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Module 8

Introduction to ISO 19011

Audit definitions
Types of audits
Auditor qualifications
Audit stages
Audit Planning
Audit Reporting

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Audit

Systematic, independent and documented process

for obtaining audit evidence and evaluating it
objectively to determine the extent to which agreed
criteria are fulfilled.

ISO 9000:2005

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Audit

A SYSTEMATIC investigation of the INTENT,

IMPLEMENTATION and EFFECTIVENESS of
SELECTED parts of the quality management
system of an organization, process or department.

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Audit

A FORMAL activity to INDEPENDENTLY examine

OBJECTIVE EVIDENCE and verify compliance or
otherwise with SPECIFIED REQUIREMENTS.

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Objective Evidence

Data supporting the existence or verity of something ISO 9000:2005

May be obtained through observation, measurement, test or other means
May be stated or (preferably) documented
Can be verified

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Specified Requirements

Environmental Management System requirements

Manuals
Procedures/work instructions
Environmental Norms
Legal requirements - statutory, regulatory or industry body
Regulations of registration body

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Audit

Three aspects to be evaluated

1) INTENT extent to which the EMS, as it is intended to
operate, is appropriate to the organizations activities and
such as to ensure compliance with regulatory and customer
requirements
2) IMPLEMENTATION extent to which the EMS is
implemented in practice
3) EFFECTIVENESS extent to which EMS objectives are
attained

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Audit Types

1st Party US auditing our own system

(Internal)

2nd Party US auditing our supplier

(External)

3rd Party US being audited by a registration body (BSI)

(External)

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Reasons for 1st Party Audits

Requirement of ISO 14001:2004

Source of information for use by management
Powerful tool for continual improvement through
Employee involvement
Communication
Employee awareness, etc

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Reasons for 2nd Party Audits 0

Aids selection and grading of suppliers

Aids deployment of EMS requirements
One method of meeting ISO 14001:2004
Helps improve suppliers environmental systems
Foundation for supplier partnerships

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Reasons for 3rd Party Audits 1

May reduce need for 2nd party audits

Recognition of conformity to an international standard
Contributes to reduction in avoidable problems to environment by suppliers
Aids market competitiveness

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Audit System 2

Various roles of an auditor

A catalyst
Management instrument
An interface with
Suppliers
Customers
Colleagues
A consultant (NOT 3rd Party)

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Auditor Requirements 3

All Audits
Understand the business
Understand the processes
Understand the interaction of processes
Team player
External, complete system audits
Understand the business sector
Proficient in auditing top management (lead auditor?)
Proficient in legal requirements (or ensure the team has the
relevant knowledge)

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Auditor Attributes 4

Local Requirements
Culture
Practices
Approach

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Auditor Attributes 5

Auditors must be flexible to

Changing situations
Differing management styles
Differing management/employee levels
Auditors must be competent in
Reasoning of nonconformities
Evaluating appropriateness of proposed corrective action
Evaluating effectiveness of corrective action

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Some Attributes of a Good Auditor

Open-minded Tenacious
Diplomatic Decisive
Observant Self-reliant
Perceptive Ethical

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The Audit Life Cycle 7

The audit life cycle is often referred to as P.E.R.C.

Planning
Execution
Recording
Close out

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Preliminary Visit 8

Clarify scope and objective of audit

Gain an understanding of the business
Define process flow and interaction
Agree procedures to be used during audit
Resolve any misunderstandings
Identify any special needs, skills, protective clothing
Identify layout of company/plant
Establish the adequacy of documentation
Assess the organizations readiness for an audit
Plan the audit

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Planning the Audit 9

Appoint a team leader

Understand the business
Understand the objective
Agree the scope
Determine the processes
Determine the interaction of the processes

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Planning the Audit 0

Calculate the audit duration

Select the team
Contact the auditee - agree the date(s)
Draw up an audit programme
Brief the team
Prepare checklist

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Audit Purpose 1

To collect objective evidence to permit an informed

judgement about the status and effectiveness of the
quality management system.

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Checklist Benefits 2

Keeps audit objectives clear

Evidence of audit planning
Maintains audit pace and continuity
Reduces auditor bias
Reduces workload during audit

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Checklist Drawbacks 3

Checklists tend to lose value if they are

Tick lists
Questionnaires
Prepare them as aides-memoire

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Checklist Preparation 4

1. Understand the process

2. Interaction of process
3. Convert clauses of the standard into questions/topics
4. Using these questions and the quality manual
Plan what to look at
Plan what look for
Consider sample sizes
5. Prepare checklist

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Representative Samples 5

When planning samples, consider

The major process of the department
The other duties it undertakes
What it does when things go wrong

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Checklist Starting Point 6

Ask for an overview of the process for ...

How do these processes interrelate with other processes within the
organization?
How are processes controlled?
How are processes monitored/measured?
What evidence of continual improvement is there?

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