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PROCESS APPROACH
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FURTHER EXCELLENCE
RELATIONSHIP MANAGEMENT
ENGAGEMENT OF PEOPLE
RISK MANAGEMENT
ABSTRACT
This document aims to provide an insight into the contents of the
current Draft revision ISO/DIS 9001 issued in May 2014 (DIS 9001).
It is not intended to be a full explanation of all of the requirements
of DIS 9001, rather it provides an overview of the key changes to
Quality Management Systems (QMS) proposed in the document. At
this stage in the ISO 9001 revision process, it is not certain that all of
the proposed requirements will be fully adopted in the final published
version of the Standard, but it is sensible to consider their likely
implications and allow time for organisations to prepare themselves well
in advance of final publication.
CONTENTS
I. INTRODUCTION .................................................................................................................................3
II. EXECUTIVE SUMMARY ..................................................................................................................4
III. ANNEX SL .........................................................................................................................................4
IV. THE CORE REQUIREMENTS OF DIS 9001 ...................................................................................6
V. CONCLUSION ....................................................................................................................................17
VI. REVISION AND IMPLEMENTATION TIMELINES ....................................................................18
VII. SGS SOLUTIONS FOR A SMOOTH TRANSITION ...................................................................18
I. INTRODUCTION
GENEVA
AMERICAS
440 OFFICES & LABORATORIES
17 700 EMPLOYEES
ASIA PACIFIC
385 OFFICES & LABORATORIES
30 300 EMPLOYEES
10%
18%
72%
ISO 9001
ISO 14001
Others
III. ANNEX SL
THE ADOPTION OF A
QUALITY MANAGEMENT
SYSTEM IS A STRATEGIC
DECISION FOR AN
ORGANIZATION
DIS 9001 more directly expects
organisations to apply a process
approach when planning, implementing
and developing their QMS. It also
includes a list of requirements identifying
the essential elements of such an
approach. The intention is to ensure that
organisations systematically define and
manage not just their processes, but also
the interaction between them.
ENHANCE THE
CONSISTENCY AND
ALIGNMENT OF ISO
MANAGEMENT SYSTEM
STANDARDS
1.
Scope
2.
Normative references
7.
Support
8. Operation
9. Performance evaluation
10. Improvement
MSS
MSS
ANNEX
SL
MSS
10
CONTINUAL IMPROVEMENT
ING
ANN
L
P
REQUIREMENTS
PERFORM
EVALU ANC
A
T
ION
QM
S
gener
al a
nd
pro
ce
s
ach
pro
ap
CUSTOMERS
P
SHI
R
DE
LE
A
4.4
CUSTOMER
SATISFACTION
PRODUCTS AND SERVICES
INPUTS
OPER
ATI O N S
OUTPUTS
SUPPORT PROCESSES
Figure 2
CLAUSE 2 NORMATIVE
REFERENCES
Although ISO 9001: 2008 currently
references ISO 9000: 2005 Quality
Management Systems Fundamentals
and Vocabulary as its only normative
reference, the content of ISO 9000:
2005 is now considered to have been
incorporated into DIS 9001 itself.
MARKET
INTERESTED PARTIES
ECONOMY
SHAREHOLDERS
ORGANISATION:
SUPPLIERS
EMPLOYEES
TECHNOLOGY
PRESSURE
GROUPS
VALUES
CULTURE
KNOWLEDGE
PERFORMACE
CULTURE
CUSTOMERS
END USERS
REGULATORS
SOCIAL
COMPETITION
Figure 3
b.
c.
CLAUSE 5 LEADERSHIP
This clause does not just simply
cover the same areas of policy,
organisational roles, responsibilities and
authorities that are present in clause
5 of ISO 9001: 2008 Management
Responsibility. There is now an
emphasis on leadership rather than
just management. Top management are
now required to demonstrate a greater
direct involvement in the organisations
QMS and the removal of the need for a
specific Management Representative
is partly an attempt to ensure that
ownership of an organisations
management system is not simply
focused on one individual.
THERE IS NOW AN
EMPHASIS ON
LEADERSHIP RATHER
THAN JUST
MANAGEMENT
CLAUSE 5.1.1 LEADERSHIP AND
COMMITMENT TO THE QUALITY
MANAGEMENT SYSTEM (QMS)
Top management must be able to
demonstrate that they have taken
responsibility for emphasising the
importance of conforming to the
requirements of their organisations
QMS. In addition, they must ensure
that the QMS is achieving its intended
results and drive continual improvement
within their organisation.
In those organisations where top
management have effectively delegated
responsibility for the QMS down to a
Management Representative (MR),
then under DIS 9001 they will now
have to demonstrate much more
direct involvement in the QMS. They
can still delegate tasks to others,
such as the MR, but otherwise the
specified requirements must be seen
to be undertaken by top management
themselves. Top management have to
be seen to be accountable for their
organisations QMS and to emphasise
the importance of effective quality
management and conformance with
QMS requirements. They must also
ensure that QMS requirements are
integral to the organisations business
processes and be consistent with
its overall strategic direction and the
context in which it operates.
Several of the DIS 9001 elements
that are aimed at top management
leadership and commitment require
them to ensure that certain activities
are undertaken or carried out, this
indicates that these tasks may be
delegated to others. However, where
there is a specific requirement that
top management must be taking,
promoting, communicating, engaging
and supporting action(s), this
indicates that they must be seen to be
undertaking these actions themselves.
CLAUSE 7 SUPPORT
Having addressed the organisations
context, commitment and planning, this
clause sets out the QMS requirements
relating to the support needed in order
to meet the organisations goals.
ORGANISATIONS NEED
TO TAKE INTO ACCOUNT
BOTH INTERNAL AND
EXTERNAL RESOURCE
REQUIREMENTS
AND
.
CAPABILITIES.
CLAUSE 7.1.3 INFRASTRUCTURE
Although this clause covers the same
requirements as ISO 9001: 2008
clause 6.3 Infrastructure, there is
now clarification in DIS 9001 that
Infrastructure can include:
transportation;
ORGANISATIONS
NEED TO DETERMINE
AND MAINTAIN THE
KNOWLEDGE OBTAINED
BY THE ORGANISATION
(INCLUDING ITS
PERSONNEL) TO
ENSURE THAT IT CAN
ACHIEVE CONFORMITY
OF PRODUCTS AND
SERVICES
This knowledge needs to be maintained
and made available where and when
necessary. It is up to the organisation
to decide how to do this and there
is no specific requirement that this
knowledge has to be retained as
documented information. Additionally,
when planning changes to its QMS or
operational activities, an organisation is
required to assess whether its existing
organisational knowledge is sufficient
to satisfactorily manage these changes
or if it needs to obtain additional
knowledge to do so and take steps to
get it if necessary.
11
12
CLAUSE 8 OPERATION
This is the clause that addresses
the main business activities of the
organisation implementing its QMS and,
in addition to requirements relating to
operational planning and control. This is
the section in which most QMS-specific
requirements are found.
ORGANISATIONS NEED
TO DEMONSTRATE A
SPECIFIC PROCESS
FOR ESTABLISHING
THE REQUIREMENTS
FOR THE PRODUCTS
AND SERVICES IT
INTENDS TO OFFER TO
CUSTOMERS
documented information which
describes the results of the review(s),
including those relating to any new or
changed requirements for products and
services.
13
14
Personnel competence
A note in DIS 9001 indicates that postdelivery activities can include actions
under warranty provisions, contractual
obligations such as maintenance
services and supplementary services
such as recycling or final disposal.
CLAUSE 9 PERFORMANCE
EVALUATION
CLAUSE 9.1 MONITORING, MEASUREMENT,
ANALYSIS AND EVALUATION
CLAUSE 9.1.1 GENERAL
The current requirement in ISO 9001:
2008 clause 8.1 that an organisation has
to plan and implement the necessary
monitoring, measurement, analysis
and improvement processes has
been replaced by the requirement that
the organisation identifies the what
how and when of the monitoring and
measurement:
ORGANISATIONS NEED
TO ACTIVELY SEEK OUT
INFORMATION RELATING
TO HOW CUSTOMERS
VIEW THE ORGANISATION
ITSELF, AS WELL AS
ITS PRODUCTS AND
SERVICES
CLAUSE 9.1.2 CUSTOMER SATISFACTION
DIS 9001 now requires organisations to
actively seek out information relating to
how customers view the organisation
itself, as well as its products and
services. There is no specific
requirement that this information has to
be documented, but an organisation will
have to demonstrate that it is actively
seeking out information on customer
perception, not just about its products
and services, but also about the
organisation itself. An organisation will
also have to show how it does this and
what it does with the information that it
collects.
15
Quality objectives
Customer feedback
16
CLAUSE 10 IMPROVEMENT
CLAUSE 10.1 GENERAL
This is a new section which emphasises
the general need to improve processes,
products and services, as well as QMS
results, in order to meet customer
requirements and enhance customer
satisfaction. Organisations will need
to demonstrate that they actively look
for opportunities to improve their
processes, products and services, as
well as the performance of their QMS.
V. CONCLUSION
As was highlighted at the beginning
of this document, DIS 9001 is only
the latest stage in the revision
process. Further revision to the QMS
requirements is possible between now
and final publication of the revised
Standard in 2015. Although this means
that not all of the requirements outlined
in this document will necessarily be
adopted in that final published version,
the significant changes that may be
introduced, that have been highlighted,
mean that all organisations should
consider the likely impact on themselves
and their QMS.
However, it is important to note that
this does not mean that an organisation
is now required to get rid of all its
exiting manuals and procedures. An
organisations existing operational
procedures, work instructions, flow
charts, process maps, etc. are all
examples of documented information
and it does not now have to remove its
current Quality Manual or documented
procedures. If an organisation wishes
to retain these then they can do so.
Similarly, organisations do not have to
re-structure, re-name or re-number
their existing manuals or procedures
just to bring them in line with the clause
structure in DIS 9001.
In many cases, organisations that have
had a QMS in place for several years will
have grown accustomed to using their
existing documentation and the process
security that it brings. There is no reason
why they should remove or replace it if
they believe it is effective. The key issue
for any organisation will be ensuring
that it meets all the requirements
in DIS 9001. The QMS structure or
documentation it uses will be irrelevant
provided that it does so.
The implications for individual
organisations will vary, depending
on the degree to which their own
QMS already covers the DIS 9001
requirements. For that reason, it would
be sensible for each organisation, even
17
DIS 9001 was issued in May 2014 and interested parties were invited to submit
comment on its contents to the ISO committee overseeing the proposed revision
(ISO/TC 176/SC 2/WG 24). These comments are subject to review by the committee
and a vote on whether to accept or reject any recommendations made. The results of
this process will form the basis of the Final Draft International Standard (FDIS), which
in turn will be followed soon after by the final published revision to ISO 9001. The
anticipated timeline for this process is outlined below:
2014
2015
2016
2017
2018
RISK-BASED THINKING
GAP ANALYSIS
ANNEX SL
EMPOWERING LEADERSHIP
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18
ABOUT SGS
Chris Trott
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SGS is recognised as the global benchmark for quality and integrity. With more than
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