhance customer satisfaction
• Achieve continual improvement of its performance in pursuit of the objectives
The ISO 9000 family addresses various aspects of quality management and includes some of ISO’s
best-known standards.
The standards provide guidance and tools for companies and organizations seeking to ensure their
products and services consistently meet customer requirements and continually improve quality.
▪ Total Quality Management
ISO 9000
ISO 9000 outlines methods for achieving and benchmarking consistent performance and service.
Its application makes the business more competitive and credible.
ISO 9000 QMS helps continually monitor and manage quality across all operations, from inception
through completion, and enhances customer satisfaction.
ISO standards are updated periodically since their original publication in 1987.
ISO 9000 actually comprises several standards.
ISO 9000:2000 specifies requirements for a QMS for any organization that needs to demonstrate its
ability to consistently provide products that meet customer and applicable regulatory requirements
and enhance customer satisfaction.
▪ Total Quality Management
ISO 9000 QUALITY MANAGEMENT SYSTEM
ISO 9000 quality system standards are a tested framework for taking a systematic approach to
managing business processes, enabling organizations to deliver products or services that meet
customer satisfaction.
QUALITY
POLICY The typical ISO QMS is structured on
four levels, usually portrayed as a
QUALITY MANUAL pyramid.
WORK INSTRUCTIONS/PROCEDURES
Quality FORMS & RECORDS
▪ Total Quality Management
ISO 9000 QUALITY MANAGEMENT SYSTEM
QUALITY Sets out what management requires its staff to do in order to ensure QMS
POLICY
Details the works to be done
QUALITY MANUAL
The number of manuals containing work instructions or
procedures are determined by the size and complexity
of the organization.
• What is to be done?
WORK INSTRUCTIONS/PROCEDURES
• How is it done?
• How does one know that it has been done properly
• What is to be done if there are problems
Capture the history of routine events and
Quality FORMS & RECORDS
activities.
▪ Total Quality Management
ISO 9000 QUALITY MANAGEMENT SYSTEM
The ISO 9000 QMS requires documentation that includes a quality manual and quality procedures, as
well as work instructions and quality records.
All documentation (including quality records) must be controlled according to a document control
procedure.
The structure of the QMS depends largely on the management structure in the organization.
ISO 9001:2000 identifies certain minimum requirements that all QMSs must meet to ensure customer
satisfaction.
ISO 9001:2000 specifies requirements for QMSs when an organization
• Needs to demonstrate its ability to consistently provide a product that meets customer and applicable regulatory
requirements
• Aims to enhance customer satisfaction through the effective application of the system, including processes for continual
improvement of the system and the assurance of conformity to customer and applicable regulatory requirements
▪ Total Quality Management
QUALITY SYSTEM DOCUMENTATION
A quality system has to cover all the activities leading to the final product or service.
The quality system depends entirely on the scope of operation of the organization and particular
circumstances, such as the number of employees, the type of organization, and the physical size of the
organization’s premises. The quality manual is the document that identifies and describes the QMS.
The adoption of a QMS should be a strategic decision of an organization.
The design and implementation of an organization’s QMS (Documentation) is influenced by
1. The organizational environment, changes in that environment, and the risks associated with that
environment.
2. Its varying needs
3. Its particular objectives
4. The products it provides
5. The processes it employs
6. Its size and organizational structure
▪ Total Quality Management
QUALITY SYSTEM DOCUMENTATION
The QMS requirements specified in the International Standard are complementary to requirements for
products.
This International Standard can be used by internal and external parties, including certification bodies,
to assess the organization’s ability to meet customer, statutory, and regulatory requirements
applicable to the product and the organization’s own requirements.
▪ Total Quality Management
QUALITY SYSTEM DOCUMENTATION
The QMS is based on the guidelines for performance improvement per ISO 9004:2000 and the quality
management requirements. The quality management principles stated in ISO 9000 and ISO 9004 have
been taken into consideration for the development of this International Standard. ISO 9000:2000
outlines the necessary steps to implement the QMS.
These are:
1. Identify the processes (activities and necessary elements) needed for QMS.
2. Determine the sequence and interaction of these processes and how they fit together to accomplish
quality goals.
3. Determine how these processes are effectively operated and controlled.
4. Measure, monitor, and analyze these processes and implement the actions necessary to correct the
process and achieve continual requirements.
5. Ensure that all information is available to support the operation and monitoring of the process.
6. Display the most options, thus helping make the right management system.
▪ Total Quality Management
QUALITY SYSTEM DOCUMENTATION
ISO 9001:2000 requirements fall into the following sections:
1. Quality management system
2. Management responsibility
3. Resource management
4. Product realization
5. Measurement analysis and improvement
These documents are regularly updated and revised to meet the changing industry
requirements due to
• Globalization
• Higher levels of expectations by customers
• Higher performance requirements
• Complex nature of environment and works
• Specialized services requirements
▪ Total Quality Management
QUALITY MANAGEMENT SYSTEM MANUAL
QMS is a set of coordinated documentation that includes a quality manual, quality procedures,
processes, as well as work instructions (details of works to be done), quality forms, and records that
are developed to meet customer and regulatory requirements, taking into consideration the
organization’s quality policies and business objectives, and improve the effectiveness and efficiency
continuously.
ISO 9001 is an international standard that is most recognized and used as an international
reference for the development of an effective QMS.
ISO 9001 contains eight quality management principles (CLIPSCFM). These are
Principle 1— Customer focus
Principle 2— Leadership
Principle 3— Involvement of people
Principle 4— Process approach
Principle 5— System approach to management
Principle 6— Continual improvement
Principle 7— Factual approach to design making
Principle 8— Mutual beneficial supplier relationship