Microbiology , pharmaceutics

1. INTERNATIONAL
STANDARDIZATION
ORGANIZATION
ISO
By
Dr. Manal El-Ashmoony, PHD

2.  ISO is a worldwide, non-governmental organization, first
established in 1946 in Geneva.
 Objectives
 To develop international standards that are equivalent or uniform
worldwide, hence the use of term ISO in the name of each
standard
 To promote the development of standardization and related
activities in the world with a view to facilitate the international
exchange of goods and services
 To develop cooperation in the spheres of intellectual, scientific,
technological and economic activity 2

3.  The short name (ISO) is a derivation from the Greek isos,
meaning "equal".
 The name (ISO) has the advantage of acceptance
internationally in almost all languages.
 ISO standards were based on the British standards BS5750
 It was firstly published in 1987.
 ISO organization publishes the standards.
 Their documentation gets through the national standards
organization of most countries.
e.g., the American National Standards Institute. 3

4. o Most standards require periodic revision.
o Several factors combine to render a standard out of date.
e.g.,
• technological evolution,
• new methods and materials,
• new quality and safety requirements.
 ISO standards should be reviewed at intervals of not more than
five years.
 Nowadays, ISO's work has resulted in over 8,000 international
standards, representing more than 170,000 pages.
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5. ISO 9000
 ISO 9000 standards series define the quality systems to:
design, development, production, installation and servicing, final
inspection and tests.
 It requires the development of a quality manual and documented
procedure which define the organization and operation of the
quality system.
 It is the responsibility of a company to create and maintain these
documents, so that they are relevant and appropriate to the
specific business operation. 5

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o ISO 9000 refers to the family of standards including:
ISO 9000, ISO 9001 and ISO 9004.
o The only standard in this group that is used to evaluate
and certify an organization is the ISO 9001 standard;
when a company refers to itself as ISO 9000 certified,
generally this is referring to the ISO 9001 standard but
not specifying which revision.
o ISO 9001:2008 is the current revision of the ISO 9001
standard, the prior version was ISO 9001:2000.

7.  ISO 9001
The contractual standard for companies that design and service what
they manufacture.
 ISO 9002
The contractual standard for companies that manufacture, but do not
design what they manufacture.
 ISO 9003
The contractual standard for companies that assemble and test
products designed and manufactured elsewhere.
 ISO 9004
A guideline for a quality system somewhat more comprehensive than
those described in the contractual standards
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ISO 9004
 It is an umbrella term that refers to a standard developed and
published by the International Organization for Standardization (ISO).
 The current version of this standard is ISO 9004:2009 and is titled
"Managing for the sustained success of an organization-A quality
management approach".
 This standard is not to be used for certifying an organization but
rather serves as a guide to support the achievement of sustained
success by a quality management approach.
 This standard applies to any organization, regardless of industry.
 The standard can be used along with the ISO 9001 standard or as a
standalone guide to help organizations achieve and maintain
objectives in the long-term.

9.  The ISO 9000 standards is framework for a quality system.
 A "Quality System" is a series of checks and balances
which, when introduced and followed, will ensure quality of
output, or product.
 ISO 9000 standards enable the manufacturers to ensure
that their products and/or services
meet their customers' requirements
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10. ISO 14000
Environmental Management
 It is a family of standards related to environmental management that exists to
help facilities:
1. To minimize how their operations (processes, etc.) negatively affect the
environment (i.e. cause adverse changes to air, water, or land)
2. To comply with applicable laws, regulations, and other environmentally
oriented requirements
3. To continually improve in the previous issues.
 ISO 14000 is similar to ISO 9000 quality management in that both pertain to the
process of how a product is produced, rather than to the product itself
 The underlying philosophy is that:
The requirements of an effective Environmental Management System (EMS)
are the same, whatever your business
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11.  The first two standards of the ISO 14000 family ISO 14004 and
ISO 14001 were published in September and October 1996,
respectively.
 The current version of ISO 14001 is ISO 14001:2015, which was
published in September 2015.
 ISO 14001 is the section in the series that includes the EMS to which
businesses can become certified.
This specifies the requirements for such Environmental
Management System (EMS).
Fulfilling these requirements demands objective evidence which can
be audited to demonstrate that the EMS is operating effectively in
conformance with the standard.
 ISO 14004: This provides guidelines on the elements of an EMS and
its implementation, and discusses principal issues involved.
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12. ISO 14644
International clean room standards
 These cover a wide variety of important clean room issues
such as design, testing, operation and bio-contamination.
 The first document published in 1999, is ISO 14644-1 and
entitled "classification of air cleanliness".
 Various committees of experts, nominated by countries
throughout the world, are writing these standards.
 The standards are as follows:
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13. ISO 14644
(Clean rooms and Associated Controlled
Environments)
This consists of the following parts:
 Part 1: Classification of air cleanliness: (14644-1)
• This gives the airborne particle limits for different standards of clean
rooms.
• It also gives the methods that should be used to measure the airborne
particles when testing a clean room to determine its class.
 Part 2: Specifications for testing and monitoring to prove continued
compliance with ISO 14644-1:
• This gives information, including time intervals, for testing a clean room
to show that it still complies with the ISO 14644-1 standard.
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14.  Part 3: Metrology and test methods:
• This gives a description of the test methods that should be used
to test the clean room to show that it is working correctly.
 Part 4: Design, construction, and startup:
• This gives general guidance as to how a clean room should be
designed, constructed and made ready for handing over to the
user.
 Part 5: Operation:
• This gives general advice on how to run a clean room.
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Part 6: Terms and definitions:
This is a collection of all the definitions of terms used in the ISO
clean room standards.
Part 7: Separative enclosures (Clean air hoods, glove-
boxes, isolator, mini-environments):
This gives information on clean air devices such as isolators and
mini-environments.
Part 8: Molecular contamination:
This gives information on gaseous contamination in clean rooms.

16. ISO 14698
Clean rooms and Associated Controlled
Environment
Bio-contamination Control
This consists of the following parts:
 Part 1: General principles and methods:
This gives information on how to establish methods for measuring
micro-organisms in the clean room.
 Part 2: Evaluation and interpretation of bio-contamination data:
This gives information on how to deal with the results obtained from
measuring micro-organisms in a clean room. 16

17. Forms of audit of companies
1- First part audits:
carried out by an organization's own stuff.
2- Second part audits:
carried out on an organization by customers.
3- Third part audits:
carried out on an organization by certified body (Auditors).
If the company has a successful auditing by a certified
body so it will take registration of certification for its
compliance with standards.
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