The future of the
ISO 9000 Family of standards
(Post conference update version for Wessex Branch)
Survey replies & analysis
250 people responded out of a mailing of
15,000
Analysis carried out at 150 replies then later
at 200 – the results stabilising at 250.
68% were direct users (i.e. not consultants or Auditors)
75% comply with 9001, with 70% saying
scope covered all functions
60% with engineering background
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Usage & perception
90% have read ISO 9000
99% have read ISO 9001
58% have read ISO 9004
With 44% of these reading it as part of a course
(so only 29% of total have read without compulsion)
9% used the self assessment in 9004
84% described a QMS as “the way we manage the
business”
23% of auditors said it was a ‘description’
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Benefits
84% claimed improvements as a result of
9001
46% claimed it had reduced 2nd party audits
64% said ISO 9001 was helpful in
understanding and managing business
processes.
75% disagreed that it hinders the
development of a quality culture
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Change?
62% said don’t change ISO 9000
42% said don’t change ISO 9001
64% said don’t change ISO 9004
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432 Recommendations
Simplify vocabulary, language, jargon
Extend requirements
Misunderstood provisions
Improve structure of standards
Better alignment/integration
Recommendation out of scope
Additional guidance needed
Reduce requirements
Improve concepts and principles
Change wording
More or better pictures needed
Improve ISO's Standards System
Already addressed in the standard
More cross referencing
0%
5%
10%
15%
20%
25%
30%
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Draft CQI Position Paper
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Proposition 1 ~ Continued development
• Supports continued development of the ISO 9000 family of standards
• Encourages a move towards a single management system standard with
separate standards for use in assessing capability in areas such as
quality, environment, etc.;
• Opposes the proliferation of ISO 9001 derivatives that embody ISO 9001
requirements in their entirety;
• Supports the development of other management system standards
providing they adopt common principles and vocabulary;
• Suggests that the revision cycles of ISO 9000, ISO 9001 and ISO 9004
are harmonised and that ISO 9000 become a leading rather than a
lagging standard
• Suggests that more is done to promote ISO 9000 and ISO 9004 through
a more favourable pricing structure and bundling offers.
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Proposition 2 ~ Introduce fundamental
concepts in ISO 9000 1/2
• Organization purpose - purpose needs to be outwardly
looking towards society
• The external environment - must adapt to the environment
for it to survive and achieve its aims
• Management systems - one system of management for
accomplishing its mission
• The importance of stakeholders - organizations and
individuals they depend upon for their success
• The importance of quality - quality needs to be the first
priority
• Quality management - Providing the organization with the
capability of delivering the required outputs
• Achieving quality - depends upon the organization possessing
competent people, capable processes and adequate resources.
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Proposition 2 ~ Introduce fundamental
concepts in ISO 9000 2/2
Role of standards
• to assist customers translate their needs into common product
quality requirements that will ensure uniform acceptance
criteria (Product standards e.g. ISO 12944)
• to assist organizations develop, operate and maintain effective
management systems (Guidance standards e.g. ISO 9000 &
ISO 9004)
• to enable customers to acquire a level of confidence in a
supplier’s capability (Assurance standards e.g ISO 9001, ISO
10012)
• to assist customers in assessing the capability of potential
suppliers (Assessment standards e.g. ISO 19011)
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Proposition 3 ~ Extend and amend the
quality management principles in ISO 9000
1/1
1. Customer focus
2. Quality first (New)
3. Leadership
4. Involvement of people
5. The process approach (Amended)
6. The systems approach to management (Amended)
7. Improvement (Amended)
8. The factual approach
9. Mutually beneficial relationships (Amended)
10. Assurance (New)
11. Control (New)
12. Agility ?
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Quality first principle
To ensure productivity, safety, efficiency and effectiveness the
quality of work must be the number one priority at all levels.
An organization applying the quality first principle will be one in which
people:
• can be trusted to supply the required outputs of the required
quality on time;
• find the best value solutions that fulfil the requirements;
• are authorised to stop a process that is going out of control;
• don’t compromise on the quality of work in return for short term
gain;
• do what they say when they say they will do it;
• act ethically and with transparency in what they do to build
trust;
• are aware of what they do to others and Society generally and
manage any risk of the impact of their outcomes before they
become a reality.
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Assurance principle
The need for confidence in the integrity of the provisions made to
create and supply products increases in proportion to the
complexity of organizations and their products.
An organization applying the assurance principle will be one in
which managers:
• understand the requirements the organization is under obligation to
satisfy;
• understand the complexity of the plans for meeting these
requirements;
• confirm that these plans, if followed, will deliver outputs that meet
the requirements;
• decide the level of assurance required on the basis of the risks that
will be encountered in implementing these plans
• gather objective evidence that plans are being followed;
• gather objective evidence that requirements are being met
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Control principle
To adhere to a standard, prevent change or stay on course work
needs to be under control and this only arises when variation from
prescribed standards is managed within agreed limits
An organization applying the control principle will be one in which
people:
• are not held accountable for results over which they have no
control;
• decide what needs to be controlled on the basis of what is important
for the organization to meet the needs of its stakeholders;
• develop or choose units of measure for the parameters to be
controlled;
• establish or choose a standard level of performance that is
consistent with the organization’s objectives etc……..
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Amended principles
• Process approach - Objectives can be achieved more effectively
and efficiently at any level if the work to achieve them is
managed across the organization regardless of the functions or
levels of those involved in executing the work.
• Systems approach - By managing the organization as a system of
interacting interdependent variables, outcomes consistent with
stakeholder needs are more likely to be produced.
• Mutually beneficial relationships - Every organization depends on
the support of its investors, customers, employees, suppliers and
the community to achieve its strategic objectives and needs to
foster a mutually beneficial relationship in exchange for the risks
they bear.
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Proposition 4 ~ Re-structure the ISO
9000 family of standards
Either consolidate ISO 9000, ISO 9001 and ISO 9004 into one
standard, include a guide to the use and application of the
requirements of ISO 9001 and rewrite ISO 9004 as a guide to
quality management system development or
a) Invoke ISO 9000 in clause 5.1 of ISO 9001 so that it makes
the concepts and principles in ISO 9000 part of the
assessment criteria
b) Split ISO 9000 into 3 parts covering fundamental concepts
and principles, a guide to quality management system
development and a vocabulary
c) Reference all the guides in the family within ISO 9000 in the
context in which they are to be used.
d) Split ISO 9001 in to 2 parts one being the requirements and
the other a guide to the use and application of the
requirements
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Proposition 5 ~ Align ISO
9001 with its purpose
The original intent of the ISO 9001 design specification
should be re-enforced and the following changes
implemented:
• The title should be changed to Quality Management
Systems - Requirements for Quality Assurance making
clear the intended use of the standard.
• The purpose and scope statements should be retained
but the requirements amended so that they are
expressed as results to be achieved and demonstrated
rather than actions to be undertaken.
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Proposition 6 ~ Promote
better use of vocabulary
• The terms that are fundamental to understanding ISO
9001 should be defined within ISO 9001
• Commonly used business terms should be introduced
within the associated notes of a definition to enable
users to better understand the context.
• An up to date vocabulary database should be
maintained on the ISO Web site for use by standards
writers and users.
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Proposition 7 ~ Promote use
of ISO 9000
In order to promote better use of ISO 9000 it is
proposed that
• the term “systems” is removed from the title
and scope of ISO 9000
• that guidance on the selection and use of
each standard in the ISO 9000 family is
introduced
• that rules are established that prohibit multiple
definitions of the same term in the same
context.
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What now?
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Get consensus of Project team
Get SDG approval
Get PPB approval
Present to BSQ QS/1
Agree need for revision of principles by end of March 2011
Define revised principles by end of June 2011
New draft principles by end of December 2011
Agree need to revise ISO 9001 by end of June 2011
Agree ISO 9001 Design Spec by mid 2012
Complete drafting process by mid 2015
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