WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES

Maheshwari et al. World Journal of Pharmacy and Pharmaceutical Sciences

SJIF Impact Factor 6.041

Volume 5, Issue 8, 1832-1843 Review Article ISSN 2278 4357

IMPACT OF ISO ON QUALITY OF PRODUCT IN INDUSTRIES

Dr. Dilip Maheshwari* and Shrutay Mehta

1
Head of Department, Quality Assurance and Regulatory Affairs, L.J. Institute of Pharmacy,
Ahmedabad, Gujarat.
2
Student, Quality Assurance and Regulatory Affairs, L.J. Institute of Pharmacy,
Ahmedabad, Gujarat.

ABSTRACT
Article Received on
20 June 2016, International Organization for Standardization is a non-governmental
Revised on 10 July 2016, organization. It is used for the welfare of the world companies and
Accepted on 31 July 2016
DOI: 10.20959/wjpps20168-7504 organizations. It has been formed for the harmonization of the trade
and peaceful and errorless trade and outsourcing of the products. It
comprises of mainly three parts-members, experts and TC/ISO. ISO
*Corresponding Author
standards make a considerable and positive contribution daily, to the
Dr. Dilip Maheshwari
Head of Department, lives of people across the world. ISO provides practical tools to tackle
Quality Assurance and various global challenges. ISO works by establishing various
Regulatory Affairs, L.J. international standards in all work sectors. It has implemented ISO
Institute of Pharmacy,
9000,ISO 14000 to name a few from the list which benefits a
Ahmedabad, Gujarat.
pharmaceutical company tremendously be it for customer benefits or
for companys success to be confident and reliable by a customer. ISO has established
standards in sectors such as food industry, pharmaceutical industry, to protect social rights of
an individual, for assurance of quality of the product being sold by a company, for protecting
the natures property and also enhancing it is beauty in ISO 14000. It also works for
preventing ambiguous codes in different languages, thus making codes in a systematic form
used globally which is included in ISO 639. It takes immense care in developing and
implementing safety measures formed for the professionals and the workers earning their
living from a hazardous place and therefore has established ISO 45001. Moreover, ISO works
for the consumption, storage and reusing the natural sources of energy in ISO 50001.
Implementation of ISO standards provides the company to be successful and helps achieve
customer trust and assure quality for the goods of the company. This article shows how
different ISOs are important for the welfare and constant up-gradation of a company on a

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long run.

KEYWORDS: ISO 9001, ISO 14001, ISO 50001, quality system, management
responsibility.

INTRODUCTION
International Organization for Standardization is a private, non-governmental organization. It
is the largest developer of international standards and specifications for different products,
systems and services to provide safety, efficacy and quality. Till now more than 20,500
international standards have been set. They deal with 164 countries across the world with the
Central Secretariat situated in Geneva, Switzerland. It started working officially on 23rd
February, 1947. There are about 229 technical committees working under ISO. It helps make
compatible products, deal with safety issues of products and services and also generate ideas
[1]
and technological solutions.

ISO has three official languages- English, French and Russian. It is called IOS in English and
[3]
OIN in French. It has been derived from Greek word isos, synonym equal .

Popular standards that are widely accepted and commonly used are as follows:
ISO 9000 Quality management
ISO 14000 Environmental management
ISO 3166 Country codes
ISO 50001 Energy management
ISO 31000 Risk management
ISO 22000 Food safety management
ISO 27001 Information security management
ISO 45001 Occupational health and safety

ISO benefits in following ways:

o To harmonization of all standards across the countries to boost the trade between them.
o Development of co-operation in intellectual, scientific, economical and technological
sectors.
o Minimization of trade and technical barriers.
o Facilitating outsourcing and specialization for countries.
o Reassuring the consumers regarding the safety and quality of the products.
Apart from the above benefits of ISO, the additional positive economic effects of

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standards are as follows:-

They have the potential to exploit the network externalities to the fullest.
They have the ability to increase the productive and innovative efficiency.
They function in disciplined manner and hence, can decrease the imperfect information.
They are able to diffuse different information available to them.
They are implemented to reduce the management and production cost.
They believe in promoting the competition amongst the countries, so as to improve the
product quality.
Their efforts are to foster public welfare in the world.

ISO working- it mainly works through the co-ordination of members, experts and ISO/CS.
An international standard is developed through a series of precise principles:
I. New standard is proposed to relevant technical committee
II. If accepted, a working draft is prepared by the experts of working group
III. This is then shared with technical committee and ISO/CS
IV. Members are requested to comment on the draft
V. Final draft is send to all the ISO members
VI. If approved, it is thus called the International Standard

ISO 9000 Quality Management

ISO 9000 series is a result of evolutionary process. The ISO 9000 family includes various
aspects of quality management and contains some well-known standards too. It guides and
provides the tool to the companies and organizations to always be with the costumers
requirements and constantly in improving the product quality. Can be applied to any
company. Adopted by United States as the ANSI/ASQC Q90 series. It helps to improve the
company internally with planning, control and the most important being the documentation.
ISO 9000 is composed of a series of 5 documents from 9000-9004:

o ISO 9000 - Fundamental and vocabulary.

o ISO 9001 - Quality management system, Quality assurance for designing, development,
production, installation and servicing.
o ISO 9002- Quality system, Quality assurance for designing, development,
production, installation and servicing.
o ISO 9003 - Quality system, Quality assurance in final inspections, audits and testing.

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o ISO 9004 - Key elemental guidelines on Quality management and Quality system. It
involves six types.

o Standards in ISO 9000 family also includes:

o ISO 9001:2015 - sets out the requirements of a quality management system.
o ISO 9000:2015 - covers the basic concepts and language.
o ISO 9004:2009 - focuses on how to make a quality management system more efficient
and effective.
o ISO 19011:2011 - sets out guidance on internal and external audits of quality
management systems.

ISO 9001 Quality Management System

An international standard for quality management, suitable for any business. Its
implementation involves evidence of best management practice, health and safety
performance and a commitment to continuous training and development for all staff. It deals
with the requirements of the Quality Management System. The useful clauses are:
Quality management system
Management responsibilities
Resource management
Product realization
Measurement, analysis and improvement

ISO 9001 Revised

International standards are revised to keep it current and relevant to the current scenario. The
ISO 9001 was modified to a new and higher leveled structure that can be conjuncted with
[2]
other management system standards .

ISO 9001:2015
ISO 9001:2015 sets out the criteria for a quality management system and is the only standard
in the family that can be certified. It is flexible to be used by any organization irrespective of
its sector and field of activity. Over 170 countries are certified to 9001. It always strives to
improve strong customer focus, motivation from top management and process and continual
improvement. ISO 9001:2015 ensures that customers are always provided with consistent,
good quality products and services which leads business benefits. It is developed to be with

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the latest trends and be compatible with other standards like ISO 14001.

ISO 14000 Environmental Management System

ISO 14000 standards provide practical tools to organizations and companies of all kinds that
are willing to manage their environmental responsibilities in response to the global
warming and ozone depletion due to industrial activities. It provides a framework for the
development of environmental management system and supporting audit program. Moreover,
it assures to decrease the harmful effects occurring to the environment due to the companys
various activities.

ISO 14000 family includes following standards

o ISO 14001 - EMS Specification with guideline for use
o ISO 14004 - EMS General guideline on principles , system and supporting technique
o ISO 14010 - Guideline for environmental auditing General principle
o ISO 14011 - Guideline for environmental auditing Auditing of environmental
management system
o ISO 14012 - Guideline for environmental auditing Qualification criteria and others.
It includes following standards also:
o ISO 14001:2015 - Environmental management systems Requirements with guidance for
use.
o ISO 14004:2004 - Environmental management systems General guidelines on
principles, systems and support techniques.
o ISO 14006:2011 - Environmental management systems Guidelines for incorporating
eco-design.
o ISO 14064-1:2006 - Greenhouse gases Part- 1: Specification with guidance at the
organization level for quantification and reporting of greenhouse gas emissions and
removals.

ISO 14001:2015 and ISO 14006:2011 focus on environmental systems while others are
associated with auditing, communication, labeling, life cycle analyses and environmental
changes like climate change.

ISO 14001 Environmental Management System

An international standard for an Environmental Management System (EMS), which involves
regulatory compliance and ideally waste minimization, reduced environmental impact and

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reduced costs. Implementation involves everyone in the company and all the aspects of its
processes and products that impact on the environment. There are more than 3,00,000
certifications to ISO 14001 in 171 countries around the world.

ISO 14001:2015
It sets out the criteria for environmental management system and it can also be certified. It
organizes a framework that can be followed by a company or an organization in regard of set-
uping an effective environmental management system. It can also be used by external
stakeholders along with the company and the employees to assure that the environmental
impact is being measured and improved.

ISO 3166 Country Codes

ISO 3166 is the international standard for the country codes for their subdivisions. The
purpose of ISO 3166 is to define internationally recognized codes of letters and numbers that
we can use when we refer to countries and subdivisions. However, it doesnt decline the
names of countries. The information comes from the United Nations sources (terminology:
bulletin country names and the country and regions codes for statistical use maintained by the
United Nations statistical divisions).

ISO 3166 has three parts:

1. Codes for countries.
2. Codes for subdivisions.
3. Formerly used codes (codes that were once used to describe countries but are no longer
used).

ISO 50001 Energy Management

Using energy efficiently helps organizations save money as well as helping to conserce
resources and tackle climate change. ISO 50001 supports organizations in all sectors to use
energy more efficiently through the development of an energy management systems(EnMS).

The ISO 50001 family standards include following standards:

o ISO 50001:2011-Energy management systems Requirements with guidance for use.
o ISO 50002:2014 - Energy audits Requirements with guidance for use.
o ISO 50003:2014 - Energy management systems Requirements for bodies providing
audit and certification of energy and management systems.

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ISO 50001:2011 Energy Management System

ISO 50001:2011 is based on the management system model of continual improvement also
used for other well-known standards such as ISO 9001 or ISO 14001. It helps the
organizations to improve quality and management.

It provides framework of requirements for organization:

To develop a policy for more efficient use of energy.
To use data to better understand and make decisions about energy use.
To measure the results.
To continually improve energy management.

Like other ISO managements, certification of ISO 50001:2011 is possible but it is not
compulsory.

ISO 31000 Risk Management

Risk affecting organizations can have the consequences in various areas like economic
performance, professional reputation, environmental, safety and social outcome. Hence, it
helps in working in a tension free environment and work efficiently.

The family of ISO 31000 includes following standards too:

ISO 31010:2009 - Risk management - Risk assessment techniques
ISO 31000:2009 - Risk management Principles and guidelines
ISO Guide 73:2009 - Risk management Vocabulary

ISO 22000 Food Safety Management

ISO 22000:2005 specifies requirements for a food safety management system where an
organization in the food chain needs to demonstrate its ability to control food safety hazards
in order to ensure that food is safe at the time of human consumption. It is applicable to all
organizations, regardless of size, which are involved in aspect of the food chain and want to
implement systems that consistently provide safe products. The means of meeting any
requirements of ISO 22000:2005 can be accomplished through the use of internal or external
resources. ISO 22000:2005 specifies requirements to enable an organization:

a) To plan, implement, operate, maintain and update a food safety management system
aimed at providing products that, according to their intended use, are safe for the

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consumer,
b) To demonstrate compliance with applicable statutory and regulatory food safety
requirements,
c) To evaluate and assess customer requirements and demonstrate conformity with those
mutually agreed customer requirements that relate to food safety, in order to enhance the
customer satisfaction,
d) To effectively communicate food safety issues to their suppliers, customers and relevant
interested parties in the food chain,
e) To ensure that the organization conforms to its stated food safety policy,
f) To demonstrate such conformity to relevant interested parties, and
g) To seek certification or registration of its food safety management system by an external
organization, or make a self-assessment or self-declaration of conformity to ISO
22000:2005.

ISO 27001 Information Security Management

Information security is a complex area, demanding standards to address specific aspects.
These are currently addressed by ISO 17799 and the emerging ISO 27001. ISO 17799 is a
code of practice for information security. It details hundred of specific controls which may be
applied to secure information and related assets. It comprises of 115 pages organized over 15
major sections.

ISO 27001 is a specification for an Information Security Management System, sometimes

abbreviated to ISMS. It is the foundation for third party audit and certification. It comprises
34 pages over 8 major sections.

Both standards are intended to apply to all organizations, whether commercial or otherwise,
and should assist anyone with responsibility for managing information security.

ISO 45001 Occupational Health and Safety

ISO 45001, Occupational health and safety management systems Requirements, that deals
with lowering the burden of occupational injuries and diseases by providing a framework to
improve employee safety, reduce workplace risks and create better, safer working conditions
all over the world. ISO 45001 can be used by any organization irrespective of nature of its
work, and integrated into other health and safety programs such as worker wellness and
wellbeing. It also addresses many, if not all, legal requirements in the area.

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Implementations of ISO 9000 and ISO 14000

ISO gives pharmaceutical industry new management tool to improve patient safety. Product
and service quality will improve which decreases defects and waste. ISO standards can be
implemented in various ways and at various departments in an industry. Some of the areas
where ISO 9000 and 14000, important standards for a pharmaceutical industry, are as
follows:-

Implementations of ISO 9000

Management responsibility
Make sure all management and staff members understand how their jobs affect quality.
Quality system reviews should be carried out by senior managers. Changes to the quality
system must be implemented without delay.

Quality System
Quality plans can also have several levels, from general to specific. Like procedures, quality
plans explain how quality requirements will be met. But, unlike procedures, plans are usually
tied to a time frame and often involve contractual obligations.

Contract review
Make sure you understand what customers need.

Design Control
Design control is very important because many quality requirements can be satisfied through
good design. Make sure you develop plans to evaluate, test, and measure the safety,
dependability, and performance of your products. Your design teams should know what kinds
of information should be shared, who should get this information, how it should be
transmitted, and what records should be kept.

Document Control
Control documents by maintaining a central registry that specifies exactly which documents
should be controlled, their revision status, what kind of approvals they need, and how they
should be distributed and stored. Develop procedures to control changes in documents and
data.

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Customer-supplied Product
Clarify who is responsible for telling the customer that products supplied to you by him are
unsuitable. The supplier should ensure that all products and services provided by your
customers are suitable.

Process Control
Develop a record keeping system that can prove that your products meet requirements and
your quality system is implemented. Your records can be either paper based or electronic as
long as they document the performance of your quality system.

Inspection, measuring, and test equipment

Handling, storing, packaging, and delivery
Procedures for handling, storing, packaging, and delivery should cover both in- process
materials and finished products. Tools and equipment, used to handle products, should be
appropriate and well maintained. Storage methods should ensure that products are secure and
protected from damaging environmental conditions. Packaging methods must ensure that
products are identified and protected against damage, deterioration, or contamination.
Delivery methods must ensure that the products are protected from loss, damage,
deterioration, or contamination.

Quality Records
Develop a record keeping system that can prove that your products meet requirements and
your quality system is implemented. Your records can be either paper based or electronic as
long as they document the performance of your quality system. When you determine how
long old quality system records should be kept, consider contractual and regulatory
requirements as well as the life expectancy of your products.

Implementations of ISO 14000

In order to achieve environmental planning, at least, the organizations should:-
Define roles, responsibilities and authorities for facilitating EMS effectively.
Communicate to the staffs at each level for the importance of conformance to the
environmental policy; provide appropriate training to personnel performing the tasks to
gain their knowledge and competence.
Identify potential accidents and emergency situations for preventing and mitigating the
environmental impacts that may be associated with them and periodically test such

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procedures where practicable.

By implementing ISO, processes will be aligned with customer expectations and company
goals, therefore forming a more organized operating environment for the management and
employees. Process improvements will help to motivate employees and increase staff
involvement. Products and services will be continually improved. All of these benefits will
[6]
continually lead to better financial results, hence creating more value for ones business.

Conformity of products and services to ISO standards provides assurance about their quality,
safety and reliability for consumers. By defining the characteristics that products and services
will be expected to meet on export markets, ISO gives developing countries a basis for
[7]
making the right decisions when investing their scarce resources.

Benefits of ISO 9000 and ISO 14000

The implementing the super standards, i.e. ISO 9000 and ISO 14000, following benefits can
be obtained on a long run:-

Benefits of ISO 9000

It is the most effective quality system management.
It saves money on the recalled batch and the scrap.
It also provides the company with marketing benefits.
Due to quality management, it improves the services provided to the customers and
hence, improves customer satisfaction and clients too.
It gives opportunities for oversea businesses to the companies.
It is responsible for increasing business repeated orders, reduced waste and employee job
satisfaction.
Through implementing ISO 9000, one can improve the financial performance against the
competitors.

Benefits of ISO 14000

It protects the human health.
It has the potential to protect environment from the probable impacts of the activities,
products and services.
It has the potential to lead to competitive advantages for businesses in areas such as

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enhancing raw materials and strengthening supply management in order to justify and
make the administration of legally binding environment laws safer, as well as to improve
corporate image.

CONCLUSION
Hence, ISO standards are a guide that can help transform the companys quality system into
an effective system that meets and exceeds customer expectations. One would start to realize
various benefits as they are implemented and adhered to the quality standards, and the
benefits can be accrued over time. Thus, we can say that ISO standards are meant to preserve
the air, water, soil quality, gas emissions, radiation and environmental aspects of products
and lead the world on the path of maintaining and improving the quality of the products along
with its safety and efficiency of the product.

REFERENCES
1. ISO 9001:2015 and ISO 14001:2015.
www.isoindia.org
2. Different ISO standards,
www.iso.org
3. Aba EK, Badar MA (A Review of the Impact of ISO 9000 and ISO 14000 certifications),
The Journal of Technology Studies, 2013; 39(1): 42-50.
4. Information on ISO,
https://en.wikipedia.org/wiki/International_Organisation_for_Standardisation
5. Implementation of ISO,
http://www.overmanassoc.com/quality_iso/why_iso/
6. Benefits of ISO,
http://www.virtualprojectconsulting.com/the-benefits-of-iso-standards-for-your-business/
7. Vaidu FM, Casadesus Fa M, et al (ISO 9000 and ISO 14000 standards: an international
diffusion model), International Journal of Operations and Production Management, 2006;
26(2): 141-165.
8. Tari JJ, Franciso J, et al (Benefits of ISO 9001 and ISO 14001 standards: A literature
review), Journal of Industrial Engineering and Management, 2012; 5(2): 296-322.

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