ISO

1. ISO Certifications

2. Origin of ISO Standards
• Published from the International Organization for
Standardization.
About International Organization for Standardization
– Worldwide federation of national standards bodies
– Presently comprising of 170 member countries
– Promotes development of standardization and related
activities across the world
– Objective is to facilitate exchange of goods and services
and development of cooperation in intellectual, scientific,
technological and economic activities.
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3. About ISO
• ISO develops standards and guides to encourage
good practice in accréditation and certification.
• ISO does not issue certificates.
• ISO does not accredit, approve or control the
certification bodies.
• ISO does not carry out ISO 9001 or ISO 14001
certification.
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ISO 9000 Series of Standards
• Initial standards based on BS 5750: 1979 that was
developed by British Standards Institution (BSI)
• ISO 9000 series was first published in 1987
• About ISO 9000 family of standards
– Relate to Quality Management Systems
– Designed to help organizations as guidelines
– Ensures that the customers & stakeholders needs are met

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Evolution of ISO 9000 Series
• ISO 9000: 1987 came up with 3 models for quality
management systems
– ISO 9001: 1987
• Model for quality assurance in design, development, production,
installation and servicing
– ISO 9002: 1987
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Model for quality assurance in production, installation and servicing
Similar to the ISO 9001: 1987 version except covering the creation of new
products.
– ISO 9003: 1987
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Model for quality assurance in final inspection and test
Not concerned with how the product was made and was only concerned
about the final inspection and testing of quality.

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Evolution of ISO 9000 Series
• ISO 9000 series was first amended in 1994 which had the
following details.
ISO 9000: 1994 emphasized on:
– Preventive action instead of checking just the final product
– Need for evidence of compliance along with the documented
procedures
ISO 9001: 2000 version: Amendment resulted in combination
of the 9001, 9002 and 9003 standards into one called the
9001.
– Design & development procedures were required only if the company
was engaged in creation of new products
– Process Management, monitoring and optimizing company’s task
instead of just inspection, was included
– Involvement of top management
– Expectation of continual process improvement and tracking customer
satisfaction
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About ISO 9000 Standards
• The family of ISO 9000 standards developed by International
Organization for Standardization and is made of the following
core standards
– ISO 9000: 2000
• Fundamentals & Vocabulary
– ISO 9001: 2000
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Quality Management Systems – Requirements
Deals with the requirements that have to be met by the organizations
which want to adopt the ISO standards.
– ISO 9004: 2000
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• Quality Management Systems – Guidelines for performance
improvements
Relates to organizations who wish to improve beyond the scope of ISO
9001:2000.
• Has an element of self evaluation and this standard does not stand for
certification.

8. Evolution of ISO 9000 Series
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9. Evolution of ISO 9000 Series
• ISO 9001: 2008 version
– Introduced clarifications to the requirements of ISO 9001:
2000 version
– Also introduced certain changes to make is consistent with
ISO 14000: 2004 certification
ISO 9001 and ISO 14001 are among ISO's most well
known standards ever
– ISO 9001 helps organizations to implement quality
management
– ISO 14001 helps organizations to implement
environmental management.
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10. About ISO 14000 Standards
• ISO 14000 family of Standards pertain to
Environmental Management
These standards help organizations
– Minimize the negative affect on the environment in their
operations
– Comply with applicable laws, regulations and other
environmentally oriented requirements
– Continually improve the above
ISO 19011 audit standard applies when auditing for
both 9000 and 14000 compliance.
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11. Evolution of ISO 14000 Series
• BSI Group publishes the first Environmental
Management System Standards BS 7750: 1992
• ISO 14000 series first published in 1996.
– ISO 14001: 1996 relates to standards used by
organizations for designing and implementing an effective
environmental management system
– ISO 14004: 1996 relates to general guidelines on
principles, systems and support techniques
• The latest amended standard among ISO 14000 series
is ISO 14001: 2004, which is a generic standard.
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12. Generic Standards
ISO 9001 and ISO 14001 are generic standards.
Generic means that the same standards can be applied:
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• to any organization, large or small, whatever its product or
service,
in any sector of activity, and
whether it is a business enterprise, a public administration, or
a government department.
no matter what the organization's scope of activity
if it wants to establish a quality management system, ISO
9001 gives the essential features
or if it wants to establish an environmental management
system, ISO 14001 gives the essential features.
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13. Quality Management
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ISO 9001 is for quality management.
Quality refers to all those features of a product (or
service) which are required by the customer.
Quality management means what the organization
does to
– ensure that its products or services satisfy the customer's
quality requirements
– comply with any regulations applicable to those products
or services
– enhance customer satisfaction, and
– achieve continual improvement of its performance
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14. Environmental Management
• ISO 14001 is for environmental management.
• This relates to what the organization does to:
– minimize harmful effects on the environment
caused by its activities,
– to conform to applicable regulatory
requirements, and to
– achieve continual improvement of its
environmental performance.
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Management System
• Management system means what the organization
does to manage its processes, or activities in order
that
–its products or services meet the
organization’s objectives, such as
• satisfying the customer's quality requirements,
• complying to regulations, or
• meeting environmental objectives

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Management System
• Management system means
– To be really efficient and effective
– the organization can manage its way of doing things by
systemizing it.
– Nothing important is left out.
– Everyone is clear about who is responsible for doing
what, when, how, why and where.
Management system standards provide the
organization with an international, state-of-the-art
model to follow.
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ISO Standards & Management Systems
• Large organizations, or ones with complicated
processes, could not function well without
management systems.
• Companies in such fields as aerospace, automobiles,
defence, or health care devices have perfected
management systems over the years.
• The ISO 9001 and ISO 14001 management system
standards make these successful practices available
for all organizations.

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Benefits of ISO 9001 & ISO 14001
• International, expert consensus on state-of-the-art
practices for quality and environmental management
• Common language for dealing with customers and
suppliers worldwide in B2B.
• Increase efficiency and effectiveness.
• Model for continual improvement.

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Benefits of ISO 9001 & ISO 14001
• Model for satisfying customers and other
stakeholders.
Build quality into products and services from design
onwards.
Address environmental concerns of customers and
public, and comply with government regulations.
Integrate with global economy
Sustainable business
Unifying base for industry sectors
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Benefits of ISO 9001 & ISO 14001
• Qualify suppliers for global supply chains
• Technical support for regulations
• Transfer of good practice to developing
countries
• Tools for new economic players
• Regional integration
• Facilitate rise of services

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Our Take from ISO Standards
• Organization can implement and benefit from an ISO
9001 or ISO 14001 system without having it certified
Certification is not a requirement of ISO 9001 or ISO
14001
Certification is a decision to be taken for business
reasons:
– if it is a contractual, regulatory, or market requirement,
– If it meets customer preferences
– it is part of a risk management programme, or
– if it will motivate staff by setting a clear goal
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22. Our Take from ISO Standards
• Both ISO 9001 and ISO 14001 concern the way an
organization goes about its work
Processes affect final products or services and they are
process standards.
ISO 9001 gives the requirements for what the organization
must do to manage processes affecting quality of its products
and services through
– Setting Processes
– Documentation & Document Control
– Customer Focus
– Production Processes & Monitoring Processes
– Reviews, Controls and Improvement
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23. ISO 9001 on Setting Processes
• Through the implementation of ISO 9001 Standards, an
organization
– determines the processes needed for the quality management system
and their application,
– determines the sequence and interaction of these processes,
– determines criteria and methods needed to ensure that both the
operation and control of these processes are effective,
– ensures the availability of resources and information necessary to
support the operation and monitoring of these processes,
– monitors, measures where applicable and analyzes these processes,
– implements actions necessary to achieve planned results and
continual improvement of these processes.
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24. ISO 9001 Process: Documentation
• For the implementation, an organization,
needs to document
– Quality policy and quality objectives
– Quality manual
– Procedures and records
– Records necessary to ensure
• Effective Planning
• Operation of processes
• Control of processes
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25. ISO 9001 Process:
Document Control
• ISO 9001 requires organizations to control various documents
– to approve documents for adequacy prior to issue,
– to review and update as necessary and re-approve documents,
– to ensure that changes and the current revision status of documents
are identified,
– to ensure that relevant versions of applicable documents are available
at points of use,
– to ensure that documents remain legible and readily identifiable,
– to ensure that documents of external origin determined by the
organization are identified and their distribution controlled, and
– to prevent the unintended use of obsolete documents, and
– to apply suitable identification to obsolete documents if they are
retained for any purpose.
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26. ISO 9001 Process:
Customer Focus
• For the implementation of ISO 9001 an organization
needs to determine and document:
– requirements specified by the customer, including the
requirements for delivery and post-delivery activities,
– requirements not stated by the customer but necessary
for specified or intended use, where known,
– statutory and regulatory requirements applicable to the
product, and
– any additional requirements considered necessary by the
organization.
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27. ISO 9001 Process on
Production & Service
• ISO 9001 requires all production and service to happen under
controlled conditions while ensuring:
– the availability of information that describes the characteristics of the
product,
– the availability of work instructions, as necessary,
– the use of suitable equipment,
– the availability and use of monitoring and measuring equipment,
– the implementation of monitoring and measurement activities, and
– the implementation of product release, delivery and post-delivery
activities
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28. ISO 9001 Process: Monitoring &
Measuring Equipment Control
• ISO 9001 requires processes to ensure that monitoring and measurement
can be carried out, and is carried out in a manner that is consistent with
the monitoring and measurement requirements
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– calibrated, verified or both at specified intervals, or prior to use, against
measurement standards traceable to international or national measurement
standards; where no such standards exist, the basis used for calibration or
verification shall be recorded,
adjusted or re-adjusted as necessary,
have identification in order to determine it’s calibration status,
safeguarded from adjustments that would invalidate the measurement result,
and
protected from damage and deterioration during handling, maintenance and
storage. Back
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29. ISO 9001 Process:
Provision of Reviews
• ISO 9001 recommends provision of timely
management reviews. The input to management
review includes information on below:
– results of audits,
– customer feedback,
– process performance and product conformity,
– status of preventive and corrective actions,
– follow-up actions from previous management reviews,
– changes that could affect the quality management system,
and
– recommendations for improvement. Back
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30. ISO 9001 Process on Controls
• Provisions are made to ensure control over various non-
conformities while also advising on the course of action on
the same
– by taking action to eliminate the detected nonconformity,
– by authorizing its use, release or acceptance under concession by a
relevant authority and, where applicable, by the customer, and
– by taking action to preclude its original intended use or application.
– by taking action appropriate to the effects, or potential effects, of the
nonconformity when nonconforming product is detected after
delivery or use has started.
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31. ISO 9001 Process on
Improvements
It recommends actions for Corrective and Preventive Actions
to be taken for improvements through
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– reviewing nonconformities, including customer complaints,
– determining the causes of nonconformities,
– evaluating the need for action to ensure that non-conformities do not
recur,
– determining and implementing action needed,
– records of the results of action taken, and
– reviewing the effectiveness of the corrective action taken
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ISO Certifications: Conclusions
• ISO develops standards and guides to encourage good
practice in accréditation and certification.
Processes affect final products or services and ISO 9001 or
ISO 14001 are process standards.
Certification is a decision to be taken for business reasons:
– if it is a contractual, regulatory, or market requirement,
– If it meets customer preferences
– it is part of a risk management program, or
– if it will motivate staff by setting a clear goal
Certification is not a requirement of ISO 9001 or ISO 14001
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