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Frequently Asked Questions (FAQ's)&nbs= p;

This list of Frequently Asked Questions (FAQs) has been prepared by ISO/TC 176/SC 2 to support the
publication of ISO 9001:2008 and of ISO 9004:2009. Input has been obtained = from experts and users of
the ISO 9000 standards, expressed during seminars and presentations around the world.

The list will be review= ed and updated on a regular basis to maintain its accuracy, and to include new
questions where appropriate. = It is intended that this list will also provide a good source of information
for = new users of the standards.

For the latest version of the FAQs, reference shou= ld be made to the web site: www.iso.org/tc176
/sc2/public .
The FAQs given below have been categorized as follows:

1. ISO
2. ISO 9000 Family of standards
3. ISO 9001
4. ISO 9004
1. ISO
1.1 What is ISO?
The Interna= tional Organization for Standardization (ISO) was established in 1947 and is (currently) an
association of approximately 160 National Standards Bodies, which each represent their own country. ISO
employs a system of Technical Committees, Sub-committees and Working Groups to develop
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International Standards. Besides the National Standards Bodies, ISO permits other international
organizations that develop standards to participate in its wo= rk, by accepting them as Liaison members.
ISO works in accordance with an agreed set of rules of procedure, the ISO/IEC Directives, which also
include requirements on the presentation of standards. For further details please r= efer to ISO's own web
site at http= ://www.iso.org/
1.2 Who are the National Standards Bodies, and who represents my coun= try at ISO?
Please use the link on ISO's web site that gives details, including contact information, of the National
Standards Bodies: www.iso.org/iso/about/iso_members.htm
1.3 Is there any way I can participate in the development of standards?
Yes. If you are interested you should contact your National Standards Body = for further details.
Information on ISOs member National Standards Bodies can be found at= : http://www.iso.org/iso/about
/iso_members.htm
2. ISO 9000 Family of standards
2.1 What are the ISO 9000 standa= rds ?
The ISO 900= 0 standards are a collection of formal International Standards, Technical Specification= s,
Technical Reports, Handbooks and web based documents on Quality Management. There are
approximately 25 documents in the collection altogether, with new= or revised documents being
developed on an ongoing basis.
(It should be noted that many of the International Standards in the ISO 9000 family are numbered in the
ISO 10000 range.)
2.2 Who is respon= sible for developing the ISO 9000 standards?
ISO Technical Committee (TC) number 176 (ISO/TC 176), and its Sub-committee= s, are responsible for
the development of the standards. The work is conducted= on the basis of "consensus" among quality and
industry experts nomin= ated by the National Standards Bodies, representing a wide range of interested
parties.
2.3 Where can copies of the standards be obtained?
Copies of the standards may be purchased from your National Standards Body, or from ISO itself
(sales@iso.org). Many National Standards Bodies have them available in local-language versions.
2.4 Where can copies of the supporting ISO 9000 guidance notes or other documents be found ?
Copies of the ISO 9000 Introduction and Support Pack= age modules:
Guidance on ISO 9001:2008 Sub-clause 1.2 'Applicat= ion'
Guidance on the Documentation requirements of ISO 9001:2008
Guidance on the Terminology used= in ISO 9001 and ISO 9004
Guidance on the Concept and Use = of the Process Approach for management systems
Guidance on 'Outsourced Processe= s'
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as well as details of the Quality Management Principles can be found at: www.iso.org/tc176/sc2/public
Copies of the ISO 9001 Auditing Practices Group guidance notes can be fo= und at: www.iso.org/tc176
/ISO9001AuditingPracti= cesGroup
Copies of the sanctioned ISO/TC 176 sanctioned Interpretations of ISO 9001 can be found at: ht=
tp://www.tc176.org/
2.5 Where can information be obtained on the ISO 9000 standards?
There are a number of sources of information on the ISO 9000 quality manage= ment system standards,
including ISO's web site (www.iso.org), w= hich carry information on the standards. Your National
Standards Body should be able to provide copies of the standards, and registrars/certifica= tion bodies will
be able to provide guidance on registration arrangements.
2.6 Why are standards revised?<= br>
ISOs formal review proces= s:
o = Requires continual review to keep standards up to date. Must be initiated within 3 years of
publication of a standard.
&= nbsp; User inputs fr= om:
o&nb= sp; global user questionnaires/surveys
= o = market Justification Studies
= o = Suggestions arising from the interpretation process
= o = Opportuniti= es for increased compatibility with ISO 14001
= o = The need for greater clarity, ease of use, and improved translation
&nbs= p; Current tre= nds:
= o = Keeping up = with recent developments in management system practices.
2.7 Who is responsible for revising ISO 9001 and ISO 9004?
The revision process is the responsibility of ISO Technical Committee no.176, Sub-commit= tee no.2
(ISO/TC 176/SC 2) and is conducted on the basis of consensus among qua= lity and industry experts
nominated by ISO Member bodies, and representing all interested parties.
2.8 Where can I obtain informat= ion on the standards?
ISO maintains a web site at http://www.iso.org/ that carries general information on the standards. Your
National Standards Body can g= ive you additional information about national versions.
2.9 Are the standards available= in my national language?
The active participation of experts from around the world in the preparation of the new standards
facilitates their translation into many different languages.
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ISO itself publishes standards in English and French.
You should contact your National Standards Body to see if they have your national language translations
of the standards.
2.10 Where can my organization = go if it needs additional clarification or interpretation of the
standards?
The starting point for any individual request for an interpretation sho= uld be with the enquirer's
National Standards Body. ISO Central Secretariat and ISO/TC 176/SC 2 cannot accept direct
requests from individuals for interpretations= of the ISO 9000 standards. ISO/TC 176 has a
Working Group that only accepts formal requests for interpretations from the National Standards
Bodies. The agreed interpretati= ons can be found at http://www.tc176.org/.
2.11 Do the standards address financial issues?
Financial issues are not addressed in ISO 9001:2008, which is a requirements standard.
The ISO 10014:2006 and ISO 9004:2009 guidance standards emphasize the finan= cial resources
needed for the implementation and improvement of a quality manage= ment system.
2.12 What are the benefits of ISO 9001:2008 and ISO 9004:2009?
For ISO 9001:2008 the major benefits are:
= Simple= to use=
= Clear in language
= Readily translatable and easily understandable
= Compatibility with other management systems such as ISO 14001.
For ISO 9004= :
&s= ect;&n= bsp; Facilitates improvement in users quality management systems.
= Provides guidance to an organization for the creation of a quality management system that:
o = creates value for its customers, via the products it provides
o = creates value for all other interested parties
o = balanc= es all interested-party viewpoints.
= Provides guidance for managers on leading their organization towards sustained success.
= Forward compatibility to allow organizations to build on existing qua= lity management
systems.
2.13 What are the main benefits to be derived from implementing an ISO 9000 quality management
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system?
The ISO 9000 standards give organizations an opportunity to increase value = to their activities and
to improve their performance continually, by focusing = on their major processes. The standards
place great emphasis on making quality management systems closer to the processes of
organizations and on continual improvement. As a result, they direct users to the achievement of
business results, including the satisfaction of customers and other interes= ted parties.
The management of an organization should be able to view the adoption of the quality management
system standards as a profitable business investment, not just as a required certification issue.
Among the perceived benefits of using the standards are: =
&nbs= p; The connect= ion of quality management systems to organizational processes
The encouragement of a natural progression towards improved organizational performance,
via:
= o = the use of = the Quality Management Principles
= o = the adoptio= n of a "process approach"
= o = emphasis of= the role of top management
= o = requirements for the establishment of measurable objectives at relevant functions and le=
vels
= o = being orientated toward "continual improvement" and "customer satisfaction", including
the monitoring of information on "custom= er satisfaction" as a measure of system performance.
= o = measurement= of the quality management system, processes, and product
= o = considerati= on of statutory and regulatory requirements.
= o = attention to resource availability
2.14 Are the standards compatible with natio= nal quality award criteria?
The standards are based on 8 Quality Management Principles, which are aligned with the
philosophy and objectives= of most quality award programs.
These principles are:
&nbs= p; Customer fo= cus,
&nbs= p; Leadership,=
&nbs= p; Involvement= of people,
&nbs= p; Process approach,
&nbs= p; System appr= oach to management,
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&nbs= p; Continual improvement,
&nbs= p; Factual approach to decision making, and
&nbs= p; Mutually be= neficial supplier relationships.
=
ISO 9004 recommends that organizations perform self-assessments as part of their management of
systems and process= es, and includes an annex giving guidance on this approach. This is similar to
= many quality awards programmes.
2.15 Why is the monitoring of "customer satisfaction" inclu= ded in the standards?
"Customer satisfaction" is recognized as one of the driving crite= ria for any organization. In order
to evaluate if a product meets customer needs and expectations, it is necessary to monitor the extent
of customer satisfaction. Improvements can be made by taking action to address any identified
issues and concerns.
2.16 Can the standards improve "customer satisfaction"?
The quality management system details that are described in the standards a= re based on Quality
Management Principles that include the "process approach" and "customer focus". The adoption
of these principles should provide customers with a higher level of confidence that products will
meet their needs and increase their satisfaction.
2.17 What is meant by "con= tinual improvement"?
Continual improvement is the process focused on continually increas= ing the effectiveness and/or
efficiency of the organization to fulfil its polic= ies and objectives. Continual improvement (where
"continual" highligh= ts that an improvement process requires progressive consolidation steps)
respo= nds to the growing needs and expectations of the customers and ensures a dynamic evolution
of the quality management system.
2.18 What is a process?=
Any activity or operation, which receives inputs and converts them to outputs, can be considered as
a process.&n= bsp; Almost all activities and operations involved in generating a produc= t or
providing a service are processes.
For organizations to function, they have to define and manage numerous inter-linked processes.
Often= the output from one process will directly form the input into the next process. The
systematic identification and management of the various processes employed within an
organization, and particularly the interactions between such processes, may= be referred to as the
process approach to management.
For further information, refer to the paper Guidance on the Concept and Use of the Process
Approach, available from <= /span>www.iso.org/tc176/sc2/public.
2.19 What is the "process approach"?
The "process approach" is a way of obtaining a desired result, by managing activities and related
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resources as a process. The "process approach" is a key element of the ISO 9000 standards. For
further guidance, please refer to the ISO 9000 Introduction and Support Pac= kage module:
Guidance on the Concept and Use of the Process Approach for management systems.
2.20 Can the "process approach" be applied to other managem= ent systems?
Yes. The "process approach" is a generic management principle, wh= ich can enhance an
organizations effectiveness and efficiency in achievi= ng defined objectives.
2.21 How can the PDCA cycle be used in the "process approach&quo= t;?
The PDCA cycle is an established, logical, method that can be used = to improve a process.
This requires:
(P) planning (what to do and how= to do it),
&nbs= p; (D) executi= ng the plan (do what was planned),
&nbs= p; (C) checkin= g the results (did things happened according to plan) and
&nbs= p; (A) act to improve the process (how to improve next time).
The PDCA cycle can be applied within an individual process, or across a gro= up of processes.
2.22 Can any organization apply the "process approach"?
Yes. Many organizations already apply a "process approach" without recognizing it. They could
achieve additional benefits by understanding and controlling it.
2.23 Why should an organization apply the "process approach"= ;?
By applying the "process approach" an organization should= be able to obtain the following types of
benefits:
&= sect; = The integration and alignment of its processes to enable the achievement of its
planned results.
&= sect; = An ability to focus effort on process effectiveness and effici= ency.
&= sect; = An increase in the confidence of customers and other interested parties as to the
consistent performance of the organization.
&= sect; = Transparency of operations within the organization.
&= sect; = Lower costs and shorter cycle times through effective and efficient use of resources.
&= sect; = Improved, consistent and predictable results.
&= sect; = The identification of opportunities for focused and prioritized improvement
initiatives.
&= sect; = The encouragement and involvement of people, and the clarifica= tion of their
responsibilities.
&nbs= p; The elimination of barriers between different functional units= and the unification of
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their focus to the objectives of the organization.
= Improved management of process interfaces.
=
2.24 What is meant by the sequence of processes and their "interactions"?
The "sequence" of processes shows how the processes follow, or li= nk, to each other to result in a
final out= put.
For example, the output from one process may become the input of the next process or processes.
The "interactions" show how each process affects or influences on= e or more of the other processes.
For example, the monitoring or controlling of a process may be established in a separate process.
2.25 How can the processes in an organization be determined?
Identify the organization's intended outputs, and the processes needed for achieving them. These
will need to include processes for Management, Resources, Realization and Measurement and
Improvement.
&= nbsp; Identify all process inputs and outputs, along with the suppliers and customers, who
may be inte= rnal or external.
Identify the sequence and interacti= ons of the processes.
2.26 Should an organization define and document all its processes?
The main purpose of documentation is to enable the consistent and stable op= eration of an
organization's processes.
Although statutory, standards' or customer requirements may require certain documentation, there
is no defined catalogue, or list of processes that has to be documented in ISO 9001, apart from the
6 indicated= ones.
The organization should determine which processes are to be documented on t= he basis of:
= &= nbsp; The size of the organization and type of its activities,
= &= nbsp; The complexity of its processes and their interactions,
= &= nbsp; The criticality of t= he processes and
&nbs= p; Availabilit= y of competent personnel.
A number of different methods= can be used to document processes, such as graphical
representations, written instructions, checklists, flow charts, visual media, or electronic methods.=
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2.27 How mu= ch detail is required in process documentation?
The extent of detail is likely to depend upon factors such as:
&nbs= p; the size of an organisation and its ty= pes of activities,
&nbs= p; the complex= ity of its processes and their interactions, and
&nbs= p; the compete= nce (level of education, training, skills and experience) of its personnel.
2.28 Is there a standard way of descri= bing a process?
No, there is no standard way to describe a process. It depends on the cultu= re, management style,
staff literacy, personal attributes and their interaction= s.
A process may be described using a flow chart, block diagram, responsibility matrix, written
procedures or pictures.
Process flowcharts or block diagrams can show how policies, objectives, influential factors, job
functions, activities, material, equipment, resour= ces, information, people and decision making
interact and/or interrelate in a logical order.
2.29 What should an organization do to adopt the "process approach"?
To adopt the "process approach" an organization should apply the following steps:
&nbs= p; Identify the processes of the organization,
&nbs= p; Plan the processes,
&nbs= p; Implement a= nd measure the processes,
&nbs= p; Analyse the= processes,
&nbs= p; Improve the processes.
2.30 What is a "process owner&quo= t;?
A person who is given the responsibility and authority for managing a particular process is
sometimes referred to as the "process owner"= ;.
It may be useful for an organization's Management to appoint individual "process owners" and to
define their roles and responsibilities; these should include the responsibility for ensuring the
implementation, maintenance and improvement of their specific process and its interactions.=
It should be noted, however, that ISO 9001:2008 does not specifically requi= re the appointment of
"process owners".
2.31 How ca= n a process be measured?
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There are various methods of measuring process controls and process performance, ranging from
simple monitoring systems up to sophisticated statistically based systems (e.g. statistical process
control, or SPC, systems). The selection and use of any particular method will be dependent = on the
nature and complexity of an organization's processes and products. The = effectiveness of an
individual process may be measured by the conformity of its output or product to customer
requirements. Its efficiency may be measured from its u= se of resources. In all cases the
measurement of the process determines if its (measurable) objectives have been achieved.
Sometimes it only requires monitoring to confirm process operations.
Typical factors that are useful to consider when identifying measures of process control and process
performance include:
Conformity with requ= irements,
Customer satisfactio= n,
Supplier performance= ,
On time delivery,
Lead times,
Failure rates,
Waste,
= &= nbsp; Process costs.<= /o:p>
= &= nbsp; Incident frequency
2.32 What is the difference between a "process" and a "procedure"?
A "process" may be explained as a set of interact= ing or interrelated activities, which are employed
to add value. A "procedure" is a method of describing the way or How in which all= or part of that
process activities shall/should be performed.
ISO 9000:2005 defines a procedure as a "specified way to carry out = an activity or a process", which
does not necessarily have to be documented.
2.33 An organization has a well-established set of procedures. Can th= ese procedures be used to
help describe its processes?
Yes, if the procedures describe inputs and outputs, appropriate responsibilities, controls and
resources needed to satisfy customer requirements.
2.34 Which standard are organizations registered/certified to?
Organizations have their quality management system registered/certified to = ISO 9001:2008. The
scope of registration/ certification will need to reflect precisely and clearly the activities covered by
the organization's quality management system; any exclusion to non-applicable requirements of the
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stan= dard (permitted through ISO 9001 clause 1.2 "Application") will need t= o be documented
and justified in the quality manual (see also the ISO/TC 176/SC2= ISO 9000 Introduction and
Support Package module Guidance on ISO 9001:2008 clause 1.2 'Application').
2.35 Can an organization be certified/registered to ISO 9004?=
ISO 9004 is a guidance standard, which is not intended to be used for third party
registration/certification purposes. A key element of ISO 9004 = is the ability to perform
self-assessments. Third party quality management sys= tem certifications/ registrations are
performed to ISO 9001:2008.
2.36 What is happening to the o= ther standards and documents in the ISO 9000 family?
The four primary standards of the current ISO 9000 family are ISO 9000:2005, ISO 9001:2008, ISO
9004:2009 and ISO 19011:2002.
ISO 19011:2002 is currently being revised, with a new version expected in 2011.=
The ot= her standards and documents are being reviewed and updated as necessary
2.37 What has happened to the ISO handbook = ISO 9001 for Small Businesses?
A new edition was published in June 2010, to reflect the changes in ISO 9001:2008.
2.38 How are the standards applicable to organizations that provide services. ?
The standards are applicable to all types of organizations, operating in all types of sectors, including
service providers.
(Note: the definition of the term 'product' in ISO 9000:2005 also includes 'services'. ISO 9001:2008
and ISO 9004:2009 have been written to reflect th= is definition.)
2.39 What do quality management practitioners (consultant, auditor, or trainer) need to know about
the standards?
As a minimum, quality management practitioners should familiarize themselves with the
requirements of ISO 9001:2008, and also with the content and philosophies of ISO 9000:2005, ISO
9004 and the Quality Management Principles.
Practitioners whoa are already familiar with ISO 9001:2000 should become aw= are of the
clarifications introduced in ISO 9001:2008, and their implications, prior to conducting audits to that
standard, or giving training and consultancy.
They should understand their clients activities and processes, before providing appropriate
interpretations of the requirements of the standards,= to add value to the client's operations.
ISO/TC 176 has developed the standard ISO 10019 Guidelines for the selec= tion of quality
management system consultants and use of their services, whi= ch may be useful to refer to for
further guidance.
2.40 How should regulatory bodies use the standards?
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Regulatory bodies should review their regulations currently in effect (or u= nder development) and
identify points where reference to the quality management system standards would be appropriate,
before making recommendations to the legislative body.
2.41 What do auditors need to know about the standards?
Auditors, whether external or internal, should be able to demonstrate their competence on the
structure, content and terminology of the standards, and = also on the underlying Quality
Management Principles.
The standards require that auditors are able to understand the organization= 's activities and
processes and appropriately audit against the requirements of the ISO 9001 in relation to the
organization's objectives. According = to joint advice from the International Accreditation Forum
(IAF), ISO's Policy Committee for Conformity Assessment (ISO-CASCO) and ISO TC 176, auditors
sh= ould be able to demonstrate competency in:
&nbs= p; The requirements of the ISO 9001:2008.
&nbs= p; The concepts and terminology of the ISO 9000:2005.
&nbs= p; The eight <= /span>Quality Management Principles
&nbs= p; A general understanding of ISO 9004
&nbs= p; Familiarity with the auditing guidance standard ISO 19011.

ISO/TC 176, ISO/CASCO and the IAF have established an ISO 9001 Auditing Practices Group,
which has issued a number of web based guidance not= es to assist auditors (see www.iso.org/tc176
/ISO9001AuditingPracti= cesGroup)
3.1 How much is the implementation of ISO 9001:2008 going to cost= ?
It is not possible to give a definitive cost for implementing a QMS that meets the re= quirements of
ISO 9001.
The implementation costs, and associated certification costs, will be depen= dent on factors such as:
the size of the organization (a few employees versus many)
its organizational structure (a single division versus multiple ones= )
its geographical locations (a single site, versus multiple ones in m= any countries)
the maturity of its existing QMS (is there an existing functional QM= S in the organization that
just needs amending to meet the standard, or does the organization have to start one from scratch)
the complexity of its products (simple manufacturing or service deli= very processes versus
complex ones requiring statistical process controls)
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One of the goals of ISO/TC 176/SC 2 is to produce standards that will minimize = any potential costs
during a smooth implementation. Any additional costs may be consid= ered as a value-adding
investment. A key factor in the development of ISO 9001:2= 008 was to limit the impact of changes
on users.
3.2 What are the main c= hanges in ISO 9001:2008 as compared to ISO 9001:2000?
ISO 9001:2008 has been developed in order to introduce clarifications to the existing requirements
of ISO 9001:2000 and changes that are intended to imp= rove compatibility with ISO 14001:2004.
ISO 9001:2008 does not introduce additio= nal requirements nor does it change the intent of the ISO
9001:2000 standard.
Certification to ISO 9001:2008 is not an upgrade, and organizations that are certified to ISO
9001:2000 should be afforded the sa= me status as those who have already received a new certificate
to ISO 9001:200= 8. However, all organizations are expected to have made the migration to using=
ISO 9001:2008 by November 2010.
All changes between ISO 9001:2000 and ISO 9001:2008 are detailed in Annex B= to ISO 9001:2008.
3.3 How will the implementa= tion of ISO 9001:2008 help my organization to improve its
efficiency?=
ISO 9001:2008 aims at guaranteeing the effectiveness (but not necessarily t= he efficiency) of the
organization. For improved organizational efficiency, however, the best results ca= n be obtained by
using ISO 9004:2009 in addition to ISO 9001:2008. The guiding quality management principles are
intended to assist an organization in continual improvement, which should lead to efficiencies
throughout the organization.
3.4 Is an organization's ISO 9001 certificate applicable to all of its products ?
When an organization seeks to have its quality management system registered/certified to ISO
9001:2008, it is required to agree a "scop= e of certification" with its registrar/certification body.
This will define= the products to which the organization's quality management system is applicabl=
e, and against which it will be assessed. An organization is not oblige= d to include within its "scope
of certification" all the products that= it provides (note that the ISO 9000:2005 definition of
"Product" includes "services"), but may be selective about those that are included. All applicable
requirements of ISO 9001:2008 will need to be addressed by the organization's quality management
system that covers those products that are included in the "scope of certification".
Customers should ensure that a potential supplier's "scope of certification" covers the products that
they wish to order. Caveat Emptor!
3.5 What can an organiz= ation do if it is not able to comply with all of the requirements of ISO
9001?
ISO 9001 allows for the exclusion of some of its requirements (via clause 1= .2 Application), but
only if it can be shown that these requirem= ents are not applicable to the organization.
Exclusions are limited to the requirements given in Section 7 ("Product Realization"), where
individual requirements may only be excluded if it can be shown that they do not affect the
organization's ability to provide product that meets customer and applicable statutory or regulatory
requirements. Justification for such exclusions is also required to be deta= iled within the
organization's quality manual.
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For example, if design activities are not required by an organization to demonstrate its capability to
meet customer and applicable statutory /regulatory requirements, or if its product is provided on
the basis of established design, then it may be able to exclude some of the "design" requirements but
still be able to be registered/certifie= d to ISO 9001:2008.
For further guidance, see the ISO 9000 Introduction and Support Package mod= ule: Guidance on
ISO 9001:2008 clause 1.2 'Application= '.
3.6 How will a small organization be able to adapt the requirements of ISO 9001? What flexibility
will be allowed?
The requirements of the amended ISO 9001:2008 remain applicable to small, medium, and large
organizations alike, and such organizations should acquai= nt themselves with the clarifications in
ISO 9001:2008. ISO/TC 176 has published a handbook ISO 9001 for Small Businesses What to
do ? giving specific advice to small businesses.
The requirements of ISO 9001 are applicable to small, medium, and large organizations alike. ISO
9001:2008 provides some flexibility, through clause 1.2 Application, on the exclusion of certain
requireme= nts for specific processes that may not be performed by the organization.
If, for example, the nature of your products does not require you to perform design activities, or if
your product is provided on the basis of establish= ed design, you could discuss and justify the
exclusion of these requirements w= ith your certification/registration body (see also the ISO 9000
Introduction and Support Package module Guidance on ISO 9001:2008 clause 1.2 'Application').
However, individual organizations wi= ll still need to be able demonstrate their capability to meet
customer and applicable statutory or regulatory requirements for their products, and will need to
consider this when determining the complexity of their quality management systems.
Further guidance for small businesses may be found in the ISO handbook: = ISO 9001 for Small
Businesses What to do, Advice from ISO/TC 176
3.7 Whats the relationsh= ip between the revised ISO 9001 and ISO 14001?
Compatibility with ISO 14001:2004 has been maintained and enhanced. = C= ompatibility means
that common elements of the standards can be implemented by organizat= ions in a shared manner,
in whole or in part, without unnecessary duplication or= the imposition of conflicting requirements.
3.8 Are there any guidelines covering joint implementation of ISO 9001 and ISO 14001?<= /u>
The two standards are compatible. It is not expected that an ISO guideline = will be prepared on
this subject at the present time. If the need for such a document ar= ises, ISO will consider the
request as a new project. However, both ISO 9001 and = ISO 14001 include an annex to show the
correspondence between the two standards= .
3.9 Is there a common guideline standard for auditing QMS and EMS accord= ing to ISO 9001 and
14001?
Yes, ISO 19011:2002 provides guidelines for quality and/or environmental management systems
auditing. = Note that a project to revise ISO 19011 was started in 2008, to make it applicab= le to all
of ISOs management system standards, and is expected to be completed in 2011.
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3.10 My organization provides services. Is ISO 9001:2008 applicable to us?
ISO 9001 is equally appropriate to all sectors, including service providers. The standard is
applicable to all types of organizations.
3.11 How does ISO 9001:2008 rel= ate to the needs of specific business sectors?
ISO 9001:2008 is compatible with the existing management systems standa= rds for specific business
sectors such as ISO/TS 16949, AS 9000/EN 9100 and TL 9000.
Users of a specific sector scheme are recommended to refer to the organizat= ion that is responsible
for that sector scheme, e.g. for:
&n= bsp; ISO/TS 16 949 refer to the IATF,
&n= bsp; TL 9000 refer to the QuEST Forum
&n= bsp; For AS 9000/EN 9100 refer to the IAQG
3.12 What documentation is required by ISO 9001?
ISO 9001:2008 refers specifically to only 6 documented procedures; however, other documentation
(including more documented procedures not specifically mentioned in ISO 9001:2008) may be
required by an organization, in order to manage the processes that are necessary for the effective
operation of the quality management system. This will vary depending on the size of the
organization, the kind of activities in which it is involved and their complexity. For further
guidance, please also refer to the ISO 9000 Introduction and Support Package module "Guidance on
the Documentation Requirements of ISO 9001:2008"
3.13 What does an organization need to do to comply with ISO 9001?
When initially starting to use ISO 9001, an organization should familiarize= its personnel with the
Quality Management Principles, analyze= the standards (especially ISO 9000 and ISO 9004), and
consider how their guidan= ce and requirements may affect your activities and related processes. If
it th= en wishes to proceed to registration/certification, it should perform a gap analysis against the
requirements of ISO 9001 to determine where its current quality management system does not
address the applicable ISO 9001:2008 requirements, before developing and implementing additional
processes to en= sure that compliance will be achieved.
4. ISO 9004
4.1 What benefits are there to an organizati= on implementing ISO 9004 ?
If a quality management system is appropriately implemented, utilizing the eight Quality
Management Principles, and in = accordance with ISO 9004, all of an organization's interested
parties should benefit. = For example:
Customers and users will benefit by receiving the products (see ISO 9000:20= 05) that are:
&n= bsp; Conforming to the requirements
&n= bsp; Dependable and reliable
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&n= bsp; Available when needed
&n= bsp; Maintainable
People in the organization will benefit by:
&n= bsp; Better working conditions
&n= bsp; Increased job satisfaction
&n= bsp; Improved health and safety
&n= bsp; Improved morale
&n= bsp; Improved stability of employment
Owners and investors will benefit by:
&n= bsp; Increased return on investment
&n= bsp; Improved operational results
&n= bsp; Increased market share
&n= bsp; Increased profits
Suppliers and partners will benefit by:
<= /span>Stability
&n= bsp; Growth
&n= bsp; Partnership and mutual understanding
Society will benefit by:
&n= bsp; Fulfilment of legal and regulatory requirements
&n= bsp; Improved health and safety
&n= bsp; Reduced environmental impact
&n= bsp; Increased security
4.2 What was the need to update ISO 9004:2000?
The standards have to be kept up to date and they are regularly revi= ewed (at least every five years
under ISOs rules) and revised as necessar= y. Also the feedback from users showed that some
changes and improvements were needed.
If a product is not meeting its requirements or the expectations of its use= rs, then it should be
withdrawn, changed or improved. ISO/TC 176/SC2 received information which indicated that ISO
9004:2000 was not meeting expectations= , so decided to take action to change and improve the
product.
4.3 How was ISO 9004:= 2009 specified and developed?
In 2004 ISO/TC 176/SC2 conducted a formal review of ISO 9004:2000, in paral= lel with one for
ISO 9001:2000; this review led to a decision to revise the standard (and to amend ISO 9001). Next
followed the development and approva= l of a Design Specification in 2005, followed by the start
of the drafting process. The drafting of an ISO standard involves the achievement = of several
different successive levels of drafts; at all but the last stage, verification processes were employed to
check the drafts against the Design Specification, and during the last but one stage, a validation
process involving external reviews by potential users was employed. Most of the dra= fts were
circulated for ballot amongst ISOs member national standards bodies, leading to their approval,
and ultimately to publication of the rev= ised standard.
4.4 What are the most important changes in ISO 9004:2009?
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a) It has a new direction, giving advice on how to manage an organization f= or sustained success.
It includes guidance on the development and deployment of an organizations strategy, as well as
emphasizing inno= vation and learning.
b) It introduces two new, user-friendly, self-assessment tools; these descr= ibe possible situations in
the organization and give comparisons against each element of the standard, before rating these by
5 different levels of matur= ity.
4.5 What are the differences between ISO 9004:2000 and this new version?
ISO 9004:2000 was based closely on ISO 9001:2000. The new 2009 edition of I= SO 9004 has a
separate focus on the sustained success of an organization over = the long term.
There is much greater emphasis on: balancing the needs of all relevant interested parties; long-term
planning; strategic issues; resources; risks; innovation; learning; and the use of self-assessment
tools.
4.6 Sustained success= 221; what does it mean?
The sustained success of an organization refers to its ability to consisten= tly meet the needs and
expectations of its customers and other interested parti= es (e.g. shareholders, regulators, employees
or society), in a balanced way, in order to remain a viable entity over the long term.
4.7 What are the main features of ISO 9004:2009?
Guidance to managers on processes for an organization to create and follow = its own path towards
sustained success, including two powerful self-assessment tools (one on strategic issues and the other
on operational issues).
4.8 What are the main benefits = to users of ISO 9004:2009?
It will help them to ensure the success of their organization over the long term, by achieving higher
levels of effectiveness and efficiency in their organizations processes, in turn resulting in higher
satisfaction le= vels for all of its relevant interested parties.
4.9 Is ISO 9004:2009 useful for= Small and Medium Enterprises (SMEs) or only for large
organizations?
ISO 9004:2009 is applicable to any organization, regardless of its size, ty= pe and activity. ISO
9004:2009 is particularly suitable for SMEs, because of t= he strategy related aspects covered in it.
4.10 We have a QMS based on ISO= 9001. Why should we apply ISO 9004:2009?
ISO 9004 will help you to take your organization forward to its next stage = of quality maturity, by
enhancing its effectiveness and efficiency, and by re-orienting the organization to focus on all its
relevant interested parti= es, with the aim of achieving high levels of satisfaction of their needs and
expectations.
4.11 What organizations can use= ISO 9004:2009?
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All organizations can use ISO 9004, regardless of their size, products, activities, or type (profit,
not-for-profit, governmental body etc.).
4.12 When should ISO 9004:2009 = be applied?
In all situations where improvement is needed, or when important changes oc= cur, such as:
To improve customer satisfaction;
To reduce costs or to increase profits;
In case of an acquisition or a merger;
= In case of changes in the management of an organization;<= /o:p>
= To improve relations with suppliers;
= To increase the speed of processes.
4.13 Could we get our quality management system certified against ISO 9004:2009?
This new standard is a guideline standard, not a requirement standard; it is not suitable, or
intended, for certification purposes.
4.14 Why has the title of ISO 9= 004 changed?
ISO 9004:2009 now gives guidance on how to remain successful in the future,= so the title had to be
changed to reflect this new direction. In turbulent and constantly changing situations, organizations
can no longer just rely on be= tter performance against their current business models to survive and
be success= ful; instead they have to anticipate, be proactive and monitor, predict, and rea= ct to the
ever changing needs and expectations of their interested parties, in order to remain successful in the
future.
4.15 What is the scope of ISO 9004:2009?
This standard provides guidance to organizations to support the achievement= of sustained success
by a quality management approach. It is applicable to any organization, regardless of its size, type,
products or activity.
4.16 What is the purpose of ISO 9004:2009?
ISO 9004 now gives guidance to the management of an organization on how to achieve sustained
success by use of a quality management approach. It helps= an organization to move its
management system beyond the basic requirements of= ISO 9001, to meet the needs and
expectations of its all relevant interested parties, and guides management in assessing their
organizations strengths and weaknesses.
4.17 What are the changes in the structure of ISO 9004:2009?
ISO 9004 no longer has the same clause by clause structure as ISO 9001 (whi= ch was the case for
ISO 9004:2000). Instead the standard now starts with a clause = on managing an organization
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towards sustained success, followed by clauses on:=
&n= bsp; strategy,
&n= bsp; resources,
&n= bsp; processes,
&n= bsp; monitoring, measurement, analysis and review; and closing with,
&n= bsp; improvement, innovation and learning.
4.18 Why has the structure been changed?
The new structure is related to the question: How do you manage an organiza= tion for success in
the long term? The previous edition was more related to the question: How do you extend the
quality management system to incorporate all interested parties and support the achievement of
higher performance?
4.19 In ISO 9004:2009 the term partner is used. How do partners differ from suppliers?
Partners can be either suppliers, or other type= s of bodies. Partners can be selected
suppliers that an organizati= on chooses to have a strategic relationship with, or which are
strategically important, for its future success. Partners can also be other types of bodies other
than suppliers, e.g. some of its customers, universities/academic institutions or research
organizations, or even in so= me cases competitors (e.g. when there is a need to agree to standardize
produc= ts or technologies).
4.20 What are the differences b= etween the process approach model used in ISO 9001 and the
one used = in ISO 9004?
ISO 9004 contains a more extensive process model than the one given in = ISO 9001. While it covers
all of the elements of the ISO 9001 model, it also addresses some of the additional issues from ISO
9004 itself, such as the n= eeds of interested parties, strategy and policy, resource management
(extended), process management, innovation and learning.
4.21 What is the meaning of innovation in ISO 9004, and what should be innovated?
Innovation refers to the development of new products, processes, organizati= onal structures,
interfaces and strategy, in contrast to the improvement of the existing ones.
4.22 What is the meaning of learning in ISO 9004, and what should be covered by learning?=
Learning refers to an organization implementing processes to capture the results of experiences and
lessons learned by people, both individually and collectively, and to then apply that knowledge to
new situations, to achieve beneficial results. The learning processes should cover elements such as:
products, processes and their interfaces, organizational structures, manage= ment systems, human
aspects and culture, infrastructure, work environment, technology, and relationships with relevant
interested parties.
4.23 What should be the main st= eps to take when implementing ISO 9004:2009?
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These will depend on the organizations current situation, its ambiti= ons, its present level of
maturity, and its organizations environment (i.e. its business environment, but relati= ng to
not-for-profit type businesses, governmental bodies etc.).= In general, the mains steps should be:
a review of the organizations strategy,
conducting a self-assessment at a strategic (key elements) level,
refinement of its strategy (as a result of the self-assessment),
conducting a self-assessment at an operational (detailed) level, to identify improveme= nt
opportunities
developing a management agenda and action plans for the medium term horizon (e.g. for =
the next 2 to 3 years)
deployment and translation of the action plans into requirements for the organizations
processes, interfaces and resources (especially human resources),
execution of any improvements or change programmes,
evaluating and reviewing what has been achieved,
going back to the first step (above) to adapt and improve the whole approach (i.e. closing one
cycle of a P-D-C-A loop and starting the next one).<= /span>
4.24 What should be the first steps to take when implementing ISO 9004:2009?
If the organization has a clear strategy in place, the first step should be= a strategic (key element)
level self-assessment, to enable the organization to develop a management agenda and action plans
for the medium term horizon (e= .g. for the next 2 - 3 years). If the strategy is not available or is not
up-to-date, the first step should be a review of the organizations strategy, policies and associated
objectives, and to use these as an input = to self-assessments that should be conducted at both a
strategic (key elements) and operational (detailed) levels.
4.25 What should be the role of= top management during the implementation of ISO 9004:2009?
The top management of an organization should take the role of the most important supporter and
sponsor of such an implementation program. Implemen= ting ISO 9004 will change the way an
organization thinks and behaves, and how it communicates both internally and externally.
4.26 What should be the path to= wards sustained success, when starting with an ISO 9001 based
QMS?<= /u>
Such a path will develop in two main directions:
a) extending the coverage of the processes in the organization towards all aspects of its activities and
towards all relevant interested parties, and<= br>
b) improving each individual process with respect to its effectiveness and = its efficiency, for lasting
improvement in its performance.
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The rate at which an organization should extend its process coverage, and t= he rate at which it
should improve its processes, will be dependent on its own ambitions and its competitive position.
4.27 What could be the costs of= an improvement project or programme?
It is impossible to give an indication of the exact costs, as these will be specific to an organization
and its current situation; however, a well known rule of the thumb is that the costs of waste
reduction are of= ten between 10% and 20% of the value of that waste. Another well known figure
is that waste in industrial organizations is on average between 7% and 15% of turnover, and in
service industries is between 15% and 30%.
4.28 What should be done differ= ently when applying ISO 9004 in a not-for-profit
organization?<= br>
About the only difference for a not-for-profit organization w= hen compared to a for-profit
organization is the terminology that= is sometimes used for management issues, while the issues
remain the same for both. However, it is recognized that not-for-profit organizat= ions often have
more complex patterns of dealing with, and influencing, their interested parties, than the usual
contractual approach of for-profi= t organizations.
4.29 What are the most critical= risks for failure when applying ISO 9004 :2009?
The most critical risk is people aspects. This includes the behaviour of top management as a key
component.
4.30 What is the relationship b= etween ISO 9004:2009 and the ISO 26000 Social responsibility
standar= d?
It is frequently said that the three key pillars of sustainability are sustained economic/business
(including not-for-profit business) success, environmental protection and social responsibility, and
that an organization has to find the right balan= ce between each of these pillars in order to survive.
ISO 9004:2009 (as well as the other standards in the ISO 9000 family) relates to the first of these, =
the ISO 14000 series of standards to the second, and ISO 26000 to the third. For organizations that
are familiar with the quality management standards, but = not yet familiar with the issues relating
to social responsibility, then implementing ISO 9004:2009 could be a useful step in helping an
organizatio= n towards its adaptation of ISO 26000, through its recommendations on balancing the
n= eeds and expectations of interested parties.
4.31 What is the relationship b= etween ISO 9004:2009 and the Excellence / Award models such as
EFQM and Deming Awa= rd Prize?
It is not competing with them but gives complementary guidance on the path towards excellence.
ISO 9004:2009 is compatible with the main international= and national Excellence/Award models.
4.32 What is the relationship b= etween ISO 9004:2009 and the ISO 14000 series of standards?
ISO 9004:2009 refers to ISO 14001 under the clauses 6.5. Infrastructure, 6.8 Natural resources and
8.3.3 Internal audit. ISO 9004:2009 all but demands t= he use of the ISO 14000 series of standards,
especially when an organization is aiming to satisfy all of its relevant interested parties. This is
particula= rly the case in the areas of strategy and policies, resources, processes, produ= cts (and
their life-cycles), innovation and learning. Overall the relation betw= een these standards is
extremely important.
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4.33 What is the relationship b= etween ISO 9004:2009 and ISO 9001:2008?
ISO 9004:2009 gives guidance to an organization on the steps it should take= for improving its
quality maturity beyond that achieved from the implementation= of an ISO 9001 based QMS. Taken
together, the standards form a consiste= nt pair of standards, as both are based on the 8 quality
management principles and the Process approach model.
4.34 What is the relationship b= etween ISO 9004:2009 and other ISO standards?
ISO 9004:2009 is compatible with many other management system standards. It makes reference to
some of the ISO 14000 standards (environmental managemen= t); ISO 31000 (risk management)
and ISO 10000 series of standards (belonging to= the ISO 9000 family of standards).
4.35 What is ISO 9004:2009 NOT = for?
ISO 9004 is not a guideline for implementing a quality management system based on ISO 9001.
ISO 9004 is not a competitor t= o the business excellence awards
ISO 9004 is not for certificat= ion.
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