Understanding ISO 9001

New Trends in IE

ISO Certification
Most of the ISO Standards relate to products and
services.
The ISO 9000 and ISO 14000 families are among
ISO's best known standards ever.
ISO 9000 relates to Quality Management System.
ISO 14000 relates to Environmental Management
System.
ISO 9001:2000 and ISO 14001: 2004 are
implemented by over a million organizations in
175 countries.

ISO 9000 Family

The ISO 9000 family addresses "Quality
management".
This means what the organization does to
fulfill:
the customer's quality requirements, and
applicable regulatory requirements, while
aiming to
enhance customer satisfaction, and
achieve continual improvement of its
performance in pursuit of these objectives.

ISO 9000 Family

ISO 9000 - Quality Management Systems:
Fundamentals and Vocabulary
ISO 9001 - Quality Management Systems:
Requirements
ISO 9004 - Quality Management Systems:
Guidance for Performance Improvements
ISO 19011 - Guidelines on Quality and
Environmental Auditing

In the Global Economy

The positive roles played in globalization by ISOs
standards for quality and environmental
management systems include the following:
a unifying base for global businesses and supply
chains such as the automotive and oil and gas
sectors
a technical support for regulation as, for
example, in the medical devices sector
a tool for major new economic players to increase
their participation in global supply chains, in
export trade and in business process outsourcing;

In the Global Economy

a tool for regional integration as shown by
their adoption by new or potential members of
the European Union
in the rise of services in the global economy
nearly 32 % of ISO 9001:2000 certificates and
29 % of ISO 14001:2004 certificates in 2007
went to organizations in the service sectors,
and
in the transfer of good practice to developing
countries and transition economies

What is Quality?

Degree of
excellence!
Customer
satisfaction

ZERODEFECT

QUALITY

The ability of a
product or service to
consistently meet or
exceed customer
expectations.

doing
right the
first time,
all the
time

fitness
for use

Quality Defined
QUALITY is the degree to which a set of
inherent characteristics fulfills
requirements.
Characteristic distinguishing
feature
Requirement need or expectation
that is stated, generally implied or
obligatory

Dimensions of Quality
Performance

Safety

Aesthetics

Reliability

Special features

Durability

Conformance

Perceived
quality
Service after
sale

Quality Management System (QMS)

System set of interrelated or interacting
elements
Management System a system to
establish policy and objectives and to
achieve those objectives
Quality Management System a
management system to direct and control
an organization with regard to quality

Model of Process-Based QMS

Continual Improvement of the
Quality Management System
Management
Responsibility
Customers
Resource
Management

Customers

Input
Requirements

Measurement,
analysis and
improvement

Product
Realization

Key
Value-adding activities
Information flow

Satisfaction

Output

Product

Quality Management System (QMS)

ISO 9001:2000 specifies requirements for a
quality management system where an
organization
needs to demonstrate its ability to consistently
provide product that meets customer and
applicable regulatory requirements, and
aims to enhance customer satisfaction through
the effective application of the system, including
processes for continual improvement of the
system and the assurance of conformity to
customer and applicable regulatory
requirements.

Quality Management Principles

The quality management system standards of the
ISO 9000:2000 and ISO 9000:2008 series are
based on the eight quality management
principles.
1. Customer focus
2. Leadership
3. Involvement of people
4. Process approach
5. Systems approach to management
6. Continual improvement
7. Factual approach to decision making
8. Mutually beneficial supplier relationships

The ISO 9000 Process Approach

There are five sections in the standard that specify
activities that need to be considered when a
company implement its system :
1. Overall requirements for the quality
management system and documentation
2. Management responsibility, focus, policy,
planning and objectives
3. Resource management and allocation
4. Product realization and process management,
and
5. Measurement, monitoring, analysis and
improvement.

ISO 9001 Requirements

The standard has 8 clauses:
Clause 1.0 Scope
Information Clause 2.0 Normative References
Clause 3.0 Definitions
Clause 4.0 Quality Management Systems
Clause 5.0 Management Responsibility
Requirements Clause 6.0 Resource Management,
Clause 7.0 Product and/or Service Realization
Clause 8.0 Measurement, Analysis, and
Improvement

ISO 9001 Requirements

Process approach refers to the application of a
system of processes within an organization,
together with their identification and interactions
and the managing of these processes
This approach emphasizes the importance of:
Understanding and fulfilling requirements
The need to consider processes in terms of value
added
Obtaining results of process performance and
effectiveness
Continual improvement on processes based on
objective measure

Clause 1.0 Scope

The purpose of the standard is for the

organization to demonstrate its ability to provide
a product that meets customer and regulatory
requirements and achieves customer
satisfaction
This purpose is accomplished by evaluating and
continually improving the system, rather than the
product.
The requirements of the standard are intended
to be applicable to all types and sizes of
organizations

Clause 2.0 Normative Reference

ISO 9000:2000 Quality Management

Systems - Fundamentals and vocabulary is
a normative reference that provides
applicable concepts and definitions.

Clause 3.0 Terms and Definitions

For the purposes of this standard, the terms and

definitions given in ISO 9000:2000 apply.
In addition the supply chain is defined as:
Supplier
Organization
Customer
Must be properly understood and accurately
applied.
Auditors and others involved in the QMS
implementation and improvement are expected
to demonstrate good understanding of
definitions.

Clause 4.0 Quality Management

Systems
4.1 General Requirements
The organization shall establish, document,
implement, and maintain a QMS and continually
improve its effectiveness
It shall:
a. Identify needed processes such as
management activities, provision of resources,
product realization, and measurement
b. Determine their sequence and interaction
c. Determine criteria and methods for effective
operation and control of these processes

Clause 4.0 Quality Management

Systems
d. Ensure the availability of resources and
information necessary to support and monitor
these processes
e. Monitor, measure, and analyze these
processes, and
f. Implement actions to achieve planned results
and continual improvement of these
processes
Outsourced processes that affect the quality of
the product shall be identified and included in
the system.

Clause 4.0 Quality Management

Systems
4.2 Documentation Requirements
4.2.1 General
Documentation shall include
a. statements of quality policy and quality
objectives
b. a quality manual
c. required documented procedures
d. needed documents to ensure effective
planning, operation, and control of
processes
e. required records

Clause 4.0 Quality Management

Systems
4.2.2 Quality Manual
A quality manual shall be established and
maintained that includes:
a. the scope of the QMS with details and
justification for any exclusions
b. the documented procedures or
reference to them, and
c. a description of the interaction among
the QMS processes

Clause 4.0 Quality Management

Systems
4.2.3 Control of Documents
Documents required by the QMS shall be
controlled.
A documented procedure shall be in place
to define controls needed to:
a. Approve documents prior to use
b. Review, update, and re-approve as
necessary
c. Identify the current revision status
d. Ensure that current versions are
available at the point of use

Clause 4.0 Quality Management

Systems
e. Ensure that documents are legible and
readily identified
f. Identify and distribute documents of
external origin, and
g. Provide for the prompt removal of
obsolete documents and suitably
identify any that may be retained

Clause 4.0 Quality Management

Systems
4.2.4 Control of Records
Records are a special form of
documentation.
They shall be established and maintained
to provide evidence of conformity to
requirements, and effective operation of
the QMS.
They must remain legible, readily
identifiable, and retrievable.
A documented procedure is required to
define controls needed for identification,
storage, protection, retrieval, retention
time and disposition.

Clause 5.0 Management

Responsibility
5.1 Management Commitment
Top management must provide evidence of its
commitment to development, implementation
and continual improvement of the QMS.
Commitment must be demonstrated by:
a. communicating to the organization the
importance of meeting customer, statutory
and regulatory requirements
b. establishing a quality policy
c. ensuring quality objectives are established
d. conducting management reviews
e. ensuring resource availability

Clause 5.0 Management

Responsibility
5.2 Customer Focus
Top management refers to the person or
group of people who directs and controls an
organization.
Top management must ensure that customer
requirements are determined and are met
with the aim of enhancing customer
satisfaction.

Clause 5.0 Management

Responsibility
5.3 Quality Policy
The quality policy must:
a. be appropriate to the purpose of
organization.
b. include a commitment to comply with QMS
requirements.
c. include a commitment to continually
improve QMS effectiveness.
d. provide a framework for
establishing/reviewing quality objectives.
e. be communicated and understood within
the organization.
f. be reviewed for continuing suitability.

Clause 5.0 Management

Responsibility
5.4 Quality Planning

5.4.1 Quality Objectives

Must be established at relevant
functions and levels within the
organization.
Must include those needed to meet
requirements for product.
Must be measurable.
Must be consistent with the quality
policy.

Clause 5.0 Management

Responsibility
5.4.2 Quality Management System
Planning
Top management must ensure:
Planning is carried out to meet
requirements of 4.1 and quality
objectives.
Integrity of QMS is maintained when
changes to QMS are planned and
implemented.

Clause 5.0 Management

Responsibility
5.5 Responsibility, Authority and Communication

5.5.1 Responsibility and authority

Top management must ensure that
responsibilities, authorities and their
interrelations are defined and
communicated
5.5.2 Management Representative
Must be appointed by top
management
Must be a member of management
Ensures QMS is established,
implemented, maintained

Clause 5.0 Management

Responsibility
5.5.3 Internal communication
Top management must ensure that
Communication processes are
established within the organization.
Communication takes place
regarding effectiveness of the QMS.

Clause 5.0 Management

Responsibility
5.6 Management Responsibility
5.6.1 General
Top management must review QMS
at planned intervals to ensure
continued suitability, adequacy and
effectiveness.

Clause 5.0 Management

Responsibility
5.6.2 Review Input
Review must include assessing
opportunities for improvement and
need for changes to QMS, including
quality policy and objectives.
Include information on results of
audits, customer feedback, process
performance and product conformity,
status of preventive and corrective
actions, follow-up actions from
previous reviews, planned changes
that could affect the QMS and
recommendations for improvement.

Clause 5.0 Management

Responsibility
5.6.3 Review Output
Include any decisions and actions
related to:
a. improvement of effectiveness of
QMS and its processes
b. improvement of product related to
customer requirements, and
c. resources needed

Clause 6.0 Resource Management

6.1 Provision of Resources
Determine and provide resources needed to:
a. implement and maintain QMS and
Continually improve effectiveness of
QMS.
b. enhance customer satisfaction by
meeting customer requirements.
Resources may be people, infrastructure,
work environment, information, suppliers,
natural resources, and financial
resources.

Clause 6.0 Resource Management

6.2 Human Resources
6.2.1 General

Personnel performing work affecting product

quality must be competent on basis of
appropriate education, training, skills and
experience
6.2.2 Competence, Awareness and Training

The organization must:

a. Determine necessary competence of
personnel
b. Provide training or other actions to satisfy
needs.
c. Evaluate effectiveness of actions taken.
d. Ensure personnel are aware of relevance
and importance of their work and how they
contribute to quality objectives.
e. Maintain records of education, training, skills
and experience

Clause 6.0 Resource Management

6.3 Infrastructure
The organization shall determine, provide,
and maintain infrastructure needed to
achieve conformity to product requirements.
Infrastructure includes, as applicable:
a. buildings, workspace, utilities
b. process equipment (hardware and
software)
c. supporting services (such as transport or
communication)

Clause 6.0 Resource Management

6.4 Work Environment
The organization shall determine and
manage the work environment needed to
achieve conformity to product requirements.

Clause 7.0 Product Realization

7.1 Planning of Product Realization
Planning of realization processes must be
consistent with other processes of the QMS.
Planning must include determining:
a. Product quality objectives and
requirements.
b. Need to establish processes, documents,
resources specific to the product.
c. Required verification, validation,
monitoring, inspection and test activities
specific to product and the criteria for
product acceptance.
d. Records as evidence that realization
process and product meet requirements.

Clause 7.0 Product Realization

7.2 Customer-Related Processes
7.2.1 Determination of Requirements
Related to The Product
The organization shall determine:
a. customer specified requirements
including delivery and post delivery
requirements
b. requirements not stated by
customer but necessary
c. product statutory or regulatory
requirements, and
d. any additional requirements
determined by the organization

Clause 7.0 Product Realization

7.2.2 Review of Requirements Related to
The Product
Review requirements prior to
commitment to supply product.
Review to ensure that:
a. product requirements are defined
b. differences between past and
current requirements are resolved,
and
c. The organization has the ability to
meet defined requirements

Clause 7.0 Product Realization

7.2.2 Review of Requirements Related to
The Product
Review records and actions to be
maintained.
If customer requirements are not
documented, organization must
confirm before acceptance.
Documents must be amended to
reflect changes and relevant
personnel made aware of the
changes.

Clause 7.0 Product Realization

7.2.3 Customer Communication
Determine and implement
arrangements for communicating with
customers on:
a. product information
b. inquiries, contracts, or order
handling, including amendments,
and
c. customer feedback, including
customer complaints

Clause 7.0 Product Realization

7.3 Design and Development
7.3.1 Design and Development Planning
During this stage, the organization
shall determine the:
a. design and development stages
b. review, verification, and
validation that are appropriate to
each stage
c. responsibilities and authorities

Clause 7.0 Product Realization

7.3.2 Design and Development Inputs
Inputs include:
a. functional and performance
requirements
b. applicable statutory and
regulatory requirements
c. information derived from
previous similar designs, and
d. other essential requirements

Clause 7.0 Product Realization

7.3.3 Design and Development Outputs
Outputs shall:
a. meet the input requirements
b. Provide appropriate information for
purchasing, production, and
service provision
c. Contain reference product
acceptance criteria, and
d. Specify the characteristics of the
product that are essential for its
safe and proper use

Clause 7.0 Product Realization

7.3.4 Design and Development Review
Reviews shall be performed to:
a. evaluate the ability of the results to
meet requirements
b. identify any problem and propose
necessary actions
Risk assessment such as FMEA,
reliability prediction, and simulation
techniques can be undertaken to
determine potential failures in
products or processes

Clause 7.0 Product Realization

7.3.5 Design and Development Verification
Verification shall be performed to
ensure that outputs have met the input
requirements.
Records of the results of the
verification and any necessary actions
shall be maintained.

Clause 7.0 Product Realization

7.3.6 Design and Development Validation
Validation:
ensures that the product is capable of
meeting requirements for the specified
application or intended use
shall be completed prior to the delivery
or implementation of the product
7.3.7 Control of Design and Development
Changes
The changes shall be reviewed, verified,
validated, and approved before
implementation.
The review shall include evaluation of
the effect of changes on constituent
parts and product already delivered.

Clause 7.0 Product Realization

7.4 Purchasing
7.4.1 Purchasing Process
Ensure purchased product conforms with
specified purchase requirements.
Type and extent of control depends on
effect of purchased product on product
realization and final product.
Evaluate and select suppliers based on
ability to supply product that meets
requirements.
Establish criteria for selection, evaluation,
re-evaluation.
Maintain records of results of evaluation
and actions taken.

Clause 7.0 Product Realization

7.4.2 Purchasing Information
Describe product to be purchased,
including:
a. requirements for approval of product,
procedures, processes and equipment
b. requirements for qualification of
personnel, and
c. Quality management system
requirements
Ensure adequacy of specified purchase
requirements prior to their communication
to supplier.

Clause 7.0 Product Realization

7.4.3 Verification of Purchased Product
Verify that purchased product meets
specified requirements by inspection
or other means.
Specify verification arrangement and
method of product release in
purchasing information where
organization or its customer intends to
perform verification at suppliers
premises.

Clause 7.0 Product Realization

7.5 Production and Service Provision
7.5.1 Control of Production and Service
Provision
Plan and carry out production and service
provisions under controlled conditions.
Controlled conditions shall include:
a. availability of product characteristic
description information
b. availability of work instructions
c. use of suitable equipment
d. availability and use of suitable monitoring and
measurement devices
e. implementation of monitoring and
measurement, and
f. implementation of release, delivery and post
delivery activities

Clause 7.0 Product Realization

7.5.2 Validation of Processes for Production and
Service Provision
If output of a process for production and
service provision cannot be verified by
subsequent monitoring and measurement,
it must be validated.
Include any process where deficiencies
may become apparent only after product is
in use or service is delivered.
Validation must demonstrate ability of
these processes to achieve planned
results.
Establish arrangements for these
processes.

Clause 7.0 Product Realization

7.5.3 Identification of Traceability
Identify product by suitable means
throughout product realization where
appropriate.
Identify product status with respect to
monitoring and measurement
requirements.
Control and record the unique
identification of the product Where
traceability is a requirement.

Clause 7.0 Product Realization

7.5.4 Customer Property
Exercise care with customer property.
Identify, verify and safeguard Customer
property provided for use or to be
incorporated into the product.
Report to customer lost, damaged or
otherwise unsuitable customer property
and maintain records.

Clause 7.0 Product Realization

7.5.5 Preservation of Product
Preserve conformity of product during
internal processing and delivery to
intended destination.
Preservation includes:
a. Identification
b. handling
c. packaging
d. storage
e. protection
Preservation also applies to constituent
parts of product.

Clause 7.0 Product Realization

7.6 Control of Monitoring and Measuring Devices
Determine monitoring and measurement to be
undertaken and measurement devices needed to
provide evidence of conformity of product to
requirements.
Establish processes to ensure monitoring and
measurement can be carried out and are carried
out in a way consistent with monitoring and
measurement requirements.
Assess and record validity of previous measuring
results when equipment is found not to conform to
requirements.
Confirm ability of computer software to satisfy
intended application when used in monitoring and
measurement of specified requirements.

Clause 7.0 Product Realization

7.6 Control of Monitoring
and Measuring Devices
Where necessary to ensure valid results, measuring
equipment must be:
a. calibrated or verified at specified intervals, or prior to
use against standard traceable to international or
national standard. Where no standard exists, basis
of calibration or verification must be recorded.
b. adjusted or readjusted as necessary
c. identified to allow calibration status to be determined
d. safeguarded against adjustments that would
invalidate measurement results
e. protected from damage and deterioration during
handling, maintenance, storage

Clause 8.0 Measurement, Analysis and

Improvement

8.1 General
Plan and implement monitoring,
measurement, analysis and improvement
processes to:
a. demonstrate conformity of product
b. ensure conformity of QMS
c. continually improve effectiveness of QMS
Include determination of applicable methods,
including statistical techniques, and the
extent of their use.

Clause 8.0 Measurement, Analysis and

Improvement

8.2 Monitoring and Measurement Plan

8.2.1 Customer Satisfaction
Monitor information relating to
customer perception as to whether
customer requirements have been
fulfilled, as one of measures of
performance of QMS.
Determine methods for obtaining and
using this information.

Clause 8.0 Measurement, Analysis and

Improvement
8.2.2 Internal Audit
Conduct at planned intervals to determine
compliance and effectiveness of QMS
Plan audit program
Define audit scope, frequency, methods
Auditors properly selected to ensure
objectivity and impartiality
Auditors must not audit their own work
Documented IQA procedure
Corrective actions to findings are taken
without undue delay
Follow-up activities must include
verification of actions taken

Clause 8.0 Measurement, Analysis and

Improvement

8.2.3 Monitoring and Measurement of

Processes
Apply suitable methods for monitoring
and measurement of the QMS
processes
Methods must demonstrate ability of
processes to achieve planned results
Take correction and corrective action
when planned results are not achieved

Clause 8.0 Measurement, Analysis and

Improvement
8.2.4 Monitoring and Measurement of Product
Monitor and measure product
characteristics to verify requirements are
met
Carry out at appropriate stages of product
realization process
Maintain evidence of conformity with
acceptance criteria
Record person authorizing release of
product
Do not proceed with product release and
delivery until all planned arrangements
have been satisfactorily completed

Clause 8.0 Measurement, Analysis and

Improvement
8.3 Control of Non- Conforming Product

Identify and control product which does not

conform to prevent unintended use or delivery
Documented procedure required to define
controls, responsibilities and authorities for
dealing with nonconforming product
Maintain records of nature of nonconformities
and actions taken
Re-verify corrected nonconforming product to
demonstrate conformity
When nonconforming product is detected after
delivery or use has started, take action
appropriate to the effects or potential effects of
the nonconformity

Clause 8.0 Measurement, Analysis and

Improvement

8.3 Control of Non- Conforming Product

Deal with non-conforming product in one or
more of the following ways:
a. by taking action to eliminate the
nonconformity
b. by authorizing its use, release or
acceptance under concession by relevant
authority or where applicable the
customer
c. by taking action to preclude its original
intended use or application

Clause 8.0 Measurement, Analysis and

Improvement
8.4 Analysis of Data
Determine, collect, analyze appropriate data to:
a. demonstrate suitability and effectiveness of the
QMS
b. evaluate where continual improvement of the
QMS can be made
Include data generated as a result of monitoring and
measuring other sources.
Analysis of data must provide information relating to:
a. customer satisfaction
b. conformance to product requirements
c. characteristics and trends of processes and
products, including opportunity for preventive
action, and
d. suppliers

Clause 8.0 Measurement, Analysis and

Improvement

8.5 Improvement
8.5.1 Continual Improvement
Continually improve effectiveness of
QMS through the use of:
a. quality policy and objectives
b. audit results
c. analysis of data
d. corrective and preventive actions
e. management review

Clause 8.0 Measurement, Analysis and

Improvement
8.5.2 Corrective Action
Take action to eliminate cause of
nonconformities to prevent recurrence.
Take action appropriate to effects of
nonconformities encountered.
Documented procedure to be established to
define requirements for:
a. reviewing nonconformities, including
customer complaints
b. determining causes of nonconformities
c. evaluating need for action to ensure
nonconformities do not recur
d. determining and implementing action
needed
e. records of results of action taken, and
f. reviewing corrective action taken

Clause 8.0 Measurement, Analysis and

Improvement
8.5.3 Preventive Action
Determine action to eliminate causes of
potential nonconformities to prevent
occurrence.
Take action appropriate to effects of potential
problems.
Documented procedure must be established to
define requirements for:
a. determining potential nonconformities and
their causes
b. evaluating action needed to prevent
occurrence
c. determining and implementing action
needed
d. records of results of action taken
e. reviewing preventive action taken