Key Terms

Quality:
Degree to which a set of inherent
characteristics fulfills requirements

Process:
Set of interrelated or interacting activities
which transforms inputs into outputs

System:
Set of interrelated or interacting elements

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Key Terms

Management System :
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

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Key Terms

Quality Assurance:
Part of quality management, focused on
providing confidence that quality requirements
are fulfilled

Quality Control:
Part of quality management, focused on
fulfilling requirements for quality

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ISO 9000 Series of Standards
ISO was formed in 1947 with Headquarters at Geneva.
First International Standard ISO 9000 series was released
in 1987.
Rev-1 in 1994 ; Rev-2 in 2000 ; Rev-3 in 2008

• ISO 9000:2005 – Fundamentals and vocabulary

• ISO 9001:2000* – Requirements
• ISO 9004:2000 – Guidelines for performance
improvements
• ISO 19011:2002 - Guidelines on quality and/or
environmental management
systems auditing
* Revision has come in 2008
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Quality Management Process Model

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Quality Systems Auditing

Quality Audit: Three aspects to be evaluated

1) INTENT- extent to which the QMS, as it is intended to

operate, is appropriate to the organization’s
activities and such as to ensure compliance with
regulatory and customer requirements.

2) IMPLEMENTATION - extent to which the QMS is

implemented in practice.

3) EFFECTIVENESS – extent to which QMS objectives

are attained.

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Quality Systems Auditing
Auditor Skills: An Internal Auditor should be able to:
Determine the scope and objectives of an audit.
Prepare checklists used for evaluating quality system
elements.
Collect and analyze objective evidence to determine if the
documents and other information used to describe the quality
system are adequate to achieve quality objectives.
Collect and analyze objective evidence to determine if the
quality system complies with the specified requirements and to
evaluate the effectiveness of the quality management system.
Interview personnel at all levels, examine documents, and
observe activities and nonconformities.
Verify the accuracy of information gathered in interviews by
observation, measurements and records.
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Quality Systems Auditing

Auditor Skills:
Identify, record and investigate clues suggesting possible
nonconformities.
Document audit observations.
Complete audit observation reports and other audit
documentation.
Review observations to determine which should be
reported as conformities.
Identify nonconformities in terms of specific requirements
of the standard or other related documents against which
the audit was conducted.
Identify aspects of the system which may require further
auditing.
Complete an audit report.
Contribute to the audit reporting meeting.
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Quality Systems Auditing – Audit Planning
Audit Phases:
# Initiation - Determinations of audit objective scope, & criteria
- Establishing the Audit Team
- Preliminary Meeting
# Preparation - Planning Audit Activities
- Assignments to Audit Team
- Preparation of Checklists etc.
# Execution - Opening Meeting
- Conducting the Audit
# Reporting - Presentation of Audit Findings
- Closing Meeting
- Agreeing Corrective Actions and Time-scales
# Follow-up - Verification of Effectiveness of Corrective Action

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Quality Systems Auditing

Audit Objectives :

Examples are
a) Determining the extent of conformity of the auditee’s
management system, or parts of it, with audit criteria

b) Evaluating the capability of the management system

to ensure compliance with laws, regulations and
contractual requirements

c) Evaluating the effectiveness of the management

system in meeting specified objectives

d) Identifying areas of potential improvement of the

management system
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Quality Systems Auditing – Audit Planning

Audit Program:

An audit program shall be planned taking into

consideration the status and importance of the process
and areas to be audited as well as the results of
previous audits. The audit criteria, scope, frequency
and methods shall be defined.

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Quality Systems Auditing

Audit Scope:
The audit scope describes the extent and boundaries of the
audit in terms of factors such as physical locations,
organizational units, activities and processes to be audited
and, where relevant, the time period covered by the audit.

Audit Criteria:
The audit criteria can include applicable policies, procedures,
standards, including those relating to laws and regulations,
management system requirements, contract requirements,
industry/business sector codes of conduct, or environment
guidelines.
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Quality Systems Auditing

Audit Life Cycle:

The Audit Life Cycle is often referred to as P.E.R.C

Planning

Execution

Recording

Close out

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Quality Systems Auditing – Planning
Planning the Audit:
Appoint a Team Leader
Understand the Business
Understand the Objective
Agree the Scope
Determine the Processes
Determine the Interaction of Processes
Select a Team
Contact the Auditee – Agree the Dates
Make a Audit Program
Brief the Team
Prepare Checklist

Exercise- To prepare a Audit Plan & Audit Checklist

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Quality Systems Auditing – Audit Execution

Opening Meeting

The Audit Process

a) Gather Information
b) Verify against audit evidence
c) Compare evidence against audit criteria
d) Evaluate findings ( Audit conclusions)

Closing Meeting

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