selection_and_use_of_iso_9000_family_of_standards_2016_en.pdf

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of the ISO family of standards

Selection and use

http://www.iso.org/


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ISO family |

This publication was developed

by ISO/TC , the ISO technical

committee specialized in quality

management. For further information

on ISO and related standards,

visit https://committee.iso.org/tcsc.

The ISO amily o international qual-

ity management standards and guidelines

has earned a global reputation as a basis

or establishing effective and efficient qual-

ity management systems.

The need or International Standards is

very important as more organizations

operate in the global economy by selling or

buying products and services rom sources

outside their domestic market.

This brochure has been developed by ISO

technical committee ISO/TC , Quality

management and quality assurance, which

is responsible or developing and main-

taining the ISO amily. Supporting

guideline standards and other documents

are developed and updated on a continual

basis to meet the needs and expectationso users and the market itsel.

The brochure provides a general perspec-

tive on the ISO amily and explains

how you can use it to improve your quality

management system. It gives an overview

o the standards and demonstrates how,

collectively, they orm a basis or continual

improvement and business excellence.

This brochure providesyou with :

• An overview of

the ISO family of

core standards

• A step-by-step process

to implement a qualitymanagement system

• Examples of typical appli-

cations of the standards,

and

• A bibliography listing the

ISO family of standards

Selection and useof the ISO family of standards

https://committee.iso.org/tc176sc2https://committee.iso.org/tc176sc2


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| ISO family ISO family |

ISO specifies the basic requirements or a quality

management system that an organization must ulfil to

demonstrate its ability to consistently provide products

and services that enhance customer satisaction and

meet applicable statutory and regulatory requirements.

The standard can be used or certification/registration

and contractual purposes by organizations seeking rec-

ognition o their quality management system. ISO

has been organized in a user-riendly ormat with terms

that are easily recognized by all business sectors.

You will obtain the greatest value by using the entire

amily o standards in an integrated manner. It is highly

recommended that you use ISO to become amiliar

with the undamental concepts, principles and norma-

tive vocabulary o a quality management system beore

you adopt ISO to achieve an effective level o per-

ormance. The practices described in ISO may then

be implemented to make your quality managementsystem more efficient in achieving your business goals

and objectives.

ISO and ISO have been written to enable you

to relate them to other management systems (e.g. envi-

ronmental), or to sector-specific requirements (such as

ISO/TS in the automotive industry,AS/EN

in aviation, space and deence, TL in telecommuni-

cations) and to assist you in gaining recognition through

national or regional award programmes.

ISO , Quality management systems –

Fundamentals and vocabulary, provides

the undamental concepts, principles and

vocabulary used in the entire ISO

amily o standards. It sets the stage or

understanding the basic elements o qual-

ity management as described in the ISO

standards. ISO introduces users to

the seven quality management principles

as well as the use o the process approach

to achieve continual improvement.

ISO , Quality management systems

– Requirements, is used when you are

seeking to establish a quality man age-

ment system that provides conidence

in your organization’s ability to provide

products that ulfil customer needs and

expectations.ISO speciies the requirements

against which your quality management

system can be certiied by an external

body. The standard recognizes that the

term “ products and services ” applies to

services, processed material, hardware and

sofware intended or your customer.

The ISO familyCore standards


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There are seven clauses in the standard speciying activi-

ties that need to be considered when you implement

your system :

▸ Context o the organization

▸ Leadership

▸ Planning

▸ Support

▸ Operation

▸ Perormance evaluation

▸ Improvement

The requirements in all sections o ISO are applica-

ble. An organization will need to provide justification or

any requirement o this International Standard that the

organization determines is not applicable to the scope

o its quality management system. A manual, or other

documented inormation, will demonstrate how you

meet the ISO requirements in your organization.

ISO defines what you should do to consistently

provide product that meets customer expectations and

applicable statutory and regulatory requirements. In

addition, you will seek to enhance customer satisaction

by continual improvement o your quality management

system.

ISO standards apply a process approach. Processes are

recognized as consisting o one or more linked activities

that require resources and must be managed to achieve

predetermined output. The output o one process may

directly orm the input to the next process and the final

product is ofen the result o a network or system o

processes.

Further guidance can also be ound in the ISO :

introduction and support package prepared by sub-

committee SC , Quality systems, o ISO/TC , which

provides urther guidance on :

▸ Summary o changes

▸ Implementation

▸ Documentation requirements

▸ Process approach

▸ Risk-based thinking

▸ Frequently asked questions (FAQs)

▸ Management o change ▸ Correlation between ISO : and

ISO :

ISO/TC maintains a database o approved interpreta-

tions o the ISO standard.

ISO , Managing for the sustained success of a n

organization – A quality management approach, is used

to extend the benefits obtained rom ISO to all par-

ties that are interested in, or affected by, your operations.


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Interested parties include your employees, owners, sup-

pliers, partners and society in general.

ISO gives guidance on a wider range o objectives

o a quality management system than ISO , par-

ticularly in managing or the long-term success o an

organization. ISO is recommended as a guide or

organizations whose top management wishes to extend

the benefits o ISO in pursuit o systematic and

continual improvement o the organization’s overall

perormance. However, it is not intended or certification

or contractual purposes.

ISO , Guidelines for auditing management systems,

covers the area o auditing o quality management sys-

tems and environmental management systems. It pro-

vides guidance on audit programmes, the conduct o

internal or external audits, and inormation on auditor

competence.

ISO provides an overview o how an audit pro-

gramme should operate and how management system

audits should take place. Effective audits ensure that

an implemented QMS meets the requirements specified

in ISO .

The nature o your organization and your speciic

needs will determine how you apply these standardsto achieve your goals and objectives. Useul hints and

tips or conducting audits have been developed by the

ISO Auditing Practices Group. Inormation on

third-party auditing has also been compiled by the joint

ISO-IAF (International Accreditation Forum) Accredita-

tion Auditing Practices Group.

The implementation process is important in achiev-

ing the ull benefits o the quality management sys-

tem (QMS). Most new users will obtain measurable

payback early in the process.

▸ A QMS is a dynamic system that evolves over time

through periods o improvement.

▸ It is necessary to determine activities that already

exist and their suitability within the context o the

organization.

▸ A ormal QMS provides a ramework or planning,

executing, monitoring and improving the peror-

mance o quality management activities.

▸ In developing the QMS, the undamental concepts

and principles given in ISO can provide valu-

able guidance.

▸ A successul QMS must fit your organization. The

ollowing seven steps may be helpul as guidance :

Implementing and maintaininga quality management system

based on ISO


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▸ Agree on why to implement a QMS ▸ Determine the context o the organiza-tion, strategic objectives and businessprocesses ▸ Determine customer and interested

parties’ needs and expectations

▸ Understand the quality management

principles described in ISO

▸ Review the implication o risk-based

thinking ▸ Define the objectives o the organization

▸ Describe the scope o the QMS

▸ Define the policy

▸ Determine quality objectives

Identify key processes

▸ Identiy the processes needed to deliverproducts and services ▸ Understand ISO requirements ▸ Determine the risks and opportunitiesapplicable to the processes

Plan your QMS

▸ Identiy the gaps in the existing sys-

tem compared to QMS requirements

▸ Identiy the process controls needed

▸ Define the working environment

needed

▸ Define the skills and acilities needed

▸ Document the processes, activities andcontrols needed ▸ Prepare the documented inormation(procedures and records) required by thestandard and according to your needs

▸ Ensure the QMS conorms to

ISO requirements

Document your QMS

Implement your QMS

▸ Manage the processes

▸ Control monitoring and measuring

equipment

▸ Train employees

▸ Veriy effective operation o processes

Manage your QMS

▸ Monitor and measure perormance

▸ Audit process effectiveness

▸ Focus on customer satisaction

▸ Manage system and operational change

▸ Perorm management review

Improve your QMS

▸ Seek third-party certification/registration

o the QMS

▸ Strive or improvement with reerence to

ISO

▸ Consider implementing business excel-

lence models in company operations

Engage top management to


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Plan

Planning Performanceevaluation

Support andorganization

Quality management system

Organizationand its context

Customerrequirements

Access andexpectation

of interested parties

Leadership

Improvement

Do

Check Act

,

Products and services

Customer satisfaction

Results of the QMS

= clause number


The Plan-Do-Check-Act (PDCA) cycle

can be applied to all processes and to

the quality management system as a

whole. The figure below illustrates how

Clauses to can be grouped in rela-

tion to the PDCA cycle.

Representation o the structure o this International Standard in the PDCA cycle.

Process modelof ISO


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Example A local government in a developing country wanted

to improve its services and enhance community confi-

dence. It turned to ISO and ISO to establish

a quality management system. The guidance given in

ISO helped develop training modules in process

management, explaining how each person contributes

to achieving reliable services. Similary, the engineering

department used the guidelines contained in ISO

or managing its public works programmes. ISO

served as a basis to create training courses in the use o

quality plans, enabling a wide variety o organizations

to engage in construction and maintenance contracts,

whether or not they maintained a ormal QMS.

xamp esUsing the ISO family of standards

Example A metal parts manuacturer, recognizing the need to demonstrate its capability to produce

consistent quality product, had implemented a QMS based on ISO : and was

now required to become registered to ISO :. It reviewed the matrix showing

the correlation between ISO : and ISO : (see www.iso.org/tc/

sc/public) and saw that the basic requirements o its existing QMS could be retained.Annexes A and B o ISO : provided additional inormation when perorming a

gap analysis o its existing QMS. The manuacturer decided to retain the documented

inormation in its quality manual and the structure o the QMS afer addressing the

implication o risk-based thinking. Later, in order to bid on the supply o parts to a major

automotive company, it upgraded its quality system to meet the automotive sector-specific

requirements o ISO/TS .

http://www.iso.org/tc176/sc02/publichttp://www.iso.org/tc176/sc02/publichttp://www.iso.org/tc176/sc02/publichttp://www.iso.org/tc176/sc02/public


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Example An electrical appliance manuacturer had a well-

established company culture o continual improvement

and eective production control. The management

decided to improve the company’s development pro-

cesses and implement ISO to obtain certification

or commercial purposes. The company used ISO

to guide its improvement processes and ISO to

develop a project management plan or the development

project. Regulatory agencies demanded that products

be designed and packaged recognizing the end-o-lie

disposition o products and packaging. The company

adopted risk-based thinking and used ISO to

develop a quality plan identiying the sequence o pro-

cesses rom concept to disposal o the product. Example A large chemical processing company was required by

its major customers to gain certification to ISO and

to be environmentally riendly. To address these issues,

the company leadership planned a comprehensive

management strategy linking its QMS and an ISO

environmental management system (EMS). A thorough

review o the business processes indicated that all ele-ments o ISO were applicable to its QMS. The com-

pany used ISO/TR to guide the development o any

required documented inormation or its QMS and EMS

in its various production divisions, ISO or guid-

ance in the preparation o training plans or realizing the

required competence o its employees, and ISO or

auditing both the QMS and EMS. Management achieved

additional benefits and continual improvements using

ISO and ISO .


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Example A irm o international lawyers wanted

to improve its client management pro-

cesses using the systematic approach

ound in ISO , but did not intend to

gain certification. Its QMS provides or the

design and development o new services

such as international tax planning and

modiying traditional services to meet the

requirements o new or amended legisla-

tion. Purchasing control was included to

cover the selection o computer hardware

and sofware, as well as purchasing the

services o specialist lawyers as needed.

Afer successully implementing ISO ,

the company also used the sel-assessment

guidelines o ISO to monitor progress

as it improved its QMS to achieve greater

satisaction o customers and other rel-

evant stakeholders.

Example A bank decided to implement a quality management

system limited to the scope o its online banking ser-

vices. It used ISO to help select a quality manage-

ment consultant to guide it in its QMS implementation,

taking account o the need to meet statutory and regula-

tory requirements. The bank obtained guidance rom

ISO on quality management principles together

with quality management concepts and terminology.

It then applied all the requirements relating to opera-

tional planning and control, recognizing that design

and development are an important part o creating new

service processes. The bank used ISO to develop a

service quality plan or the provision o online services.

The plan was indispensable to personnel or identiying

which activities required participation o other unc-

tions and approvals o changes prior to implementation.

The bank used the guidelines set out in ISO/TR to

prepare the required documented inormation, which

it posted on its internal computer network to ensure

current procedures are available to staff.


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Example A ranchise organization had difficulty maintaining con-

sistent operation by ranchisees and determined that an

enhanced management system was required. It learned

that ISO included the tools it needed and, with

the help o ISO/TR , it developed the documented

inormation or its quality system to be used throughout

the ranchise network. To ensure a consistent approach

in managing customer satisaction, the organization

used guidelines or customer satisaction ound in

ISO , ISO and ISO . It also opened upan entirely new revenue stream by adding a business-to-

consumer e-commerce dimension to its operation, using

ISO as a guide to maintain a consistent customer-

riendly approach throughout its operations. When the

system was implemented, the ranchise organization

used ISO to establish an audit programme that

confirmed the ISO -based QMS continued to unc-

tion as required and was improved on a continual basis.

Example A corporation managing government inrastructure

services implemented a QMS based on ISO and

used ISO to manage the programme o projects in

planned time periods. It needed to hire large, medium-

sized and small organizations, including large con-

struction companies, consulting engineers and small

specialist companies such as geologists and small main-

tenance contractors. Only some o these organizations

had implemented ISO . The corporation specified

minimum quality management requirements or eachproject reerring to the guidance on quality plans avail-

able in ISO . Under each contract, the corporation

approved quality plans to establish jointly agreed com-

mitments. Corporation assessors monitored the various

providers to ensure the quality management require-

ments were being met.


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Most new users o the ISO amily

o standards obtain measurable benefits

soon afer implementing the requirements

in their operations. These initial benefits

are generally due to improvements in their

organization and internal communication,

and must be strengthened through effec-

tive internal auditing and management

review o system perormance. Like a ll

systems, it can either improve or become

less effective. It does not remain static or

long.

ISO provides guidelines or making

inancial and economic gains rom the

application o the ISO quality man-

agement principles. It is aimed at the

top management o organizations and

complements ISO or perormanceimprovements.

When you adopt ISO , you must strive

to satisy your customers and to achieve

continual improvement o your operations

through the QMS.

Continual improvement is a process o

increasing the effectiveness o your organi-

zation in order to ulfil established policy

and quality objectives, which are updated

periodically.ISO requires that you plan and

manage the processes necessary to continually

improve your QMS.

ISO provides guidance or defining and

implementing processes to monitor and measure

customer satisaction. Inormation obtained rom

monitoring and measuring customer satisaction

can help an organization identiy opportunities to

improve the strategies, products, processes and

characteristics that are valued by its customers

and reach its objectives. Such improvements can

strengthen customer confidence and bring com-

mercial and other benefits.

ISO can be used to go beyond ISO to

strengthen your organization’s competitive posi-

tion and provide improvements to operational

efficiency. It is recommended that you obtain data

rom various sources, both internal and external,

to assess how appropriate your quality system

objectives are to changing circumstances. This

inormation can also be used to improve the per-

ormance o all your business processes.

Many organizations expand their management

systems by extending the ISO structureto include the requirements o other manage-

ment system standards, including ISO

on environmental management systems. The

structural and organizational requirements o ISO

management system standards are designed to

be compatible.

Maintaining the benefits andcontinual improvement


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ISO Quality management systems – Fundamentals

and vocabulary

ISO Quality management systems – Requirements

ISO Managing or the sustained success o an organi-

zation – A quality management approach

ISO Quality management – Customer satisaction –

Guidelines or codes o conduct or organizations

ISO Quality management – Customer satisac-

tion – Guidelines or complaints handling in

organizations

ISO Quality management – Customer satisaction

– Guidelines or dispute resolution external to

organizations


Guidelines or monitoring and measuring

ISO Quality management systems – Guidelines or

quality plans

ISO Quality management systems – Guidelines orquality management in projects

ISO Quality management systems – Guidelines or

configuration management


Guidelines or business-to-consumer electronic

commerce transactions

ISO Measurement management systems – Require-

ments or measurement processes and measuring

equipment

ISO/TR Guidelines or quality management system

documentation

ISO Quality management – Guidelines or realizing

financial and economic benefits

ISO Quality management – Guidelines or training

ISO/TR Guidance on statistical techniques or

ISO :

ISO Quality management – Guidelines on people

involvement and competence

ISO Guidelines or the selection o quality management

system consultants and use o their services

ISO Environmental management systems – Require-

ments with guidance or use

ISO Quality management systems – Guidelines or the

application o ISO : in local government

ISO Guidelines or auditing management systems

ISO Risk management – Principles and guidelines

ISO Guidance on outsourcing

ISO/IEC Sofware engineering – Guidelines or the applica-

tion o ISO : to computer sofware

IEC - Dependability management – Part : Guidance or

management and application

IEC Design review

Quality management principles, ISO

Available rom www.iso.org.

Bibliography

http://www.iso.org/http://www.iso.org/


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ISO family |

In order or the ISO amily to maintain its effective-

ness, the standards are periodically reviewed to benefit

rom new developments in the quality management

field and also rom user eedback. ISO/TC , compris-

ing experts rom businesses and other organizations

around the world, monitors the use o the standards

to determine how they can be improved to meet user

needs and expectations when the next revisions are due.

All ISO standards are reviewed regularly or relevancy ;

changes are made when there is a demonstrated need

to improve the standard.

Based on input rom the user community, ISO/TC

will continue to evaluate and adopt new concepts in the

field o quality management or incorporation into ISO

standards. This can include sector-specific initiatives

and supporting documents within the ISO amily.

Most ISO technical committees recognize the structure

o ISO when new management systems standardsare developed or other or specific purposes.

ISO’s commitment to sustaining the ISO momen-

tum through reviews, improvement and streamlining

o the standards guarantees that your investment in

ISO today will continue to provide effective man-

agement solutions well into the uture.

The future ofthe ISO family

More information

• ISO’s Website

www.iso.org • ISO’s Website section on the

ISO family

www.iso.org/iso/iso_.htm

• ISO focus magazine

www.iso.org/isofocus

• ISO videos

www.iso.org/youtube

• Follow us on Twitter

www.iso.org/twitter

• Join us on Facebook

www.iso.org/facebook

• Join us on LinkedInwww.iso.org/linkedin

• Contact the ISO member in

your country

www.iso.org/isomembers

http://www.iso.org/http://www.iso.org/iso/iso_9000.htmhttp://www.iso.org/isofocushttp://www.iso.org/youtubehttp://www.iso.org/twitterhttp://www.iso.org/facebookhttp://www.iso.org/linkedinhttp://www.iso.org/isomembershttp://www.iso.org/isomembershttp://www.iso.org/linkedinhttp://www.iso.org/facebookhttp://www.iso.org/twitterhttp://www.iso.org/youtubehttp://www.iso.org/isofocushttp://www.iso.org/iso/iso_9000.htmhttp://www.iso.org/


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iso.org© ISO, All rights reservedISBN ----

International Organization

for Standardization

ISO Central Secretariat

Ch. de Blandonnet

Case Postale

CH – Vernier, Geneva

Switzerland

About ISO

ISO (International Organization or Standardization)

is an independent, non-governmental international

organization with a membership o * national stand-

ards bodies. Through its members, it brings together

experts to share knowledge and develop voluntary,

consensus-based, market-relevant International Stand-

ards that support innovation and provide solutions toglobal challenges.

ISO has published more than * International

Standards and related documents covering almost every

industry, rom technology to ood saety, to agriculture

and healthcare.

For more inormation, please visit www.iso.org .

* March
http://www.iso.org/http://www.iso.org/http://www.iso.org/http://www.iso.org/

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