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FAQ - QMS ISO 9000:2000

Where can my organization obtain copies of ISO 9001:2000?
Copies of ISO 9001:2000 may be purchased from the TTBS Standards Information Center. For further information please call (868) 662-8827 ext 102

Where can I obtain information on ISO 9001:2000?
There are a number of sources of information on the revision of ISO 9000 quality management system standards including of course, the Trinidad and Tobago Bureau of Standards - Certification Division. The ISO Central Secretariat in Switzerland also maintains a web site at http://www.iso.ch that carries general information on ISO 9001:2000.

Where does my organization go if it needs clarification or interpretation of ISO 9001:2000?
The starting point for any individual request for an interpretation should be with Trinidad and Tobago Bureau of Standards - Certification Division.

The 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).

Why were the standards revised?
The major reasons for the year 2000 revisions of the standards include:

Putting emphasis on 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.

What is the basis for the new standards?
The quality management principles are now the basis for ISO 9001: 2000. 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.

What are the benefits of the new ISO 9001:2000?
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 14001
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 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 ISO 14001
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 9004:2000)

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 ISO 9001:2000 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.

What is the cost of transition to the new standard?
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. For a quotation, please contact TTBS Certification Division.

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, ISO 9001:2000 include some new requirements and you should consider addressing them in your system at an appropriate opportunity.

By 15 December 2003, all organizations wishing to retain certification will have to have migrated their quality management system to being compliant with ISO 9001:2000. ISO/TC 176/SC2 has published a Transition Planning Guide to assist organizations in their migration.

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 new requirements, additional documentation may be necessary.

The International Standard ISO 9001:2000 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.

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.

How will the revised standards improve the perception of ISO 9001 certification/registration?
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.