ISO standards introduction

Witteveen+Bos South-East Asia Pte Ltd

24 February 2017
Learning outcome
˗ What is ISO?
˗ Certification body and accreditation body in Singapore
˗ ISO 9001 ?

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History
• In 1946, 25 Countries Meet in London
• International organization or body for coordination on unifications of standard
• January 1947 started operation

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Why called I S O?
• OIN (French)
• MOS (Russian)

• ISOS = Equal
• Isometric, isothermal
• International organization for standardisation
• Representative from national authorities

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I S O
• 19500 standards
• 165 member countries
• 3368 technical bodies
• Headquartered in Geneva, Switzerland.

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WHY ISO?

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Why ISO??
• Create growth
• Facilitate trade
• Open market
• Reduce risk
• Ensure that developing countries share benefits
• Ensure quality
• Continual Improvement

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ISO
• ISO main product:
• - International standard
• - Reports/specs/guide
• Revenue = sale of standards

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ISO member
1 member, 1 country. (Standard National Body)
- Singapore : ???
- Netherland : ???
- United Kingdom: ???
- United Stated: ???
- Germany : ???

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Accreditation and Certification
Which one is Accreditation & Certification ?????

The formal recognition by an independent body, that a certification body operates

according to international standards.

The provision by an independent body of written assurance that the product, service or
system in question meets specific requirements.

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Accreditation and Certification
• Certification body
Certification Body (CB), or Registrar: the organization providing auditing and
certification/registration services so called conformity assessment - demonstration that
specified requirements relating to a product, process, system, person or body are
fulfilled
• Lloyds, BSI, SGS, TUV SUD, DNV and etc

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Accreditation and certification
•Accreditation Body: organizations that provide oversight to CBs, by assessing them
against international voluntary standards

•Accreditation body : Singapore : ???

UK: ??
NL: ??

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Accreditation vs certification
Certification is not a requirement of ISO

The organization can implement and benefit from an ISO system without having it
certified.

The organization can implement them for the internal benefits without spending
money on a certification programme.

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Accreditation vs certification
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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I S O

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Logos

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ISO 9000 Family
 ISO 9000 Quality management systems – Fundamentals and vocabulary.
Covers the basics of what quality management systems are and also contains the
core language of the ISO 9000 series of standards. A guidance document used for
reference to understand terms and vocabulary related to quality management
systems.

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ISO 9000 Family
 ISO 9001 Quality management systems – Requirements
This is the only ISO9000 standard for which certification can be gained.
Intended for use in any organization regardless of size, type or product including
service. It provides a number of Quality Management System requirements which an
organization needs to fulfil to achieve customer satisfaction. It includes a
requirement for the continual improvement.

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ISO 9000 Family
ISO 9004 Quality management systems - Guidelines for performance
improvements. Covers continual improvement. This gives you advice on what you
could do to enhance a mature system. This standard very specifically states that it is
not intended as a guide to implementation.

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ISO 9001
ISO 9001 is a generic standard

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

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ISO 9001
The ISO9001:2015 Standard consists of the following sections:
Section 1: Scope
Section 2: Normative Reference
Section 3: Terms and definitions
Section 4: Context of the organisation
Section 5: Leadership
Section 6: Planning
Section 7: Support
Section 8: Operation.
Section 9 : Performance evaluation
Section 10: Improvement

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ISO 9001 Clause example
8.4 Control of externally provided processes, products and services
8.4.1 General
The organization shall ensure that externally provided processes, products and services
conform to requirements.The organization shall determine the controls to be applied to
externally provided processes, products and services

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ISO 9001 Requirement
Required documented procedures:
- Control of document and records
- Control of non-conforming product
- Corrective and Preventive actions
- Internal audits
- Quality manual and policy

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