Development of ISO 9001, Quality Management System. Disclaimer: This is based on the committee draft which may be subject to significant changes by the time the final version is published.

1. DQS-UL
Development of ISO 9001,
Quality Management System
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Preliminary internal information 9-2013

2. Identification of needs
1. Who has read CD1 of ISO 9001:2015,
who has read CD1 of ISO 14001:2015 ?
2. Who has given training to his auditors
on CD1 of ISO 9001:2015?
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3. Who has offered customer training events
on CD1 of ISO 9001:2015?

3. Content
(1) General development of ISO 9001
slides 4 – 6
(2) New structure
slides 7 – 8
(3) New content (by chapter)
slides 9 – 16
(4) Appendix A
slide
(5) Summary of changes
slides 18 – 19
(6) ISO 14001 summary
slides 20 – 24
(7) Workshop assignment
slide
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4. certified QM-systems
Certificates to ISO 9001
Asia
Europe
global
1995
20.804
92.600
127.000
2000
115.628
269.300
458.000
2005
294.066
377.200
774.000
2010
476.073
530.700
1.110.000
 Top 5 industry sectors:
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metal manufacturing, construction, electro and electronics,
machinery, trade, (+ services)

5. 25 (+1) years of ISO 9001
 1987: Qualityassurance
 20 elements
 1994: small revision
 2000: Qualitymanagement
 process model 
 2008: small revision
like ISO 14001 and others
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 2015: publication of next revision planned
 consistent structure (HLS)

6. ISO 9001 in 2015
Timelines
 June 2013: comittee draft (ISO/CD 9001)
 September 2013: ballot on first committee draft (CD 1)
 Potential 2nd CD based on ballot
 2015: FDIS and release of new revision
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 2014: DIS for discussion and modification

7. Consistent structure for MS
ISO/IEC Directives, Part 1, Consolidated ISO supplement,
2013, Annex SL, Appendix 2
sets out the high level structure, identical core text
and common terms and core definitions
that are to form, when possible, the nucleus of future and
such as ISO 9001 and ISO 14001.
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revised management system standards

8. New structure
High Level Structure
Scope
Normative reference
Terms and definitions
Context of the organization
Leadership
Planning
Support
Operation
Performance evaluation
Improvement
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1.
2.
3.
4.
5.
6.
7.
8.
9.
10.

9. Development of 9001 content
Quality is a driver
 for business success (generate income)
 for process efficiency (control cost)
Development from technical-oriented quality
(product and process)
„output matters!“
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to market-oriented quality (customer and user)

10. Drafted content /4
4. Context of the organization
4.1 Understanding the organization and its context (new)
The organization shall determine external and internal issues, that are
relevant to its purpose and its strategic direction and that affect its ability
to achieve the intended outcome(s) of its quality management system.
4.2 Understanding needs and expectations of interested parties (new)
4.3 Determining the scope of the quality management system 
4.4 Quality management system
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direct customers; end users; regulators;
suppliers, distributors, retailers or others involved in the supply chain; and
any other relevant interested parties.

11. Drafted content /5
5. Leadership
5.1 Leadership and Commitment
to the QMS (ensure achieving intended outputs) 
to the needs and expectation of customers
5.2 Quality Policy
5.3 Organizational roles, responsibilities and authorities
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Top management shall be accountable for the effectiveness of the
quality management system.
No explicit requirement to have a QM representative as member of
the organization’s management.

12. Drafted content /6
6. Planning
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
The organization shall establish quality objectives at relevant
functions, levels and processes.
6.3 Planning of changes
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The organization shall undertake change in a planned and
systematic manner, identifying risks and opportunities and reviewing
the potential consequences of change.

13. Drafted content /7
7. Support
7.1 Resources
Infrastructure, process environment, monitoring and measuring
devices, knowledge
7.2 Competence
Definition of competence (in chapter 3):
ability to apply knowledge and skills to achieve intended results
7.4 Communication
7.5 Documented information
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7.3 Awareness

14. Drafted content /8
8. Operation
8.1 Operational planning and control
8.2 Determination of market needs and interactions with customers
8.3 Operational planning process
8.4 Control of external provision of goods and services 
8.5 Development of goods and services
8.6 Production of goods and provision of services
8.8 Nonconforming goods and services
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8.7 Release of goods and services

15. Drafted content /9
9. Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
Determine what is monitored / measured, when, how
plus analysis and evaluation; ensure customer satisfaction
9.2 Internal audit
9.3 Management review
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Definitions (chapter 3):
to monitor = to determine the status of a system, a process or an activity
to measure = to determine a value

16. Drafted content /10
10. Improvement
10.1 Nonconformity and corrective action
10.2 Improvement 
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Improve the quality management system, processes and goods and
services, based on:
 results of analysis of data;
 changes in the context of the organization;
 changes in identified risk ;
 new opportunities.
Evaluate, prioritise and determine improvements!

17. Drafted content / 7 QM principles
(Annex A)
Basis for a quality management system
1. Customer focus
2. Leadership
Statement
Leaders at all levels establish unity of purpose and direction
and create conditions in which people are engaged in
achieving the quality objectives of the organization.
Rationale
3. Engagement of people
4. Process approach
Creation of unity of purpose, direction and engagement
enable an organization to align its strategies, policies,
processes and resources to achieve its objectives.
6. Evidence-based decision making
7. Relationship management
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5. Improvement

18. Expected change of content /1
 High level structure and core text from „annex SL“
 Context of the organization / understanding needs of
interested parties
 Process approach – now requirement, explicitly in 4.4.2
 Easier applicability to service industries (term „product“
replaced by „goods and services“)
 Address risks and opportunities, include contingency plans
 Purchasing is broadened in clause 8.6 Control of external
provision of goods and services, including outsourcing, etc.
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 Preventive action disappears as explicit requirement –
included in risk-based approach

19. Expected change of content /2
 Leadership and top management responsibility intensified
 Function of „management representative“ for QMS disappears
as explicit requirements
 Manage knowledge as a resource (7.1.5)
 Enhance requirements for competence of personnel (7.2, 7.3)
 Evaluate performance based on results (effectiveness)
 „document“ and „record“ = „documented information“ (7.5);
accept „documents“ on various communication media
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 Less prescriptive in calibration (7.1.4 measuring and
monitoring devices) and design/development (8.5 development
of goods and services)

20. DQS-UL
Development of ISO 14001,
Environmental Management System
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Status: September 2013

21. Revision of ISO 14001
Revision process includes two significant actions:
I.
Adoption of the “High level structure for management systems”
Alignment with the ISO Directives Annex SL (same as ISO
9001)
II.
The ‘Future Challenges for EMS Study Group’ evaluated
potential implications of evolving stakeholder expectations and
new developments in environmental management systems.
 In addition to these, the mandate for the revision requires that basic
principles and existing requirements of ISO 14001:2004 be retained
and improved.
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 Eleven themes analyzed along with obstacles and opportunities to
increase the uptake of ISO 14001 in small organizations to help them
control environmental impacts in the supply chain, engage
stakeholders, and communicate environmental commitment externally

22. Revision of ISO 14001
 Currently at Committee Draft (CD) stage.
 Revision more advanced than ISO 9001 revision;
 Publication expected for early 2015
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23. ISO 14001 CD
Scope: The scope of the EMS has been expanded to include external
impacts on the organization.
Terms and definitions: Reference to common terms and core definitions as
outlined in Annex SL and those specific to an EMS.
Context of the organisation: New requirements relating to understanding the
internal and external issues of the organization and the needs and
expectations of stakeholders.
Policy: Policy commitments have been broadened to include supporting
environmental protection. Examples such as climate change mitigation and
adaption are given.
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Leadership: Top management leadership and commitment has been
strengthened requiring EMS requirements to be implemented into the
organisation’s business strategy and ensuring the EMS achieves its intended
outcome(s).

24. ISO 14001 CD
Environmental Aspects: Now includes consideration of a life cycle
perspective when evaluating environmental aspects.
Legal Requirements and other requirements: Clause has been replaced
by ‘Legal requirements and voluntary obligations’.
Environmental objectives: Required that performance indicators are to be
defined for each environmental objective.
Evaluation of compliance: New requirement for the evaluation process
with the introduction of a requirement upon the organization to maintain
knowledge and understanding of its compliance status.
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Value chain planning and control: New clause, introducing a requirement
to ensure that upstream and downstream processes related to significant
aspects are controlled or influenced.

25. Action!
1. What are customers‘ needs at present
and in near future?
2. What services do you offer to your customers?
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3. What do you do to build adequate auditor
competence?