TC 176 — ISO 9000:2000
Family — FAQs
Why
were the standards revised?
Who is responsible for revising the standards?
Do the year 2000 revision affect my organization’s
current quality system registration?
How much does the transition to the new standards
cost?
Where can I obtain information on ISO 9000:2000?
Does my organization have to change its quality
system and, if so, when?
Does my organization have to re-write all its
documentation?
Are the revised standards more compatible with
national quality award criteria?
Do the revised standards address financial issues?
What are the benefits of the revised standards?
What are the main changes to the standards?
What new requirements have been introduced into
the revised ISO 9001 standard?
Why has the requirement for monitoring of customer
satisfaction been included in ISO 9001?
Do the revised standards improve customer satisfaction?
What is a process?
What is meant by “continual improvement”?
How does the implementation of the new standards
help my organization to improve its efficiency?
Which standard will my organization be registered
to?
How do the revised standards improve the perception
of ISO 9001 registration?
What happens to my organization if it is currently
registered to ISO 9002:1994?
Can organizations remain registered to the 1994
version of ISO 9001, 9002 and 9003?
What does my organization need to do if it is
currently registered to ISO 9002:1994 or ISO 9003:1994?
Am I able to register my organization to ISO
9004:2000?
How do certificates to the revised ISO 9001:2000
identify the scope of the quality management system?
How do interested parties benefit by the organization
adopting the new ISO 9004?
How do the consistent pair of standards affect
a registered organization?
What’s the relationship between the revised
ISO 9001 and ISO 14001?
How does a small organization adapt to the requirements
of the standard? What flexibility is allowed?
Are there any guidelines covering joint implementation
of ISO 9001 and ISO 14001?
My organization provides services. How are the
new standards applicable to us?
Is there a common guideline standard for auditing
QMS and EMS according to ISO 9001 and 14001?
I am a qualified quality management practitioner
(consultant, auditor, or trainer). What do I need to do?
My organization is a regulatory body. What do
we need to do?
What needs to be done to ensure that auditors
will be ready to work to the revised standards?
This
list of Frequently Asked Questions (FAQs) was extracted from
the FAQs prepared by the ISO Technical Committee (TC) 176.
Input was 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. The latest version of the complete list
is available on the ISO/TC 176 web site: http://www.tc176.org.
Why
were the standards revised?
The
main reason for the year 2000 revision to the ISO 9000 standards
is to give users the opportunity to add value to their activities
and to improve their performance continually by focussing
on the major processes within the organization.
Extensive
surveys were performed on a worldwide basis to understand
the needs of all users of the quality management system standards.
The new revisions took into account previous experience with
quality management system standards (1987 and 1994 editions)
and emerging insights into generic management systems. They
resulted in a closer alignment of quality management systems
with the needs of organizations and better reflect the way
organizations run their business activities.
ISO
directives also specify that standards be periodically revised
to ensure that those standards are current and satisfy the
needs of the global community.
The
major reasons for the year 2000 revisions of the standards
include emphasizing the need to monitor customer satisfaction,
meeting the need for more user-friendly documents, assuring
consistency between quality management system requirements
and guidelines, promoting the use of generic quality management
principles by organizations, and enhancement of their compatibility
with ISO 14001.
Back
to top
Who
is responsible for revising the standards?
The
revision process is the responsibility of ISO/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.
Back
to top
Do
the year 2000 revision affect my organization’s current
quality system registration?
Yes.
The strategy adopted by your organization to meet the requirements
of ISO 9001:2000 should include an appropriate timing for
upgrading your organization’s registration.
It
is expected that the process of upgrading registration/certification
will be a smooth transition that is incorporated into the
applicable Registrar’s regular audit routine.
The
International Accreditation Forum (IAF) has established a
set of guidelines for Registrars to follow, and this includes
a transition period of up to three years from the standards
publication date. You are advised to contact your registrar
to negotiate a suitable transition time frame for your own
organization.
Back
to top
How
much does the transition to the new standards cost?
One
of the goals of ISO/TC 176 was to produce standards that 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, IAF guidelines provide
for the incorporation of audits to the new standard into surveillance
visits for existing (1994) certifications, wherever possible.
Back
to top
Where
can I obtain information on ISO 9000:2000?
There
are a number of sources of information on ISO 9000:2000 quality
management system standards, including, of course, the Standards
Group web site at http://standardsgroup.asq.org, which carries
detailed information on the revision program and is updated
on a regular basis. The ISO Central Secretariat in Switzerland
also maintains a web site at http://www.iso.ch that carries
general information on the revision program. There are also
a number of publications available that focus on the ISO 9000
quality management system standards, such as THE INFORMED
OUTLOOK newsletter (for information, call 703-680-1436
or visit www.informintl.com).
Back
to top
Does
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 do include some new requirements
and you should consider addressing them in your system at
an appropriate opportunity.
Transition
planning guidelines are available to assist you in identifying
the new requirements and the timing of those changes.
Back
to top
Does
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, and already addresses
all of the new requirements, no changes are required. However,
if your current documented system does not address all of
the new requirements, additional documentation may be necessary.
ISO
9001:2000 has clarified the need for required documentation.
Only 6 documented procedures are required by the standard
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.
Back
to top
Are
the revised standards more compatible with national quality
award criteria?
The
quality management principles are now the basis for the revised
standards, making them better 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
- Mutually
beneficial supplier relationships.
Further
information on the quality management principles can be obtained
from the Standards Group web site at http://standardsgroup.asq.org
or at the TC 176/SC 2 web site at http://www.bsi.org.uk/iso-tc176-sc2.
Back
to top
Do
the revised standards address financial issues?
Financial
issues are not addressed in the ISO 9001:2000 standard, which
is a requirements standard.
The
ISO 9004:2000 guidance standard emphasizes the financial resources
needed for the implementation and improvement of a quality
management system.
Back
to top
What
are the benefits of the revised standards?
There
are a number of major benefits with the revised quality management
systems standards. The benefits are:
- Applicability
to all product categories, in all sectors and to all sizes
of organizations
- Simple
to use, clear in language, readily translatable, and easily
understandable
- Significant
reduction in the amount of required documentation
- Connection
of quality management systems to organizational processes
- Provision
of a natural move towards improved organizational performance
- Greater
orientation toward continual improvement and customer
satisfaction
- Compatibility
with other management systems such as ISO 14000
- Provision
of a consistent basis to address the needs and interests
of organizations in specific sectors (e.g. medical devices,
telecommunications, automotive, etc.)
- The
concept of the consistent pair — ISO 9001 covering
the requirements and ISO 9004 for going beyond the requirements
in order to further improve the performance of the organization
- Consideration
of the needs of and benefits to all interested parties.
Back
to top
What
are the main changes to the standards?
The
main changes that have been introduced in the consistent pair
of quality management system standards are:
- A
new process-oriented structure and a more logical sequence
of the contents.
- A
continual improvement process as an important step to
enhance the quality management system.
- Increased
emphasis on the role of top management, which includes
its commitment to the development and improvement of the
quality management system, consideration of legal and
regulatory requirements, and establishment of measurable
objectives at relevant functions and levels.
- The
concept of “Application” of the standard has
been introduced (in clause 1.2) as a way to cope with
the wide spectrum of organizations and activities.
- A
requirement for the organization to monitor information
on customer satisfaction as a measure of system performance.
- Significant
reduction in the amount of required documentation.
- Terminology
changes/improvements for easier interpretation.
- Increased
compatibility with the environmental management system
standard.
- Specific
reference to quality management principles.
- Consideration
of the benefits and needs of all interested parties.
- Addition
of the concept of organizational self-assessment as a
driver for improvement (ISO 9004).
Back
to top
What
new requirements have been introduced into the revised ISO
9001 standard?
The
new/more clearly defined requirements include:
- Continual
improvement
- Increased
emphasis on the role of top management
- Consideration
of legal and regulatory requirements
- Establishment
of measurable objectives at relevant functions and levels
- Monitoring
of information of customer satisfaction as a measure of
system performance
- Increased
attention to resource availability
- Determination
of training effectiveness
- Measurements
extended to system, processes and product
- Analysis
of collected data on the performance of the quality management
system.
Back
to top
Why
has the requirement for monitoring of customer satisfaction
been included in ISO 9001?
<“Customer
satisfaction” is recognized as one of the driving criteria
for any organization. In order to evaluate if the 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.
<Back
to top
Do
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 the product meets their needs and increases
their satisfaction.
Back
to top
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.
Back
to top
What is meant by “continual improvement”?
Continual
improvement is the process focused on continually increasing
the effectiveness and/or efficiency of the organization 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 the customers and
ensures a dynamic evolution of the quality management system.
<Back
to top
How
does the implementation of the new standards help my organization
to improve its efficiency?
ISO
9001:2000 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 the new ISO 9004:2000 in addition to ISO
9001:2000. The guiding quality management principles are intended
to assist an organization in continual improvement, which
should lead to efficiencies throughout the organization.
Back
to top
Which
standard will my organization be registered to?
Existing
ISO 9001, ISO 9002, and ISO 9003 standards will be replaced
by the revised ISO 9001 standard. The scope of registration
needs to reflect clearly the activities covered by the organization’s
Quality Management System, and any exclusions to non-applicable
requirements of the standard (through clause 1.2 “Application”)
documented and justified in the quality manual.
Back
to top
How
do the revised standards improve the perception of ISO 9001
registration?
By
demonstrating to organizations that the process of certification
based on the new ISO 9000 standards adds value to their own
business goals, a market-wide improvement in the perception
of ISO 9001 certification should be developed. The rationale
behind the revision process places great emphasis on making
quality management systems closer to the processes of the
organization and on continual improvement. As a result, the
revised standards (ISO 9001:2000 and ISO 9004:2000) are directed
to the achievement of business results, including satisfaction
of customers and others.
There
is confidence that management of the organization will be
able to adopt the quality management system standards not
only for certification purposes, but also as a profitable
investment.
Back
to top
What
happens to my organization if it is currently registered
to ISO 9002:1994?
The
organization is not obliged to include within the scope of
its certification all the products that it provides. (Note
that the ISO 9000:2000 definition of “Product” includes
services!). HOWEVER, for those products that ARE included
in the certification scope, all applicable requirements of
ISO 9001:2000 will need to be addressed. The standard allows
for the exclusion of some 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 Section 7 (“Product Realization”),
and requirements may only be excluded if it can be shown that
they do not affect the organization’s ability to provide
product which meets customer and applicable statutory/regulatory
requirements. If design activities are required to demonstrate
your organization’s capability to meet customer or statutory/regulatory
requirements for products covered by the quality management
system certification, then these design activities must be
included in the scope of your registration/certification to
the ISO 9001:2000 standard.
If
design activities are not required to demonstrate your organization’s
capability to meet customer and applicable statutory/regulatory
requirements, or if your product is provided on the basis
of established design, you will still be registered to ISO
9001:2000. In this case, you will need to justify the exclusion
of the design and development requirements in your quality
manual.
Back
to top
Can
organizations remain registered to the 1994 version of ISO
9001, 9002 and 9003?
Although
organizations are encouraged to make the transition to ISO
9001:2000 certification as soon as possible, according to
the IAF/ISO-CASCO/ISO-TC 176 Communiqué on transition policy,
organizations may choose to continue or even seek new certification/registration
to the 1994 versions of ISO 9001, ISO 9002, and ISO 9003.
Any certificates issued or renewed will, however, only remain
valid for a maximum of three years from the publication of
ISO 9001:2000.
<Back
to top
What
does my organization need to do if it is currently registered
to ISO 9002:1994 or ISO 9003:1994?
Now
that ISO 9001:2000 is published, ISO 9002 and ISO 9003 have
become obsolete. You need to evaluate which specific requirements
of ISO 9001:2000 are applicable to the nature of your business
and the extent to which your present QMS meets those requirements.
Provisions have been made to exclude non-applicable requirements
within Section 7 of the standard through clause 1.2 “Application”.
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 will need to discuss
and justify the exclusion of these requirements with your
certification/registration body.
Back
to top
Am
I able to register my organization to ISO 9004:2000?
Since
ISO 9004:2000 is a guidance document, it is not intended to
be used for third party certification purposes. A key element
in the new ISO 9004 is the ability to perform self-evaluation,
but third party QMS certifications/registrations are to ISO
9001:2000, which consolidate the old ISO 9001, 9002, and
9003 standards.
<Back
to top
How
do certificates to the revised ISO 9001:2000 identify the
scope of the quality management system?
It
has always been necessary to define clearly the scope of registration/certification.
The merging of ISO 9001, 9002, and 9003 into a single requirements
standard (ISO 9001:2000) requires more emphasis for the scope
to define the products, services and processes covered by
registration.
Back
to top
How
do interested parties benefit by the organization adopting
the new ISO 9004?
If
the system is appropriately implemented, utilizing the eight
Quality Management Principles, all the interested parties
will benefit from ISO 9004.
Customers
and users benefit by receiving the products (see ISO 9000:2000)
that are:
- Conforming
to the requirements
- Dependable
and reliable
- Available
when needed
- Maintainable
- People
in the organization 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:
- Fulfillment
of legal and regulatory requirements
- Improved
health and safety
- Reduced
environmental impact
- Increased
security.
<Back
to top
How
do the consistent pair of standards affect a registered
organization?
The
idea of a “consistent pair” of standards is the
very core of the revised standards. The aligned structure
of ISO 9001:2000 and ISO 9004:2000 encourages organizations
not only to look at their activities from a process standpoint,
but also to look beyond certification to a system which is
truly beneficial in improving operational performance.
Back
to top
What’s
the relationship between the revised ISO 9001 and ISO 14001?
The
revised ISO 9001 was developed to have enhanced compatibility
with ISO 14001, 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).
ISO
14001 and ISO 14004 are currently being revised by ISO/TC
207/SC 1. This will provide the opportunity for further enhancement
of the compatibility between the ISO 9000 and ISO 14000 standards.
Back
to top
How does a small organization adapt to
the requirements of the standard? What flexibility is allowed?
The
requirements of the revised ISO 9001 are applicable to small,
medium, and large organizations alike. Provisions have been
made to exclude non-applicable requirements through clause
1.2 “Application”. It is, however, up to the individual
organization to determine the complexity of the system needed
to demonstrate its capability to meet customer and applicable
statutory/regulatory requirements for its products.
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.
For
the quality and environmental auditing guidance standards
(ISO 10011 and ISO 14010/14011/14012) the two responsible
ISO technical committees (TC 176 and TC 207) are preparing
a single common auditing standard (ISO 19011), scheduled for
publication in the third quarter of 2002.
Back
to top
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.
Back
to top
Is
there a common guideline standard for auditing QMS and EMS
according to ISO 9001 and 14001?
Yes.
A specific agreement between TC 176 and TC 207 has set up
a joint working group which is preparing a single standard
on auditing activities, both for quality management and environmental
management systems. This new standard (ISO 19011) will replace
the existing ISO 10011 and ISO 14010/14011/14012 documents.
The planned publication date for this new standard is the
third quarter of 2002.
Back
to top
I
am a qualified quality management practitioner (consultant,
auditor, or trainer). What do I need to do?
As
a minimum, you should familiarize yourself not only with the
requirements of the new ISO 9001:2000, but also with the content
and philosophies of ISO 9000:2000, ISO 9004:2000 and the quality
management principles. You must clearly understand your client’s
activities and processes and appropriately interpret the requirements
of the standards to add value to their operations.
Back
to top
My
organization is a regulatory body. What do we need to do?
You
should review the regulations currently in effect and ensure
that any references to the quality management system standards
are appropriate. You should then examine the revised standards
and determine if the changes are relevant to the regulations
that you have issued and make recommendations to the legislative
body.
Back
to top
What
needs to be done to ensure that auditors will be ready to
work to the revised standards?
Auditors,
whether external or internal, need to demonstrate their competence
not only on the structure, content and terminology of the
revised standards, but also on the underlying quality management
principles. The revised standards require that auditors be
able to understand the organization’s activities and
processes and appropriately audit against the requirements
of the standard in relation to the organization’s objectives.
According to the IAF/ISO-CASCO/ISO TC 176 Transition Policy,
auditors must demonstrate competency in:
- The
requirements of ISO 9001:2000.
- The
concepts and terminology of ISO 9000:2000.
- The
eight Quality Management Principles.
- A
general understanding of the performance improvement guidelines
of ISO 9004:2000.
- Familiarity
with the latest draft of the auditing guidance standard
(ISO 19011).
Back
to top
|
