Diplomado en Gestión y Control de Mantenimiento

Selection and Use of the ISO 9000:2000 family of standards

The following text is an integral reproduction of the content of the brochure"ISO 9000 -
Selection and use". Hard copies of the brochure are available from sales@iso.org.

The ISO 9000 family of international quality management standards and guidelines
has earned a global reputation as the basis for establishing quality management
systems.

This brochure has been developed by ISO Technical Committee ISO/TC 176, Quality
management and quality assurance, which is responsible for developing and
maintaining the ISO 9000 family. The brochure has been updated to take into account
the revisions of several of the core series standards in the ISO 9000 family which
were published on 15 December 2000 by ISO (International Organization for
Standardization). These revised standards are identified by the "2000" in their
designation.

The purpose of this brochure is to provide you with a general perspective on the ISO
9000 family of standards with emphasis on the features of the revised versions. It
presents an overview of the standards and demonstrates how, collectively, they form a
basis for continual improvement and business excellence. In particular, you will see
how to distinguish between the various documents in the ISO 9000 family and how
they may be utilized to your maximum benefit.

The familiar three standards ISO 9001, ISO 9002 and ISO 9003 have been integrated
into the new ISO 9001:2000. This brochure provides you with general information on
how to use the revised standard together with other documents in the ISO 9000 family
to meet your specific requirements.

ISO 9001:2000 specifies requirements for a quality management system for any
organization that needs to demonstrate its ability to consistently provide product that
meets customer and applicable regulatory requirements and aims to enhance
customer satisfaction.ISO 9001:2000 has been organized in a user-friendly format with
terms that are easily recognized by all business sectors. The standard is used for
certification/registration and contractual purposes by organizations seeking recognition
of their quality management system.

The greatest value is obtained when you use the entire family of standards in an
integrated manner. It is suggested that, beginning with ISO 9000:2000, you adopt ISO
9001:2000 to achieve a first level of performance. The practices described in ISO
9004:2000 may then be implemented to make your quality management system
increasingly effective in achieving your own business goals. ISO 9001:2000 and ISO
9004:2000 have been formatted as a consistent pair of standards to facilitate their use.
Using the standards in this way will also enable you to relate them to other
management systems (e.g. environmental), many sector specific requirements (such

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as ISO/TS/16949 in the automotive industry) and will assist in gaining recognition

through national award programmes.

This brochure provides you with:

 A list of the ISO 9000 quality management standards and guidelines;

 Examples of typical applications of the documents;
 A step-by-step process to implement a quality management system;
 A brief view of the future evolution of the ISO 9000 family.

The ISO 9000 family

The standards, guidelines and technical reports which make up the ISO 9000 family
and which are listed below are available separately, or as collections. The ISO 9000
Compendium presents the ISO 9000 family in hard copy form.

Standards and guidelines Purpose

ISO 9000:2000, Quality Establishes a starting point for understanding the

management systems - standards and defines the fundamental terms and
Fundamentals and vocabulary definitions used in the ISO 9000 family which you
need to avoid misunderstandings in their use.
This is the requirement standard you use to
ISO 9001:2000, Quality assess your ability to meet customer and
management systems - applicable regulatory requirements and thereby
Requirements address customer satisfaction.

It is now the only standard in the ISO 9000 family

against which third-party certification can be
carried.

ISO 9004:2000, Quality This guideline standard provides guidance for

management systems - Guidelines continual improvement of your quality
for performance improvements management system to benefit all parties through
sustained customer satisfaction.

ISO 19011, Guidelines on Quality Provides you with guidelines for verifying the
and/or Environmental Management system's ability to achieve defined quality
Systems Auditing (currently under objectives. You can use this standard internally or
development) for auditing your suppliers.

ISO 10005:1995, Quality Provides guidelines to assist in the preparation,

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management - Guidelines for quality review, acceptance and revision of quality plans.
plans

ISO 10006:1997, Quality Guidelines to help you ensure the quality of both
management - Guidelines to quality the project processes and the project products.
in project management

ISO 10007:1995, Quality Gives you guidelines to ensure that a complex

management - Guidelines for product continues to function when components
configuration management are changed individually.

ISO/DIS 10012, Quality assurance Give you guidelines on the main features of a
requirements for measuring calibration system to ensure that measurements
equipment - Part 1: Metrological are made with the intended accuracy.
confirmation system for measuring
equipment

ISO 10012-2:1997, Quality Provides supplementary guidance on the

assurance for measuring equipment application of statistical process control when this
- Part 2: Guidelines for control of is appropriate for achieving the objectives of Part
measurement of processes 1.

ISO 10013:1995, Guidelines for Provides guidelines for the development, and
developing quality manuals maintenance of quality manuals, tailored to your
specific needs.

ISO/TR 10014:1998, Guidelines for Provides guidance on how to achieve economic

managing the economics of quality benefits from the application of quality
management.

ISO 10015:1999, Quality Provides guidance on the development,

management - Guidelines for implementation, maintenance and improvement
training of strategies and systems for training that affects
the quality of products.

ISO/TS 16949:1999, Quality Sector specific guidance to the application of ISO

systems - Automotive suppliers - 9001 in the automotive industry.
Particular requirements for the
application of ISO 9001:1994

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Examples of the ISO 9000 standards in use

ISO 9001:2000 is used if you are seeking to establish a management system that
provides confidence in the conformance of your product to established or specified
requirements. It is now the only standard in the ISO 9000 family against whose
requirements your quality system can be certified by an external agency. The standard
recognizes that the word "product" applies to services, processed material, hardware
and software intended for, or required by, your customer.

There are five sections in the standard that specify activities that need to be
considered when you implement your system. You will describe the activities you use
to supply your products and may exclude the parts of the Product Realization section
that are not applicable to your operations. The requirements in the other four
sections ? Quality management system, Management responsibility, Resource
management and Measurement, analysis and improvement? apply to all organizations
and you will demonstrate how you apply them to your organization in your quality
manual or other documentation.

Together, the five sections of ISO 9001:2000 define what you should do consistently to
provide product that meets customer and applicable statutory or regulatory
requirements. In addition, you will seek to enhance customer satisfaction by improving
your quality management system.

ISO 9004:2000 is used to extend the benefits obtained from ISO 9001:2000 to all
parties that are interested in or affected by your business operations. Interested parties
include your employees, owners, suppliers and society in general.

ISO 9001:2000 and ISO 9004:2000 are harmonized in structure and terminology to
assist you to move smoothly from one to the other. Both standards apply a process
approach. Processes are recognized as consisting of one or more linked activities that
require resources and must be managed to achieve predetermined output. The output
of one process may directly form the input to the next process and the final product is
often the result of a network or system of processes. The eight Quality Management
Principles stated in ISO 9000:2000 and ISO 9004:2000 provide the basis for the
performance improvement outlined in ISO 9004:2000.

The nature of your business and the specific demands you have will determine how
you apply the standards to achieve your objectives.

Here are a few examples:

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Example 1

A metal parts fabricating company used ISO 9000:2000 to develop a plan to

implement their quality management system. When they were ready, they prepared a
quality manual and quality system procedures as required by ISO 9001:2000,
excluding the requirements covering product design and development because their
products are made to designs prepared by their customers. Later, in order to bid on
the supply of parts to a major automotive company, they adapted their quality system
to meet the sector specific requirements of ISO/TS 16949.

Example 2

A welfare agency decided to establish a quality improvement strategy. It adopted ISO

9004:2000 as the basis for planning and implementing its system. The agency found
that ISO 9000:2000 provided very useful additional guidance and plans to seek
certification to ISO 9001:2000 to gain more credibility.

Example 3

A washing machine manufacturer had a well-established company culture of continual

improvement and effective production control. The management decided to improve
the company's development processes and to implement ISO 9001:2000 to obtain
certification for commercial purposes. The company used ISO 9004:2000 to guide its
improvement processes and ISO 10006:1997 to develop a project management plan.

Example 4

A large chemical processing company was required by its major customers to gain
registration/certification to ISO 9001:2000. In order to obtain additional benefits,
company leadership planned a comprehensive management strategy based on ISO
9000:2000 and ISO 9004:2000. A thorough review of their business processes
indicated that all elements of ISO 9001:2000 were applicable to their quality
management system. The company used ISO 10013:1999 to guide the development
of quality documentation in its various production divisions and ISO 10015:1999 for
guidance in the preparation of training plans for their employees.

Example 5

A firm of international lawyers wanted to improve their client management processes

and to achieve registration/certification to ISO 9001:2000. Their quality management
system provides for the design and development of new services such as international
tax planning and modifying traditional services to meet the requirements of new or
amended legislation. They included purchasing control to cover the selection of
computer hardware and software, as well as purchasing the services of specialist
lawyers as needed. After successfully implementing ISO 9001:2000, they used the

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self-assessment guidelines of ISO 9004:2000 to monitor their progress as they

improved their quality management system.

Example 6

A computer software developer serving a niche market recognized that as their user
base expanded they would be faced with issues concerning product management and
configuration control. Changes to base products, user hardware and regulatory
requirements were compounding customer service issues. ISO 9004:2000 provided
the guidance they needed to establish documented procedures to control process
change and improvement. ISO 10006:1997 and ISO 10007:1995 provided additional
assistance as they managed the project and prepared procedures for configuration
management. They later acquired another software developer and were able to use
their quality management system to integrate the acquisition into their own structure
very quickly with a minimum of disruption to customers.

Example 7

A bank decided to implement a quality management system for its on-line Internet
banking services. They ensured that their quality manual made clear that their other
conventional banking services were not included in their quality management system.
While adopting the requirements of ISO 9001:2000, the bank obtained guidance from
ISO 9000:2000 to interpret words and phrases used in the standard for their
application. They applied all the requirements of Clause 7, recognizing that design and
development is an important part of creating new service processes. The bank used
ISO 10013:1995 to prepare their documentation, which they posted on their internal
computer network to ensure current procedures are available to their staff.

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Implementing your ISO 9001:2000 quality management system

1. Identify the goals you want to achieve

Typical goals may be:

 Be more efficient and profitable

 Produce products and services that consistently meet customer requirements
 Achieve customer satisfaction
 Increase market share
 Maintain market share
 Improve communications and morale in the organization
 Reduce costs and liabilities
 Increase confidence in the production system

2. Identify what others expect of you

These are the expectations of interested parties (stakeholders) such as:
 Customers and end users
 Employees
 Suppliers
 Shareholders
 Society

3. Obtain information about the ISO 9000 family

 For general information, look to this brochure
 For more detailed information, see ISO 9000:2000, ISO 9001:2000 and ISO
9004:2000
 For supporting information, refer to the ISO Web site
 For implementation case studies and news of ISO 9000 developments
worldwide, read the ISO publication ISO Management Systems.

4. Apply the ISO 9000 family of standards in your management system.

Decide if you are seeking certification that your quality management system is in
conformance with ISO 9001:2000 or if you are preparing to apply for a national quality
award.
 Use ISO 9001:2000 as the basis for certification
 Use ISO 9004:2000 in conjunction with your national quality award criteria to
prepare for a national quality award

5. Obtain guidance on specific topics within the quality management system

These topic-specific standards are:
 ISO 10006 for project management
 ISO 10007 for configuration management
 ISO 10012 for measurement systems

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 ISO 10013 for quality documentation

 ISO/TR 10014 for managing the economics of quality
 ISO 10015 for training
 ISO/TS 16949 for automotive suppliers
 ISO 19011 for auditing

6. Establish your current status, determine the gaps between your quality
management system and the requirements of ISO 9001:2000
You may use one or more of the following:
 Self assessment
 Assessment by an external organization

7. Determine the processes that are needed to supply products to your

customers
Review the requirements of the ISO 9001:2000 section on Product Realization to
determine how they apply or do not apply to your quality management system
including;
 Customer related processes
 Design and/or development
 Purchasing
 Production and service operations
 Control of measuring and monitoring devices

8. Develop a plan to close the gaps in step 6 and to develop the processes in
step 7
Identify actions needed to close the gaps, allocate resources to perform these actions,
assign responsibilities and establish a schedule to complete the needed actions. ISO
9001:2000 Paragraphs 4.1 and 7.1 provide the information you will need to consider
when developing the plan.

9. Carry out your plan

Proceed to implement the identified actions and track progress to your schedule

10. Undergo periodic internal assessment

Use ISO 19011 for guidance in auditing, auditor qualification and managing audit
programmes

11. Do you need to demonstrate conformance?

If yes, go to step 12
If no, go to step 13
You may need or wish to show conformance (certification/registration) for various
purposes, for example:
 Contractual requirements
 Market reasons or customer preference
 Regulatory requirements

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 Risk management
 To set a clear goal for your internal quality development (motivation)

12. Undergo independant audit

Engage an accredited registration/certification body to perform an audit and certify that
your quality management system complies with the requirements of ISO 9001:2000.

13. Continue to improve your business

Review the effectiveness and suitability of your quality management system. ISO
9004:2000 provides a methodology for improvement.

Maintaining the benefits and continual improvement

Most new users obtain measurable benefits early in the process of deploying the
standard requirements in their operations. These initial benefits are generally due to
improvements in their organization and internal communication. The benefits must be
strengthened through effective internal auditing and management review of system
performance. Like all systems, it either improves or becomes less effective. It does not
remain static for long.

When you adopt ISO 9001:2000, you must strive for the satisfaction of your customers
and the continual improvement of your quality management system. Continual
improvement is a process of increasing the effectiveness of your organization to fulfill
your quality policy and your quality objectives. ISO 9001:2000 requires that you plan
and manage the processes necessary for the continual improvement of your quality
management system. ISO 9004:2000 provides information that will be helpful in going
beyond ISO 9001:2000 to improving the efficiency of your operation. It is
recommended that you obtain data from various sources, both internal and external, to
assess the appropriateness of your quality system goals. This information can also be
used to improve the performance of your processes.

Some organizations may expand their management systems by extending the ISO
9001:2000 structure to include the requirements of ISO 14001:1996, Environmental
management systems. The structural and organizational requirements of the two
management systems have been designed to be compatible.

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The future evolution of ISO 9000

In order for the ISO 9000 family to maintain its effectiveness, the standards are
periodically reviewed in order to benefit from new developments in the quality
management field and also from user feedback. ISO/TC 176, which is made up of
experts from businesses and other organizations around the world, monitors the use of
the standards to determine how they can be improved to meet user needs and
expectations when the next revisions are due in approximately five years' time.

ISO/TC 176 will continue to integrate quality assurance, quality management, sector
specific initiatives and various quality awards within the ISO 9000 family.

ISO's commitment to sustaining the ISO 9000 momentum through reviews,

improvement and streamlining of the standards guarantees that your investment in
ISO 9000 today will continue to provide effective management solutions well into the
future.

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