This presentation was delivered at the Business Skill Development Programme held at MCIIE, IT-BHU, Varanasi

1. ISO Certifications
Presented By:
Anupam Kumar
Reader,
School of Management Science, Varanasi.
Email: anupamkr@gmail.com

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.
© Anupam Kumar 2011 2

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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4. 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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5. 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
• 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
• 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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6. 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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7. 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
• 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
• 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.
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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:
• 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
• 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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15. 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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16. 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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17. 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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18. 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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19. 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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20. 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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21. 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.
Back
© Anupam Kumar 2011 25

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
Back
© Anupam Kumar 2011 26

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.
© Anupam Kumar 2011 Back 27

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.
Back
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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
Back
© Anupam Kumar 2011 29

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
– 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.
Back
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31. ISO 9001 Process on
Improvements
• It recommends actions for Corrective and Preventive Actions
to be taken for improvements through
– 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
Back
© Anupam Kumar 2011 33

32. 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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33. Burden of ISO Certification
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34. Bibliography
• riverheightsconsulting.com
• http://isoqualitykit.blogspot.com/
• www.iso.org
• http://en.wikipedia.org/wiki/ISO_9000
• www.iso.org/iso/ims-alerts_9001_14001_overview
• www.bis.org.in/cert/faqmscd.htm
• http://en.wikipedia.org/wiki/File:Evolution_of_ISO_9000_seri
es.png
• http://en.wikipedia.org/wiki/ISO_14000
• www.bsigroup.com/
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35. For Further Queries, Contact:
Anupam Kumar
Reader,
SMS Varanasi
Email: anupamkr@gmail.com