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Frequently Asked Questions (FAQ's)
This list of Frequently Asked Questions (FAQ's) has been updated after publication of the ISO 9000:2000 family of International Standards.
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.
What IS ISO 9001?
ISO 9001 is an internationally adopted quality system standard. It is the only quality management system to which any organization can be certified by an outside party, one which is totally independent from the organization being examined. It is intended to be the basic, or platform, system that puts in place four levels of documentation covering twenty elements in a manner that is effective for the individual organization and also meets the regulations stated in the standard. Please note we use the term "organization" instead of company or business because ISO 9001 truly is an all inclusive movement applying to any organization, whether it be for profit or non profit, or whether manufacturing or service related.
Why
were the standards revised?
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.
In addition, the year 2000 revision of the ISO 9000 standards gives users
the opportunity to further increase value to their activities and to
improve their performance continually by focusing on the major
processes within the organization.
Extensive surveys have been performed on a worldwide basis to understand
the needs of all users of the quality management system standards.
The new revisions take into account previous experience with quality
management system standards (1987 and 1994 editions) and emerging
insights into generic management systems. They result in a
closer alignment of quality management systems with the needs of
organizations and better reflect the way organizations run their
business activities.
ISO's rules of procedure (the ISO/IEC Directives) also specify that
standards be periodically revised to ensure that those standards are
current and satisfy the needs of the global community.
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 2000 revision affect my organization's current quality
system registration/certification?
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/ certification.
It is expected
that the process of upgrading registration/certification will be a
smooth transition that is incorporated into the applicable
Registration or Certification Body's regular audit routine.
Where can my organization obtain copies of the standards?
Copies of the
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)
Where can I obtain information on the 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
Where does my organization go if it needs clarification or
interpretation of the 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).
How long does it take to get certified?
It depends on two things:
I. Your objectives for the Quality Management System. If you want
the certificate, it will take a lot less time to obtain it than if
you want the employees to buy in to the QMS so you develop a much
stronger company in the long run.
II. Where your company presently is vs. where it needs to be to meet
the requirements of the standard. A well disciplined company that
needs to add only a few procedures can be certified in six months,
or less. A company starting from scratch that wants to establish an
effective QMS, which includes employee buy-in will take 18-24
months. Other companies will take somewhere in between.
In any case, the full support
of Executive Management is a must to be successful.
What is the cost to get certified?
This will vary greatly depending on the size of your company, the
pre-ISO items you already have in place, the resources you have
available, and the registrar you select. A good Baseline Analysis
will determine this for you.
Do we have to
calibrate every instrument?
No, only those that are used to determine whether the quality of the
product being produced meets the customer's specifications. However,
personally owned equipment is included.
How long do we have to keep our records?
This is determined by the supplier (you). Typically, input is
obtained from legal counsel. They need to be kept long enough to
ensure the customer's requirements are being met, especially for QS
certification.
Do auditors have access to all records?
Generally, financial and personnel records are excluded- Training
records, however, are included.
Is it really necessary to do a Baseline
Analysis?
A good Baseline analysis is highly recommended. It will focus your
efforts, save a lot of time, and reduce system installation costs.
Are
the revised standards more compatible with national quality award
criteria?
The quality
management principles are now the basis for the revised standards,
which are 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, and
-
Mutually
beneficial supplier relationships.
Does
the revised standards address financial issues?
Financial
issues are not addressed in the ISO 9001:2000 standard. The ISO
9004:2000 guidance standard emphasizes the financial resources
needed for the implementation and improvement of a quality
management system.
What
are the benefits of the revised standards?
There are a
number of major benefits with the revised quality management systems
standards. Among them 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.
What
new requirements have been introduced into the revised ISO 9001
standard?
The main new
requirements include:
-
Continual
improvement
-
Increased
emphasis on the role of top management.
-
Consideration
of statutory and regulatory requirements.
-
Establishment
of measurable objectives at relevant functions and levels.
-
Monitoring of
information on 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
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.
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.
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.
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.
How
will the implementation of the new standards help my organization to
improve its efficiency?
ISO 9001:2000
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 9004:2000 in addition to ISO 9001:2000. The guiding
quality management principles are intended to assist an organization
in continual improvement, which should lead to efficiency throughout
the organization.
What
happened to ISO 8402 and ISO 9000-1?
The terms and
vocabulary previously found in the ISO 8402 standard are addressed
in the ISO 9000:2000 (Quality Management Systems: Fundamentals
and Vocabulary) standard. The quality management concepts in
ISO 9000-1 have been integrated into the ISO 9000:2000 standard.
Which standard will my organization be registered/certified to?
All
organizations will be registered/certified to ISO 9001:2000. The
scope of registration/certification will need to reflect clearly the
activities covered by the organization's Quality Management System,
and any exclusion to non-applicable requirements of the standard
(through 1.2 "Application") documented and justified in the quality
manual. (See also the ISO/TC 176/SC2 Introduction and Support
Package: Guidance on ISO 9001:2000 Clause 1.2 Application.)
What
happened to the 1994 versions of ISO 9001, 9002 & 9003?
The year 2000
publications have superseded corresponding 1994 versions of the
standards. However, noting the IAF-ISO/CASCO-ISO/TC 176 agreement
that accredited certification to the 1994 editions should remain
possible for up to 3 years after the publication (i.e. until 15
December 2003) of the revised standards, copies of the 1994 editions
will still be available on request from ISO and the national
standards bodies during that period.
Will
I be able to certify/register my organization to ISO 9004:2000?
No. As ISO
9004:2000 is a guidance standard, 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. Third party QMS
certifications/registrations are performed to ISO 9001:2000, which
has consolidated the previous ISO 9001, 9002, and 9003 standards.
How
do certificates to 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 certification/registration.
How
will the consistent pair of standards affect a registered/certified
organization?
The idea of a
"consistent pair" of standards is the very core of the revision
process. The aligned structure of ISO 9001:2000 and ISO
9004:2000 will encourage organizations not only to look at their
activities from a process standpoint, but also to look beyond
certification to a system which will be truly beneficial in
improving operational performance.
What
should I do now?
You should
contact your National Standards Body to obtain information. (See the
ISO web site
http://www.iso.ch
for a listing of the member bodies, i.e. the national standards
bodies, contact details).
You should be
careful with the information that you receive from sources other
than your National Standards Body, professional associations, or ISO
member organizations.
It is recommended that your organization familiarize your personnel
with the quality management principles, analyze the changes in the
revised standards, and consider how those changes may affect your
activities and related processes.
My
organization is applying now for ISO 9001
certification/registration. What should I do?
Continue with
your plans to implement your system and to apply for certification.
We strongly recommend that you read the new standards, particularly
ISO 9004 in conjunction with ISO 9001, and ensure that your quality
management system effectively adds value to your organization's
activities.
How
does ISO 9001:2000 relate to the needs of specific business sectors?
The text of
ISO 9001:2000 is more generic than the 1994 version in order to be
applicable to different types of product and to organizations of
different sizes. Due to this generic nature it may be that
some industrial or commercial sectors will identify additional
requirements to attend to their specific needs.
To assure
consistency between the ISO 9001 requirements and sector
requirements, a pilot study has been conducted using the development
of an automotive industry document as the test vehicle. The
pilot project has successfully achieved the publication of an ISO
technical specification (ISO/TS 16949). The full results of the
pilot scheme, and the working methods employed, will be reviewed in
due course.
How will 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 will 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 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:
-
Fulfillment
of legal and regulatory requirements
-
Improved
health and safety
-
Reduced
environmental impact
-
Increased
security
How
will a small organization be able to adapt the requirements of the
standard? What flexibility will be allowed?
The
requirements of the revised ISO 9001 are applicable to small,
medium, and large organizations alike. ISO 9001:2000 provides
some flexibility, through clause 1.2 “Application”, on the exclusion
of certain requirements for specific processes (i.e. those covered
by clause 7, such as design activities) that may not be performed by
the organization. However, the individual organization will
still need to be able demonstrate its capability to meet customer
and applicable statutory or regulatory requirements for its
products, and will need to consider this when determining the
complexity of its quality management system.
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).
A recent
review of ISO 14001 and ISO 14004 by ISO/TC 207/SC 1 has led to the
initiation of a revision of those standards. This will provide
the opportunity for further enhancement of the compatibility between
the ISO 9000 and ISO 14000 standards.
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.
What
needs to be done to ensure that auditors are ready to work to the
revised standards?
Auditors,
whether external or internal, will have 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 are
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 the ISO 9001:2000.
-
The concepts
and terminology of the 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).
