Vishal Sachdeva et al.

/ Journal of Pharmacy Research 2012,5(8),4108-4112

Review Article
ISSN: 0974-6943

Available online through

www.jpronline.info

ISO 9000 & its Importance in Pharmacy

Vishal Sachdeva*, Vipin Kukkar, Vikram Jeet Singh, Shishir Jha
Seth G. L. Bihani S. D. College of Technical Education (Institute of Pharmaceutical Sciences & Drug Research)
Gagan Path, Sri Ganganagar (Rajasthan) 335001, INDIA

Received on:14-05-2012; Revised on: 16-06-2012; Accepted on:27-07-2012

ABSTRACT
ISO 9000 Quality Management System is a structural framework of a business system that specifies, in very broad terms, the necessary components of
a quality management system. Subjective studies suggest that ISO 9000 can help organizations improve their management practices. In this paper, the
researcher examined the effectiveness of the ISO 9000 certification, and tested whether earning the ISO 9000 certification leads to improvement in quality
management practices, in medication management practices, and in organizational management systems in health care setting. 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.
Key words: ISO, Quality Management, Pharmacy.

INTRODUCTION
ISO (International Organization for Standardization) is the worlds largest
developer and publisher of International Standards.
ISO is a network of the national standards institutes of 162 countries,
one member per country, with a Central Secretariat in Geneva, Switzerland,
that coordinates the system.
ISO is a non-governmental organization that forms a bridge between
the public and private sectors. On the one hand, many of its member
institutes are part of the governmental structure of their countries, or are
mandated by their government. On the other hand, other members have
their roots uniquely in the private sector, having been set up by national
partnerships of industry associations.
Therefore, ISO enables a consensus to be reached on solutions that meet
both the requirements of business and the broader needs of society.
ISOs NAME
Because International Organization for Standardization would have
different acronyms in different languages (IOS in English, OIN in French
for Organisationinternationale de normalisation), its founders decided to
give it also a short, all-purpose name. They chose ISO, derived from the
Greek isos, meaning equal. Whatever the country, whatever the
language, the short form of the organizations name is always ISO.
Why Standards matter
Standards make an enormous and positive contribution to most aspects of
our lives.
Standards ensure desirable characteristics of products and services such as
quality, environmental friendliness, safety, reliability, efficiency and
interchangeability - and at an economical cost.

*Corresponding author.
Vishal Sachdeva
106-A, Setia Colon St. No. 3
Sri Ganganagar (Rajasthan)
India, 33500

When products and services meet our expectations, we tend to take this for
granted and be unaware of the role of standards. However, when standards
are absent, we soon notice. We soon care when products turn out to be of
poor quality, do not fit, are incompatible with equipment that we already
have, are unreliable or dangerous.
When products, systems, machinery and devices work well and safely, it is
often because they meet standards. And the organization responsible for
many thousands of the standards which benefit the world is ISO.
Who Standards Benefit
ISO standards provide technological, economic and societal benefits.
For businesses, the widespread adoption of International Standards means
that suppliers can develop and offer products and services meeting
specifications that have wide international acceptance in their sectors.
Therefore, businesses using International Standards can compete on many
more markets around the world.
For innovators of new technologies, International Standards on aspects
like terminology, compatibility and safety speed up the dissemination of
innovations and their development into manufacturable and marketable
products.
For customers, the worldwide compatibility of technology which is achieved
when products and services are based on International Standards gives them
a broad choice of offers. They also benefit from the effects of
competition among suppliers.
For governments, International Standards provide the technological and
scientific bases underpinning health, safety and environmental legislation.
For trade officials, International Standards create a level playing
field for all competitors on those markets. The existence of divergent
national or regional standards can create technical barriers to trade.
International Standards are the technical means by which political trade
agreements can be put into practice.

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For developing countries, International Standards that represent an
international consensus on the state of the art are an important source
of technological know-how. By defining the characteristics that products
and services will be expected to meet on export markets, International
Standards give developing countries a basis for makingthe right
decisions when investing their scarce resources and thus avoid squandering
them.
For consumers, conformity of products and services to International
Standards provides assurance about their quality, safety and reliability.
For everyone, International Standards contribute to the quality of life in
general by ensuring that the transport, machinery and tools we use are safe.
For the planet we inhabit, International Standards on air, water and soil
quality, on emissions of gases and radiation and environmental aspects of
products can contribute to efforts to preserve the environment.
ISO 9000 Origin
The story of ISO 9000 is a story of standards, methods and regulation. The
brief history that follows is in no way comprehensive but is intended to
illustrate four things

that standards are an ancient concept that survived several millennia;

that a means of verifying compliance often follows the setting of

standards;

that the formalizing of working practices is centuries old and seen

as a means to consistently meet standards;

that market regulation (relative to the standard of goods and services) has been around for centuries for the protection of both
craftsmen and traders.
ISO 9000 is a symptom of practices that were around centuries before
anyone coined the term quality management. It is in some respects a natural
progression that will continue to evolve. The story is told from a British
viewpoint.

ISO 9004

Quality Management Systems-Guidelines For Performance

Improvements
ISO 14000 Series on Environmental Management
ISO 19011 Guidelines for Quality and/Or Environmental Management
Systems Auditing
Types of ISO 9000
What is the difference between ISO 9001 / 9002 / 9003?
ISO 9001
Is the most complete and demanding standard in the ISO 9000 series. It
covers product design, engineering,manufacturing, purchasing, marketing,
sales, product storage, shipping and handling and product servicing.
ISO 9002
is the next most demanding standard in the ISO 9000 series
is designed to assure customers that the quality system is in place from
manufacturing to service.
ISO 9003
is the least demanding standard in the ISO 9000 series.
It addresses only the requirements for detection and control of problems
during final inspection and testing of less complex products or services.
ISO 9000 Series Quality Management System
Principles
1 CUSTOMER FOCUSED ORGANIZATION
2 LEADERSHIP
3 -INVOLEMENT OF PEOPLE
4 - PROCESS APPROACH
5 - SYSTEM APPROACH TO MANAGEMENT
6-CONTINUAL IMPROVEMENT
7- ACTUAL APPROACH TO DECISION MAKING
8- MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIPS

How ISO Standars are developed?

The national delegations of experts of a technical committee meet to discuss,
debate and argue until they reach consensus on a draft agreement. This is
circulated as a Draft International Standard (DIS) to ISOs membership as
a whole for comment and balloting.

On September 17, 1999, NASA became the first multi-site government

agency in the world to achieve ISO 9001 registration status for all of its
sites, fulfilling a goal set by NASA Administrator Daniel Goldin on November
13, 1996.

Many members have public review procedures for making draft standards
known and available to interested parties and to the general public. The ISO
members then take account of any feedback they receive in formulating
their position on the draft standard.

ISO 14000
The ISO 14000 environment management standards exist to help
organizations minimize how their operations negatively affect the
environment.

If the voting is in favour, the document, with eventual modifications,

is circulated to the ISO members as a Final Draft International Standard
(FDIS). If that vote is positive, the document is then published as an
International Standard.

ISO 14001
ISO 14001 is generic and flexible enough to apply to any organization
producing any product or service anywhere in the world.

Every working day of the year, an average of eight ISO meetings are taking
place somewhere in the world. In between meetings, the experts continue
the standards development work by correspondence. Increasingly, their
contacts are made by electronic means and some ISO technical bodies have
already gone over entirely toworking electronically, which speeds up
the development of standards and cutstravel costs.
Popular Standards
ISO 9000 Quality Management Systems - Fundamentals And
Vocabulary
ISO 9001 Quality Management Systems Requirements

ISO 14020
covers labels and declarations.
ISO 14030
discusses post-production environmental assessment.
ISO 14040
discusses pre-production planning and environment goal setting.
ISO 9000 SERIES
The ISO, based in Switzerland, first published the ISO 9000 standards in
1987. The series was designed as a means to increase customer confidence

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in the quality of supplied materials, products, or services. This was especially
important for trade between different countries with different languages
and cultures. Not surprisingly, the initial emphasis was within the European
Economic Community as part of the movement to a unified market. The
standard has evolved over several revisions. The initial 1987 version, ISO
9000:1987, although structured like the British Standard BS 5750, included
numerous documents then in use around the world. Although the Standard
has gone through two more iterations, which have resulted in some radically
changed language, all the core, prevention-oriented quality assurance
requirements were present in the 1987 document. The language of this first
version of the Standard was influenced by existing U.S. and other Defence
Military Standards (MIL SPECS), so was more accessible to
manufacturing, and was well-suited to the demands of a rigorous, stable,
factory-floor manufacturing process. With its structure of twenty
elements of requirements, the emphasis tended to be overly placed on
conformance with procedures rather than the overall process of management,
which was the actual intent.
The 1994 version, ISO 9000:1994 emphasized quality management and
quality assurance via preventive actions, and continued to require evidence
of compliance with documented procedures. Unfortunately, as with the
first edition, companies tended to implement its requirements by creating
shelf-loads of procedure manuals, and becoming burdened with an ISO
bureaucracy. Adapting and improving processes could be particularly difficult
in this kind of environment. The 2000 version, ISO 9000:2000 that consists
of ISO 9001:2000 and ISO 9004:2000, made a significant change by actually
placing the concept of process management front and center in the Standard.
There was no change in the essential goals of the Standard, which was all
about a documented system, not a system of documents. The goal was
always to have management system effectiveness via process performance
metrics. The third edition makes this more visible and so reduced the emphasis
on having documented procedures if clear evidence could be presented to
show that the process was working well. Expectations of continual process
improvement and tracking customer satisfaction were made explicit at this
revision. ISO 9000 has gained extensive acceptance, having been adopted
by over 100 countries. Compliance is voluntary; however, some companies
have made certification a condition of doing business. The registration
process involves independent audit and confirmation that quality systems
are in compliance with the standard. A fee is involved and periodic
reinspection is required. A certificate of compliance is provided. This is the
converse of the U.S. GMP situation, where compliance is assumed unless
the FDA states otherwise, and no certificate of compliance is provided.
However, a major benefit of ISO 9000 has been to allow and encourage
nonregulated industries to introduce a quality management system.
Previously, the only widely established systems included regulations such
as GMPs aimed at specific industries and award programs such as Deming
and Malcolm Baldrige. None of these had universal coverage, although the
World Health Organization GMPs do apply to many countries. Since the
pharmaceutical industryis already subject to quality regulations, attaining
ISO 9000 or 9001certification is not a goal of pharmaceutical manufacturers.
However, suppliers to the pharmaceutical industry have sought it.
Evolution of ISO 9000 Standards
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 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 9003
into 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 optimisation of a companys tasks and activities,
instead of just inspection of 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 continualprocess 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.
2008 version
ISO 9001:2008 basically renarrates ISO 9001:2000. The 2008 version 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.
ISO 9000 has eight quality management principles on which the quality
management system standards of the revised ISO 9000:2000 series are
based. The principles are derived from the collective experience and
knowledge of the international experts who participate in ISO Technical
Committee ISO/TC 176, quality management, and QA, which is responsible
for developing and maintaining the ISO 9000 standards . The eight quality
management principles are defined in ISO 9000:2000, Quality Management
Systems Fundamentals and Vocabulary, and in ISO 9004:2000, Quality
Management Systems Guidelines for Performance Improvements. A
comparison to U.S. GMP is presented.
Principle 1: Customer Focus
Organizations depend on their customers and therefore should understand
current and future customer needs, should meet customer requirements and

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strive to exceed customer expectations.Customer focus is a critical business
focus and is not covered in the U.S. GMPs other than the need to have
products that meet the standards and specifications.
Principle 2: Leadership
Leaders establish unity of purpose and direction of the organization. They
should create and maintain the internal environment in which people can
become fully involved in achieving the organizations objectives. There is
no mention of Leadership in the U.S. GMPs but the concept is included in
the Quality Systems Approach to Pharmaceutical GMP Regulations final
guidance, September, 2006 where providing leadership is the first item in
the management responsibilities section.
Principle 3: Involvement of People
People at all levels are the essence of an organization and their full
involvement enables their abilities to be used for the organizations benefit.
Responsibilities of the quality unit and personnel qualifications are covered
in the U.S. GMPs and the develop personnel concept is in the Quality
Systems Approach guidance.
Principle 4: Process Approach
A desired result is achieved more efficiently when activities and related
resources are managed as a process.

assist organizations improve performance. The standards can be used

without being linked with certification.
All organizations have a quality management system but its formalization
is optional. The system enables the organization to achieve its objectives
and therefore exists independently of whether or not ISO 9000 is used and
whether or not ISO 9000 Certification is obtained.
Remove the two outer pillars and the organization remains stable! The
foundation upon which the three pillars stand is the body of knowledge
that represents the field of quality management. Most of this knowledge is
channelled through the management system, somewhat less is channelled
through the standard (ISO 9000) and a particular branch ofthe body of
knowledge is channelled through certification. An organizationcould absorb
and apply all relevant knowledge and therefore obtain noadditional support
from ISO 9000 standards or ISO 9000 certification. Anotherorganization
may absorb and apply some knowledge directly from thefoundation but
require the support of the ISO 9000 standards to helpunderstanding and
application. A third organization may absorb and applylittle knowledge
directly from the foundation and require both the support ofthe ISO 9000
standards and ISO 9000 certification to maintain a stable androbust
management system.(Hoyle D. 2001)
Importance of ISO 9000 in Pharmacy

Principle 5: System Approach to Management

Identifying, understanding, and managing interrelated processes as a system
contributes to the organizations effectiveness and efficiency in achieving
its objective. Principles 4 and 5 are not covered in the U.S. GMPs but the
concepts are implied in the Quality Systems Approach guidance.
Principle 6: Continual Improvement
Continual improvement of the organizations overall performance should
be a permanent objective of the organization. The closest thing to continual
improvement is the corrective and preventive action (CAPA) GMP practices
that are typically the results of a failure investigation.
Principle 7: Factual Approach to Decision Making
Effective decisions are based on the analysis of data and information. The
basis of science and supporting data is a fundamental expectation of the
U.S. GMPs and quality by design (QBD) initiatives.
Principle 8: Mutually Beneficial Supplier Relationships
An organization and its suppliers are interdependent and a mutually
beneficial relationship enhances the ability of both to create value. Control
of materials and components is a U.S. GMP requirement and quality
agreements and supplier contracts are expected practices but relationships
are not a requirement.
The Three Pillars of ISO 9000
ISO 9000 Certification is only of any value in markets where it provides the
confidence needed for free trade. ISO 9000 as a symbol has become
synonymous with certification, quality management systems, documentation
and internal audits to such an extent that if one were to dispense with ISO
9000 certification, one also ceases to maintain a quality management system,
ceases to conduct audits and ceases to use documentation. We have to
divorce certification from systems and systems from standards and correct
a few misconceptions. ISO 9000 Certification is optional and whether or
not your organization is ISO 9000 certificated, it does not by itself affect
the performance of an organization. It is a flag of confidence that is visible
to others with whom you trade. Certification is inextricably linked to the
standard. ISO 9000 is a series of standards and their use is optional. They
do not affect the performance of an organization although their use can

ISO Gives Pharmaceutical industry new management tool to improve

patient safety
The benefits of implementing Good Manufacturing Practices and quality
management are henceforth made easier to achieve for the pharmaceutical
sector thanks to ISO.
The standard is of vital importance to the pharmaceutical industry and its
suppliers of pharmaceutical primary packaging materials. For the first time,
the principles of Good Manufacturing Practice are specified as part of an
ISO standard.
Good Manufacturing Practices (GMP) relate to quality control and quality
assurance enabling companies in the pharmaceutical sector to minimize or
eliminate instances of contamination, mix-ups, and errors. This in turn,
protects the customer from purchasing a product which is ineffective or
even dangerous. Up until now, however, there was no applicable guideline
or rule for primary packaging materials, which contain, seal or are used for
dose application and have direct contact with the medicinal product.
The publication of ISO 15378:2006, Primary packaging materials for
medicinal products Particular requirements for the application of ISO
9001:2000, represents an international consensus on good practice and
establishes a benchmark that can be applied for 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.
In addition, the new standard gives guidance on risk management and
validation and in line with current developments worldwide contains
guidance annexes on both these aspects.
The standard is applicable to all primary packaging materials (glass, rubber,
plastic, aluminum, etc.).

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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 and from ISO Central Secretariat.
ISO 9000 IN R&D

Process driven quality system much as ISO 9001 are potentially

of great value to control the quality of the R&D process

ISO 9001: 2000 provides an ideal opportunity for R&D managers to achieve the benefits of total quality management and
thus improvement in various key performance.

Within the R&D context, ISO 9001 is becoming more popular as

a way of making people think and plan ahead and as providing
a disciplined way of capturing the R&D.

The revised version of ISO 9001 look into the dynamic character
of organisations in which issues such as leadership, people involvement, system approach to management, continuous,
improvernent and a fact -based approach to decision-making for
example receive special attention. The need for more dynamic
approach To R&D management has been emphasized for years.

ISO 9001 addresses both the issues of better control and continuously raising the R&D standards

ISO 9001 is a good means of providing a framework for developing a quality system in R&D. It outlines the organizational
structural management responsibilities, procedures and processes
required to set the base for a holistic quality management system.
Other Applications of ISO 9000 Iin Pharmacy
1. Increased Efficiency
Companies that go through the ISO 9001:2000 Quality Management
Standards certification process have given a lot of thought to their processes
and how to maximize quality and efficiency. Once certified for QMS, the
processes are established and guidelines in place for anyone to follow
easily, making training, transitions, and trouble-shooting easier
2. Increased Revenue
Studies have shown that ISO QMS certified companies experience increased
productivity and improved financial performance, compared to uncertified
companies.
3. Employee Morale
Defined roles and responsibilities, accountability of management, established
training systems and a clear picture of how their roles affect quality and the
overall success of the company, all contribute to more satisfied and motivated
staff.
4. International Recognition
The International Organization for Standardization (ISO) is recognized
worldwide as the authority on quality management.
5. Factual Approach to Decision Making
The ISO 9001:2000 QMS standard sets out clear instructions for audits
and process reviews that facilitate information gathering and decision making
based on the data.
6. Supplier Relationships
Mutually beneficial supplier relationships are one of the key attractions to
ISO certification. Following the processes for documentation and testing
ensure quality raw materials go into your production system. The process

also requires thorough evaluation of new suppliers before a change is made

and/or consistency with respect to how and where orders are placed.
7. Documentation
The ISO QMS standard requires documentation of all processes and any
changes, errors and discrepancies. This ensures consistency throughout
production and accountability of all staff. This also guarantees traceable
records are available in case of non-compliant products or raw materials.
8. Consistency
One of the foundations of ISO; All processes from research and development,
to production, to shipping, are defined, outlined and documented, minimizing
room for error. Even the process of making changes to a process is
documented, ensuring that changes are well planned and implemented in the
best possible way to maximize efficiency. Recommendations in the biotech
industry to use XML authoring or similar software formatting for data
collection, reports, and product labelling, minimizes the risk of obsolete
documents/labels being mistakenly used.
9. Customer Satifaction
Client confidence is gained because of the universal acceptance of the ISO
standards. Customer satisfaction is ensured because of the benefits of ISO
9001:2000 QMS to company efficiency, consistency and dedication to
quality service.
10. Improvement Processes
The ISO 9001:2000 QMS outlines audit processes, management review
and improvement processes based on collected data. Improvements are
carefully planned and implemented based on facts, using a system of
documentation and analysis, to ensure the best decisions are made for your
company.
REFERENCES
1. Hoyle D. (2001) Iso 9000 Quality Systems Handbook Fourth
Edition butterworth-Heinemann, Linacre House, Jordan Hill,
Oxford Woburn 83-90
2. Nally J. (2007) Good Manufacturing Practices For
Pharmaceuticals sixth edition by Informa Healthcare USA, Inc.
New York, ny 10016 350-352
3. Leonard S. (2003) Gmp/Iso Quality Audit Manual for Healthcare
Manufacturers and Their Suppliers sixth edition volume 1 by
CRC Press United States of America 07
4. Macey S. (2001) An Integrated Model For Performance
Management Based On Iso 9000 And Business Excellence Models
2001 National Library Of Canada. 51
5. Other Application of ISO at www.biotech.about.com/od/
isocertification/tp/ISOQMS/.htm accessed on 22 march 2012
6. Kenkel J. 2000 A Primer on Quality In The Analytical
Laboratory Published By Crc Press Llc , United States Of
America 1-2
7. Sharma D. (2005). The association between ISO 9000
certification and financial performance. The International Journal
of Accounting 40.
8. Introduction to ISO Available at http://www.iso.org/iso/about.htm
9. Types of ISO 9000 Available at http://www.pharmainfo.net/
reviews/international-organization-standardization
10. Iso Gives Pharmaceutical Industry New Management Tool To
Improve Patient Safety available at http://www.iso.org/iso/
pressrelease.htm?refid=Ref998

Source of support: Nil, Conflict of interest: None Declared

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