Guardian Independent Certification

Chapter 1

Introduction of ISO 9001:2008 & Related

Standards

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Related Standards
• ISO9000: 2005
• ISO 9004: 2009
• ISO 19011: 2002

OVERVIEW OF ISO 9000:2005

 Revision to ISO 9000:2000

 Revision to ISO 9000:1994
 Cancel and Replace ISO 8402:1994

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OVERVIEW OF ISO 9000:2005

• Describe fundamentals of QMS & specifies the

terminology for QMS.

OVERVIEW OF ISO 9000:2005

Example: Definition of Process Approach:-

The systematic identification and management

of the processes employed within an
organisation and particularly the interactions
between such processes is referred to as the
‘process approach’.

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Overview of ISO 9004:2009

• Managing for the sustained success

of an organization

Overview of ISO 9004:2009

• Definition
– Sustained success: result of the ability of the
organization to achieve and maintain its
objectives in the long term
– The sustained success of an organization is
demonstrated by its ability to satisfy needs and
expectations of its customers and other
interested parties over the long term and in a
balanced way.

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Overview of ISO 9004:2009

– Organization’s environment is a combination
of external and internal factors and conditions
that can affect the achievement of an
organization’s objectives, and its behaviour
towards interested parties.

– Provides wider focus on quality management

then ISO 9001; it addresses the needs and
expectations of all interested parties and their
satisfaction.

Overview of ISO 9001:2008

MODEL OF A PROCESS-
PROCESS-BASED QUALITY MANAGEMENT SYSTEM

Continual Improvement of the Quality Management Systems

Customer Management Customer

Customer
Customer
Responsibility

Measurement
Analysis and Satisfaction
Satisfaction
Resource Improvement
Management

Output
Requirements Product
Requirements Product
Realization

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OVERVIEW OF ISO 9001:2008

6 types of document are used in the QMS.
Each organisation determines the extent of documentation
required and the media to be used. This depends on
factors such as:

Type and size of the organisation

Complexity of service
Complexity of products
Customer requirements
Applicable regulatory requirements
Demonstrated ability of personnel
Extent necessary to demonstrate fulfillment of QMS
requirements

OVERVIEW OF ISO 9001:2008

QMS and other management system focuses (2.11)

The QMS is that part of the organisation’s management

system that focuses on the achievement of results in relation
to the quality objectives to satisfy the needs, expectations
and requirements of interested parties, as appropriate.
The quality objectives complement other objectives of the
organisations such as those related to growth, profitability,
etc.
The organisation’s MS can be assessed against the
organisation’s MS requirements or against the
requirements of IS. They can be carried out separately or
in combination.

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OVERVIEW OF ISO 9001:2008

Relationship between QMS and excellence

models (2.12)

The approaches of QMS and organisational

excellence models are based on common
principles.
The difference lies in their scope of application.

OVERVIEW OF ISO 9001:2008

TERMS AND DEFINITIONS

Product [3.4.2] is defined as “result of a process [3.4.1]”.

Process [3.4.1] is defined as “set of interrelated or
interacting.

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ISO 19011: 2002

Guidelines for Auditing Quality and/or
Environmental Management Systems
Published in October 2002.
Prepared jointly by ISO/TC 176 & ISO/TC 207
Replaced:
- ISO 10011-1:1990, ISO 10011-2:1991 & ISO 10011-3:
1991;
- ISO 14010:1996, ISO 14011:1996 & ISO 14012:1996

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NOTES

ISO 19011:2002

ISO 19011 is intended to provide guidelines for auditing ISO 9001-based quality
management systems (QMS) and ISO 14001-based environmental management
systems (EMS); however, it will also be sufficiently general such that it can be applied to
any QMS or EMS.
ISO 19011 reflects the changes made to ISO 9001:2000, Quality Management Systems
- Requirements, which was issued in December 2001, including the new business model
for the standard. ISO 19011 is intended to apply to both internal and external auditing,
and may be used as part of auditor certification and training.

STRUCTURE OF ISO 19011:

0. Introduction
1. Scope
2. Normative References
3. Terms and Definitions
4. Principles of Auditing
5. Managing an Audit Program
6. Audit Activities
7. Competence of Auditors
ISO 19011 is a guideline standard which means its use is not mandatory unless it is
invoked as part of a multiple party agreement, such as contract or other legal
agreement. As a guideline standard, its implementation is generally not auditable
because the elements of the standard are not requirements and because there may be
others ways of accomplishing the same objectives.

Auditors including those who audit internally within their own organizations, need to
aware of the development of ISO 19011, the new standard that combines into one
document on auditing guidelines for quality management systems and environmental
management systems.

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