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C- OMPM8 Special Topics in Operations
Management
Module 9
1st Semester | AY 2021 - 2022
Module 9: ISO 9000 Quality Management
System
1. Overview
Module 9 covers the explanation of the quality management system of an organization. Likewise, it
discusses the quality manual as well as the benefits and risk management.
2. Content / Discussion
Organizations need a structured and systematic approach to implement the principles,
practices, and techniques of total quality. According to American Society for Quality (ASQ)
online glossary, a quality management system (QMS) can be considered a mechanism for
managing and continuously improving core processes to “achieve maximum customer
satisfaction at the lowest overall cost to the organization”. It applies and synthesizes
standards, methods, and tools to achieve quality-related goals. Thus, a quality management
system represents a specific implementation of quality concepts, standards, and tools and is
unique to an organization. A QMS provides a basis for documenting processes used to control
and improve operations, drive innovation, and achieve the following objectives:
a. Higher product conformity and less variation
b. Fewer defects, waste, rework, and human error
c. Improved productivity, efficiency, and effectiveness
One of the first things to do is to establish a quality policy- a formal document that
demonstrates a commitment to achieving high quality and meeting customer expectation.
Next, management must establish an organizational structure for its QMS that includes
responsibilities, methods of communication, maintenance of essential records and
documentation, and procedures for reviewing performance. The core of QMS is focused on
creating the goods and services that customer wants.
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Faculty: Mr. Albert B. Martinez, LPT, MBA 1 | Page
C- OMPM8 Special Topics in Operations
Management
Module 9
1st Semester | AY 2021 - 2022
QUALITY MANUAL
A quality manual serves as a permanent reference for implementing and maintaining the
system. A quality manual need not be complex; a small company might need only a dozen
pages while a large organization might need manuals for all key functions. Sufficient records
should be maintained to demonstrate conformance to requirements and verify that the
quality system is operating effectively. Typical records that might be maintained are
inspection reports, test data, audit reports, and calibration data. They should be readily
retrievable for analysis to identify trends and monitor the effectiveness of corrective actions.
Finally, the system needs to be maintained and kept up to date. This maintenance can be
facilitated through internal audits, which focus on identifying whether documented
procedures are being followed and are effective, and reporting the issues to management for
corrective action.
ISO 9000 Family of Standards
Although many ways exist to structure a QMS, many organizations start with the ISO family
of standards, which are a set of standards and guidelines for quality management systems
that represents an international consensus or good quality management practices. They
provide a comprehensive framework for designing and managing a quality management
system and help organization establish a process orientation and the discipline to document
and control key processes. ISO is a scientific term for equal (as in isotherm lines on a weather
map, which shows equal temperatures). The intent was to ensure that organizations certified
under ISO 9000 standards have quality equal to their peers. The standards have been
adopted in the United States by the American National Standards Institute (ANSI) with the
endorsement and cooperation of the American Society for Quality (ASQ). The standards
required documentation for all processes affecting quality and suggest that compliance
through auditing leads to continuous improvement. In some foreign markets, companies will
not buy from suppliers who are not certified to the standards. For example, many products
sold in Europe, such as telecommunication equipment, medical services, gas appliances, toys,
and construction products require product certification to assure safety. Often, ISO
certification is necessary to obtain product certification. Thus, meeting these standards
became a requirement for international business. The standards were intended to meet five
objectives:
a. Achieve, maintain, and seek to continuously improve product quality.
b. Improve the quality of operations to continually meet customers’ and stakeholders’
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needs.
Faculty: Mr. Albert B. Martinez, LPT, MBA 2 | Page
C- OMPM8 Special Topics in Operations
Management
Module 9
1st Semester | AY 2021 - 2022
c. Provide confidence to internal
management and other employees that quality requirements are being fulfilled.
d. Provide confidence to customers and other stakeholders that quality requirements
are being achieved.
e. Provide confidence that quality system requirements are fulfilled.
The standards consist of three documents:
1. ISO 9000:2005 Fundamentals and vocabulary: this document provides fundamental
background information and establishes definitions of key terms used in the
standards.
2. ISO 9001: 2008 Requirements. This is the core document that provides the specific
requirements for a quality management system to help organizations consistently
provide products that meet customer and other regulatory requirements.
3. ISO 9004: 2009 Guidelines for performance improvements. This document provides
guidelines to assist organizations in improving and sustaining their quality
management systems.
ISO 9000 has three principal benefits:
1. It provides discipline. ISO 9001 requirement for audits forces an organization to
review its quality system on a routine basis.
2. It contains the basics of a good quality system. ISO 9001 includes basic requirements
for any sound quality system, such as understanding customer requirements,
ensuring the ability to meet them, and ensuring people resources capable of doing the
work that affects quality.
3. It offers a marketing program. ISO certified organizations can use their status to
differentiate themselves in the eyes of customers.
ISO 9001 QUALITY MANAGEMENT SYSTEM
It is an International Standard that gives requirements for an organization’s quality
management system. It is part of a family standards published by the International
Organization for Standardization (ISO) and often referred to as the “ISO 9000 series” or “ISO
9000 family”. For this reason, you may sometimes hear your suppliers refer to being “ISO
9000 certified”. This will normally mean that they are claiming to have a QMS that meets the
requirements of ISO 9001, the only standard in the ISO family that can be used for the
purpose of conformity assessment. The objective of ISO 9001 is to provide a set of
requirements that, if effectively implemented, will give you confidence that your supplier can
consistently provide products and services that meet your needs and expectations, and
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comply with applicable regulations.
Faculty: Mr. Albert B. Martinez, LPT, MBA 3 | Page
C- OMPM8 Special Topics in Operations
Management
Module 9
1st Semester | AY 2021 - 2022
ISO 9001 adopts a risk-based
(preventive) approach to quality that covers a wide range of topics, including your supplier’s
top management commitment to quality, its customer focus, the adequacy of its resources,
employee competence, process management ( for production, service delivery, and relevant
administrative and support processes), quality planning, design of the products and services
it provides, review of incoming orders, the appropriate monitoring and measurement of its
processes, its processes to resolve complaints, corrective actions, and a requirement to drive
improvement.
ISO 14001 ENVIRONMENTAL MANAGEMENT SYSTEMS
It is developed to provide a management system to help organizations reduce their
environmental impact. The standard provides the framework for organizations to
demonstrate their commitment to the environment by:
Reducing harmful effects on the environment
Providing evidence of continual improvement of environmental management
Meeting environmental requirements
ISO 14001 provides a framework for organizations to improve their environmental
management systems:
Develop an environmental policy and establish a plan for procedures and control
Set measurable targets to meet anti-pollution requirements
Training, communication, and documentation set up throughout the organization
Operational control to identify risks and impacts
Planning for an emergency event
Continuous monitoring
Benefits of ISO 14001
By achieving ISO 14001 certification, you will be able to clearly demonstrate your
commitment to reducing waste and recycling materials where appropriate. The benefits to
your organization will not just be in cost saving, they may also prove beneficial when
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tendering for new business. Other benefits include improved efficiency, employee
engagement, and mitigating the risk of fines and prosecutions.
ISO31000 RISK MANAGEMENT
Faculty: Mr. Albert B. Martinez, LPT, MBA 4 | Page
C- OMPM8 Special Topics in Operations
Management
Module 9
1st Semester | AY 2021 - 2022
It is a family of standards relating to risk
management codified by the International Organization for Standardization. The purpose of
ISO 31000: 2009 is to provide principles and generic guidelines on risk management. It seeks
to provide a universally recognized paradigm for practitioners and companies employing
risk management processes to replace the myriad of existing standards, methodologies and
paradigm that differed between industries and regions.
ISO 31000: 2009 provides generic guidelines for the design, implementation, and
maintenance of risk management processes throughout an organization. This approach to
formalizing risk management practices will facilitate broader adoption by companies who
require an enterprise risk management standard that accommodates multiple management
systems. The scope of this approach to risk management is to enable all strategic
management and operational tasks of an organization throughout projects, functions, and
processes to be aligned to a common set of risk management objectives. ISO 31000: 2009
gives a list on how to deal with risk:
1. Avoiding the risk by deciding not to start or continue with the activity that gives rise
to the risk.
2. Accepting or increasing the risk in order to pursue an opportunity.
3. Removing the risk source.
4. Changing the consequences.
5. Sharing the risk with another party or parties (including contracts and risk
financing).
6. Retaining the risk by informed decisions.
ISO 26000 SOCIAL RESPONSIBILITIES
It is the designation of the future International Standard giving guidance on social
responsibility. It is intended for use by organizations of all types, in both public and private
sectors, in developed and developing countries. It will assist them in their efforts to operate
in the socially responsible manner that society increasingly demands.
WHY IS ISO 26000 IMPORTANT?
Sustainable business for organizations means not only providing products and services that
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satisfy the customer, and doing so without jeopardizing the environment, but also operating
in a socially responsible manner. Pressure to do so comes from customers, consumers,
governments, associations, and the public at large. At the same time, far-sighted
organizational leaders recognize that lasting success must be built on credible business
Faculty: Mr. Albert B. Martinez, LPT, MBA 5 | Page
C- OMPM8 Special Topics in Operations
Management
Module 9
1st Semester | AY 2021 - 2022
practices and the prevention of
activities such as fraudulent accounting and labor exploitation.
ISO 22000 FOOD SAFETY MANAGEMENT SYSTEMS
It can be applied to any organization in the food chain, farm to fork. Becoming certified to
ISO 22000 allows a company to show their customers that they have a food safety
management more important as customers demand safe food and food processors require
that ingredients obtained from their suppliers to be safe. The standard requires food safety
management system processes including:
Having an overall food safety policy for your organization, developed by top
management.
Setting objectives that will drive your company efforts to comply with this policy.
Establishing a group of qualified individuals to make up a food safety team. Having
an emergency plan.
Establishing a traceability system for identification of products.
Controlling, monitoring, and measuring devices.
Continually updating and improving the FSMS.
Online sources/references
https://asq.org>quality-resources What is ISO 14001?
https://www.british-assessment.co.uk> What are the ISO 14000 requirements?
Cachon, Gerard and Terwiesch, Christian (2017) Operations Management, New York.
Create (2016) Operations Management, New York, USA: McGraw Hill Education
Companies, Inc.
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