Module 6
Module 6
ISO: ISO role; Functions of ISO, Quality System Family Series ISO 9000; ISO 14000;
ISO21000.
Six Sigma: Features of Six Sigma, Goals of Six Sigma, DMAIC, Six Sigma implementation.
Supply Chain and Operations: Supply Chain “KEIRETSU”, Core Competency, Relationship of
Operations and Supply Chain; Relationship of Purchasing and Supply Chain; Sources, Service
Quality and Supply Chain
Role of ISO
The ISO plays an important role in facilitating world trade by providing common standards
among different countries. These standards are intended to ensure that products and services are
safe, reliable, and of good quality.
Functions of ISO
It serves as a safety guard for the customer.
They make trade between the two countries.
They provide the technology to the government for health, safety.
They helps in transferring technology to developing countries.
They also helps in development, manufacturing, supply
There is often confusion around the family of ISO 9000 standards which are a series of
documents that define requirements and guidelines for a quality management
system (QMS): ISO 9000 (Guidelines), ISO 9001 (requirements), ISO 9002 (Guidelines), etc.
But an organization can only achieve certification to ISO 9001.
ISO 9001
Clause 1 Scope is the first clause in the ISO 9001:2015 standard. This clause is only
informational and does not in fact have any requirement that needs to be met. The first clause
covers the QMS requirements. In all, the standard has ten sections, the first three are purely
informational. The requirements an organization needs to meet to achieve certification are
contained within clauses 4-10. To learn more about this requirements see:
4: Context of the organization
5: Leadership
6: Planning
7: Support
8: Operation
9: Performance evaluation
10: Improvement
Section 1 states that organizations needs to demonstrate its ability to consistently provide
products that meet both the requirements set forth by the customer and by statutory and
regulatory requirements AND that organizations must aim to enhance customer satisfaction
through effectively using the standard to by using processes for improvement of the QMS.
ISO 9001 is a generic standard aimed to be applicable to any organization regardless of size,
sector or products and services it provides.
ISO 9001:2015 specifies requirements for a quality management system when an organization:
a) Needs to demonstrate its ability to consistently provide products and services that meet
customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system,
including processes for improvement of the system and the assurance of conformity to customer
and applicable statutory and regulatory requirements.
All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any
organization, regardless of its type or size, or the products and services it provides.
ISO 9002:1994
The three standards (ISO 9001:1994, ISO 9002:1994, and ISO 9003:1994) were combined into
ISO 9001 in the year 2000 revision (ISO 9001:2000) which was replaced by ISO 9001:2008 and
subsequently ISO 9001:2015. So if you are searching for that particular standard, you may wish
instead to investigate the revised standard’s requirements here, or look at a more general
definition of what is ISO certification and what it means.
In reference to ISO 9002, it was last revised in 1994 and was titled: Model for quality assurance
in production, installation, and servicing had basically the same material as ISO 9001 but
without covering the creation of new products. It was very applicable for contract manufacturing.
Organizations now use ISO 9001 standard and take exception to certain clauses of the standard
which involve the design of products and/or service. So there is no longer a need for
ISO9002:1994.
ISO 9004:2018,
“Quality management – Quality of an organization – Guidance to achieve sustained success”,
gives guidelines for enhancing an organization’s ability to achieve sustained success. This
guidance is consistent with the quality management principles given in ISO 9001:2015. ISO
9004:2018 is applicable to any organization, regardless of its size, type, and activity.
ISO 9001 provides a framework for an organization to manage their processes in an
effective Quality Management System. ISO 9001 Section 10 “Improving the 9001 Quality
Management System” discusses ongoing opportunities to enhance customer satisfaction such as
improvements to products or services. Ultimately, improving the effectiveness of the QMS will
help meet your customers’ requirements.
The 4th edition of ISO 9004 provides guidance for organizations to achieve sustained success in
an ever-changing environment, with reference to the seven quality management
principles described in ISO 9001:2015.
ISO 9004:2018 offers guidelines for success by considering the quality of an organization, which
it defines as the degree to which the characteristics of the organization fulfill the needs and
expectations of its customers and other interested parties.
ISO 9004:2018 addresses the improvement of the organization’s overall performance. It includes
the planning, implementation, analysis, evaluation, and improvement of an effective and efficient
management system.
ISO 9004:2018 recommends the involvement of top management for understanding the context
of the organization, and considering external and internal issues. Top management’s focus on the
organization’s ability to meet the needs and expectations of customers and other relevant
interested parties, and provides confidence in achieving sustained success.
ISO 14000
The ISO 14000 series of environmental management standards are intended to assist
organizations manage the environmental effect of their business practices. The ISO 14000
series is similar to the ISO 9000 series published in 1987.
ISO 14001:2015 specifies the requirements for an environmental management system that an
organization can use to enhance its environmental performance. ISO 14001:2015 is intended for
use by an organization seeking to manage its environmental responsibilities in a systematic
manner that contributes to the environmental pillar of sustainability.
ISO 14001:2015 helps an organization achieve the intended outcomes of its environmental
management system, which provide value for the environment, the organization itself and
interested parties. Consistent with the organization's environmental policy, the intended
outcomes of an environmental management system include:
Enhancement of environmental performance;
Fulfillment of compliance obligations;
Achievement of environmental objectives.
ISO 14001:2015 is applicable to any organization, regardless of size, type and nature, and
applies to the environmental aspects of its activities, products and services that the organization
determines it can either control or influence considering a life cycle perspective. ISO 14001:2015
does not state specific environmental performance criteria.
ISO 14001:2015 can be used in whole or in part to systematically improve environmental
management. Claims of conformity to ISO 14001:2015, however, are not acceptable unless all its
requirements are incorporated into an organization's environmental management system and
fulfilled without exclusion.
ISO 14004:2016 provides guidance for an organization on the establishment, implementation,
maintenance and improvement of a robust, credible and reliable environmental management
system. The guidance provided is intended for an organization seeking to manage its
environmental responsibilities in a systematic manner that contributes to the environmental pillar
of sustainability.
This International Standard helps an organization achieve the intended outcomes of its
environmental management system, which provides value for the environment, the organization
itself and interested parties. Consistent with the organization's environmental policy, the intended
outcomes of an environmental management system include:
- Enhancement of environmental performance;
- Fulfillment of compliance obligations;
- Achievement of environmental objectives.
The guidance in this International Standard can help an organization to enhance its
environmental performance, and enables the elements of the environmental management system
to be integrated into its core business process.
NOTE While the environmental management system is not intended to manage occupational
health and safety issues, these can be included when an organization seeks to implement an
integrated environmental and occupational health and safety management system.
ISO 14004:2016 is applicable to any organization, regardless of size, type and nature, and
applies to the environmental aspects of its activities, products and services that the organization
determines it can either control or influence, considering a life cycle perspective.
The guidance in this International Standard can be used in whole or in part to systematically
improve environmental management. It serves to provide additional explanation of the concepts
and requirements.
ISO 14001
ISO 14005:2019
This document gives guidelines for a phased approach to establish, implement, maintain and
improve an environmental management system (EMS) that organizations, including small and
medium-sized enterprises (SMEs), can adopt to enhance their environmental performance.
The phased approach provides flexibility that allows organizations to develop their EMS at their
own pace, over a number of phases, according to their own circumstances. Each phase consists
of six consecutive stages. The system's maturity at the end of each phase can be characterized
using the five-level maturity matrix provided in Annex A.
This document is applicable to any organization regardless of their current environmental
performance, the nature of the activities undertaken or the locations at which they occur.
The phased approach enables an organization to develop a system that ultimately satisfies the
requirements of ISO 14001.
The guidance does not cover those elements of specific systems that go beyond ISO 14001 and it
is not intended to provide interpretations of the requirements of ISO 14001.
ISO 21000
ISO 21001:2018 specifies requirements for a management system for educational
organizations (EOMS) when such an organization:
a) needs to demonstrate its ability to support the acquisition and development of competence
through teaching, learning or research;
b) aims to enhance satisfaction of learners, other beneficiaries and staff through the effective
application of its EOMS, including processes for improvement of the system and assurance of
conformity to the requirements of learners and other beneficiaries.
All requirements of ISO 21001:2018 are generic and intended to be applicable to any
organization that uses a curriculum to support the development of competence through teaching,
learning or research, regardless of the type, size or method of delivery.
ISO 21001:2018 can be applied to educational organizations within larger organizations whose
core business is not education, such as professional training departments.
ISO 21001:2018 does not apply to organizations that only produce or manufacture educational
products.
Six Sigma:
Six Sigma (6σ) is a set of techniques and tools for process improvement. It was introduced by
American engineer Bill Smith while working at Motorola in 1986. A six sigma process is one in
which 99.99966% of all opportunities to produce some feature of a part are statistically expected
to be free of defects.
Six Sigma strategies seek to improve manufacturing quality by identifying and removing the
causes of defects and minimizing variability in manufacturing and business processes. This is
done by using empirical and statistical quality management methods and by hiring people who
serve as Six Sigma experts. Each Six Sigma project follows a defined methodology and has
specific value targets, such as reducing pollution or increasing customer satisfaction.
The term Six Sigma originates from statistical modeling of manufacturing processes. The
maturity of a manufacturing process can be described by a sigma rating indicating its yield or the
percentage of defect-free products it creates—specifically, to within how many standard
deviations of a normal distribution the fraction of defect-free outcomes corresponds.
DMAIC
DMAIC is a data driven quality strategy used to identify opportunities in the process to make
improvements and reduce the errors and defects
Types of Keiretsu
Keiretsu are categorized into two types – horizontal and vertical keiretsu. A description of each
is provided below:
Horizontal Keiretsu
A horizontal keiretsu consists of large independent companies that are in different industry
sectors making up the group. There is usually no holding company leading a horizontal keiretsu.
However, there are large companies with an influence that directs activities of the keiretsu.
Normally, there is a bank and a trading company in the group that exert influence in terms of
decision making and overall direction of the grouping. In addition, a horizontal keiretsu will
include an insurance company and a large manufacturer. The financier, trading company,
insurance company, and large manufacturer are the fulcrum of the group and provide an identity
for the keiretsu. The Mitsubishi keiretsu is one example of a horizontal keiretsu with the above
features.
In a horizontal keiretsu, the bank plays a key role in the grouping. The bank is the chief financier
of the keiretsu, as it facilitates the largest advances to companies in the grouping. However,
members in the group are free to get funding from other banks and the lead bank acts as the
guarantor for loans extended by outside banks.
The relationship between the companies and the bank is usually cordial given the cross-
shareholding that exists between them. The trading company plays a crucial role, which includes
coordinating trade within the group, as well as among other keiretsu, independent organizations,
and foreign entities.
As highlighted above, Mitsubishi is a horizontal keiretsu, where at the center is The Bank of
Tokyo Mitsubishi. Other influential companies include Mitsubishi Motors, Mitsubishi Trust and
Banking, Meiji Mutual Life Insurance Company, and Mitsubishi Shoji is the trading company.
Vertical Keiretsu
A vertical keiretsu takes on a steeper structure compared to horizontal keiretsu. It is led by one
large entity that defines the whole grouping through its products, influence, and the dependence
of the other members on the large lead company. The other members are smaller and are usually
suppliers of the large firm. Vertical keiretsu are common in the automotive industry, electronics,
broadcasting, advertising, and other industries.
Vertical keiretsus are characterized by a pyramidal structure in which there are a few tiers of
suppliers involved. The first-tier suppliers are companies that supply items directly to the leading
firm. The second-tier suppliers are suppliers of products to the first-tier firms and the tiers go
down as far as is needed.
It is quite possible that the leading firm may not be aware that there are other smaller firms in the
hierarchy of the keiretsu. At the same time, it is also likely that some lower-tier firms may not be
aware that they are in the same keiretsu with the leading firm. A vertical keiretsu can be
notoriously big with many smaller firms in the hierarchy.
Pros of Keiretsu
An alliance built on long-term close business relationships ensures a stable and reliable supply
chain to ensure business continuity and protecting proprietary technology.
Keiretsu members share business best practices and improve risk management by
reducing unknown variables.
Reduction in costs of procurement through sourcing products from within the keiretsu
increases efficiency within the supply chain. This efficiency gave birth to the just-in-time
stock management system, which is a very efficient method.
Keiretsu holds each other’s shares through cross-shareholding, which prevents the threat
of hostile takeovers.
The sharing of information within the keiretsu has the potential to increase efficiency.
Cons of Keiretsu
The Keiretsu system reduces competition within the keiretsu, which can lead to inefficient
processes and service delivery.
There is a risk of companies within the keiretsu to borrow beyond their means and
undertake risky strategies since capital is readily available from the lead bank.
Because of the bigger size of the keiretsu, it is likely to be unable to respond swiftly to
changes in the market, culture, and technology.
The keiretsu system can result in closed markets and monopolistic tendencies.
Core Competency
A core competency is a concept in management theory introduced by C. K. Prahalad and Gary
Hamel It can be defined as "a harmonized combination of multiple resources and skills that
distinguish a firm in the marketplace" and therefore are the foundation of companies'
competitiveness
Core competencies fulfill three criteria
1. Provides potential access to a wide variety of markets.
2. Should make a significant contribution to the perceived customer benefits of the end
product.
3. Difficult to imitate by competitors.
For example, a company's core competencies may include precision mechanics, fine optics, and
micro-electronics. These help it build cameras, but may also be useful in making other products
that require these competencies.
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