Overview of ISO 9001

and ISO 14001

ISO 9001 and ISO 14001 in brief
 ISO9001 and ISO 14001 are among ISO's most well known
standards ever.
 Theyare 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.
Quality management
 ISO 9001 is for quality management.
 Quality refers to all those features of a product (or service)
which are required by the customer.
 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.
Quality management (cont.)
Quality management also means what the
organization does to
enhance customer satisfaction, and
achieve continual improvement of its
performance.
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.
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, and
whether it is a business enterprise, a public
administration, or a government department.
Generic standards (cont.)
Generic also signifies that
no matter what the organization's scope of
activity
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.
Management systems
 Management system means what the organization does to
manage its processes, or activities in order that
 its products or services meet the organization’s objectives,
such as
 satisfying the customer's quality requirements,
 complying to regulations, or
 meeting environmental objectives
Management systems
 To be really efficient and effective, the organization can
manage its way of doing things by systemizing it.
 Nothing important is left out.
 Everyone is clear about who is responsible for doing what,
when, how, why and where.
 Management system standards provide the organization with
an international, state-of-the-art model to follow.
Management systems (cont.)
Large organizations, or ones with
complicated processes, could not function
well without management systems.
Companies in such fields as aerospace,
automobiles, defence, or health care devices
have been operating management systems for
years.
The ISO 9001 and ISO 14001 management
system standards now make these successful
practices available for all organizations.
Processes, not products
Both ISO 9001 and ISO 14001 concern the
way an organization goes about its work.
They are not product standards.
They are not service standards.
They are process standards.
They can be used by product manufacturers
and service providers.
Processes, not products (cont.)
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.
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,
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.
Certification not a requirement
Certification is not a requirement of ISO
9001 or ISO 14001.
The organization can implement and benefit
from an ISO 9001 or ISO 14001 system
without having it certified.
The organization can implement them for the
internal benefits without spending money on
a certification programme.
Certification is a business decision
Certification is a decision to be taken for
business reasons:
if it is a contractual, regulatory, or market
requirement,
If it meets customer preferences
it is part of a risk management programme, or
if it will motivate staff by setting a clear goal.
ISO does not certify
ISO does not carry out ISO 9001 or ISO
14001 certification.
ISO does not issue certificates.
ISO does not accredit, approve or control the
certification bodies.
ISO develops standards and guides to
encourage good practice in accreditation and
certification.
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.
It is the only standard in the ISO 9000 family that
can be used for certification.
There are 16 other standards in the family that
can help an organization on specific aspects such
as performance improvement, auditing, training…
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…
The ISO Survey
The ISO Survey (cont.)
The worldwide total of certificates to ISO
9001:2001 at the end of 2007 was 951 486.
This was increase of 6 % over 2006 when
the total was 896 929 certificates.
Certificates had been issued in 175 countries
compared to 170 the previous year.
The ISO Survey (cont.)
The ISO Survey (cont.)
The worldwide total of ISO 14001
certificates at the end of 2007 was 154 572.
This was an increase of 21 % over 2006
when the total was 128 211.
Certificates had been issued in 148 countries
compared to 140 the year before.
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 in B2B.
Increase efficiency and effectiveness.
Model for continual improvement.
Benefits of ISO 9001 and ISO 14001
(cont.)
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.
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
Benefits of ISO 9001 and ISO 14001
(cont.)
Transfer of good practice to developing
countries
Tools for new economic players
Regional integration
Facilitate rise of services
ISO 9001:2000
Documentation Requirements
Based on ISO/TC 176/SC 2

ISO 9001:2000
 Two of the Most Important Objectives in
the Revision of the ISO 9000- Standard

To develop a simplified set of standards that will be

equally applicable to small as well as medium and
large organizations
For the amount and detail of documentation required
to be more relevant to the desired results of the
organization’s process activities
ISO 9001:2000
Significantly reduces documentation
requirements
Is much less prescriptive
Allows more flexibility in choice of
documentation system
ISO 9001:2000
Enables each organization to develop the
minimum amount of documentation needed in
order to demonstrate the effective planning,
operation and control of its processes and the
implementation and continual improvement
of the effectiveness of its quality management
system
What Is a Document?

Communication of information
Evidence of conformity
Knowledge sharing
Communication of Information
The type and extent of the documentation will
depend on the nature of the organization’s products
and processes
The degree of formality of communication systems
The level of communication skills
The organizational structure
Evidence of Conformity
Provision of evidence that what was planned
has actually been done.
Say what you do, do what you say and prove
it.
Knowledge Sharing
In order to disseminate and preserve the
organization’s experiences.
Example: a technical specification, which can
be used as a base for design and development
of a new product.
Document Mediums
Paper
Magnetic
Electronic
Photographic
Master Sample
Other
Clause 4.1, General Requirements
Documented statements of quality policy and quality
objectives
A quality manual
Documented procedures required by the
international standard
Documents needed by the organization to ensure
effective planning, operation and control of its
processes
Records required by the international standard
Documented Statements of Quality Policy (1
of 2)
Defined in Clause 5.3
 Appropriate to the purpose of the organization
 Includes a commitment to comply with
requirements and continually improve the
effectiveness of the Quality Management System
 A framework for establishing and quality
objectives
Documented Statements of Quality Policy (2
of 2)
Defined in Clause 5.3
Is communicated and understood within the
organization
Is reviewed for continuing suitability
Documented Statements of Quality
Objectives
Defined in Clause 5.4.1
Includes those needed to meet requirements
for product [Clause 7.1]
Are established at relevant functions and
levels within the organization
Are measurable and consistent with Quality
Policy
Quality Manual
Minimum content specified in Clause 4.2.2
Scope of the Quality Management System,
including details of and justification for any
exclusions
Documented procedures established for the
QMS, or references to them
Description of the interaction between
processes of the QMS
Quality Manual-Structure
Structure of the manual is a decision for the
organization based on:
Organization’s size
Organization’s complexity
Organization’s culture

Controlled in accordance with the requirements

of Clause 4.2.3
Documented Procedures
Required by ISO 9001:2000
Control of documents (Clause 4.2.3)
Control of records (Clause 4.2.4)
Internal Audit (Clause 8.2.2)
Control of nonconforming product (Clause 8.3)
Corrective action (Clause 8.5.2)
Preventive Action (Clause 8.5.3)
Documents Needed by the Organization

Specifically referenced in ISO 9001:2000

Quality policy (Clause 4.2.1a)
Quality objectives (Clause 4.2.1a)
Quality Manual (Clause 4.2.1b)
Additional Documentation

There are several requirements of ISO 9001:2000

where an organization could add value to its
Quality Management System and demonstrate
conformity by the preparation of other
documents
Additional Documentation
Process maps, process flow charts,and/or process
descriptions
Organization charts
Specifications
Work and/or test instructions
Production schedules
Approved suppliers lists
Test and inspection plans
Quality plans
Documented Procedures
Controlled in accordance with Clause 4.2.3
May combine the procedure for several
activities into one document
May require more than one document for a
single procedure
May require additional procedures in order to
implement an effective QMS
Records
Requirements for control of records are different
from those for other documents
All records have to be controlled in accordance with
the requirements of Clause 4.2.4
Organization are free to develop records that may be
needed to demonstrate conformity of their processes,
products, and QMS
Required Records (1 0f 2)
 Management reviews  Results of design and
(5.6.1) development reviews
 Education, training, skills (7.3.4)
and experience (6.2.2e)  Results of design and
 Evidence that the development verification
realization processes and  Results of design and
resulting product fulfill development validation
requirements (7.1d)  Results of review of design
 Design and development and development changes
inputs (7.3.2) (7.3.7)
Required Records (2 of 2)
 Results of supplier  Basis for calibration of
evaluations (7.4.1) measuring equipment
 To demonstrate process
(7.6a)
 Results of calibration (7.6)
validity where output
 Internal audits (8.2.2)
cannot be measured
 Release of product (8.2.2)
(7.5.2d)
 The unique identification  Nonconforming product

of a product (7.5.3) (8.3)

 Results of corrective action
 Customer property (7.5.4)
(8.5.2)
 Results of preventive
action (8.5.3)
Preparing to Implement a QMS
Process approach
Identify the processes necessary for effective
implementation
Understand interactions between these
processes
Document the processes to assure effective
operation and control
Processes Include

Management
Resources
Productrealization
Measurement
Process Analysis
Should be driving force for defining amount
of documentation, taking into account the
requirements of ISO 9001:2000
Should not be the documentation that drives
the processes
Demonstrating Conformity With ISO
9001:2000

May not need extensive documentation

Must be able to provide objective evidence of
effectiveness of processes and quality
management system
Objective Evidence
Data supporting the existence or verity of something
(Clause 3.8.1 of ISO 9000:2000)
May be obtained through observation, measurement,
test or other means
Does not necessarily depend on documented
procedures, records or other documents except
where specifically required by ISO 9001:2000
Objective Evidence
Where the organization has no specific
procedure for a particular activity, and this is
not required by specification, it is acceptable
for this activity to be conducted using as a
basis the relevant clause of ISO 9001:2000
Example: Internal and external audits
Terms and Definitions
 Document - information and its supporting medium (ISO
9000:2000 Clause 3.7.2)
 Procedure – Specified way to carry out an activity (3.7.4)
 Quality Manual – Document specifying the quality
management system of an organization
 Quality Plan – document specifying which procedures and
associated resources shall be applied, by whom and when to a
specific project (3.7.5)
 Record – document stating results achieved or providing
evidence of activities performed (3.7.6)
 Specification – document stating requirements
Bibliography
 Guidance on the Documentation Requirements of
ISO 9001:2000
ISO/TC 176/SC 2/N525R
March 2001
 Quality Management Systems – Requirements
ISO/FDIS 9001