ISO

diligentdeputyΔιαχείριση

8 Νοε 2013 (πριν από 3 χρόνια και 9 μήνες)

85 εμφανίσεις

1


www.iso.org

International Organization

for Standardization

2


ISI and AGMARK

ISI Certification

Indian Standards Institute now known as Bureau of Indian Standard
(BIS) is a registered society under Government of India. BIS main
functions include the development of technical standards, product
quality and management system certifications and consumer affairs.


Agmark Certification

AgMark is an acronym for Agricultural Marketing and is used to certify
the food products for quality control. Agmark has been dominated by
other quality standards including the non manufacturing standard ISO
9000.


Hallmark Certification

3


Who created the standards?

International Organization for Standardization
-

1946
Geneva

ISO tech committee
-

TC 176 started in 1979

Standards created in 1987

To eliminate country to country differences

To eliminate terminology confusion

To increase quality awareness



4


How did ISO get started?

1926
-

International Federation of the National Standardizing
Associations (ISA)

1946 London
-

delegates from 25 countries decided to create a
new international organization "the object of which would be to
facilitate the international coordination and unification of
industrial standards

1947
-

ISO began to officially function

1951
-

The first ISO standard was published


"Standard reference temperature for industrial length
measurement".



5


ISO Organization

General

Assembly


Council

Technical

Management Board

Technical Advisory

Groups

Policy

Development

Committees

Technical Committees

Technical Committees

Technical Committees

6


ISO 9000:2000

ISO 9000:2000

Quality Management Systems: fundamentals and
vocabulary

ISO 9001:2000

Quality Management Systems


Requirements
(required for certification)


Management responsibility


Resource management


Product/service realization


Measurement, analysis, improvement

ISO 9004
-
2000

Quality Management Systems

Guidelines for
performance improvement

7


ISO 9001 and ISO 14001 in brief

ISO 9001 and ISO 14001 are among
ISO's most well
known standards

ever.

They are implemented by more than a million

organizations

in some
175 countries
.

ISO 9001

helps organizations to implement
quality
management.

ISO 14001

helps organizations to implement
environmental management
.


8


Quality management

ISO 9001 is for
quality management
.

Quality management

means what the organization does to

ensure that its products or services satisfy the customer's
quality
requirements

and

comply with any
regulations

applicable to those products or
services.

enhance
customer satisfaction
, and

achieve
continual improvement

of its performance.


9


Environmental management

ISO 14001 is for
environmental management
. This means what the
organization does to:

minimize harmful effects

on the environment caused by its
activities,

to conform to applicable
regulatory requirements
, and

to achieve continual improvement of its
environmental
performance
.

10


Generic standards

ISO 9001 and ISO 14001 are
generic

standards.


Generic

means that the same standards can be applied:

to
any organization
, large or small, whatever its product or service,

in
any sector

of activity, whether it is a business enterprise, a public
administration, or a government department.

if it wants to establish a
quality management system
, ISO 9001 gives
the essential features

or if it wants to establish an
environmental management system
, ISO
14001 gives the essential features.


11


Processes, not products

Both ISO 9001 and ISO 14001 are concerned with
the way an
organization goes about its work
.

They are not product/service standards.

They are
process

standards.

They can be used by
Product manufacturer and service providers
.

Processes affect final products or services.

ISO 9001

gives the requirements for what the organization must do to
manage
processes affecting quality

of its products and services.

ISO 14001

gives the requirements for what the organization must do
to manage
processes affecting the impact of its activities on the
environment
.


12


Elements of the standards

Management responsibility

Resource management

Quality System

Contract Review

Design Control

Document Control

Purchasing

Purchaser
-
Supplied Product

Product Identification and
Traceability

Process Control

Inspection and Testing

Inspection, Measuring and Test
Equipment

Inspection and Test Status

Control of Non
-
conforming product

Corrective Action

Quality Records

Internal Quality Audit

Training

Servicing

Statistical Techniques

13


Why is ISO 9000 important?

ISO 9000 certification required

by suppliers of “Regulated Products”

health, safety, and the environment

Globalization impact

Legal aspects

To comply with customers who require ISO 9000

To sell in the global market

To compete in domestic markets

To improve the quality system

To minimize repetitive auditing by similar and different customers

To improve subcontractors’ performance


14


Certification and registration

Certification
is known in some countries as
registration
.

It

means that an
independent, external body

has audited
an organization's management system and verified that it
conforms to the requirements specified in the standard
(ISO 9001 or ISO 14001).

ISO does not carry out certification

and does not issue
or approve certificates,

15


Accreditation

Accreditation

is like certification of the certification body.

It means the formal approval by a specialized body
-

an
accreditation body
-

that a certification body is competent
to carry out ISO 9001:2008 or ISO 14001:2004
certification in specified business sectors.

Certificates issued by accredited certification bodies
-

and
known as
accredited certificates
-

may be perceived on
the market as having increased credibility.

ISO does not carry out or approve accreditations.

16


Ten Steps to ISO Registration

ISO 9000

2. Select the appropriate standard

1. Set the registration objective

3. Develop and implement the quality system

4. Select a third
-
party registrar and apply

5. Perform self
-
analysis audit

6. Submit quality manual for approval

7. Pre
-
assessment by registrar

8. Take corrective actions

9. Final assessment by registrar

10. Registration!

17


Six Essential Elements of a Successful
Registration Effort

Senior Management Commitment to the Effort

Appropriate ISO 9000 Training

An Effective Management Review Process

Documentation of the Quality System

An Effective Internal Auditing System

An Effective Corrective Action Process

18


Documentation for ISO systems

Quality Policy Manual (What?, Why?)

Quality System Procedures (Who?, When?, Where?)

Work Instructions (how?)

Records, Formats, Forms (Evidence)

19


Quality

principles

underlying

ISO 9000:2000

Customer focus

Leadership

Involvement of people

Process approach

System approach to management

Continuous improvement

Decisions based on facts

Mutually beneficial supplier relationships


20


Quality Audits

“a systematic, independent examination to determine whether quality
activities and results comply with planned arrangements, whether
these arrangements are implemented effectively, and whether these
are suitable to achieve objectives”

Types

First party audit (Internal), Second party audit (by customer), Third
party audit (by independent agency)

Systems audit, Process audit, Product audit, Adequacy audit,
Compliance audit

21


Stages in conducting quality audit

Audit Planning: schedules, personnel, checklist

Execution


opening meetings, audit process, noting of conformities

Reporting


observations, suggestions for corrective actions

Follow
-
up


implementation of corrective actions

Checklist:

Whether system to ensure quality has been established

Whether the system is documented

Whether the documented system meets requirements

Whether the system implemented is documented

Whether the system is effective in achieving orgn. objectives & goals

22


The ISO 9000 family

ISO 9001

is the standard that gives the requirements for a
quality
management system
.

ISO 9001:2008

is the latest, improved version.

ISO 9001:
design, development, production installation, and servicing
of products or services

ISO 9002:
exludes design and development

ISO 9003:
final inspection and testing

ISO 9004:
guidelines for applying the elements of the Quality
Management System

23


The ISO 14000 family

ISO 14001

is the standard that gives the requirements for
an
environmental management system.

ISO 14001:2004

is the latest, improved version.

It is the
only standard

in the ISO 14000 family that can
be used for
certification
.

The ISO 14000 family includes
21 other standards

that
can help an organization specific aspects such as
auditing, environmental labelling, life cycle analysis…


24


Benefits of ISO 9001 and ISO 14001

International, expert consensus on state
-
of
-
the
-
art practices for quality
and environmental management.

Common language for dealing with customers and suppliers worldwide

Increased efficiency and effectiveness.

Model for continual improvement.

Model for satisfying customers and other stakeholders.

Build quality into products and services from design onwards.

Address environmental concerns of customers and public, and comply
with government regulations.

Integrate with global economy.



25


Benefits of ISO 9001 and ISO 14001
(cont.)

Sustainable business

Unifying base for industry sectors

Qualify suppliers for global supply chains

Technical support for regulations

Transfer of good practice to developing countries

Tools for new economic players

Regional integration

Facilitate rise of services