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F.A.Q.'s |
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F.A.Q.'s |
| What are the benefits of the revised ISO 9000 standards? |
There are a number of major benefits with the revised quality management
systems standards. Among them are:
(Source: International Organization for Standardization) |
| 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:
(Source: International Organization for Standardization) |
| What new requirements have been introduced into the revised ISO 9001 standard? |
The main new requirements include:
(Source: International Organization for Standardization) |
| Why has the requirement for monitoring of customer satisfaction been included in ISO 9001? |
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"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.
(Source: International Organization for Standardization) |
| Will the revised standards improve customer satisfaction? |
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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.
(Source: International Organization for Standardization) |
| What is a process? |
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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.
(Source: International Organization for Standardization) |
| What is meant by "continual improvement"? |
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"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.
(Source: International Organization for Standardization) |
| How will the implementation of the new standards help my organization to improve its efficiency? |
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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.
(Source: International Organization for Standardization) |
| How will the revised standards improve the perception of ISO 9001 certification/registration? |
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By demonstrating to organizations that the process of certification
based on the new ISO 9001 standard 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.
(Source: International Organization for Standardization) |
| Which standard will my organization be registered/certified to? |
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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.
(Source: International Organization for Standardization) |
| What happened to the 1994 versions of ISO 9001, 9002 & 9003? |
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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.
(Source: International Organization for Standardization) |
| What will happen to my organization if it is currently registered/certified to ISO 9002:1994? |
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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.
(Source: International Organization for Standardization) |
| Can organizations remain certified/registered to the 1994 version of ISO 9001, 9002 and 9003? |
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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 accredited
certificates issued or renewed will, however, only remain valid for a
maximum of three years after the publication of ISO 9001:2000
(i.e. until 15 December 2003).
(Source: International Organization for Standardization) |
| What does my organization need to do if it is currently registered/certified to ISO 9002:1994 or ISO 9003:1994? |
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Since publication of ISO 9001:2000, ISO 9002 and ISO 9003 are superseded.
You will 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.
(Source: International Organization for Standardization) |
| Will I be able to certify/register my organization to ISO 9004:2000? |
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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.
(Source: International Organization for Standardization) |
| How do certificates to the revised ISO 9001:2000 identify the scope of the quality management system? |
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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.
(Source: International Organization for Standardization) |
| How will a small organization be able to adapt the requirements of the standard? What flexibility will be allowed? |
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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.
(Source: International Organization for Standardization) |
| What’s the relationship between the revised ISO 9001 and ISO 14001? |
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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.
(Source: International Organization for Standardization) |
| My organization provides services. How are the new standards applicable to us? |
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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 9000:2000 also
includes services. ISO 9001:2000 and ISO 9004:2000 have been written
to reflect this definition.)
(Source: International Organization for Standardization) |
