Frequently Asked Questions (FAQ's)
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 the revision of ISO 9004. 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 reviewed 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 should be
made to the open access web site at www.iso.org/tc176/sc2.
1. What is ISO?
The International Organization for Standardization (ISO) was
established in 1947 and is (currently) an association of approximately 157
National Standards Bodies, which each represent their own country. ISO employs
a system of Technical Committees, Sub-committees and Working Groups to develop
International Standards. Besides the National Standards Bodies, ISO permits
other international organizations that develop standards to participate in its
work, 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 refer
to ISO's own web site at www.iso.org
2. Who are the
National Standards Bodies, and who represents my country 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
3. What are the
ISO 9000 standards ?
The ISO 9000 standards are a collection of formal International
Standards, Technical Specifications, 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.)
4. Who is responsible
for developing the ISO 9000 standards?
ISO Technical Committee (TC) number 176 (ISO/TC 176), and its Sub-committees,
are responsible for the development of the standards. The work is conducted on
the basis of "consensus" among quality and industry experts nominated
by the National
Standards Bodies, representing a wide
range of interested parties.
5. 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.
6. Where can copies of the supporting
ISO 9000 guidance notes or other documents be found ?
Copies of the ISO 9000 Introduction and Support Package
modules:
§
Guidance on ISO 9001:2008 Sub-clause 1.2 'Application'
§
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 Processes'
as well as details of the Quality Management Principles can be
found at:
www.iso.org/tc176/sc2
Copies of the ISO
9001 Auditing Practices Group guidance notes can be found at:
www.iso.org/tc176/ISO9001AuditingPracticesGroup
Copies of the
sanctioned ISO/TC 176 sanctioned “Interpretations”
of ISO 9001 can be found at: www.tc176.org
7. Where can information be obtained on the ISO 9000 standards?
There are a number of sources of information on the ISO 9000 quality management
system standards, including ISO's web site (www.iso.org),
which carry information on the standards. Your National
Standards Body should be able to provide
copies of the standards, and registrars/certification bodies will be able to
provide guidance on registration arrangements.
8. Why are the standards being revised?
§
ISO’s formal review process:
o
Requires continual review to keep standards up to date. Must
be initiated within 3 years of publication of a standard.
§
User inputs from:
o
A global user
questionnaire/survey
o
A market Justification Study
o
Suggestions arising from the interpretation process
o
Opportunities for increased compatibility with ISO 14001
o
The need for greater clarity, ease of use, and improved
translation
§
Current trends:
o
Keeping up with recent developments in management system
practices.
9. Who is responsible for revising the
standards?
The
revision process is the responsibility of ISO Technical Committee no.176,
Sub-committee no.2 (ISO/TC 176/SC 2) and is conducted on the basis of consensus
among quality and industry experts nominated by ISO Member bodies, and
representing all interested parties.
10. When will the revised standards be
available?
The
revised quality management system standards (ISO 9000, 9001 and 9004) are
scheduled as follows:
§
ISO 9000:2005
already published – no major changes expected for 2009
§
Current plan is
for small changes to ISO 9001 (an “amendment”) to be published in November
2008.
§
More
significant changes are planned for ISO 9004 (a “revision”) to be published in
mid 2009.
11. How much is the implementation of
the new standard going to cost?
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 considered as a value-adding investment. A
key factor in the development of ISO 9001:2008 was to limit the impact of
changes on users.
12. Where can I obtain information on
the revised standards?
ISO
maintains a web site at www.iso.org that
carries general information on the revision program. Your National Standards Body will give you
additional information and the certification/registration bodies will be able
to provide guidance on transitional arrangements in due course.
13. Where can my organization go if it
needs additional clarification or interpretation of the ISO 9001:2008 standard?
The
starting point for any individual request for an interpretation should 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 interpretations can be found at www.tc176.org.
14. Will my organization need a full
reassessment once the revised standards are available?
This is primarily an issue between your organization and your
registration/certification body. ISO/TC 176 is working with the
It is expected that conformity to the new ISO 9001:2008 standard will be
evaluated by certification bodies during regular surveillance visits and that
full reassessment will only take place once current certificates expire.
However, it should be noted that ISO and the
15. Will the revised standards be
available in my national language immediately after they are published by ISO?
The active participation of experts from
around the world in the preparation of the new standards, and the broad
distribution of the draft standards, will facilitate the timely translation of
the International Standards.
Given the global importance of the quality management system standards, many
National Standards Bodies are already working on the translation issue. ISO itself will publish the new standards in
English and French, but if national language translations of the standards are
currently available from your National Standards Body, we expect that they will
have the translation of the revised standards ready at the time of publication
by ISO or very soon thereafter.
For further details contact your National Standards
Body.
16. Will my organization have to
re-write all its documentation?
No.
ISO 9001:2008 doesn’t introduce major changes to the requirements, when
compared to ISO 9001:2000. However, to benefit from the changes, we suggest you
get acquainted with the new version of the standard and the clarifications
introduced. If, during your analysis of the clarifications you find there are
differences from your current interpretation of ISO 9001:2000, then you should
analyse the impact on your current documentation and make the necessary arrangements
to update it. It is intended that the amendment of ISO 9001 will have minimal
or no impacts on documentation.
17. Will the
revised 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 guidance standards will emphasize the financial
resources needed for the implementation and improvement of a quality management
system.
18. What are
the benefits of the revised standards?
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:
§
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
balances all interested-party viewpoints.
§
Provides guidance for managers on
leading their organization towards sustained success.
§
Forward compatibility to allow
organizations to build on existing quality management systems.
19. What are the main changes in ISO 9001:2008?
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 improve
compatibility with ISO 14001:2004. ISO 9001:2008 does not introduce additional
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 same status as those who have
already received a new certificate to ISO 9001:2008
All changes between ISO 9001:2000 and ISO 9001:2008 are detailed in Annex B to
ISO 9001:2008.
20. What are
the main benefits to be derived from implementing an ISO 9000 quality
management 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 interested 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:
§
The connection 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 adoption of a "process approach"
o
emphasis of the role of top management
o
requirements for the establishment of measurable objectives
at relevant functions and levels
o
being orientated
toward "continual improvement" and "customer satisfaction",
including the monitoring of information on "customer satisfaction" as
a measure of system performance.
o
measurement of the quality management system, processes, and
product
o
consideration of statutory
and regulatory requirements.
o
attention to resource availability
21. How will the implementation of the amended
standard help my organization to improve its efficiency?
ISO 9001:2008 aims at guaranteeing the effectiveness (but not necessarily the
efficiency) of the organization. For
improved organizational efficiency, however, the best results can be obtained
by using ISO
22. What
benefits are there to an organization 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 9000:2005)
that are:
§
Conforming to the requirements
§
Dependable and reliable
§
Available when needed
§
Maintainable
People in the organization will benefit by:
§
Better working conditions
§
Increased job satisfaction
§
Improved health and safety
§
Improved morale
§
Improved stability of employment
Owners and investors will benefit by:
§
Increased return on investment
§
Improved operational results
§
Increased market share
§
Increased profits
Suppliers and partners will benefit by:
§
Stability
§
Growth
§
Partnership and mutual understanding
Society will benefit by:
§
Fulfilment of legal and regulatory requirements
§
Improved health and safety
§
Reduced environmental impact
§
Increased security
23. Are the standards compatible with national 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:
§
Customer focus,
§
Leadership,
§
Involvement of people,
§
Process approach,
§
System approach to management,
§
Continual improvement,
§
Factual approach to decision making, and
§
Mutually beneficial supplier relationships.
ISO 9004
recommends that organizations perform self-assessments as part of their
management of systems and processes, and includes an annex giving guidance on
this approach. This is similar to many quality awards programmes.
24. Why is the
requirement for monitoring "customer satisfaction" included in ISO
9001?
"Customer satisfaction" is recognized as one of the driving criteria
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.
25. Can the standards improve "customer satisfaction"?
The quality management system details that are described in the standards are
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.
26. What is
meant by "continual improvement"?
Continual improvement is the process focused on continually
increasing the effectiveness and/or efficiency of the organization to fulfil
its policies and objectives. Continual improvement (where "continual"
highlights that an improvement process requires progressive consolidation
steps) responds to the growing needs and expectations of the customers and
ensures a dynamic evolution of the quality management system.
27. What is a
process?
Any
activity or operation, which receives inputs and converts them to outputs, can
be considered as a process. Almost all
activities and operations involved in generating a product 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 www.iso.org/tc176/sc2.
28. What is the "process approach"?
The "process approach" is a way of obtaining a desired
result, by managing activities and related 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 Package
module: Guidance on
the Concept and Use of the Process Approach for management systems.
29. Can the "process approach" be applied to other
management systems?
Yes. The "process approach" is a generic management principle, which
can enhance an organization’s effectiveness and efficiency in achieving defined
objectives.
30. How can the PDCA cycle be used in the "process
approach"?
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),
§
(D) executing the plan (do what was planned),
§
(C) checking the results (did things happened according to
plan) and
§
(A) act to improve the process (how
to improve next time).
The PDCA cycle can be applied within an individual process, or
across a group of processes.
31. 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.
32. 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:
§
The integration
and alignment of its processes to enable the achievement of its planned results.
§
An ability to
focus effort on process effectiveness and efficiency.
§
An increase in
the confidence of customers and other interested parties as to the consistent
performance of the organization.
§
Transparency of
operations within the organization.
§
Lower costs and
shorter cycle times through effective and efficient use of resources.
§
Improved,
consistent and predictable results.
§
The
identification of opportunities for focused and prioritized improvement
initiatives.
§
The
encouragement and involvement of people, and the clarification of their responsibilities.
§
The elimination
of barriers between different functional units and the unification of their
focus to the objectives of the organization.
§
Improved
management of process interfaces.
33. What is meant by the “sequence” of processes and their
"interactions"?
The "sequence" of processes shows how the processes follow, or link,
to each other to result in a final output.
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 one or
more of the other processes. For example, the monitoring or controlling of a
process may be established in a separate process.
34. 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.
§
Identify
all process inputs and outputs, along with the suppliers and customers, who may
be internal or external.
§
Identify the
sequence and interactions of the processes.
35. Should an organization define and document all its
processes?
The main purpose of documentation is to enable the consistent and stable
operation 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 the
basis of:
§
The
size of the organization and type of its activities,
§
The
complexity of its processes and their interactions,
§
The
criticality of the processes and
§
Availability 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.
36. How much detail is required in process documentation?
The extent of detail is likely to depend upon factors such as:
§
the size of an
organisation and its types of activities,
§
the complexity of its processes and their interactions, and
§
the competence
(level of education, training, skills and experience) of its personnel.
37. Is there a standard way of describing a process?
No, there is no standard way to describe a process. It depends on the culture,
management style, staff literacy, personal attributes and their interactions.
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, resources,
information, people and decision making interact and/or interrelate in a
logical order.
38. What should an organization do to adopt the
"process approach"?
To adopt the "process approach" an organization should apply the
following steps:
§
Identify the processes of the organization,
§
Plan the processes,
§
Implement and measure the processes,
§
Analyse the processes,
§
Improve the processes.
39. What is a "process owner"?
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 require
the appointment of "process owners".
40. How can a process be measured?
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 use 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 requirements,
§
Customer
satisfaction,
§
Supplier
performance,
§
On
time delivery,
§
Lead
times,
§
Failure
rates,
§
Waste,
§
Process
costs.
§
Incident
frequency
41. What is the difference between a "process" and
a "procedure"?
A "process" may be explained as a set of interacting 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.
42. An organization has a well-established set of
procedures. Can these 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.
43. 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"
44. 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 standard
(permitted through ISO 9001 clause 1.2 "Application") will need to 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').
45. 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 guidance
and requirements may affect your activities and related processes. If it then
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 ensure
that compliance will be achieved.
46.
What will happen to the 2000 version of ISO 9001?
ISO 9001:2008 will supersede ISO 9001:2000 However, noting the
47. Can organizations remain certified/registered to the 2000 version?
Yes. Certification to ISO 9001:2008 is not an “upgrade”, and organizations that
are certified to ISO 9001:2000 should be afforded the same status as those who
have already received a new certificate to ISO 9001:2008. However, certificates
to ISO 9001:2000 will only remain valid until 2 years after the publication of
ISO 9001:2008. Contact your certification/registration body to get details on
the certificates transition process.
48. What will happen to the other
standards and documents in the current (2000) ISO 9000 family?
The four primary standards of the current ISO 9000 family are the following:
§
ISO 9000:2005 already published – no major changes
expected for 2009
§
ISO 9001:2000 to be superseded by ISO 9001:2008
§
More significant changes are planned for ISO 9004 with
a planned publication date of late 2009.
§
ISO 19011:2002 is currently beginning the revision
process, with a new version expected in 2011.
The other standards and documents will be reviewed and updated as
necessary
49. How soon
can my organization seek certification to ISO 9001:2008?
ISO 9001: 2008 certificates can only be granted after its publication as an
International Standard.
50. Will I be able to certify/register
my organization to ISO 9004:2009?
Since
ISO 9004:2009 will be a guidance document, it is not intended to be used for
third party certification purposes.
51.
My organization is thinking about developing a Quality Management System
to ISO 9001. Should we wait until the
revised standards are published?
No, you should not delay the introduction of the quality management system in
your organization. Like those who are currently in the process of being registered/certified, anything you do now to lay the
foundation of a quality management system within your organization will be
beneficial.
52. My organization is applying for ISO
9001 certification in 2008. What should I do?
Organizations
in the process of certification to ISO 9001:2000 are recommended to apply for
certification to ISO 9001:2008, as soon it is published. Up to its publication
you can still apply for certification to ISO 9001:2000.
53. 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 system
certifications/ registrations are performed to ISO 9001:2008.
54. 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 "scope of
certification" with its registrar/certification body. This will define the
products to which the organization's quality management system is applicable,
and against which it will be assessed. An organization is not obliged 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!
55. What can an organization 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 requirements 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 detailed
within the organization's quality manual.
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/certified to
ISO 9001:2008.
For further guidance, see the ISO 9000 Introduction and Support Package module:
Guidance on
ISO 9001:2008 clause 1.2 'Application'.
56. 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 acquaint
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 requirements 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 established
design, you could discuss and justify the exclusion of these requirements with
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 will 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
57. What will happen to the
ISO handbook “ISO 9001 for Small Businesses”?
It remains fully applicable. A project has been started to update the handbook
to reflect the changes in ISO 9001:2008.
58. What’s the relationship
between the revised ISO 9001 and ISO 14001?
Compatibility with ISO 14001:2004 has been maintained and enhanced. “Compatibility” means that common elements of the standards can be
implemented by organizations in a shared manner, in whole or in part, without
unnecessary duplication or the imposition of conflicting requirements.
59. Are there any
guidelines covering joint implementation of ISO 9001 and ISO 14001?
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 arises, 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.
60. Is there a common guideline standard for
auditing QMS and
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, and is expected to be
completed in 2011.
61. 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 9004:2000 have been written to reflect this
definition.)
62. My organization provides services. Is the new 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.
63. 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 aware
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 client’s 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 selection
of quality management system consultants and use of their services, which
may be useful to refer to for further guidance.
64. How should
regulatory bodies use the standards?
Regulatory bodies should review their regulations currently in effect (or under
development) and identify points where reference to the quality management
system standards would be appropriate, before making recommendations to the
legislative body.
65. 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 (
§
The requirements of the ISO 9001:2008.
§
The concepts and terminology of the ISO 9000:2005.
§
The eight Quality
Management Principles
§
A general understanding of ISO 9004
§
Familiarity with the auditing guidance standard ISO 19011.
ISO/TC 176,
66. How will ISO 9001:2008 relate to the needs of
specific business sectors?
ISO
9001:2008 remains compatible with the existing management systems standards for
specific business sectors like ISO/TS 16949, AS
9000/EN 9100 and TL 9000.
Users of a specific sector scheme are recommended to refer to the organization
that is responsible for that sector scheme, e.g. for:
§
ISO/TS 16 949 refer to the
§
TL 9000 refer to the
§
For AS 9000/EN 9100 refer to the IAQG
67. My organisation fulfils
the ISO 9001:2000 requirements. What do I need to do?
An organization who’s QMS fulfils the requirements of ISO 9001:2000 should
check that they are following the clarifications introduced in the amended
standard ISO 9001:2008.
ISO 9001:2008 has been developed in order to introduce clarifications to the
existing requirements of ISO 9001:2000. It does not introduce additional
requirements nor does it change the intent of the ISO 9001:2000 standard.
68. What is the impact of
ISO 9001:2008 on certification?
Certification to ISO 9001:2008 is not an “upgrade”, and organizations that are
certified to ISO 9001:2000 should be afforded the same status as those who have
already received a new certificate to ISO 9001:2008.
ISO and the International Accreditation Forum (
“Accredited
certification to the ISO 9001:2008 shall not be granted until the publication
of ISO 9001:2008 as an International Standard.
Certification of conformity to ISO 9001:2008 and/or
national equivalents shall only be issued after official publication of ISO
9001:2008 (which should take place before the end of 2008) and after a routine
surveillance or re-certification audit against ISO 9001:2008.
Validity of
certifications to ISO 9001:2000
One year after publication of ISO 9001:2008 all
accredited certifications issued (new certifications or re-certifications)
shall be to ISO 9001:2008.
Twenty four months after publication by ISO of ISO
9001:2008, any existing certification issued to ISO 9001:2000 shall not be
valid.”
69. 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 ISO’s member National Standards Bodies can be found at: http://www.iso.org/iso/about/iso_members.htm