ISO 9000 SERIES

INTRODUCTION:
ISO is the worlds largest developer of voluntary standards. ISOS
core activity is the development of voluntary standards but its scope is
expanding in the areas of services, management practices and conformity
assessment. ISO standards therefore have a growing economic and social
impact.
The ISO is responsible for developing, maintaining and publishing
the ISO family. ISO is a non government organization network of the
national standards institute of 150 countries with one member per country
with a central secretariat in Geneva, Switzerland co-ordinates the system. It
was created in 1947.
DEFINITION:
ISO is the fundamental generic element that would form the basis
for a series of internationally recognized quality management standards.
ISO 9000series is a set of internationally quality system standards for
a) designing.
b) manufacturing.
c) servicing the product your company produces.
This quality system was audited by the third party with the resulting
being published. The third party audit of the quality system should be

likened by the financial audit. Financial health is determined by an

examination of the balance sheet and product quality is determined by an
examination of the quality system.

Thus the goal of ISO is customer driven system of

Quality control and quality assurance
ISO (International Organization for Standardization):
ISO is a world wide federation of national standard bodies presently
comprising of about 140 members , one in each country.
Its members are divided into 3 groups:
a) Member bodies: participation in meeting and have full voting rights.
Ex: India, china, Brazil, Japan.
b) Correspondence bodies: may participate and have no voting rights.
Ex: Afghanistan, Angola, Nepal, Uganda.
c) Subscriber members: No participation & have no voting rights.
Ex: Dominicia, Cambodia, Burundi, Lesitho.
The prime aim of ISO is to promote the development of
standardisation and releated activities with a

view to improve the

international exchange of goods and services.

ISO 9000 STANDARDS:

It is published by the international organization for standardization
based in Switzerland. It is an international set of quality standards

documented by the members of ISO technical committee and presented in

the form of ISO STANDARDS.

HISTORY/ EVOLUTION OF ISO STANDARDS:

The concept of quality might have originated with the origin of
mankind.
But in 19th century, the first attempt to standardize quality was
made in America for defence items. This standardisation gave rise to MILQ-9858 & M IL-I-45208 as quality system specification and inspection
respectively. Both the standards are used even today in American Defence
contracts. From the basis of above standards, a series of standards are
assigned to use within NATO and those standards are referred as Allied
Quality Assurance Publications (AQAP) 1, 4 and 9.
Mean while U.K who did not accept AQAP, even being a member
of NATO, introduce 3 analogues specifications that were called as defence
standards (DEF_STANS). U.K adopted the above standards, (which were
previously meant for defence contracts) within the industry. Which resulted
in the evolution of British BS 4891 and BS 5171.
At the same time in the united market of Europe, there were trade disputes
arised due to different standards practiced by different countries. Therefore
EEC (European Economic Community) in order to harmonize the quality
standards, applied global approach under the Chairmanship of Canada in
regard to certification and testing on dec 21-1989. The standards thus
formulated for certification and testing ultimately took in the form of ISO
9000 series of standards.

What is ISO 9000 series?

ISO 9000 is a set of standards for quality management systems that
is accepted around the world (or). It deals with quality management systems
for assuring quality of products and services.

What is ISO 9001?

The standards intended for quality management system assessment
& registration is ISO 9001.

Why we need ISO 9000?

1. ISO 9000 ensures consistent quality: It helps to maintain consistently
of product quality so that the criterion fitness for use is maintained.

2. ISO 9000 generates profits: It generates profits by impacting customer

confidence, lowering production costs and improving productivity.

3. ISO is for export: The driving force behind ISO 9000 accreditation is
its export prospects, that it helps a company in becoming a global
competitor or to penetrate the world market easily.

For ex: exports of products to 12 members of EEC/EFTA and

countries like Singapore, Argentina, Brazil, etc requires ISO certification. In
the near future for business within the country also requires ISO
accreditation.

CONSTITUENTS OF ISO 9000 SERIES QUALITY SYSTEM

The ISO 9000 series consists of 5 documents i.e.,
Quality System

Title
Quality management &

What it contains
Guidelines for selection and

ISO 9000

Quality Assurance

use of standards

standards.
Model for quality assurance
ISO 9001

in design/development
Quality systems.

production installation &

servicing.
Model for quality assurance
ISO 9002

Quality systems

in production installation &

Quality systems

servicing.
Model for quality assurance

Quality management &

in final inspection & testing.

Guidelines for designing

Quality system elements

quality systems & its

ISO 9003

ISO 9004

management

DETAILED STRUCTURES OF 9000 SERIES QUALITY

SYSTEM:
I. ISO 9000: Quality management & quality assurance stardards.
ISO 9000 defines terms and provides overall guidance on the
selection & application of the three main standards (i,e ISO 9001, ISO 9002,
& ISO 9003). It is a descriptive document & is not part of the
registration/certification process.
ISO 9000 CONSISTS OF 4 PARTS (SUB-CLASSES).
ISO 9000-1 Guidelines for selection & use. (Provide guidance on which std
to use)
ISO 9000-2 Guidelines for the application of ISO 9001, ISO 9002, ISO
9003. (Guidance in implementation)
ISO 9000-3 Guidelines for the application of ISO 9001 to the development,
supply & maintenance of software.
ISO 9000-4 Guide to dependability program management (Provide
guidance when the emphasis is on product on service
reliability)

II. ISO 9001: Quality system

Model for quality assurance in design development, production,

installation & servicing. It Involves product design, development,
productions, installation & servicing. In case of ISO 9002 & 9003 the
emphasis is not given to product design & development. The design &
production of customized packaging or third party development &
Production of OTC medicines should be addressed by this standard.
III. ISO 9002: Quality systems
Model for quality assurance in production installation & servicing:This standard applies to more routine production where
product quality requirements can be adequately expressed in terms of
specification. In these situation design criteria are either un-important or
have been resolved. Therefore it is identical to ISO 9001 with the exclusion
of selection in design control. (production &supply of excipients & bulk
pharmaceuticals could be fit into this standard.
IV. ISO 9003: Quality system
Model for quality assurance in final inspection & test:This applies to contracted arrangements that rely on a
suppliers ability to detect control non conforming products by final testing
& inspection. It is difficult to perceive to Situation where this would apply
within the pharmaceutical industry, where quality must be built in to design
& production of the product.
V. ISO 9004: Quality management & quality system elements
Like ISO 9000 it is a descriptive document which provides more
detailed guidance on the quality elements included in the registration or
certification standards ISO 9000, ISO 9002, & ISO 9003.
SUB CLASES OF ISO 9004:

SUB CLASES
ISO9004-1
ISO9004-2
ISO9004-3
ISO9004-4
ISO9004-5
ISO9004-6
ISO9004-7
ISO9004-8

WHAT IT DEALS
General guidelines
Guidelines for service
Guidelines for processed materials
Guidelines for quality improvement
Guidelines for quality plans
Guidelines for quality assurance on project management
Guidelines for configuration management
Guidelines for quality principles, their application to
management practices.

ELEMENTS OF ISO 9000 SERIES:

1. MANAGEMENT RESPONSIBILITY:
The involvement & contribution of top management is required in
defining quality policy & its Objectives. This is not specific requirement in
cGMP, but it is assumed. ISO also carry out the evaluation of cost associated
with the quality and cost/benefit ratio is determined. Such an evaluation is
not included in cGMP. But in cGMP it is implied that 100% compliance is
required regardless of cost.

2. QUALITY SYSTEM:
A documented quality system is to be implemented and maintained
usually in the format of a Quality manual. A life cycle approach is proposed,
which includes all the elements starting from market research to define
customer needs and preferences to final products, after sale and final
disposal.

Most of this topic are included in the cGMP and cGMP are more
concerned with product safety & efficacy than with customer satisfaction.
3. CONTRACT REVIEW:
A contract should exist between the suppliers and the manufactures
that clearly defines the Quality requirements and assures that the suppliers
have the ability to meeting its requirements.
4. DESIGN CONTROL:
ISO 9000 provides extensive guidance regarding design control.
ISO 9000 series supersedes cGMP in design control. It involves the
conversion of customer needs to final products. Each and every step in the
design/development process is monitored to assure the quality of the final
product. This level of control during product design and development is not
included in the cGMP.
5. DOCUMENT CONTROL:
It involves the effective control of approved documentation from
initiation, issue to use. Obsolete documentation must be removed from the
operation and change over procedures is required.

6. PURCHASING:
It defines how to assure the quality of purchased materials and what
are the steps to be taken for the steps to be taken for the selections of sub
contractors. cGMP only address from recipt of purchased materials onwards.
7. CONTROL OF CUSTOMER SUPPLIED PRODUCTS:

Customer means sub contractors. There should be proper control

over the customer supplied products, which are used in the formulation of
products and proper record should be maintained.
8. PRODUCT IDENTIFICATION AND TRACIABILITY:
It involves the identification and traceability of product during the
various stages of productions, delivery and installator and proper records of
identification should be maintained.
9. PROCESS CONTROL:
It means the production should be carried out in accordance with
the planned and approved processes, during which there should be
appropriate controls. Inadequate planning can have adverse impact on
quality, especially for rush jobs where shortcuts may be taken. The
properly planned process control can reduce the cost of quality failure
(reworks, rejections and recalls)
10.INSPECTION AND TESTING:
It includes the inspection and testing of purchased materials to
assure the quality.
11.CONTROL OF MEASURING AND TEST EQUIPMENT:
Measuring and test equipment must be calibrated and appropriate
action should be taken, If the equipment is found to be outside the accepted
ranges.
12.INSPECTION AND TEST STATUS:
It refers to the status identification of materials and products, that
means, like cGMP, it make use of tags such as:
Undertesting - yellow

Pass

- green

Rejected

- red

Which are used to identify conforming and non conforming products.

13.CONTROL OF NON CONFORMING PRODUCTS:
Non conforming products quality not yet confirmed. There should
be proper control over the non conforming products by maintaining
procedure related to identification evaluation documentation and disposition
of non conforming materials.
The disposition includes the reworking acceptance if non
conformance will not adversely impact on further processing or quality or
ejection. But cGMP allows only rejection.
Ex: tablets reprocessed after defoiling the defective strips.
14.CORRECTIVE AND PREVENTIVE ACTION:
It includes the retention of records relating to product quality for
agreed period of time. The ISO 9004-1 defines what a type of document has
to be retained. Which includes specification and test methods, test results
production records, validation report, audit reports and quality cost reports.
15.INTERNAL QUALITY AUDITS:
It means internal audits should be performed and documented in
accordance with the defined plan to provide assurance of ongoing process.
Two types :
1) System audit: to check activity that can affect final product quality.
2) Product audit: to assure the quality of product. Internal auditing
permits

various

functioning.

departments

to

continuously

improve

their

16.TRAINING:
Training is required for all the personnel, who are engaged in
quality related activities and record are to maintained. ISO 9004-1 refers to
the importance of motivations quality awareness measurement an
recognition of performance. None of these important features are included in
the GMP.
17.SERVICING:
There should be procedures to evaluate and report on performance.
18.STATISCAL TECHNIQUES:
Statistical techniques are applied to verify process capability and
product characteristics.
There are various statistical techniques like:
1) Design of experiments and factorial analysis.
2) Analysis of variants (ANOVA).
Which are carried out in various fields like market analysis, product
design, stability, process controls and capability, sampling and data analysis.

HOW OFTEN ARE THE ISO 9000 STNDARDS REVISED?

The original series of standards ISO 9000, 9001, 9002, 9003 and
9004 were issued in 1987. Subsequent revisions are always listed with the
standard(ex: ISO 9001-1994). It was the intent Of

ISO to review the

standards every 5 years.

WHAT IS ISO REGISTRATION?

When an assessment of a companys quality system is conducted by
a registrar and he is found that the company is in compliance with ISO
standards (9001, 9002 or 9003).
The registrar recommends registration to the accreditation agency.
The accreditation agency reviews the registrars findings and if satisfied by

accreditation agency, permits the registrar to issue a certificate of

registration.
It is important to remember that THE QUALITY SYSTEM IS
REGISTERED NOT THE PRODUCT PRODUCED.

ISO 9000 REGISTRATION PROCESS:

Application
Documentation review
Pre assessment

Application accepted
Review of documentation and issue report
visit site, assessment of documentation &

Registration audit

implementation
assess implementation and effectiveness of

Registration decision
Post registration

quality systems
Review audit for registration
Periodic survey of quality system

Surveillance

DIFFERENCES BETWEEN ISO 9000 AND cGMP:

cGMP
1) cGMP adopted by most of industries and give importance in both
formulations and bulk manufacturing.
2) Its compliance is assured and no certificate of compliance is provided.
3) It do not address business results. They measure customer satisfaction
& dissatisfaction.
4) Its quality is assured during manufacturing and is ensured through
process of testing & maintained & monitored up to sale.
5) It is not concerned with the selection of suppliers & maintenance of
records of such suppliers.
6) Control during product design & development is not included in gmp.
7) Corrective & preventive actions are not taken to prevent the future
occurrence.

8) cGMP evaluation punish non compliance.

ISO 9000
1) Introduction is somewhat limited to pharmaceutical field, and
importance is given only on bulk pharmaceuticals.
2) After an independent audit, if the company is compliant with the
standards a certificate of compliance is provided.
3) It includes strategic planning and business results.
4) ISO is concerned with quality, which is built during manufacturing
and is ensured through process of testing and maintained and
monitored even after release for sale.
5) ISO is concerned with the selection of suppliers and maintenance of
records of such supplier.
6) Control during product design and development is included in ISO.
7) Corrective and preventive actions are taken to prevent the future
occurrence.
8) Malcom Baldrige National quality Awards [MBNQA] and ISO
recognize and reward achievement by the awards or certification.

ADVANTAGES OF IMPLEMENTING ISO:

The organization will derive following benefits by deploying QMS.
1) Change of thought pattern of people towards continual improvement
from the current level of performance.
2) Reduced cycle time of product development and manfacture of
medicines.
3) Increased return on investment and improved operational results.
4) Increased market share and profits.
5) Improved organizations image in the market.
6) User will benefit by improved quality medicines, tablets , capsules,
syrups and injectables at low price.

EMPLOYEES IN THE ORGANIZATION WILL BENEFITS BY:

1) Better working conditions.
2) Increased job satisfaction.
3) Improved morale.
4) Improved stability of employment.
Society will benefit by the organizations fulfillment of legal and
regulatory requirements, improved health and satety. Reduced
environmental impact and increased security.

LOOP HOLES OR LIMITATIONS OF ISO STANDARDS:

1) Unlike Cgmp, ISO 9000 compliance is voluntary however some
companies have made certification for doing business.
2) ISO 9000 does not include measures if effectiveness with respect
to product quality. But it is implied that compliance with
procedures will improve product quality.
3) The certification is costly in terms of consultant fees and
management time.therefore it had become a license to trade rather
than a quality improvement tool.