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QUALITY MANAGEMENT
REVISION OF ISO 9001 CHANGES AND IMPACT

The International Organization for Standardization (ISO) is
currently working on a revision of ISO 9001, the leading stand-
ard for quality management systems that is expected to be pub-
lished in September 2015. Since 4
th
July 2013, the ISO/CD
9001:2013 has been circulated for commenting. The draft shows
clear changes compared to the current ISO 9001:2008. DNV
Business Assurance therefore recommends that companies
should acquaint themselves with the draft at an early stage.

With more than 1.1 million certificates worldwide, nearly half a
million certificates in Europe and nearly 50.000 certificates in
Germany, the ISO 9001 standard is the leading standard for
management systems and can be considered the mother of all
system standards. Therefore the expectations of those who have
to work with this standard are high: external and internal audi-
tors, system representatives, consultants and last but not least
the companies top management.
After the last revision of ISO 9001 (2008) has brought only slight
changes, the version presented by ISO for discussion the so
called Committee Draft indicates that there will be some cru-
cial changes in 2015. ISO revises its standards on a regular basis
in order to adapt those to current requirements of the public.
DNV Business Assurance has summarized the major aspects
according the state of affairs.

What will change?
What does that mean for the people involved in quality
management?
What are the next steps in the revision process?

WHAT WILL CHANGE?
Structural changes
The first significant change indicated in the draft is the change
of structure. For the revised version of ISO 9001, the so called
High Level Structure will be adapted. The High Level Struc-
ture is a generic structure that can be applied to all ISO man-
agement system standards and provides structure, identical core
text and common terms as well as core definitions that are to
form, when possible, the nucleus of future and revised manage-
ment system standards such as ISO 9001.


For companies this change means that the integration of differ-
ent standards will be easier in future.

The new structure of ISO 9001 will probably be as follows:

New structure of ISO 9001
[Status: Committee Draft June 2013]
1. Scope

2. Normative references

3. Terms and definitions: Reference to the generic terms
named in Annex SL and other terms specific to the stand-
ard.
4. Context of the organization: Understanding the intern and
extern dependencies and interactions, the stakeholder re-
quirements and expectations, the management system and
its field of application.
5. Leadership: Management responsibility and commitment,
policy, organizational roles, responsibilities and authorities.
6. Planning: Actions to address risks and opportunities, quality
objectives and planning to achieve them.
7. Support: Resources, competence, awareness, communica-
tion and documented information (required documents
and records).
8. Operation: Planning and control.

9. Performance evaluation: Monitoring, measurement, analysis
and evaluation, internal audit and management review.
10. Improvement: Non-conformities, corrective actions and
improvement.

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Changes in content
The content of the standard has been revised as well. This affects
definitions on the one hand and focusing on subject areas on
the other hand. We have listed the changes and their impact on
the quality management of companies and their interested par-
ties below:

Risk based approach
A significant change is the risk based approach. Taking risks
into consideration is required in several clauses of the
standard: in the process approach, the leadership and espe-
cially in planning. The documented information of the
management system must be adequate to the risks related to
conformity and customer satisfaction and enable the organ-
ization to exploit opportunities.
Therefore companies should use risk management tools and
mechanisms in future and derive regulations and improve-
ment activities for the management system from this.

Process approach
In contrast to the recommendation in the current ISO
9001:2008, the process approach is demanded now. The
significant requirements are summarized in clause 4.4.2.
For companies this means that processes, their order and in-
teractions including the related additional conditions (re-
sources, measurement) have to be defined more clearly.


Documented Information
With the intention of making the implementation and use
of a management system more flexible and traceable, the
current terms documents, records, documented proce-
dures etc. will be replaced by the generic term document-
ed information.
For a companys practice of quality management this means
that in the current draft less documented procedures are
required. Therefore the company has to define the neces-
sary extent of documented information itself in order to as-
sure the effectiveness of the management system.

Goods and Services
Instead of the term product, goods and services will be
referred to. Through this clear term, the generic character
of the standard will be improved and service providers will
find it easier to use it.

WHAT DOES THAT MEAN FOR THE PEOPLE INVOLVED IN
QUALITY MANAGEMENT?
The changes indicated in the new ISO 9001 draft also have an
effect on the people involved in quality management. Some
aspects are shown below:
Acquirement of knowledge and skills
The ISO 9001 revision comes along with some major chang-
es. Accordingly, all individuals involved in implementing
and auditing the standard will have to look further into top-
ics like risk management and process orientation.

Auditor requirements
Good auditors have always worked like expected from the
standard to come. Furthermore, DNV Business Assurance
auditors are already well prepared for future requirements
due to applying DNVs Risk Based Certification auditing
method.

Adequacy of the auditing method
The assessment of the adequacy of regulations and present-
ed evidence will play a bigger role in future. Auditing pro-
cesses and their interactions and dependencies will move to
the center of activities (interfaces).

Audit duration
A change in audit duration is not expected.


WHAT ARE THE NEXT STEPS IN THE REVISION PROCESS?
Following the usual procedure for the revision of standards, the
official draft of the International Standard (DIS) is to be antici-
pated in the second half of 2014. The later finalized draft (FDIS)
is expected for the middle of 2015 and the final issue of the new
standard as ISO 9001:2015 is scheduled for September 2015.
After publication of a new standard ISO usually grants a transi-
tion period. Users will have to adapt their quality management
system to the new requirements during this period.
At the same time, ISO is working on the revision of ISO 14001
for environmental management systems. The publication is
expected earlier in 2015.
It is anticipated that the comments and objections to both drafts
of these essential management system standards will influence
each other, as ISO intends a common structure and congruence
of contents.



USEFUL LINKS
International Organization for Standardization (ISO)
http://www.iso.org/iso/home.html
Quality management with DNV Business Assurance
www.dnvba.de/qualitaet
10 golden rules for internal audits"- a guide by DNV Business
Assurance (German document)
http://www.dnvba.com/de/zertifizierung/Managementsystem
-Zertifizierung/Qualitatsmanagement/Pages/Registrierung-
interne-Audits.aspx

CONTACT
Thomas Beck
Telephone: 0201-7296 356
thomas.beck@dnv.com