(ISO 9000 SERIES)
S.RAJESH KUMAR
M.Pharmacy 2nd semester
Department of Industrial pharmacy
University college of pharmaceutical sciences
Kakatiya university,
warangal - 506009
CONTENTS:
 INTRODUCTION
 DEFINITION
 PURPOSE
 WHAT STANDARDS MATTER
 ISO BRAND
 EXAMPLES
 ELEMENTS OF THE STANDARDS
 THE ISO 9000 SERIES
 IMPLEMENTATION OF ISO 9000 QMS
 CONCLUSION
 REFERENCES
Introduction
 ISO (International Organization for Standardization) is the largest
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developer and publisher of international standards.
It is founded on 23 February 1947 and has its head quarters in Geneva,
Switzerland .
The organization promulgates world wide proprietary industrial and
commercial standards.
The organization adopted ISO based on the Greek word `isos`
meaning “equal”. It means it reflects the aim of the organization to
equalize and standardize across cultures.
ISO has more than 17500 International Standards and other types of
normative documents in the current portfolio.
Definition
 ISO is a non-governmental organization that forms a
bridge between the public and private sectors.
 ISO defines itself as a non-governmental
organization, its ability to set standards that often
become law, either through treaties or national
standards, makes it powerful than most nongovernmental organizations.
Purpose
 The purpose of ISO is to promote harmonization of
processing, manufacture and quality assurance
standards among industrial nations.
Why standards matter
 Standards make an enormous and positive contribution to most
aspects of our lives.
 They ensure desirable characteristics of products and services such as
quality ,environmental friendliness, safety ,reliability, efficiency and
interchangeability - and at an economical cost.
What standards do
~ ISO standards
- make the development, manufacturing and supply of products
and services more efficient, safer and cleaner
- facilitate trade between countries and make it fairer.
- provide governments with a technical base for health, safety and
environmental legislation and conformity assessment.
Contd….
 Share technological advances and good management
practice
 Disseminate innovation
 Safe guard consumers and users in general, of products and
services
 Make life simpler by providing solutions to common
problems
 ISO standards provide technological, economic and social
benefits.
 ISO standards are useful to everyone in the world
What International standardization means
 International standards provide a reference
framework, or a common technological language,
between suppliers and their customers.
 This facilitates trade and the transfer of technology.
Elements of the standards
 Management responsibility
 Inspection and testing
 Resource management
 Inspection, measuring and test
 Quality system
 Contract review
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 Design control
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 Document control
 Purchasing
 Purchaser-supplied product
 Product identification and
traceability
 Process control
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equipment
Inspection and test status
Control of non-conforming
product
Corrective action
Quality records
Internal quality audit
Training
Servicing
Statistical techniques
The ISO 9000 series
 The ISO 9000 series is more systematic in approach
and structure.
 It is broader since it also encompasses the design stage
 The GMP standards can be demonstrated.
 It was taken into account during recent revisions of
GMPs such as those of excipients by IPEC as well as for
the Medical Devices Quality Systems Regulations of
U.S.FDA
ESSENTIAL STEPS TO IMPLEMENT ISO 9000 QMS
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Top management commitment
Establish implementation team
Start ISO 9000 awareness programs
Provide training
Conduct initial status survey
Create a documented implementation plan
Develop QMS documentation
Document control
Implementation
Internal quality audit
Management review
Pre assessment audit
Certification and registration
Continual improvement.
Contd…
 The three series 9000 documents now are:
 9000:2000 Quality management systems – fundamentals and
vocabulary
 9001:2000 Quality management systems – requirements
 9004:2000 Quality management systems – guidelines for performance
improvement
 It covers full range from design through development, manufacturing
,and production to supply and service.
 ISO 9001:2000
 Quality management systems – requirements (required for
registration)
~ Management responsibility
~ Resource management
~ product/service realization
~ Measurement ,analysis and improvement
Management responsibility
 Define a quality policy that describes the organization's attitude towards quality
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 Define the organizational structure that you will need in order to manage a
quality system
# Responsibility and authority
* define quality system responsibilities , give quality system personnel
the authority to carry out these responsibilities and ensure that the interactions
between these personnel are clearly specified. Make sure all of this is well
documented.
# identify the resources that people needed to perform , manage and verify
quality system work and provide them. Make sure that only trained personnel
are assigned.
# the senior executive is appointed to manage the quality system and ensure
that quality system is developed and implemented.
A management review is given to senior managers to ensure the effectiveness of
the quality system. These reviews should be carried out on regular basis and
should be documented and records are maintained.
Quality system
 Quality system is developed and a manual is prepared which contains quality
policy, objectives, overview of the system ,procedures records ,control quality
system work practices, guide the implementation of system and explain how
the system is audited.
 Quality system procedures are developed and implemented that are consistent
with quality policy. These procedures need to be documented and keep up to
date.
 Develop quality plans that show how you intend to fulfill quality system
requirements. Quality plans are developed for products ,processes, projects and
customer contracts.
 Contract review
# The contract review procedures should ensure that all contractual
requirements are acceptable before agree to provide products to the customers.
# Records are maintained and documented the review of customers orders and
contracts.
Product development and design
 The procedures required for the product design and development need to be
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developed and documented to ensure that all requirements are met.
Create design and development planning procedures
Identify the groups who should be routinely involved in the product design and
development process, and ensure that their design input is properly
documented, circulated and reviewed.
Develop procedures to ensure that all design input requirements are identified,
documented and reviewed and that all design flaws, ambiguities
,contradictions and deficiencies are resolved.
Design outputs are usually documented. These documents are useful for
purchasing , production, installation ,inspection, testing and servicing.
These documents should be reviewed and approved before they are distributed
These are accepted only if they meet official acceptance criteria
The procedures are needed to develop to control design out puts
Design review procedures needed to be planned, performed , documented and
recorded.
Finally the product development and design should be verified.
Product identification and tracing
 Develop and documented procedures are necessary to identify and track
products from start to finish
 Process control requirements
 Develop procedures to plan ,monitor and control the production,
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installation and servicing processes. The procedures need to be
documented, approved and performed by quality personnel
Develop procedures that allow you or your customers to verify the
acceptability of products you have purchased.
Supplier verification at subcontractor's place
Customer verification of subcontracted product.
Protect customer supplied products.
Control of inspection equipment
 The inspection equipment which is needed to be controlled is to
calibrated, maintained and it should be appropriate, effective and
secure.
 Inspection and test status of products
each and every product is identified
the test status of each product is documented and respected
through out the production, installation and servicing process.
# control of nonconforming products
procedures are developed to control the nonconforming products and
these are reviewed, reworked,regraded,retested,recordedand discussed
with the customers
# corrective or preventive actions procedures needed to eliminate the
causes for nonconformity
Handling. storage and delivery
 Procedures are developed and documented for handling, storage and deliver of
the products.
 Develop packaging and marking methods and procedures to protect and
control the quality of products and packing materials.
 Develop methods and procedures to protect and preserve product quality prior
to delivery while the product is till under the organization's supervision and
control.
 Develop procedures to protect the products after final testing and inspection
and during delivery.
 Develop a quality control record keeping system
 Develop internal audit procedures
 Develop training procedures
 Develop service procedures which are to be documented
 Select the statistical techniques in order to establish, control and verify
* process capabilities
* product characteristics
Difference between ISO 9001and ISO 14001
 The vast majority of ISO standards are highly specific to a particular
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product, material or processes.
The ISO 9001 (quality) and ISO 14001(environment) are “generic
management system standards”.
ISO 9001 contains a set of generic requirements for implementing a
quality management system and ISO 14001 for an environmental
management system.
Generic standards are applied to any organization.
Today, many products require testing for conformity with specifications
or compliance with safety ,or other regulations before they can be put
on many markets.
ISO guides and standards for conformity assessment represent an
international consensus on best practice.
Other ISO series
 The ISO 14644 and 14698 series founded by ISO/TC 209
 The ISO 14644 series covering general contamination control topics
 The ISO 14698 series on biocontamination control issues
 NEWER SERIES:
 Energy and nano technology
 Nanotechnology cover a wide variety of applied science and technology
 International standards contribute at three levels
~ assisting the innovation process
~ addressing the challenges in measurement at the nano scale
And ~ helping to alleviate concerns over potential health and
environmental impacts.
Contd…..
 ISO/TR 12885:2008, Health and safety practices in
occupational settings relevant to nanotechnologies was
developed by ISO/TC 229, Nanotechnologies.
 The latest ISO 27000-series international standards for
information security management.
 ISO/TS 27687:2008 is concerned with the terminology and
definitions for the objects at the nano scale, which comes
in several shapes (nanoparticle, nanofibre,nanoplate)
 ISO 15022 was prepared by technical committee
ISO/TC68,banking,securities and related financial services.
ISO membership countries
 It has 3 membership categories
 Member bodies are national bodies that are considered to
be most representative standards body in each country.
These are the only members of ISO that have voting rights.
 Correspondent members are countries that do not have
their own standards organization. These members are
informed about ISOs work but do not participate in
standards promulgation.
 Subscriber members are countries with small economies.
They pay reduced membership fees, but can follow the
development of standards.
ISO international partners
 ISO collaborates with the partners in international organization, the
International Electrotechnical Commission(IEC) and International
Telecommunication union(ITC). The above three are present in
Geneva,Switzerland,have formed the World Standards Cooperation
(wsc) to act as a strategic focus for collaboration and the promotion of
international standardization.
 ISO has a close relation ship with the WTO.
 It collaborates with the United Nations(UN) organization and its
specialized agencies and commissions such as
CODEX Alimentarius, on food safety measurement, management
and traceability
UN Economic Commission for Europe(UN/ECE) WHO,
International Maritime Organization(IMO) ,World Tourism
Organization etc.
CONCLUSION
 Many companies see the introduction of a quality
management system as a major step forward in controlling
and improving their key processes.
 Implementation of ISO 9000 affects the entire
organization right from the start if pursued with total
dedication, it results in cultural transisition to an
atmosphere of continuous improvement.
 ISO enables a consensus to be reached on solutions that
meet both the requirements of business and the broader of
society.
REFERENCES
 Robert A. Nash, Alfred H. Watcher ;“Pharmaceutical Process Validation”, third edition
 Dale, B. G. and Oakland, J. S., Quality Improvement Through Standards (2nd Edn),
Stanley Thornes (Publishers) Ltd. Cheltenham, 1994.
 Marquardt, D., Chové, J., Jensen, K. E., Petrick, K., Pyle, J. and Strahle D., ‘Vision
2000: The Strategy for the ISO 9000 Series Standards in the ’90s’, Quality Progress, 24
(5), 1991, pp. 25-31
 Bemowski, K. and Stratton, B., ‘How do People Use the Baldrige Award Criteria?’,
Quality Progress, 28 (5), 1995, pp. 43-47.
 [4] Gadd, K., Oakland, J. S. and Porter, L. J., ‘Business Self-Assessment and Evaluation
of Current European Practice’, Proceedings of the 1996 Learning Edge Conference,
Paris, April 24-26, 1996, EFQM, pp. 292-315.
 [5] Hesseling, P., Kringloop Van Kennis in Economische Organizaties, Stenfert Kroese,
Leiden, 1984.
 www.iso.org
 www.wikipedia.org
 www.osun.org
 www.pharmainfo.net