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ISO 9001:2008 Quality management systems




Definition and overview

General Scope
Normative References
Terms and definitions

What is Quality
The act of overseeing all activities and tasks
maintain a desiredlevel of

Quality Control

A process by which entities review the quality of all factors involved

in production

ISO 9000defines quality control as "A part of quality management

focused on fulfilling quality requirements

Emphasis on three aspects:

1. Elements such as controls, job management, defined and

well managed processes, performance and integrity criteria,
and identification of records
2. Competence, such as knowledge, skills, experience, and
3. Soft elements, such as
culture,motivation,team spirit, and quality relationships.


There is a tendency for

individual consultants and
organizations to name
their own unique
approaches to quality
controla few of these
have ended up in
widespread use

Quality Assurance

A way of preventing mistakes or defects in manufactured products

and avoiding problems when delivering solutions or services to

ISO 9000 defines as part ofquality managementfocused on

providing confidence that quality requirements will be fulfilled

This defect prevention in quality assurance differs subtly from

defect detection and rejection inquality control, and has been
referred to as ashit leftas it focuses on quality earlier in the process

Management of thequalityof raw materials, assemblies, products

and components, services related to production, andmanagement,
production andinspection processes

Two principles included in quality assurance are: "Fit for purpose"

(the product should be suitable for the intended purpose); and
"right first time" (mistakes should be eliminated).

Quality Management System

A collection ofbusiness processesfocused on

achievingquality policyand quality objectives to meet
customer requirements

Expressed as the organizational structure, policies,

procedures, processes and resources needed to
implementquality management

International Organization of

TheInternational Organization for Standardization(ISO) is

aninternational standard-setting body composed of representatives from
various nationalstandards organizations

Founded on 23 February 1947, the organization promotes worldwide

proprietary, industrial and commercialstandards. It is headquartered
inGeneva, Switzerland,and as of 2013 works in 164 countries

Is an independent, non-governmental organization, the members of which

are the standards organization of the 164 member countries

It is the world's largest developer of voluntary international

standards and facilitates world trade by providing common standards
between nations.

Nearly twenty thousand standards have been set covering everything

from manufactured products and technology to food safety, agriculture
and healthcare.


ISO has three membership categories:


Member bodiesare national bodies considered the

most representative standards body in each country.
These are the only members of ISO that have voting


Correspondent membersare countries that do not

have their own standards organization. These members
are informed about ISO's work, but do not participate in
standards promulgation.


Subscriber membersare countries with small

economies. They pay reduced membership fees, but can
follow the development of standards.

International Standards and other publications

ISO's main products are international standards. ISO also publishes

technical reports, technical specifications, publicly available
specifications, technicalcorrigenda, and guides

International standards: These are designated using the

formatISO[/IEC] [/ASTM] [IS] nnnnn[-p]:[yyyy] Title

nnnnnis the number of the standard

pis an optional part number

yyyyis the year published

Titledescribes the subject.

IECforInternational Electrotechnical Commissionis included if the standard

results from the work of ISO/IEC JTC1 (the ISO/IEC Joint Technical Committee)

ASTM(American Society for Testing and Materials) is used for standards

developed in cooperation withASTM International

yyyyandISare not used for an incomplete or unpublished standard and

may under some circumstances be left off the title of a published work.

International Standards

International Standards are developed by ISO technical

committees(TC) and subcommittees(SC) by a process
with six steps:

Stage 1: Proposal stage

Stage 2: Preparatory stage

Stage 3: Committee stage

Stage 4: Enquiry stage

Stage 5: Approval stage

Stage 6: Publication stage

ISO documents are copyrighted and ISO charges for most

copies. It does not, however, charge for most draft copies
of documents in electronic format.

Although they are useful, care must be taken using these

drafts as there is the possibility of substantial change


ISO 9000 and ISO 9001

TheISO 9000family ofquality management systems standards is designed

to help organizations ensure that they meet the needs of customers and
other stakeholders while meeting statutory and regulatory requirements
related to a product. ISO 9000 was first published in 1987

ISO9000 deals with the fundamentals of quality management

systems,including the eight management principles upon which the
family of standards is based

ISO 9001 deals with the requirements that organizations wishing to meet
the standard must fulfill

Third-party certification bodies provide independent confirmation that

organizations meet the requirements of ISO 9001

Over one million organizations worldwideare independently certified,

making ISO 9001 one of the most widely used management tools in the
world today

Reasons for having ISO


It has been observed that

purchasers require their suppliers to hold ISO 9001


a number of studies have identified significant financial

benefits for organizations certified to ISO 9001

certified organizations achieved superior return on assets


While the connection between superior financial

performance and ISO 9001 may be seen from the examples
cited, there remains no proof of direct causation

Studies have suggested that while there is some evidence

of this, the improvement is partly driven by the fact that
there is a tendency for better performing companies to
seek ISO 9001 certification

ISO 9001:2008 Quality management systems

General: This IS specifies requirements for a quality
management system where an organization
Needs to demonstrate its ability to consistently provide
product that meets customer and applicable statutory and
regulatory requirements, and
(b) Aims to enhance customer satisfaction through the
effective application of the system, including processes for
continual improvement of thwe system and the assurance
of conformity to customer and applicable statutory and
regulatory requirements

ISO 9001:2008 Quality management systems

1. All requirements are generic and are intended to be
applicable to all organizations, regardless of type, size and
product provided
2. If any requirements of this IS cant be applied due to the
nature of an organization and its product, this can be
considered for exclusion
3. If exclusions are made, claims of conformity to this IS are
not acceptable unless these exclusions are limited to
requirements within clause 7, and such exclusions do not
affect the organizations ability, or responsibility, to provide
product that meets customer and applicable statutory and
regulatory requirements

ISO 9001:2008 Quality management systems

Normative References
The following referenced documents are
indispensable for the application of this
document. For dated references, only the edition
cited applies. For undated references, the latest
edition of the referenced document (including
any amendments) applies.
ISO 9000:2005, Quality management systems
Fundamentals and vocabulary

ISO 9001:2008 Quality management systems


Terms and definitions

For the purposes of this document, the terms and definitions
given in ISO 9000 apply. Throughout the text of this
International Standard, wherever the term "product"
occurs, it can also mean "service"