MODULE 9

ISO 9000 QUALITY MANAGEMENT SYSTEM

Introduction

Standards are primarily used to facilitate global trade and prevent harm to consumers
and society. Before 1980, during the pre-standardization era, there were numerous national and
international standards. Standards for electrical, mechanical, and chemical process compatibility
have been around for decades. Other standards such as military standards were produced for the
army and other organizations for the nuclear power industry, and, to a lesser extent, for industrial
and commercial use. There are historical connections and commonalities among these standards.
However, their vocabulary and content were frequently inconsistent and unsuitable for
widespread usage in international trade. As a result, companies were left to build their own
standards or adapt the existing ones. This simply served to reduce commonality more. There was
a need to fill a hole in the 1980s as the majority of enterprises in the industrialized world started
to enhance quality and safety at historic rates. A standard quality management system that
would serve as an informal "contract" between the customer and the supplier would fill this gap.
The ISO 176 Technical Committee created the ISO 9000 set of standards to fill this gap. Later on,
ISO 14000 was used to fill a similar gap in environmental standards. Many organizations globally
started to use these benchmarks as a "certified" standard for effectiveness.

Learning Outcomes
 After completing the module, the student should be able to:
1. define what is ISO;
2. differentiate the various ISO Standards;
3. classify the internal and external forces; and
4. identify the quality system certifications.

Lesson 1. ISO 9000 Quality Management System Standard (Defeo, 2017)

The implementation of quality systems by businesses around the world and international
trade have both benefited greatly from the ISO 9000 standards. Over 70 nations have made the
international standards part of their national standards. They have been used in a variety of
commercial and governmental regulatory sectors. The management systems used by
corporations to guarantee quality in product design, production, distribution, and support are
covered by the ISO 9000 standards. The standards apply to all generic product categories:
hardware, software, processed materials, and services. The complete set of ISO 90O0 family of
standards provides quality management guidance, quality assurance requirements, and
supporting technology for an organization's quality management system. The standards apply to
all general product categories: hardware, software, processed materials, and services. The
complete set of ISO 90O0 family of standards provides quality management guidance, quality
assurance requirements, and supporting technology for an organization's quality management
system. The standards provide guidelines or requirements on what features are to be present in
the management system of an organization but do not prescribe how the features are to be
implemented. This no prescriptive character allows the standards their wide application for varied
items and circumstances. Upon implementing ISO 9000, an organization can be registered as a
Certified Quality Management System.
The standards in the ISO 9000 family were created and are generated and retained by
Technical Committee 176 of the International Organization for Standardization (ISO). The
inaugural meeting of ISO/TC176 was held in 1980. ISO 8402, the vocabulary standard, was first
published in 1986. The initial ISO 9000 series was published in 1987, consisting of the following:
 Fundamental concepts and road map guideline standard ISO 9000
  Three alternative requirements standards for quality assurance (ISO 9001, ISC 9002, or
ISO 9003)
 Quality management guideline standard ISO 9004
Since 1987, additional standards have been published. The ISO 9000 family now contains
a variety of standards supplementary to the original series. In particular, revisions of the basic ISO
9000 series, ISO 9000 through ISO 9004, were published in 1994, 2000, 2008, and, most recently,
in 2015 under the name ISO 9000:2015. This section is prepared in regard to the 2015 changes
following an introductory introduction to the original standard.
ISO 9000 has been adopted and enforced worldwide for quality assurance functions in
each two-party written agreement and third-party certification/registration things. Periodic police
work audits that are a part of the third-party certification/registration arrangements worldwide
offer continued motivation for provider organizations to take care of their quality systems in
complete agreement and to boost the systems to repeatedly meet their objectives for quality.
The marketplace for quality management and quality assurance standards itself grew
chop-chop, part in response to trade agreements like the eu Union (EU), the final Agreement on
Tariffs and Trade (GATT), and also the North yankee trade Association (NAFTA). These
agreements all rely upon standards that implement the reduction of nontariff trade barriers. The
ISO 9000 family occupies a key role in implementing such agreements.

Lesson 2. ISO 9001: 2015 (Defeo, 2017)

Certificates for the ISO 9001 normal are issued to over one thousand thousand
organizations in over one hundred seventy countries.. Once twenty five years since the
implementation of the primary ISO 9001 normal, it became necessary to introduce a Holy Writ.
whereas the scope of the 9001 normally failed to be amended considerably, the structure and
terms are updated to permit for easier alignment with different management systems standards.
ISO 9001:2015 currently follows identical High-Level Structure as different ISO Standards, which
makes integration easier for organizations victimizing multiple management systems. As much as
new words, organizations might select those terms that best suit their operations and don't seem
to be needed to adapt the new terms.

One of the key word changes is the replacement of product with product and services;
this was done so the quality is additionally applicable to a wider variety of industries, and
specifically service industries. Documents and records were replaced with documented
information so as to permit for additional flexibility in organizations documentation processes.
This leaves the choice to the organization to work out that procedures have to be compelled to
be documented to what extent.
In addition to changes in word, 2 new clauses are introduced relating to the context of
the organization: clause 4.1. Understanding the organization and its context and 4.2.
Understanding the wants and expectations of interested parties. These new clauses need the
organization to spot a large variety of problems and needs which will impact the design of their
quality management system. The clauses assume a stake- holder approach and specialize in
neutral Relationship Management (SRM), which matches on the far side the previous stress on
client Relationship Management (CRM). With this approach, stakeholders embrace all interested
parties, however solely need the organization to fulfil the wants and expectations of these
interested parties. The World Health Organization area unit deemed relevant to the standard
Management System.

The 2015 revision conjointly places an additional vital specialization in leadership for
being in charge of quality. the quality needs that management assigns, communicates, and
ensures understanding of quality roles and responsibilities. It conjointly needs that management
widen their scope of review to the strategic level, together with the interests of relevant
interested parties once considering risks and opportunities for the organization.
Another vital amendment within the 9001:2015 normal is that the stress on a risk-based
approach. whereas there's risk inherent in all told aspects of a high quality management system,
risk- based mostly thinking ensures that these risks are unknown, thought-about and controlled
throughout the planning and implementation of the method. Risk-based thinking was introduced
during this version of the quality in many clauses. Organizations are a unit needed to grasp risk
assessment and establish and act on each risk and opportunity. However, with the new normal
there's no formal demand for a documented risk management method.

Lesson 3. External Driving Forces (Defeo, 2017)

The driving forces that have resulted in widespread implementation of the ISO 9000
standards may be summed up in one phrase: the economic process of business. Expressions like
the "post industrial economy" and "the international village" mirror profound changes in recent
decades. These changes embody the following:

 New technology in virtually all industry/economic sectors.

 Worldwide electronic communication networks.
 Widespread worldwide travel.
 Dramatic increase in world population.
 Depletion of natural resource reserves, arable land, fishing grounds, and fossil fuels.
 More intensive use of land, water, energy, and air.
 Widespread environmental problems/concerns.
 Downsizing of large organizations and other organizations, flattened organizational
structure and outsourcing of functions outside the core functions of the organization.
 Number and complexity of language, culture, and legal and social frameworks
encountered in the global economy.
 Diversity is a permanent key factor.
 Developing countries becoming a larger proportion of the total global economy;
there are new kinds of competitors and new markets

These changes have crystal rectifiers to hyperbolic economic competition, hyperbolic

client expectations for quality, and hyperbolic demands upon organizations to fulfill additional
rigorous necessities for quality of their product.
Globalization of business could be a reality even for several small- and medium-size
organizations. These smaller organizations, also as their giant counterparts, currently notice that
a number of their prime competitors square measure probably to be primarily based in another
country. Fewer and fewer businesses are able to survive by considering solely competition inside
the local people. This affects the strategic approach and therefore the product coming up with
organizations of all sizes.

Lesson 4. Internal Response to the External Forces (Defeo, 2017)

Resources and structure culture and on empowering and sanctioning folks to try to do
their jobs. ISO 9000 implementation involves establishing policy, setting objectives for quality,
planning management systems, documenting procedures, and coaching for job skills. All of those
components are components of instructing what people's jobs are.
Organizations have adopted performance excellence programs that embody business
method management as a way of adapting to dynamic client desires. This idea is stressed within
the ISO 9000 standards. Metrics are being employed more and {more} to characterize product
quality and client satisfaction more effectively.
Organizations are implementing higher product style and work method style procedures,
and improved production methods. Benchmarking and competitive assessment are used more
and more.
An important question that's usually asked is "In this world of speedy amendment,
however will one family of standards, ISO 9000, apply to all or any business and economic
sectors, all products, and every one size of organizations?"
ISO 9000 standards ar supported on the thought that the peace of mind of consistent
product quality is best achieved by coinciding application of 2 styles of standards:

 Product standards (technical specifications)

 Quality system (management system) standards

Product standards give the technical specifications that apply to the characteristics of the
merchandise and, often, the characteristics of the method by that the merchandise is created.
Product standards are specific to the actual product: each its meant practicality and its end-use
things that the merchandise might encounter.
The management system is the domain of the ISO 9000 standards. it's by suggests that of
the excellence between product specifications and management system options that the ISO
9000 standards apply to all or any industry/economic sectors, all product, and every one sizes of
organizations

Lesson 5. Distinctions between Organizational Performance Excellence

Programs and ISO Standards (Defeo, 2017)

The ISO 9000 family standards contain necessities and pointers. it's a high quality
management system model to be used for quality assurance functions for providing confidence
in product and repair quality. A necessities commonplace becomes binding upon a company
where the organization:

 Is expressly known as up in a very contract between the organization and its client
 Seeks and earns third-party certification and registration

All of the ISO 9000 family standards are generic, within the sense that they apply to any
product or any organization. All of the ISO 9000 family standards are non-prescriptive within the
sense that they describe what management system functions shall or ought to be in place;
however they do not order the way to perform those functions.
ISO 9004 is comparable to several National Awards for Excellence in that it provides a
model for structure performance excellence and quality management. The foremost distinction is
that most National Awards Criteria are business outcomes centered and therefore the ISO 9000
standards don't seem to be. Why? As a result the ISO 9000 wasn't developed to incorporate
several of the enablers and influencers which will assure that each one processes (production and
nonproduction) in a company are unceasingly improved. In fact, ISO 9000 is targeted on
effectiveness of processes, and National Awards and most Organization Performance Excellence
Systems are centered on effectiveness and potency.
The ISO 9000 standards don't embrace the total scope of managing for quality. They
weren't designed to be. As a result of complaints, we regularly hear ISO 9000 didn't do what we
tend to expect it to try and do, whereas others aforesaid it had been nice for them. Those that
expressed it didn't work had Associate in Nursing expectation that the quality alone, once
enforced, would guarantee improved quality and higher monetary performance. They weren't
glad. They additionally didn't understand that the quality doesn't embrace provisions for these
alternative tasks that have to happen on the far side of the merchandise and repair production
processes.
If ISO 9004 were the registration commonplace, additional organizations would see the
good thing about registrations as a result of ISO 9004 may be used as Associate in Nursing
structure performance excellence system. IS0 9001 solely|is merely|is simply|is just|is barely}
Associate in Nursing assurance system centered on processes that only impact client necessities
being met). This can be a set of what's required to structure performance excellence programs;
the organizations that expressed that ISO 9004 worked for them used the quality as a building
block to a more robust system. They crammed within the gaps wherever the quality wasn't
designed to try and do. As a result, these organizations saw ISO Standards as a vital part of their
performance excellence program.
We outline structure performance excellence systems with the inclusion of designing,
Control, Associate in Nursing improvement ways and applied to any or all processes in an
enterprise, as essential to manage for quality. Quality Assurance is a vital part of this technique
since it provides info on however our system is acting to predetermine product specs and plans.
Quality control is totally different from quality assurance. Management is regarding what
to watch to make sure necessities are met whereas assurance is regarding reviewing and auditing
your system to prove that your organization is holding the gains on enhancements or dynamic
client wants.
One of the foremost pressing wants within the early years of ISO/TC176 work was to
internationally harmonize the meanings of terms like "quality control" and "quality assurance."
These 2 terms, specifically, were used with diametrically totally different meanings among varied
nations, and even among nations. The term "quality management'' was introduced into the ISO
9000 standards as the umbrella term for internal control and quality assurance. The term "quality
management" was outlined, enclosed in ISO 8402, and adopted internationally. This, in turn,
enabled agreement on consonant definitions of the meanings of every of the terms "quality
control" and "quality assurance."
According to ISO 9000:2015, the basic ideas and principles of quality management within
the International commonplace are applicable to the following:
 Organizations seeking sustained success through the implementation of a quality
management system
 Customers seeking confidence in an organization's ability to consistently provide
products and services conforming to their requirements
 Organizations seeking confidence in their supply chain that product and service
requirements will be met
 Organizations and interested parties seeking to improve communication through
a common understanding of the vocabulary used in quality management
 Organizations performing conformity assessments against the requirements of
ISO 9001
 Providers of training, assessment, or advice in quality management
Lesson 6. Quality System Certification/Registration (Defeo, 2017)

The earliest users of quality assurance necessities standards were giant client
organizations like electrical power suppliers and military organizations. These customers typically
purchase complicated merchandise to specific practical styles. In such things, quality assurance
necessities are a unit referred to as up in a very two-party contract wherever the providing
organization (i.e., the supplier) is cited because the "first party" and also the client organization is
cited because the "second party." Such quality assurance necessities generally embrace
provisions for the providing organization to own internal audits sponsored by its management to
verify that its quality system meets the contract necessities. These are unit first-party audits. Such
contracts generally additionally embrace provisions to own external audits sponsored by the
management of the client organization to verify that the provider organization's quality system
meets the contract necessities. These area unit second-party audits. At intervals a written
agreement arrangement between 2 such parties, it's potential to tailor the wants, as acceptable,
associate in nursing to take care of an current dialogue between client and provider.
When such assurance arrangements become a widespread observation throughout the
economy, the two-party, individual-contract approach becomes onerous. There develops a state
of affairs wherever every organization within the offer chain is subject to periodic management
system audits by many shoppers and is itself subjecting several of its sub-suppliers to such audits.
There's loads of redundant effort throughout the provision chain as a result of every organization
being audited multiple times for basically constant necessities. The conduct of audits becomes a
big value component for each organization's activity, the audit and also the organizations being
audited.

Certification/Registration-Level Activities
The development of quality system certification/registration could be a means to scale
back the redundant, non-value-adding effort of those multiple audits. A third-party organization,
that is termed a "certification body" in some countries, or a "registrar" in alternative countries
(including the United States), conducts a proper audit of a provider organization to assess
correspondence to the suitable quality system customary, say, ISO 9001 or ISO 9002. Once the
provider organization is judged to be in complete correspondence, the third party issues a
certificate to the activity organization and registers the organization's quality system in a very
publicly offered register. Thus, the terms “certification" and "registration" carry constant market-
place which means as a result of their 2 serial steps signifying prospering completion of constant
method.
To maintain its registered standing, the provider organization should pass periodic police
work audits by the registrar. Police work audits area units typically conducted semi-annually. They
will be less comprehensive than the complete audit. If so, a full audit is performed each few
years.
In the world nowadays, there are many unit certification bodies/registrars. Most of them
are unit personal, for-profit organizations. Their services are unit valued by the provider
organizations they register, and by the client organizations of the provider organizations, as a
result of the registration service adds worth within the offer chain. It's crucial that the registrars
do their work aptly and objectively, which all registrars meet customary necessities for his or her
business activities. They are, in fact, provider organizations that give a required ser- vice product
within the economy.

Accreditation-Level Activities
To ensure competency and sound judgment of the registrars, systems of registrar
certification are started worldwide. Certification bodies audit the registrars for conformity to
straightforward international guides for the operation of certification bodies. The standard system
of the registrar comes under scrutiny by the certification body through audits that cover the
registrar's documented quality management system, the qualifications and certification of
auditors employed by the registrar, the record keeping, and alternative options of the workplace
operations. Additionally, the certification body witnesses selected audits done by the registrar's
auditors at the power of the shopper provider organization.

Mutual International Acceptance

Various alternative countries have additionally enforced these 3 areas of activity:
1. Accreditation of certification bodies/registrars
2. Certification of auditors
3. Accreditation of auditor training courses

Various bilateral mutual recognition agreements are unit in situ between bound countries
whereby, for instance, the certification of Associate in nursing auditor in one country carries over
into automatic recognition of that certification in another country. In alternative things, a memo
of understanding has been negotiated between, say, the certification bodies in 2 countries,
whereby they enter into a cooperative mode of operation preliminary to moving into a proper
mutual recognition agreement. Underneath a memo of understanding, the certification bodies
might together conduct the audit of a registrar, and also the auditors might together document
the results of the audit. However, every of the certification bodies would create its own call
whether or not to grant or continue the certification, because the case is also.
In principle, there ought to be no want for a provider organization to get quite one
certification/registration. A certificate from a registrar licensed anyplace within the world ought
to, in essence, be accepted by client organizations anyplace else within the world. In my opinion,
it takes time to make infrastructure comparable in any country. It takes overtime (measured in
years) for that infrastructure to mature in its operation and for confidence to make in alternative
countries. Of course, not all countries attempt to start their own infrastructure; however it might
be better to have their provider organizations World Health Organization would like to become
registered do therefore by using the services of Associate in nursing licensed registrar from
another country.
Indeed, several registrar organizations have established operations internationally and
supply services in several countries. Such registrars typically get certification in multiple countries
as a result of their customers (supplier organizations) exploring for certification underneath a
system with which they're acquainted and have developed confidence.
At the current time, there's a multiplicity of arrangements involving single or multiple
accreditations of registrars, single or multiple certifications of auditors, and single or multiple
accreditations of coaching courses. The general system is moving toward widespread mutual
recognition, however the last word to take a look at of quality is that the marketplace
temperament to simply accept one certification and one certification.
The alignment for Standardization (ISO), in Jan 1995 reaffirmed its support for the
standard System Assessment Recognition (QSAR) and approved an idea of action for setting the
program in motion. This effectively ordered the muse for a voluntary system aimed toward
encouraging worldwide acceptance of ISO 9000 certificates.
The current standing wherever registrars and course suppliers might have multiple
accreditations, and auditors might have multiple certifications, could appear to own additional
redundancy than is critical. If we have a tendency to step back and compare this state of affairs to
the choice of widespread second-party auditing of the standard systems of provider
organizations, it should be acknowledged that the current state of affairs is best as a result of
there's
 Much less redundancy of auditing
 Much improved consistency of auditing
 The potential for even less redundancy and more improved consistency through the
employment of international standards and guides as criteria and thru mutual
harmonization efforts driven by the marketplace
Formal International Mutual Recognition
For us, there's one more complication. Nearly alone among the countries of the planet,
the U.S. standards system could be a personal sector activity. The National Standards Institute, a
personal sector organization, is the coordinating body for standards within the us. Underneath
the ANSI umbrella, several organizations manufacture and maintain numbers of yankee national
standards. Most of those standards relate to product technical specifications. Among the biggest
U.S. producers of standards area unit such organizations because the yank Society of Testing and
Materials (ASTM), the yank Society of Mechanical Engineers (ASME), and also the Institute of
Electrical and physics Engineers EEE), however there are a unit several alternative organizations
that manufacture yank national standards applicable to specific merchandise or fields of activity.
The ANSI system provides an even standard development method that's open, fair, and provides
access to all or any parties that will be materially affected by a custom. The success of the U.S.
system is due to the predominance of the U.S. economy internationally and also the widespread
adoption of U.S. standards for transnational or international use.
However, there are 3 levels of activities and infrastructure in reference to conformity
assessment in international trade. 2 levels have already been discussed: the certification/
registration level and also the certification level. The third level is recognition. At the popularity
level, the national government of country A affirms to the govt. of country B that A's certification
and certification infrastructure conforms to international standards and guides. In most countries
of the planet wherever the standards system goes past a government or semi-government
agency and also the certification activities area unit distributed by that agency, the popularity
level is nearly automatic. Within the US, numerous government agencies are also referred to
supply formal recognition.

Conformity Assessment and International Trade

 The conformity assessment approach of the EU typifies what's happening in several
components of the planet. For a regulated product to be sold in any EU country, it should bear
the "CE" mark. Underneath the EU's standard approach, to qualify to be ready to use the mark,
the provider organization should manufacture proof of conformity in four areas:
1. Technical documentation of product design
2. Type testing
3. Product surveillance (by samples, or by each product)
4. Surveillance of quality assurance

Depending on the directive, the EU can supply suppliers numerous routes (modules) to
satisfy the wants. These routes vary from "Internal management of Production," that focuses on
the merchandise police work aspects, to "Full Quality Assurance," which generally focuses on
certification/registration to ISO 9001 and depends upon the ISC 9001 necessities for capability in
product style. In most modules, the manufacturer should submit product units, and/or product
style technical info, and/or quality system info to a certification body that has been selected by
the govt. as a "notified body." In some modules, the notified body should additionally give for
product tests wherever needed. Many modules involve certification to ISO 9001, ISO 9002, or ISO
9003.
Implementing this standard approach to conformity assessment for regulated
merchandise by the European Union (then referred to as the European Community) was the
biggest, single, early impetus to the speedy unfold of certification/registration to ISO 9001 or ISO
9002 worldwide. For instance, concerning 1/2 the volume of U.S. trade with Europe is in regulated
merchandise. However, world trends in technology and in necessities for quality, and also the
value savings of third-party versus widespread second-party auditing, as mentioned antecedently
area unit powerful extra incentives and endurance for sustained international use and growth of
third-party quality system certification/registration.
Moreover, for a provider organization it's not effective to try to own 2 quality
management systems, one for regulated merchandise and another for non-regulated
merchandise. Consequently, there are multiple incentives for big numbers of provider
organizations, engaged directly or indirectly in international trade, to control a high quality
management system that conforms to ISO 9001 or ISO 9002, as acceptable.

Guiding Principles
 There are several registrars; every is registering several provider quality systems. Every
provider is addressing many shoppers. It’s impractical to adequately monitor the operations of
such a system exclusively by periodic audits conducted by the Associate in nursing certification
body. Consequently, the tenet ought to be that primary reliance should be placed on the
conception of "truth in labeling," by means of which each client has routine, prepared access to
the data upon which to evaluate all four parts of the scope of a supplier's registered quality
system.

Reference
Defeo (2017). Juran’s Quality Handbook: The Complete Guide to Performance Excellence, Seventh
Edition. McGraw-Hill Education.Philippines