Frequently
Asked Questions (FAQ's)
This list of Frequently Asked Questions (FAQ's) has been updated
after publication of the ISO 9001:2008. 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.
ISO 9001:2008 was released on November 13, 2008
ISO and IAF have agreed that
ISO 9001:2008 introduces no new requirements. The
revised quality standard only introduces clarifications to the
existing ISO 9001:2008 requirements, and changes to improve
consistency with ISO 14001:2004, the environmental standard.
Details of changes
According to a
joint announcement by the ISO (International Organization
for Standardization) and the IAF (International Accreditation
Forum), the two organizations have agreed to
an implementation plan for a smooth migration to ISO 9001:2008.
1) Certification to ISO 9001:2008
will only be issued after publication of ISO
9001:2008 (November 13, 2008) and after a routine surveillance audit
or re-certification audit against ISO
9001:2008.
2) One year after publication of ISO
9001:2008, all certifications issued (new
certifications and re-certifications)
must be to ISO 9001:2008.
3) Two years after publication of ISO
9001:2008, existing ISO 9001:2000
certifications will not be valid.
This transition plan is possible,
because ISO and IAF have agreed that ISO
9001:2008 introduces no new requirements. The
revised quality standard only introduces clarifications to the
existing ISO 9001:2008 requirements, and changes to improve
consistency with ISO 14001:2004, the environmental standard.
Who is responsible for revising
the standards?
The revision process is
the responsibility of ISO Technical Committee (TC) 176 and is
conducted on the basis of consensus among quality and industry
experts nominated by ISO Member bodies,
and representing all interested parties
Will the year 2008 revision
affect my organization's current quality system
registration/certification?
Possibly !!!
Do you outsource some of
your processes that affect your ability to meet product requirements
??
Is your Management
Representative a member of your organizations management team, or
are they contractors (not an employee) or are they employees, but
not a member of management ??
If the answer to either
of these questions is yes, then your system may be affected.
For
details - click here
The International Accreditation Forum
(IAF has already established a set of guidelines for Certification
Bodies/ Registrars to follow during the transition.
1) Certification to ISO 9001:2008
will only be issued after publication of ISO
9001:2008 (November 13, 2008) and after a routine surveillance audit
or re-certification audit against ISO
9001:2008.
2) One year after publication of ISO
9001:2008, all certifications issued (new
certifications and re-certifications)
must be to ISO 9001:2008.
3) Two years after publication of ISO
9001:2008, existing ISO 9001:2000
certifications will not be valid.
This transition plan is possible,
because ISO and IAF have agreed that ISO
9001:2008 introduces no new requirements. The
revised quality standard only introduces clarifications to the
existing ISO 9001:2008 requirements, and changes to improve
consistency with ISO 14001:2004, the environmental standard.
Have any standards been
replaced or withdrawn ?
Withdrawn Standards
ISO 9000-3:1997 (replaced by ISO
90003:2004)
ISO 10011-1: 1990 (replaced by ISO
19011:2002)
ISO 10011-2: 1991 (replaced by ISO
19011:2002)
ISO 10011-3:1991 (replaced by ISO
19011:2002)
ISO 10012-1:1992 (replaced by ISO
10012:2003)
ISO 10012-2:1997 (replaced by ISO 10012:2003)
How much is the transition to
the new standards going to cost?
One of the goals of ISO/TC
176 is to produce standards that will minimize any potential costs
during a smooth transition. Any additional costs may be
considered as a value-added investment.
The cost of implementing any necessary changes in order to meet the
new requirements of ISO 9001:2000 will vary from one organization to
another, depending on various factors such as the actual state of
implementation of the quality management system, the size and
complexity of the organization, the attitude and commitment of the
top management, etc. It is expected that the benefits to all
organizations will outweigh eventual costs associated with the
transition.
Regarding the costs of upgrading the certification, the International
Accreditation Forum's (IAF) guidelines provide for the
incorporation of audits to the new standard into surveillance visits
for existing certifications, wherever possible.
Where can my organization
obtain copies of the revised standards?
Copies of the revised
standards may be purchased from National Standards Bodies. Many
countries may have these available in local-language versions (see ISO
Online for a listing of member body, i.e. national standards
bodies, contact details)
[FAQ 005]
Where can I obtain information
on the revised standards?
There are a number of
sources of information on the revision of ISO 9000 quality
management system standards, including, of course, this web site,
which carries detailed information on the revised standards and is
updated on a regular basis. ISO Central Secretariat in
Switzerland is also maintaining a web site at http://www.iso.ch
that carries general information on the revised standards.
Your National Standards Body should be able to provide copies of the
revised standards and registrars/certification bodies will be able
to provide guidance on transitional registration arrangements (see
the ISO web site for a listing of the member bodies, i.e. the
national standards bodies, contact details).
[FAQ 006]
Where does my organization go
if it needs clarification or interpretation of the revised
standards?
.
The starting point for any individual request for an interpretation
should be with the enquirer's national standards body. ISO central
secretariat and TC 176 cannot accept direct requests from
individuals for interpretations of the ISO 9000 standards. Instead,
ISO/TC 176 has established a Working Group for interpretation, with
a formal procedure to provide answers to the questions that are
forwarded by the national standard bodies.(See the ISO web site http://www.iso.ch
for a listing of the member bodies, i.e. the national standards
bodies, contact details).
[FAQ 007]
Will my organization need a
full reassessment for the revised standards?
No, not under normal
circumstances. This is primarily an
issue between your organization and your registration/certification
body. 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
if current certificates expire.
[FAQ 008]
Will my organization have to
change its quality system and, if so, when?
It is not the intention
that you should have to change the whole structure of your system or
re-write all your procedures; however, the revised standards include
some minor changes that you should consider addressing them in
your system at an appropriate opportunity.
[FAQ 09]
Will my organization have to
re-write all its documentation?
No. If your
current quality management system is successfully implemented,
satisfies the needs and objectives of your organization, reflects
the way your organization works, addresses all of the new
requirements, no changes are required. However, if your
current documented system does not address all of the requirements, additional documentation may be necessary.
The International Standard ISO 9001:2008 has clarified the need for
required documentation. Only 6 documented procedures are required by
the standards for administration of the system; however, other
documented procedures may be required by your organization in order
to manage the processes which are necessary for the effective
operation of the quality management system. This will clearly
vary depending on the size of the organization, the kind of
activities in which it is involved and their complexity.
[FAQ 010]
Are
the revised standards more compatible with national quality award
criteria?
The 8 quality management
principles are the basis for ISO 9001:2008, which are aligned with the philosophy and objectives of most quality
award programs. These principles are:
[FAQ 011]
Does the revised standards
address financial issues?
Financial issues are not
addressed in the ISO 9001:2008 standard. The ISO 9004:2008 (not yet
issued) guidance
standard is expected to continue to emphasize the financial resources needed for the
implementation and improvement of a quality management system.
[FAQ 012]
Will the revised standards
improve customer satisfaction?
The quality management
system described in the revised standard is 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 increases their
satisfaction.
[FAQ 017, March 2001]
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 making 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.
The revised quality management system standards are based on just
such a process approach, in line with the guiding quality management
principles.
[FAQ 018, March 2001]
What is meant by
"continual improvement"?
"Continual
improvement" requires an organization to focus on continually
increasing the effectiveness and/or efficiency of its processes, to
fulfill 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 customers and ensures a dynamic evolution
of the quality management system.
[FAQ 019, March 2001]
How will the implementation of
ISO 9001:2008 help my organization to improve its efficiency?
ISO 9001:2008 aims at
guaranteeing the effectiveness (but not necessary the efficiency) of
the organization. For improved organizational efficiency,
however, the best results can be obtained by using the new ISO
9004:2008 (not yet issued) in addition to ISO 9001:2008. The guiding quality
management principles are intended to assist an organization in
continual improvement, which should lead to efficiency throughout
the organization.
[FAQ 020, March 2001]
What’s the relationship
between the revised ISO 9001 and ISO 14001?
The revised ISO 9001 has
been developed to enhance compatibility with ISO 14001 Environmental
management systems, particularly with regard to terminology and
content. There is close collaboration between the technical
experts of ISO/TC 176 and ISO/TC 207 (the Technical Committee
responsible for the ISO 14000 series of standards).
[FAQ 041, March 2001]
Are there any guidelines
covering joint implementation of ISO 9001 and ISO 14001?
It is expected that the
revisions of the two standards will be compatible in terminology and
content. 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.
ISO 19011:2002 is for quality and
environmental auditing guidance.
Will there be a common
guideline standard for auditing QMS and EMS according to ISO 9001
and 14001?
Yes. ISO 19011:2002
is a single standard
on auditing activities, both for quality management and
environmental management systems. This standard replaced the existing ISO 10011 and ISO 14010/14011/14012 documents.
My organization provides
services. How are the new standards applicable to us?
The standards are
applicable to all types of organizations. The language in the
revised standards is simpler, more user-friendly, and with less
manufacturing bias. The new standards are equally appropriate to all
sectors, including service providers.
(Note: the definition of the term 'product' in ISO 9000:2005 also
includes services. ISO 9001:2008 and ISO 9004:2008 (not yet
released) have been written
to reflect this definition.)
