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
