by user






Needs and expectations
for the ISO9001 2015 renewal
Juhani Anttila, Academician
International Academy for Quality (IAQ)
Helsinki, Finland
[email protected] , ww.QualityIntegration.biz
September, 2014
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under the Creative Commons 3.0 License
(Mention the origin)
35 years ISO 9000 standardization,
Five generations ISO 9000 standards
Technical committee ISO/TC 176 formed in 1979.
Five generation of the ISO 9000 series standards:
ISO 8402:1986, and ISO 9000/9001/9002/9003/9004:1987
ISO 9000/9001/9002/9003/9004:1994
ISO 9000/9001/9004:2000
ISO 9000:2005, ISO 9001:2008, and ISO 9004:2009
ISO 9001:2015 and ISO 9004:20??
In addition to prepare standards for quality
management, the work in committee ISO/TC 176 has
an important role in the worldwide quality discipline
and social collaboration of the professionals.
Requirements for the ISO 9001 revision 2015
Strategic objectives of the ISO 9000 responsible committee ISO/TC 176/SC2
Systematic review on ISO 9001:2008
Worldwide user survey of the ISO 9001 and 9004 standards
Analysis of the quality management concepts for considering the future ISO 9000 work
Design specification: Challenging targets to meet the needs and expectations of modern
Renewed quality management principles (QMPs)
ISO Directives Annex SL: High level structure, identical core text, common terms and
core definitions in the management system standards
Emphasized a harmonized risk management approach with the ISO 31000
Design specification for the ISO 9001 revision 2015
The revision will:
a) Take account of changes in quality management systems practices and technology
since the last major revision to ISO 9001 (in the year 2000) and to provide a stable core
set of requirements for the next 10 years or more.
b) Ensure that requirements in this standard reflect the changes in the increasingly
complex, demanding, and dynamic environments in which organizations operate.
c) Ensure that requirements are stated to facilitate effective implementation by
organizations and effective conformity assessment by 1st, 2nd and 3rd parties.
d) Ensure that the standard is adequate to provide confidence in those organizations
meeting the standard’s requirements
How well have these requirements been realized in the standard?
Revision of the ISO 9000 QMPs
(Quality management principles)
The existing ISO 9000 QMPs:
1. Customer focus
2. Leadership
3. Involvement of people
4. Process approach
5. System approach to management
6. Continual improvement
7. Factual approach to decision making
8. Mutually beneficial supplier
Revised QMPs in 2013:
1. Customer focus
2. Leadership
3. Engagement of people
4. Process approach
Evidence-based decision making
Relationship management
Quality management,
Performance improvement
and organizational excellence
QMPs are fundamental truths or propositions that serve as the foundation for a system of belief
or behavior, or for a chain of reasoning for the ISO 9000 standardization.
How well have these QMPs taken into account in the standard?
The common structure for all management system
requirements standards supports business integration
Required contents for the discipline XXX management in an organization:
E.g. quality is a
7. Support
XXX discipline.
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented
8. Operation
8.1 Operational planning and control
9. Performance evaluation
9.1 Monitoring, measurement, analysis
and evaluation
9.2 Internal Audit
9.3 Management review
10. Improvement
10.1 Nonconformity and corrective action
10.2 Continual improvement
Factually this a general structure for any business management. All XXX aspects are standardized
and implemented to organization’s business processes according to this structure.
4. Context of the organization
4.1 Understanding of the organization
and its context
4.2 Understanding the needs and
expectations of interested parties
4.3 Determining the scope of the XXX
management system
4.4 XXX management system
5. Leadership
5.1 Leadership and commitment
5.2 Policy
5.3 Organizational roles,
responsibilities and authorities
6 Planning
6.1 Actions to address risks and
6.2 XXX objectives and planning to
achieve them
(Ref.: ISO Directives Annex SL )
How well have this structure realized in the standard text?
Risk management in the ISO 9001:2015
The new ISO 9001 standard makes risk-based thinking more explicit than the previous ones and
this covers the whole standard including requirements for the establishment, implementation,
maintenance and continual improvement of the quality management system.
Organizations must decide how the necessary risk management is to be applied to the entire
organization, at its different areas and levels, at any time, as well as to specific functions,
projects and activities. Standard ISO 31000 provides guidelines on formal risk management and
recommends how the organization can develop, implement and continuously improve a
framework whose purpose is to integrate the process for managing risk into the organization's
overall governance, strategy and planning, management, reporting processes, policies, values
and culture.
How well have risk management items realized and allocated in the standard text?
Pros and cons of the general international standardization
All standardization has positive and proactive aims:
• Improved business performance and confidence, and quality of products
• Decreased operational costs
• Improved communication between people and organizations
Pros of general standardization:
Cons of general standardization:
• Broad acceptance and distribution • There is uneven and unbalanced groups of voluntary
of the texts
people participating the standardization work.
• Extensive expertise in preparing • Management of the standardization is weak.
and commenting the standards
• Only communally interesting issues are accepted to the
• Wide commitment and recognition final standard texts mainly due to the consensus principle.
• No restrictions for innovative
• Influence of the strong and active individuals and lobbying.
• Only trivial means to implement the standard clauses may
be considered in the standards.
• Handling of the issues in the standard text is superficial.
• Standardization process is very slow.
• Participating in standardization is expensive.
All general international standards have serious inadequacies, inconsistencies and other problems
mainly due to the normal standardization processes and particularly the consensus practices.
Organizations applying the standards should highlight their own responsibility of business leaders
and experts and clarify, correct, and complete general standards and find creative solutions in their
implementations in order to achieve business benefits.
a linking factor between science and practice
An activity giving solutions for repetitive application, to problems essentially in the
spheres of science, technology and economics, aimed at the achievement of the optimum
degree of order in a given context. Generally, the activity consists of the processes of
formulating, issuing and implementing standards.
(ISO Guide 2)
A technical specification or other document available to the public, drawn up with
the cooperation and consensus or general approval of all interests affected by it,
based on the consolidated results of science, technology and experience, aimed at
the promotion of optimum community benefits and approved by a standardization
(ISO Guide 2)
Implementing the ISO 9000 series of standards
The ISO 9000 standards series for quality management systems (QMS) is it is an ensemble of:
ISO 9000: Fundamentals and vocabulary
ISO 9001: Requirements
ISO 9004: Managing for the sustained success of an organization
Different parts of the series form a complementary whole.
Starting point for implementing ISO 9001 is the organization itself, its business needs,
and its QMS:
ISO 9001 presents requirements for organizations’ QMS
QMSs should be created by organizations themselves. QMSs have not
been specified in any standards.
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