Shobhit Sharma et al.

/ International Journal of Advances in Pharmaceutical Research

IJAPR Review Article

Available Online through ISSN: 2230 7583
www.ijapronline.org

ROLE OF ISO IN PHARMACY

Shobhit Sharma*, Akanksha Gupta, Mahesh K. Gupta, Mahaveer P. Khinchi, Dilip Agrawal,
Natasha Sharma, Sandeep Singh,

Kota College of Pharmacy, Kota, Rajasthan Pin -324005

Received on 10 02 - 2012 Revised on 20 03- 2012 Accepted on 14 05 2012

ABSTRACT
The ISO 9000 series of quality management systems standards, introduced in 1986, has been adopted at over
560,000 locations worldwide. Anecdotal evidence suggests that firms can achieve internal benefits such as quality
or productivity improvements or that certification can help firms maintain or increase their market share, or both.
Others argue that the standard is too generic to cause performance improvement but can be seen as a signal of good
management. This article highlighted on the global adoption of ISO and ISO certification for maintaining the
quality of the product. An introduction of ISO families including 14000 series and some of the series of ISO used
in medical fields and also include the procedure to get industry ISO certified. Benefits of ISO certification and ISO
9001 includes the various benefits like better products, improved profit levels results as productivity improves,
customer satisfaction, superior design etc. The author want to focus in this article the role of ISO is beneficial for
pharmacy students or in pharmacy field in pharmacy accreditation services, patient safety, pharmacy quality,
unifying base for industry, transfer of goods to developing countries, increase efficiency and effectiveness.
Keywords: ISO 9000, ISO 14000, Global adoption, ISO pharmacy role, ISO Certification

INTRODUCTION
ISO is the word that represents the
International Organization for Standardization. It's
not the acronym for the International Organization
for Standardization as many people think. It is the
worldwide federation of national standards bodies
for approximately 130 countries. The ISO 9000
standards are produced by an international consensus
of countries with the aim of creating global standards
of product and service quality. These sets of
standards form a quality management system and are
applicable to any organization regardless of product,
service, organizational size, or whether it's a public
or private company.
* For Correspondence:
Shobhit Sharma
C/o Dr. M.K. Gupta
Kota College of Pharmacy, Rajasthan -324005
Mobile no. 09772302220
E.mail: shobhitsharma53@rediffmail.com
ISO covers all technical fields and is not limited to
any particular discipline. It does not, however, cover
electrical or electronic engineering which are the
responsibility of the IEC. The responsibility for
information technology is performed by a joint
ISO/IEC technical committee.
Our business can be certified against one of three
quality systems: ISO 9001, ISO 9002 or ISO 9003.
1. ISO 9001 sets out the requirements for an
organization whose business processes range all the
way from design and development, to production,
installation and servicing;
2. ISO 9002 is the appropriate standard for
organizations that do not design and develop
products, since it does not include the design control
requirements of ISO 9001. Its requirements are
identical aside from that distinction.

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 Shobhit Sharma et al. / International Journal of Advances in Pharmaceutical Research
3. ISO 9003 is the appropriate standard for an
organization whose business processes do not
include design control, process control, purchasing
or servicing. It focuses on inspection and testing to
ensure that final products and services meet specified
requirements. [1]
HISTORY OF ISO
The standard started out as BS5750 and
arose out of the need to improve the quality of
production line manufacturing, this being the
predominant industry type in the UK in the 50s and
60s. This emphasis however eventually caused many
problems with its interpretation and application to
the service sector industries that arose in the 80s and
90s.
The BS5750 name was dropped in 1987 in
favour of the international standard, known since by
its generic convention ISO 9000, and the use of The
Standard then grew throughout many other
industrialised countries as well as in the UK. A
significant reason for the rise in ISO 9001
certifications in the UK has been the increasing
demands by governmental type organizations and
major civil engineering contractors etc. that their
suppliers were ISO 9001 registered. Although
meeting the Standard was intended to guarantee
quality, this unfortunately did not always happen as
ISO 9001 did not, in its earlier form, really
encourage business improvement as such, and
notably did not even say much about customer
service; rather it was more a means of controlling
conformance as well as the presumed
nonconformities.
It became normal for businesses to focus so much on
the ISO 9001 requirements themselves that they
missed the point about meeting their customers
needs and improving the quality of their products or
services. It was not unusual for ISO 9001 to be seen
as totally separate from the real day to day business
operation. Sadly, examples of this misconception are
still around today. Fortunately many of the earlier
shortcomings were addressed in the significant Year
2000 update which moved away from just managing
conformance to cover many of the wider issues
concerned with managing a business, as well as
laying greater emphasis on the key areas of customer
focus, people involvement, and importantly,
continuous improvement.
IJAPR / June. 2012/ Vol. 3 /Issue. 6 / 937 945
The most recent update to ISO 9001 was in 2008 and
the current version to which organizations are
assessed is ISO 9001:2008, however the changes
made in 2008 are quite minor and do not
significantly affect the actual requirements; the
changes being mostly to clarification notes. There
are in fact a range of standards within the ISO 9000
family, and one that is definitely worth a closer look
is ISO 9004, which is in fact a very useful guide to
implementing ISO 9001, and can help users to
understand more fully how to go about ensuring
genuine continuous improvement. ISO 9001:2000
was undoubtedly a big step in the right direction, and
is certainly more relevant to todays service sector
industries. However the key to ensuring that
ISO 9001 delivers real business benefits and service
improvements is in its implementation. [2]
ISO FAMILIES
1987 version
ISO 9000:1987 had the same structure as the UK
Standard BS 5750, with three 'models' for quality
management systems, the selection of which was
based on the scope of activities of the organization:
ISO 9001:1987 Model for quality assurance in
design, development, production, installation, and
servicing was for companies and organizations
whose activities included the creation of new
products.
ISO 9002:1987 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.
ISO 9003:1987 Model for quality assurance in final
inspection and test covered only the final inspection
of finished product, with no concern for how the
product was produced.
ISO 9000:1987 was also influenced by existing
U.S. and other Defense Standards ("MIL SPECS"),
and so was well-suited to manufacturing. The
emphasis tended to be placed on conformance with
procedures rather than the overall process of
management, which was likely the actual intent.
1994 version
ISO 9000:1994 emphasized quality
assurance via preventive actions, instead of just
checking final product, and continued to require
evidence of compliance with documented
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procedures. As with the first edition, the down-side
was that companies tended to implement its
requirements by creating shelf-loads of procedure
manuals, and becoming burdened with an ISO
bureaucracy. In some companies, adapting and
improving processes could actually be impeded by
the quality system.
2000 version
ISO 9001:2000 combined the three
standards9001, 9002, and 9003into one, called
9001. Design and development procedures were
required only if a company does in fact engage in the
creation of new products. The 2000 version sought to
make a radical change in thinking by actually
placing the concept of process management front and
center ("Process management" was the monitoring
and optimizing of a company's tasks and activities,
instead of just inspecting the final product). The
2000 version also demanded involvement by upper
executives in order to integrate quality into the
business system and avoid delegation of quality
functions to junior administrators. Another goal was
to improve effectiveness via process performance
metrics: numerical measurement of the effectiveness
of tasks and activities. Expectations of continual
process improvement and tracking customer
satisfaction were made explicit.
The ISO 9000 standard is continually being
revised by standing technical committees and
advisory groups, who receive feedback from those
professionals who are implementing the standard.
ISO 9001:2008 only introduced
clarifications to the existing requirements of ISO
9001:2000 and some changes intended to improve
consistency with ISO 14001:2004. There were no
new requirements. For example, in ISO 9001:2008, a
quality management system being upgraded just
needs to be checked to see if it is following the
clarifications introduced in the amended version.[3]
14000 versions
The major objective of the ISO 14000 series
of norms is "to promote more effective and efficient
environmental management in organizations and to
provide useful and usable tools - ones that are cost
effective, system-based, flexible and reflect the best
organizations and the best organizational practices
available for gathering, interpreting and
communicating environmentally relevant
information".
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Unlike previous environmental regulations,
which began with command and control approaches,
later replaced with ones based on market
mechanisms, ISO 14000 was based on a voluntary
approach to environmental regulation. The series
includes the ISO 14001 standard, which provides
guidelines for the establishment or improvement of
an EMS. The standard shares many common traits
with its predecessor ISO 9000, the international
standard of quality management, which served as a
model for its internal structure and both can be
implemented side by side. As with ISO 9000, ISO
14000 acts both as an internal management tool and
as a way of demonstrating a companys
environmental commitment to its customers and
clients.[4]
ISO 14000 SERIES STANDARDS:
ISO 14001 Environmental management
systemsRequirements with guidance for
use.
ISO 14004 Environmental management
systemsGeneral guidelines on principles,
systems and support techniques.
ISO 14015 Environmental assessment of
sites and organizations.
ISO 14020 series (14020 to 14025)
Environmental labels and declarations.
ISO 14030 discusses post production
environmental assessment.
ISO 14031 Environmental performance
evaluationGuidelines.
ISO 14040 series (14040 to 14049), Life
Cycle Assessment, LCA, discusses pre-
production planning and environment goal
setting.
ISO 14050 terms and definitions.
ISO 14062 discusses making improvements
to environmental impact goals.
ISO 14063 Environmental
communicationGuidelines and examples.
ISO 14064 Measuring, quantifying, and
reducing Greenhouse Gas emissions.
ISO 19011 which specifies
one audit protocol for both 14000 and 9000
series standards together. This replaces ISO
14011 meta-evaluationhow to tell if your
intended regulatory tools worked. 19011 is
now the only recommended way to
determine this.[4,5]
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LIST OF SOME ISO SERIES STANDARDS ISO 10993-19 Physico-chemical,

RELATEDTO MEDICAL FIELD ISO morphological and topographical
10993 :- Biological evaluation of medical devices characterization of materials.

ISO 10993-1 Evaluation and testing within ISO 10993-20 Principles and methods for
a risk management process. immunotoxicology testing of medical
devices.
ISO 10993-2 Animal welfare requirements.
ISO 11137 Sterilization of health care
ISO 10993-3 Tests for genotoxicity, products Radiation.[5,6]
carcinogenicity and reproductive toxicity.
PROCEDURE TO OBTAIN ISO
ISO 10993-4 Selection of tests for
CERTIFICATION
interactions with blood.

ISO 10993-5 Tests for in vitro cytotoxicity. Five steps for obtaining ISO certification:

ISO 10993-6 Tests for local effects after 1. Match your organization to the ISO certification
implantation. that best fits its focus and customer base. Obtaining
ISO certification requires a significant investment of
ISO 10993-7 Ethylene oxide sterilization a company's time and resources. Management should
residuals. carefully assess which certification to pursue by
determining which ISO standards are commonly
ISO 10993-9 Framework for identification required by their target customers; the level of
and quantification of potential resources and time required creating, document and
degradation products. implementing the necessary processes and
procedures; and the costs associated with achieving
ISO 10993-10 Tests for irritation and skin and maintaining ISO certification.
sensitization.
ISO 9000, which addresses quality management
ISO 10993-11 Tests for systemic toxicity. standards, and ISO 14000, which incorporates
standards related to how a company's practices
ISO 10993-12 Sample preparation and minimize harmful effects to the environment, are the
reference materials. most popular ISO standards. ISO also has a number
of certifications for specific industry sectors,
ISO 10993-13 Identification and including agriculture, food technology, oil and gas,
quantification of degradation products from shipbuilding and others.
polymeric medical devices.
2. Learn the required standards for your desired ISO
ISO 10993-14 Identification and certification. Companies can purchase detailed
quantification of degradation products from information on the requirements for each ISO
ceramics. certification from the ISO website. Many companies
also hire ISO consultants to assist them in
ISO 10993-15 Identification and developing and implementing a program to obtain
quantification of degradation products from ISO certification.
metals and alloys.
3. Develop and complete the necessary
documentation to meet ISO certification standards.
ISO 10993-16 Toxicokinetic study design
What this usually means for most companies is the
for degradation products and leachable.
development of detailed procedure and policy
ISO 10993-17 Establishment of allowable manuals that document a company's processes and
limits for leachable substances. procedures for handling quality and management
issues, such as inventory control, customer
ISO 10993-18 Chemical characterization of fulfillment and organization charts.
materials.

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 Shobhit Sharma et al. / International Journal of Advances in Pharmaceutical Research
In many cases, the company already has a process or
procedure for dealing with the issue; all that's needed
is to make sure that the process or procedure is
accurately documented in a manner that meets ISO
standards. In other cases, it may be necessary to
develop and implement a new procedure.
4. Train management and employees on ISO
standards and conduct an internal audit. Companies
should maintain ISO training logs. Before pursuing
actual certification, it is a good idea for companies to
develop their own in-house ISO team and conduct an
internal audit to make sure that ISO standards and
requirements are being met.
5. Schedule a certification audit with an accredited
ISO registrar. Most experts advise choosing a
reputable ISO registrar who is located close to your
facility to reduce travel expenses.[7]
TIMELINE AND COST IMPLICATIONS OF
IMPLEMENTING ISO:
It is obvious that there are many advantages
to ISO certification. Certification should not be
undertaken lightly, however, as it is extremely time
consuming and costly. By rough estimate, it can take
anywhere from six to 18 months to document your
business operations, with another one to three
months to verify against actual operations. Fees for
consultants to help guide your business through the
process of documentation and certification are
around the $10,000 to $20,000 magnitude. Make
sure you hire the right consultant for the job. Don't
forget about the time spent by employees during
documentation and away from production -- these
can add up also. [8]
THE BENEFITS OF ISO CERTIFICATION:
ISO 9000 provides a framework and
systematic approach to managing business processes
to produce a product/service that conforms to
customer expectations. For customers, the
certification of suppliers to ISO standards means that
they can be assured that the development of their
products and services are compliant to reference
documents that are globally accepted. This, of
course, means that customers and suppliers are able
to compete in markets around the world. The
benefits of becoming certified are numerous;
companies should ensure that they are pursuing
certification for the right reasons. [9]
1. To improve business processes and save money.
Most companies implementing ISO 9000
IJAPR / June. 2012/ Vol. 3 /Issue. 6 / 937 945
certification report increases in business process
efficiencies, reductions in waste, and improved
product quality.
2. To qualify for new customers. Many corporations
see ISO 9000 Certification as an essential
requirement for conducting business with a new
vendor.
3. To enter global markets. ISO 9000 standards are
required in many countries.
THE BENEFITS OF ISO-9000:
There has been so much written about the benefits of
having ISO-9000 registration, there isn't enough space
on this website to repeat it all. We will attempt to list
some of the basic benefits here.[10]
1. ISO-9000 forces an organization to focus on "how
they do business". Each procedure and work
instruction must be documented and thus, becomes the
springboard for Continuous Improvement.
2. Documented processes are the basis for repetition
and help eliminate variation within the process. As
variation is eliminated, efficiency improves. As
efficiency improves, the cost of qualityis reduced.
3. With the development of solid Corrective and
Preventative measures, permanent, company-
wide solutionstoqualityproblemsarefound.
4. Employee morale is increased as they are asked to
take control of their processes and document their
work processes.
5. Customer satisfaction, and more importantly
customer loyalty, grows. As a company transforms
from a reactive organization to a pro-active,
preventative organization, it becomes a company
people want to do business with.
6. Reduced problems resulting from increased
employee participation, involvement, awareness and
systematic employee training.
7. Better products and services result from Continuous
Improvement processes.
8. Fosters the understanding that quality, in and of
itself, is not limited to a quality department
but iseveryone'sresponsibility.
9. Improved profit levels result as productivity
improves and rework costs are reduced.
10. Improved communications both internally and
externally which improves quality, efficiency, on time
delivery and customer/supplier relations.
THE BENEFITS OF ISO 9001REGISTRATION
INCLUDE
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 Shobhit Sharma et al. / International Journal of Advances in Pharmaceutical Research

1. Increased Productivity. The growth in ISO 9001 certification is

shown in the table below. The worldwide total of ISO
2. Increased efficiency of the company's internal 9001 certificates can be found in the ISO Survey of
operations. 9001 from Dec 2000 to 2011.[12,13,14]

3. Clearer definition of responsibility and

In recent years there has been a rapid growth
accountability.
in China, which now accounts for approximately a
4. Better traceability of quality problems to their root quarter of the global certifications.
causes.
Table 2. Top 10 ISO 2001Certificates Countries
5. Less time required to fix errors.
Rank Country No. Of certificates
6. Increase in the number of activities that are 1 China 2,10,773
performed properly on the first try. 2 Italy 1,15,359
7. Lower costs. 3 Japan 73,176
4 Spain 65,112
8. Lower costs and increased productivity. 5 India 46,091
6 Germany 45,195
9. Fewer procedures - elimination of unnecessary 7 USA 36,192
approvals and redundant work practices. 8 UK 35,517
9 France 22,981
10. Reduced number, cost, and scope of customer 10 Netherland 18,922
audits.

11. More effective marketing. ROLE OF ISO IN PHARMACY

12. Greater access to foreign markets that require ISO 1.ISO gives pharmaceutical industry new
9001. management tool to improve patient safety:
The benefits of implementing Good
13. Greater likelihood of winning government Manufacturing Practices and quality management are
contracts. henceforth made easier to achieve for the
pharmaceutical sector thanks to a new standard from
14. Improved ability to compete with larger, more ISO."The standard is of vital importance to the
established, software firms. pharmaceutical industry and its suppliers of
pharmaceutical primary packaging materials. For the
15. Broader exposure to new clients. first time, the principles of Good Manufacturing
Practice are specified as part of an ISO standard,"
16. Competitive advantage over those firms not explained Dr. Jrgen Thrk, Convenor of the working
registered to ISO 9001. group that developed the new standard. Good
Manufacturing Practices (GMP) relate to quality
17. Superior design. control and quality assurance enabling companies in
the pharmaceutical sector to minimize or eliminate
18. Improved reuse practices and easier retrieval of
instances of contamination, mix-ups, and errors. This
software components.
in turn, protects the customer from purchasing a
19. Fewer recurring errors. product which is ineffective or even dangerous. Up
until now, however, there was no applicable guideline
20. Increased designer self-discipline. or rule for primary packaging materials, which
contain, seal or are used for dose application and have
21. Greater customer confidence in the company's direct contact with the medicinal product. The
products.[10,11] publication of ISO 15378:2006, Primary packaging
materials for medicinal products Particular
GLOBAL SCENARIO requirements for the application of ISO 9001:2000,
represents an international consensus on good practice
and establishes a benchmark that can be applied for

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 Shobhit Sharma et al. / International Journal of Advances in Pharmaceutical Research
quality improvement, training, auditing and
certification. Developed with the participation of
pharmaceutical sector experts, ISO 15378:2006
incorporates in a single document the quality
management requirements of ISO 9001:2000 together
with the Principles of Good Manufacturing Practice
(GMP) for the design, manufacturing and supply of
primary packaging materials for medicinal
products.ISO 15378:2006 was developed by ISO
technical committee ISO/TC 76, Transfusion, infusion
and injection equipment for medical and
pharmaceutical use. The standard costs 154 Swiss
francs and is available from ISO national member
institutes (see the complete list with contact details)
and from ISO Central Secretariat.[15]
2 .USP GUIDELINES FOR MONITORING OF
SYSTEM
The United States Pharmacopoeia (USP) recently
released procedures and requirements for
compounding sterile preparations. General chapter
<797>, titled "Pharmaceutical Compounding? Sterile
Preparations," states that sterile compounding
procedures require clean facilities, specific training for
operators, air quality evaluations, and a sound
knowledge of sterilization and stability principles. The
nature of defining how these preparations shall be
compounded is related to the potential risk to patients,
should errors occur.
Environmental Requirements
Preparations are compounded according to 1 of 3
risk factors: low, medium, and high. Those
preparations that are compounded as aseptic
parenterals have the greatest risk of contamination,
and therefore they must be compounded in an area
tolerating only the lowest level of risk. According to
the USP <797>, "aqueous injections for administration
into the vascular and central nervous systems pose the
greatest risk of harm to patients if there are errors of
nonsterility and large errors in ingredients," and
therefore the greatest level of control over
compounding must be proven. They must be
compounded under a "laminar flow clean-air hood,
barrier isolator, or other contamination control device
appropriate for the risk level, that provides an
adequate critical site environment." Critical site
environments, defined below, must be proven to meet
the International Standards Organization's (ISO)
standard for cleanliness to ISO14644-1 Class 5, where
no more than 3520 particles at 0.5 microns are present
per cubic meter (m3) of sampled air. The ISO classes
will be discussed briefly in this article.
The supporting area, or clean room area where the
IJAPR / June. 2012/ Vol. 3 /Issue. 6 / 937 945
laminar flow stations are located, should meet at least
ISO 8 air quality standard. The supporting area will be
discussed in greater detail below.
For a better understanding of the requirements, a
document to read in conjunction with the USP <797>
is the FDA's Guidance for Industry: Sterile Drug
Products Produced by Aseptic Processing Current
Good Manufacturing Practice, September 2004. This
document identifies how the manufacturing and
compounding of sterile products and preparations
should be undertaken, and it defines certain elements
of critical environments.
ISO 5
The USP defines a critical area as the central location
for performing sterile manipulations, which should be
a laminar flow, ISO 5 environment. The FDA
guidance defines it as follows: A critical area is one in
which the sterilized drug product, containers, and
closures are exposed to environmental conditions that
must be designed to maintain product sterility.
Activities conducted in such areas include
manipulations (example, aseptic connections, sterile
ingredient additions) of sterile materials prior to and
during filling and closing operations.The USP and the
FDA share a harmonized view of both the definition
of critical areas and the activities that are critical in
nature. In addition, the FDA defines the limit of
particles in air:
Air in the immediate proximity of exposed sterilized
containers/closures and filling/closing operations
would be of appropriate particle quality when it has a
per-cubic-meter particle count of no more than 3520
in a size range of 0.5 micron and larger when counted
at representative locations normally not more than 1
foot away from the work site, within the airflow, and
during filling/closing operations. This level of air
cleanliness is also known as Class 100 (ISO 5).
Therefore, those activities that pose the greatest risk to
final product quality must be done in an environment
that meets ISO 5 requirements again showing
harmonization.
ISO 8
The USP states that a supporting area must meet an air
quality standard of at least ISO 8.The FDA
recommends the following:
The nature of the activities conducted in a supporting
clean area determines its classification. FDA
recommends that the area immediately adjacent to the
aseptic processing line meet, at a minimum, Class
10,000 (ISO 7) standards)under dynamic conditions.
Manufacturers also can classify this area as Class
1,000 (ISO 6) or maintain the entire aseptic filling
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 Shobhit Sharma et al. / International Journal of Advances in Pharmaceutical Research
room at Class 100 (ISO 5). An area classified at a
Class 100,000 (ISO 8) air cleanliness level is
appropriate for less critical activities (eg, equipment
cleaning).
Again, there is harmonization between the FDA and
the USP on the expectations of supporting clean areas,
although the FDA is more precise in defining that the
risk of each area should be assessed and a
classification assigned according to that risk. The
Table is an extract from the FDA guidance and can be
directly compared with that shown in USP <797>.The
Table also identifies the maximum permissible
microbiological limits for the associated preparation
and compounding areas.
Monitoring Frequency
In accordance with the USP <797>, a critical area
must prove to meet ISO 5 classification requirements
at least once in a 6-month period. The same interval
also is found in the ISO14644-2 guide. In addition, the
frequency of determining the cleanliness class of the
supporting area is at least once per 6 months, as
recommended by the USP. This interval is defined in
the ISO14644-2 as being at least every 12 months, so
the expectations of the USP are higher than those of a
typical ISO 8 clean room.[16]
3. ISO 9000 QUALITY MANAGEMENT
SYSTEM IN HEALTH CARE
The qualitative approach of this study was designed to
collect information pertaining to the effect of the ISO
9000 certification on the Organizational Management
Systems, and to complement the quantitative approach
of this study. Using a purposeful sampling method, the
structured interviews enabled the researcher to gain
perceptions on the effect of the ISO 9000 certification
on the organizational management systems. Data were
analyzed through a constant comparative method. As a
result, the following three topics were investigated:
Customers /Suppliers Relationship Management,
Human Resources Management, and Operations
Management. The findings revealed a friendly
atmosphere, a strong collaborative partnership
between the pharmacy and its internal customers
(physicians, nurses, and other caregivers) and external
customers (patients), a lack of direct interaction with
its suppliers, employee participation in decision
making was effective, a lack of training and
educational program, and intense process management
activities. However, the results showed this hospital
pharmacy as deficient in using technology assessment
services such as bar code medication administration
system, preprinted order sets system, and computer
decision support. A full usage of technology could
IJAPR / June. 2012/ Vol. 3 /Issue. 6 / 937 945
have optimized the entire process. Overall, this study
presents ISO 9000 Quality Management System as
effective in improving the pharmacy management
systems. A well documented and consistent ISO 9000
Quality Management System can contribute
significantly to improve performances in health care
setting.[17]
ADVANTAGES
It is widely acknowledged that proper quality
management improves business, often having a
positive effect on investment, market share, sales
growth, sales margins, competitive advantage, and
avoidance of litigation include the quality principles in
ISO 9000:2000 are also sound, according to Wade and
also to Barnes, who says that "ISO 9000 guidelines
provide a comprehensive model for quality
management systems that can make any company
competitive." Implementing ISO often gives the
following advantages:[18]
1. Creates a more efficient, effective
operation
2. Increases customer satisfaction and
retention
3. Reduces audits
4. Enhances marketing
5. Improves employee motivation,
awareness, and morale
6. Promotes international trade
7. Increases profit, reduces waste and
increase productivity.
CONCLUSION
After a brief literature survey on globalization
of ISO that ISO certification is very necessary for the
all type of industries like electrical, pharmacy,
management including health care department and
medical field. ISO is also applied in big laboratories
where more research has been conducted. ISO gives
various ISO series to different industries for doing
their work in different fields.ISO gives different series
of ISO for different- different works. In global
adoption we have seen that the ISO certifications
increasing from year to year. China is the first country
who has large number of ISO certification and India is
on the fifth number in ISO certification. If there is a
industry on small scale it should also have the ISO
certification for doing the work. ISO give the quality
to the product and increase the position of the industry
in the global market because if we are ISO certified
than we can do market with various foreign industries.
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