ISO 9000: 2000 Series

Awareness & Internal

Auditor Certification
Course
Instructor
Mohamed Ghorab
November 2008
2
Audience Acquaintance / Ice Breaker:

Introduce yourself

What Company do you work for?

Any previous Quality Management or
auditing experience?

Define a process in your company which has
a direct impact on the customer (External)


3
Basics
Switch mobile phones to the silent mode.

Toilets.

Break.

Material provided.

A written open book final exam
4
Is THE Global Group
Established in 1878 - Head Office in Geneva,
Switzerland.

42000 employees -1000 Offices and 320 Laboratories
in more than 120 Countries.

SGS is recognized as the global benchmark for the
highest standards of expertise, quality and integrity.
5
We provide leading & innovative services to all
industries
Certification
Inspection & Verification
Outsourcing
Risk Management
Technical Consulting
Testing & Analysis
Trainings

:

In the areas of:
ISO 9000: 2000 Series
Awareness & Internal
Auditor Certification Course
6
Course Objectives:
Understand and apply the process approach to auditing.
Understand the structure and content of ISO 9001: 2000 and
the support documents.

Who should attend?

A person who has the competence to conduct an audit.
Demonstrated personnel attributes and demonstrated ability
to apply knowledge and skills.
7
Goal of ISO 9001: 2000
The goal of this Technical Specification
is the development of a quality
management system that provides for:

Continual improvement
Emphasizing defect prevention and
The reduction of variation and waste in
the supply chain.
8
Course Outline:
Introduction to ISO 9000: 2000
family of standards
ISO 9001: 2000 overview & Clause 4

ISO 9001: 2000: Clause 5, 6
ISO 9001: 2000: Clause 7, 8

Internal Auditor Qualification
Day 1
Day 2
Day 3
Session 1
Session 3
Session 4
Session 5
Session 2
9
Session 1:

Introduction to ISO 9000: 2000
Family of standards
10
The benefits of a quality management system
ISO 9000 family of Standards
The process approach
The quality management principles

Introduction to the ISO 9000 series of
Standards
11
Evolution of QMS Standards

MIL - Q - 9858 USA ~ 1958
BS 5750 Part I , II ,III UK ~ 1979
ISO 9001 , 9002 & 9003 1987
ISO 9001 , 9002 & 9003 1994
ISO 9001 : 2000 2000
12
ISO 9000 family
ISO 9000 -- Quality management systems -
Fundamentals and vocabulary

ISO 9001 - Quality management systems -
Requirements

ISO 9004 - Quality management systems -
Guidelines for performance
improvements
13
ISO 9000:2005
Replaces ISO 8402
Comprises:

2.0 Fundamentals of quality management systems

3.0 Terms and definitions
14
2.0 Fundamentals of
quality management systems
rationale for quality management systems
process approach
quality policy and quality objectives
role of top management
documentation
role of statistical techniques
15
3.0 Terms and definitions
terms having a special meaning
Written definitions

Cross references to other defined terms

Terms may be replaced by its definition in
other definitions
16
Example definition
Specification:
document (3.7.2) stating requirements (3.1.2)

or by replacing the terms in bold:

information and its support medium stating need
or expectation that is stated, generally implied or
obligatory
17
Relationship between ISO 9001 & 9004
consistent pair for use together or independently

ISO 9001 sets out requirements

ISO 9004
provides guidance for improvement
not for implementation of ISO 9001 or
certification/contractual use

18
Compatibility with other Standards
IS0 14001 - Environmental management
systems - specification with
guidance for use


OHSAS 18001 Occupational health and safety
management systems -
specification

19
ISO 19011
contains information on:
Terms and definitions
Principles of auditing
Managing an audit programme
Audit activities
Competence and evaluation of auditors
Guidelines for quality and/or environmental
management systems auditing
20
Identification of processes

ISO 9001: 2000 requires:
The organization shall identify processes needed for
the quality management system and their
application throughout the organization.
Determine the sequence and interaction of these
processes.
Measure, monitor and improve these processes.
21
Process

Any Activity or set of activities that
uses resources to transform inputs
to outputs
22
A process

A process has a start and an end defined by
two limits.


And a chain of activities between these two
limits
INPUT
Customer who
has a need
OUTPUT
Customer who
has a need met
Input
Step
1
Step
2
Step
N
Output
23
Plan-Do-Check-Act cycle & continual improvement
Act
How to improve
next time?
Take actions to continually
improve process performance
effectiveness and efficiency

Plan
What to do
How to do it
Establish objectives
necessary to deliver
results in accordance
with customer
requirements
and the organisation's
policies
Check
Did things happen
according to plan?
Monitor and measure
processes and product
against policies, objectives
and requirements
Do
Do what was
planned
Implement the
processes
24
Management
responsibility
Resource
management
Measurement
analysis and
improvement
Continual improvement of the
quality management system
Customers Customers
Product
realisation
Satisfaction Requirements
Product
Input Output
Process approach
25
Process Approach
4
8
7
6
5
26
8 Quality Management Principles

Customer Focus
Leadership
Involvement of People
Process Approach
System Approach to management
Continual Improvement
Factual Approach to decision making
Mutually beneficial supplier relationship


27
8 Quality Management Principles

Customer Focus (1, 5.1, 5.2, 5.6.1, 8.2.1, 8.3)
Leadership (5.3, 5.4.1)
Involvement of People (5.5.3, 6.2.2)
Process Approach (4.1, 5.1)
System Approach to management (4.1, 5.1, 5.4.1, 5.6.1)
Continual Improvement (Goal, 1, 5.1, 5.3, 8.5.1)
Factual Approach to decision making (5.6.1, 8.2.2, 8.4)
Mutually beneficial supplier relationship (7.4)


28
Process Improvement
(Shewart Cycle)

Plan
What and why?
Do
How, when, and how much?
Check
How will you know it worked?
Act
How do you plan to fully adopt?
Act Plan
Check
Do
29
The Dilbert Cycle
Blame someone
else for
catastrophe
Adopt unproven
process or
technology
Make wild guess
at what is wrong
ACT
30
Plan-Do-Check-Act diagram
Requirement
Plan
Corrective
Action
Do Check Conforms?
Product /
Service
Feedback
Loop
Yes
No
Continual Improvement
Requirement
Plan
31
Audit Tool: Turtle Diagram
Outputs

Conforming product
delivered to customer
schedule (8.2.1)
Inputs

Customer schedule (7.5.1)
Raw materials (7.4)
How?
Control plans (7.5.1)
Work instructions (7.5.1)
Preventive maintenance (7.5.1)
SPC (8.1.1)
Nonconforming product procedure (8.3)
Dispatch process (7.5.1)
Contingency plan (6.3.2)
Document control/ records (4.2.3/4)
What Results?
Analysis of data (8.4.1)
Customer satisfaction (8.2.1)
Other Organizational objectives (5.4.1)
Maintenance objectives (7.5.1)
Cost of poor quality (5.6.1)
Process capability (8.2.3)
Management review (5.6.1)
Continual improvement results (8.5)
Audit records (8.2.2)
With Who?
Competence criteria (6.2.1)
Induction/ training records (6.2.2)
Agency/ Contract labour (6.2.2.3)
Job responsibilities/ authorities (5.5)
Training effectiveness (6.2.2)
SPC awareness (8.1.2)
Personnel safety (6.4.1)
Awareness of policy/ objectives (6.2.2)
With What?
Plant and machinery (6.3)
Process equipment (6.3)
Measuring equipment (7.6)
Tooling (7.5.1)
Maintenance (7.5.1)
Packaging/labeling (7.5.5)
Customer property (7.5.4)
Transportation (6.3)
(Support Processes)
IT
Human resource
Logistics
Sales
Quality
Preventive maintenance
Process:


Manufacturing
Process (7.5)
32
Session 2:

ISO 9001: 2000 Overview

33
ISO 9001:2000 overview
The structure of ISO 9001:2000
Scope and application of ISO 9001:2000
ISO 9001:2000 Clause 4:
Quality management system
General requirements
Documentation requirements

34
The structure of ISO 9001:2000
Scope
Normative reference
Terms and definitions
Quality management system
Management responsibility
Resource management
Product realization
Measure, analysis and improvement
Comprises 8 clauses:

35
ISO 9001 - Scope
The requirements are:
for those who need to:
demonstrate ability to provide consistently product that
meets customer and regulatory requirements

enhance customer satisfaction and continual improvement

applicable to all organisations

generic

36
Application of the Standard
Exclusions:
may be due to:
- nature of the product
- customer requirements
- applicable regulatory requirements

limited to Section 7 only

must be justified
may not be requirements which affect the ability
or responsibility to provide product that meets
customer and regulatory requirements
37
ISO 9001; clause 4
4
Quality Management System
4.1
General requirements
4.2
Documentation requirements
4.2.4
Records
4.2.2
Quality Manual
4.2.1
General
4.2.3
Control of documents
38
The End of Day 1
Mohamed Ghorab
Mohamed.ghorab@sgs.com

39
Session 3:

ISO 9001: 2000: Clause 5, 6
40
ISO 9001:2000 clause 5, Management responsibility
Management commitment
Customer focus
Quality Policy
Planning
Responsibility, authority and communication
Management review

41
ISO 9001; clause 5 (1)
5
Management responsibility

5.1
Management commitment
5.2
Customer focus
5.3
Quality policy
42
ISO 9001; clause 5 (2)
5
Management responsibility
5.4
Planning
5.5
Responsibility, authority
and communication
5.6
Management review
5.4.1
Quality objectives
5.4.2
Quality management
system planning
5.5.1
Responsibility and
authority
5.5.2
Management
representative
5.5.3
Internal communication
5.6.1
General
5.6.2
Review input
5.6.3
Review output
43
SMART

The more the goals reflects the customers needs and
expectations, the more successful the project will be.

An effective quality planning goal has five
characteristics (SMART):
Specific.
Measurable.
Agreed upon/Achievable.
Realistic
Time-phased.

44
ISO 9001:2000 clause 6, Resource management
Provision of resources
Human resources
Infrastructure
Work environment
45
ISO 9001; clause 6
6
Resource management
6.1
Provision of
resources
6.2
Human
resources
6.2.2
Competence, awareness
and training
6.2.1
General
6.3
Infrastructure
46
Session 4:

ISO 9001: 2000: Clause 7, 8
47
ISO 9001:2000 clause 7, Product realization

Planning of product realization
Customer-related processes
Design and development
Purchasing
Production and service provision
Control of monitoring and measuring devices

48
ISO 9001; clause 7 (1)
7
Product realization
7.1
Planning of
Product realization
7.2
Customerrelated
processes
7.2.2
Review of requirements
related to the product
7.2.1
Determination of requirements
related to the product
7.2.3
Customer
communication
49
ISO 9001; clause 7 (2)
7.3 Design and development
7.3.1 Design and development planning
7.3.2 Design and development inputs
7.3.3 Design and development outputs
7.3.4 Design and development review
7.3.5 Design and development verification
7.3.6 Design and development validation
7.3.7 Design and development changes
50
ISO 9001; clause 7 (3)
7.4 Purchasing
7.4.1 Purchasing process
7.4.2 Purchasing information
7.4.3 Verification of purchased product
51
ISO 9001; clause 7 (3)
7.5 Production and service provision
7.5.1
Control of production and service provision
7.5.2
Validation of processes for production
and service provision
7.5.3 Identification and traceability
7.5.4 Customer property
7.5.5 preservation of product
7.6 Control of monitoring and measuring devices
52
ISO 9001:2000 clause 8
Measurement, analysis and improvement

General
Monitoring and measurement
Control on nonconforming product
Analysis of data
Continual improvement

53
ISO 9001; clause 8 (1)
8.2 Monitoring and measurement
8.2.1
Customer satisfaction
8.2.2
Internal audit
8.2.3
Monitoring and measurement of processes
8.2.4
Monitoring and measurement of product
8.1 General
54
ISO 9001; clause 8 (2)
8.5 Improvement
8.5.1
Continual improvement
8.5.2
Corrective action
8.5.3
Preventive action
8.3 Control of nonconforming product
8.4 Analysis of data
55
The End of Day 2
Mohamed Ghorab
Mohamed.ghorab@sgs.com

56
Session 5:

Internal Auditor Qualification
57
Internal Auditor Qualification
ISO 19011

Auditor: a person who has the competence to
conduct an audit.

Competence: Demonstrated personal attributes
and demonstrated ability to apply knowledge and
skills.
58
Auditor Competence defined in ISO 19011
Quality
system
knowledge
Personnel attributes
Environment
System
knowledge
Generic
Knowledge
Education Work Experience Auditor training Audit Experience
59
Current techniques

What is your organizations current
process for qualifying internal
auditors?

How is competence maintained?
60
Personnel Attributes
Ethical: Fair, truthful, sincere, honest, discreet
Open minded: Willing to consider other points of view
Diplomatic: Tactful in dealing with people
Observant: Actively aware of physical surroundings and
activities
Perceptive: Instinctively aware of and able to understand
situations
Versatile: Adjusts readily to different situations
Tenacious: Persistent, focused on achieving objectives
Decisive: Reaches timely conclusions based upon logical
reasoning and analysis
Self reliant: Acts and functions independently while
interacting effectively with others
61
Auditor Qualification Criteria

Education
Training in ISO 9001: 2000
Work Experience
Quality management experience
Demonstrated ability to apply knowledge and
skills

62
Audits parties levels
Accreditation Body
Certification Body
O
R
G
A
N
I
Z
A
T
I
O
N
C
U
S
T
U
M
E
R
S
U
P
P
L
I
E
R
3
rd
p
3
rd
p
3
rd
p
1
st
p
1
st
p 1
st
p
2
nd
p 2
nd
p
4
th
p
2
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p
63
Why conduct Internal Audits?

To comply with quality management system
standards!
To help facilitate continuous improvement of the
quality management system
Help in sharing best practices between
departments
Provides management information about the state
of the business
Helps focus attention on need for system
compliance.
64
Phases of an audit

Audit planning and scope
Preparation
Documentation
Checklist (your own)
Executing the audit
Opening meeting
Collecting evidence
Closing meeting
Audit report preparation / distribution
Corrective action follow up / Close out.
65
Audit Planning
The audit program shall be planned taking into
consideration:
Status and importance of the processes and areas to be
audited.
Results of previous audits.
When internal / external non conformities or customer
complaints occur, the audit frequency shall be
appropriately increased.
Cover all processes & activities (Procedures) in
accordance with an annual plan.

Prepare an audit plan to satisfy the system and
process audit requirements in 9001: 2000
66
Process Approach to auditing methodology
What are the objective(s) for the process?
How do they link to business objective?
What activities are carried out in the process?
What are the applicable support processes?
How is achievement measured?
What results are actually being achieved?
What actions are planned to ensure
achievement of defined objectives?
What improvement efforts are being made?
67
ISO 9000: 2000 definitions

Conformity:
Fulfillment of requirement

Nonconformity:
Non fulfillment of a requirement
68
Reporting Findings

Evidence gathered should be evaluated against
requirements defined in ISO 9001: 2000,
customer requirements, and organizations
management system
Confirm decisions:
(Conformity, Non conformity or Observation)
Where found, prepare written nonconformities /
Observation.
69
Corrective action follow up

Auditee is responsible for determining root
cause, and initiating corrective and preventive
action needed to address nonconformities

Auditors responsibility is to verify corrective
and preventive action is effectively
implemented within the agreed timescale
70
The End of Day 3 & the Course
Mohamed Ghorab
Mohamed.ghorab@sgs.com

THANKS