AMB7123

Quality Systems
Management
Chapter 5 - ISO 9000
Content
• Introduction
• History of ISO
• 9001:2008 Quality System Document
• 9001: 2008 Quality Manual Worksheet
Introduction
ISO & ISO Standards www.iso.org

• ISO – International Organization for Standardization. Has 162

member countries
– a network of national standards bodies (individuals or
companies cannot become members)
– Each member represent ISO in its country
(Malaysia is represented by Dept of Standards, Malaysia)
• Prominent ISO standards:
– ISO 9000 - Quality Management System
– ISO 14000 - Environmental Management System
– Actually ISO publishes more than 19.5K international stds
Introduction (cont.)
What are ISO 9000 Standards?
• ISO 9000 Standards
• Define the required elements of an effective Quality
Management System
• Can be applied to any company
• Standards are reached by consensus with each
organisation representing the interests of its stakeholder
members.
• Adopted by the United States as the ANSI/ASQC Q90
series.
Have undergone several revisions:
• Revised 2000, 2004, 2008 , 2015
Introduction (cont.)
What is a “standard”?
• ISO defines a standard as a document that provides
requirements, specifications, guidelines or
characteristics that can be used consistently to
ensure that materials, products, processes and
services are fit for their purpose.
Introduction (cont.)
What is a management system?
– ISO defines it as a the set of procedures an organization
needs to follow in order to meet its objectives.
What is a system?
– a set of things working together as parts of a mechanism
or an interconnecting network; a complex whole
– a set of principles or procedures according to which
something is done; an organized scheme or method
What is a quality system?
(save that for the time being……)
Introduction (cont.)
Who created international standards?
• International Organization for Standardisation –
Geneva
• ISO is one of three global organisations that develop
international standards for the world
• The other two are: IEC & ITU
• ISO tech committee TC 176 – started working on quality
standardisation in 1979
• International quality standards created in ‘87
• To eliminate country-to-country differences
• To eliminate terminology confusion
• To increase quality awareness
Introduction (cont.)
ISO Governance Structure

Technical
Management Board
Introduction (cont.)
Examples of what ISO has accomplished
• ISO film speed code
• Standard format for telephone and banking cards
• ISO 9000 which provides a framework for quality
management and quality assurance
• ISO 14000 series provides a similar framework for
environmental management
• Internationally standardized freight containers
• Standardized paper sizes.
• Automobile control symbols
• ISO international codes for country names, currencies and
languages
Introduction (cont.)
What is ISO 9001?
• A process-centric standard that sets out the requirements
for a quality management system.
• It is about what an organisation must do to manage
processes affecting quality of its products/services in order
to be more efficient and improve customer satisfaction
• It is not a product/service standard
• Can be used by product manufacturers and svc providers

– ISO 9001 – focuses on processes affecting quality

– ISO 14001 – focusses on processes affecting the impact of an
organisation’s activities on the environment.
History of ISO
How did ISO get started?
Efforts on the internationalisation of standards began in 1906
with the establishment of IEC. However early trace of ISO
standards has its root in ISA.
• 1906: International Electrotechnical Commission
• An organization that prepares and publishes International Standards
for all electrical, electronic and related technologies.
• Organisation is still very active, and its focus is acknowledged by ISO
via an agreement reached with IEC in 1976.
• 1926: International Federation of the National Standardizing
Associations (ISA)
• Emphasis was given on mechanical engineering.
• Activities ceased during WWII
History of ISO
How did ISO get started?.....
• 1946 (London): Delegates from 25 countries decided to create
a new international organisation with the objective "to
facilitate the international coordination and unification of
industrial standards”.
• The organisation is called the “International Organisation for
Standardisations” or “ISO”
• 1947: ISO began its operation on 23 Feb
• 1951: ISO introduced the first ISO standard
• Standard reference temperature for industrial length
measurement
• 1959-1969: US DoD MIL-Q-9858 published a series of quality
assurance standards
History of ISO
How did ISO get started?.....
• 1969: MIL-Q-9858 standards revised and adopted into NATO
Allied Quality Assurance Publications (AQAP)
• AQAP is a series of quality standard documents focusing
on the selection criteria and requirements for design,
development and production, and criteria for selection of
suppliers
• 1979: NATO AQAP was in turn revised by British Standard
Institute (BSI) and published into BS 5750 series of quality
requirements standards. BS 5750 submitted to ISO for
adoption.
• 1987: BS 5750 adopted as ISO 9000:1987
History of ISO (cont.)
ISO 9000 Structure
• The original ISO 9000:1987 standard had similar structure
as BS 5750 with three models of standard.
- ISO 9001:1987
- Model for quality assurance in design, development,
production, installation, and servicing.
- This was for companies/organisations whose activities included
the creation of new products.
- ISO 9002:1987
- Model for quality assurance in production, installation, and
servicing.
- For companies without product design & development.
- ISO 9003:1987
- Model for quality assurance in final inspection and test
- Focused only on final inspection, with no concern how a
product was produced.
History of ISO (cont.)
ISO 9000 Structure….
• ISO 9000 Has undergone several revisions.
• ISO 9000:1994
- Emphasised on QA via preventive actions, which required evidence
of compliance with documented procedures.
• Revision in 2000
- Replaced all three former models of 1994 i.e. ISO 9001, ISO 9002
and ISO 9003
- Introduced “process management” concept that involved
monitoring and optimisation of tasks and activities.
- Other new requirements:
- Tracking customer satisfaction
- Involvement of upper executives
- Integration of quality into business system
- improve effectiveness via process performance metrics
History of ISO (cont.)
ISO 9000 Structure….
• Revision in 2008 was basically the same as Rev.2000
• ISO 9001:2008 did not introduce additional requirements
• Nor did it change the intent of the ISO 9001:2000 standard.
• ISO 9001:2008 was developed in order to:
• Introduce clarifications to the existing requirements of ISO 9001:2000
and
• Introduce changes that are intended to improve consistency with ISO
14001:2004, Environmental Management Systems.
• ISO 9001:2008 is supplemented by two other standards in the
family – ISO 9000:2005 (QMS – fundamentals & vocabulary
– ISO 9004:2009 (sustenance of co. QM approach)
History of ISO (cont.)
ISO 9000 Structure….
• ISO 9001:2008 specifies requirements for a quality
management system where an organization:
• needs to demonstrate its ability to consistently provide product
that meets customer and applicable statutory and regulatory
requirements, and
• aims to enhance customer satisfaction through the effective
application of the system, including processes for continual
improvement of the system and the assurance of conformity to
customer and applicable statutory and regulatory requirements.
History of ISO (cont.)
ISO 9000 Structure….
– All requirements of ISO 9001:2008 are generic
– intended to be applicable to all organizations, regardless of type,
size and product provided.
– If any requirement(s) of ISO 9001:2008 cannot be applied
due to the nature of an organization and its product, this
can be considered for exclusion.
– If exclusions are made, claims of conformity are not acceptable
unless these exclusions are limited to requirements within product
realisation and such exclusions do not affect the organization's
ability, or responsibility, to provide product that meets customer
and applicable statutory and regulatory requirements.
ISO 9001 Certification
Clarification on ISO & ISO 9001 Certification
• ISO does not carry out certification and does not issue or
approve certificates
• ISO does not accredit, approve or control the certification
bodies but it develops standards and guides to encourage
good practice in accreditation and certification.
• An organization can implement and benefit from an ISO
9001 system without having it certified (i.e. certification is
not necessary)
ISO 9001 Certification (cont.)
Clarification on ISO & ISO 9001 Certification….
An organization implements ISO 9001 certification for
business reasons
• To comply with contractual, regulatory, or market
requirements.
• To enhance company image in the eyes of customers,
employees and shareholders.
• Implemented as part of risk management initiative.
• To show commitment to quality, customers, and a
willingness to work towards improving efficiency.
ISO 9001 Certification (cont.)
Clarification on ISO & ISO 9001 Certification….
….
• To demonstrate the existence of an effective quality
management system that satisfies the rigours of an
independent, external audit.
• To give a competitive edge to an organisation's marketing.
An organisation with ISO 9001certification means that
an independent, external body has audited the
organisation's management system and verified that it
conforms to the requirements specified in the standard.
ISO 9001 Certification (cont.)
ISO 9001 Certification Bodies
• These are organisations that have been
accredited by the country’s Accreditation Body
to provide ISO 9001 certification
• e.g. SIRIM QAS Sdn Bhd
Accreditation Body of a country
(recognised by Law), for examples
• US – ANAB
• UK – UKAS
• Malaysia – Standards Malaysia (Department
of Standards, Malaysia)
ISO 9001 Certification (cont.)
Other Reasons for Adopting ISO 9000
• To comply with customers who require ISO 9000
• To sell in the European Union market
• To compete in domestic markets
• To improve the quality system
• To minimize repetitive auditing by similar and different
customers
• To improve subcontractors’ performance
ISO 9001 Certification (cont.)
Importance of ISO 9000
• European Union directive
• ISO 9000 certification required by suppliers of
“Regulated Products”
• health, safety, and the environment
• EC has strict corporate liability legislation protecting
consumers.
• Globalization impact
 ISO 9001 Revisions
Why was ISO 9001 revised?
• Structure
• ISO 9001:2015 now follows the same overall structure as
other ISO management system standards (High-Level
Structure), making it easier for anyone using multiple
management systems.
• Focus on risk-based thinking
• This has always been part of the standard, but the new
version gives it increased prominence.
 ISO 9001 Revisions…
From ISO 9001:2008 to ISO 9001:2015
• All ISO standards are reviewed and revised regularly to make
sure they remain relevant to the marketplace.
• ISO 9001 has been updated to take into account the different
challenges that businesses now face.
• For example, increased globalisation has changed the way
we do business and organisations often operate more
complex supply chains, and there are increased expectations
from customers.
• ISO 9001 needs to reflect these changes in order to remain
relevant.
 ISO 9001 Revisions…
From ISO 9001:2008 to ISO 9001:2015…
• The new version of the standard brings the user a number of
benefits.
• ISO 9001:2015:
• Puts greater emphasis on leadership engagement
• Helps address organisational risks and opportunities in a structured
manner
• Uses simplified language and a common structure and terms,
particularly helpful to organisations using multiple management
systems
• Addresses supply chain management more effectively
• Is more user-friendly for service and knowledge-based organisations
Transition Period to ISO
9001:2015
What will happen to existing Certified ISO
9001:2008 organisations?
• They need to upgrade their quality management systems
to the new edition of the standard and seek certification
to it.
• They have a three-year transition period until end of
September 2018 to move to ISO 9001:2015 version. After
that, a certificate complying to ISO 9001:2008 will no
longer be valid.
 Next ISO 9001 edition?
• ISO 9001 standard is periodically reviewed and revised in order to keep it
relevant and useful.

• Typical update cycle is 6-8 years

• In mid 2021, ISO announced to leave ISO 9001:2015 as is.

• This was based on user survey and internal review of existing standards.

• Based on ISO input, the next systematic review of ISO 9001 standard will be
in 2026. This implies that the next version will likely be published in
2030.