ISO 9000: 2008 Series

Awareness & Internal

Auditor Certification
Course
Prepared & Instructed by

Mohamed Ghorab
June 2010

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)

Mohamed Ghorab, June 2010 1

 Basics

Switch mobile phones to the silent mode.

Toilets.

Break.

Material provided.

A written Work Shop

Is THE Global Group

Established in 1878 - Head Office in Geneva,

Switzerland.

42’000 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.

Mohamed Ghorab, June 2010 2

 We provide leading & innovative services to all
industries

Certification

Inspection & Verification

Outsourcing
In the areas of:
Risk Management

Technical Consulting

Testing & Analysis

Trainings ®:
ISO 9000: 2000 Series
Awareness & Internal
Auditor Certification Course
5

Course Objectives:

Understand and apply the process approach to auditing.

Understand the structure and content of ISO 9001: 2008 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.

Mohamed Ghorab, June 2010 3

 Goal of ISO 9001: 2008

The goal of this Standard 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.

Course Outline:

Session 1
Introduction to ISO 9000: 2008

family of standards Day 1
Session 2
ISO 9001: 2008 overview & Clause 4

Session 3
ISO 9001: 2008: Clause 5, 6

Day 2
Session 4
ISO 9001: 2008: Clause 7, 8

Session 5
Internal Auditor Qualification

Day 3

Mohamed Ghorab, June 2010 4

 Session 1:

Introduction to ISO 9000: 2008

Family of standards

Introduction to the ISO 9000 series of

Standards

The benefits of a quality management system

ISO 9000 family of Standards

The process approach

The quality management principles

10

Mohamed Ghorab, June 2010 5

 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

ISO 9001: 2008 2008

11

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
12

Mohamed Ghorab, June 2010 6

 ISO 9000:2005

Replaces ISO 8402

Comprises:

2.0 Fundamentals of quality management systems

3.0 Terms and definitions

13

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

14

Mohamed Ghorab, June 2010 7

 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

15

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

16

Mohamed Ghorab, June 2010 8

 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

17

Compatibility with other Standards

IS0 14001 - Environmental management

systems - specification with
guidance for use

OHSAS 18001 Occupational health and safety

management systems -
specification

18

Mohamed Ghorab, June 2010 9

 ISO 19011

Guidelines for quality and/or environmental

management systems auditing

contains information on:

Terms and definitions

Principles of auditing

Managing an audit programme

Audit activities

Competence and evaluation of auditors

19

Identification of processes

ISO 9001: 2008 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.

20

Mohamed Ghorab, June 2010 10

 Process

Any Activity or set of activities that

uses resources to transform inputs
to outputs

21

A process

A process has a start and an end defined by

two limits.
INPUT OUTPUT
Customer who Customer who
has a need has a need met

And a chain of activities between these two

limits
Step Step Step Output
Input
1 2 “N”
22

Mohamed Ghorab, June 2010 11

 Plan-Do-Check-Act cycle & continual improvement

Establish objectives
Take actions to continually necessary to deliver
improve process performance – results in accordance
effectiveness and efficiency with customer
Act Plan requirements
• What to do
• How to improve • How to do it
and the organisation's
next time? policies

Check Do
• Do what was
• Did things happen planned
according to plan?
Monitor and measure Implement the
processes and product processes
against policies, objectives
and requirements

23

Process approach

Continual improvement of the

quality management system

Management
Management
responsibility
responsibility

Customers Customers

Requirements Measurement
Measurement Satisfaction
Resource
Resource analysis
management analysisand
and
management improvement
improvement

Input Output
Product
Product Product
realisation
realisation

24

Mohamed Ghorab, June 2010 12

 Process Approach

6 4 8

25

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

26

Mohamed Ghorab, June 2010 13

 8 Quality Management Principles

Customer Focus (1, 5.1, 5.2, 5.6.2, 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)

27

Process Improvement
(Shewart Cycle)

Plan
• What and why?
Act Plan

Do
• How, when, and how much? Check Do

Check
• How will you know it worked?

Act
• How do you plan to fully adopt?

28

Mohamed Ghorab, June 2010 14

 The Dilbert Cycle

Blame someone
else for Make wild guess
catastrophe at what is wrong

ACT

Adopt unproven
process or
technology

29

Plan-Do-Check-Act diagram

Requirement
Requirement

Yes
Product /
Plan
Plan Do Check Conforms?
Service

No
Corrective Feedback
Action Loop

Continual Improvement

30

Mohamed Ghorab, June 2010 15

 Audit Tool: Turtle Diagram
With Who?
With What? Competence criteria (6.2.1)
Plant and machinery (6.3) Induction/ training records (6.2.2)
Process equipment (6.3) Agency/ Contract labour (6.2.2)
Measuring equipment (7.6) Job responsibilities/ authorities (5.5)
Tooling (7.5.1) Training effectiveness (6.2.2)
Maintenance (7.5.1) SPC awareness (8.1.2)
Packaging/labeling (7.5.5) Personnel safety (6.4.1)
Customer property (7.5.4) Awareness of policy/ objectives (6.2.2)
Transportation (6.3)

Inputs Process: Outputs

Customer schedule (7.5.1) Conforming product

Raw materials (7.4) delivered to customer
Manufacturing schedule (8.2.1)

Process (7.5)

How?
Control plans (7.5.1) What Results?
Work instructions (7.5.1) Analysis of data (8.4.1)
(Support Processes) Customer satisfaction (8.2.1)
Preventive maintenance (7.5.1)
IT Other Organizational objectives (5.4.1)
SPC (8.1.1)
Human resource Maintenance objectives (7.5.1)
Nonconforming product procedure (8.3)
Logistics Cost of poor quality (5.6.1)
Dispatch process (7.5.1)
Sales Process capability (8.2.3)
Contingency plan (6.3.2)
Quality Management review (5.6.1)
Document control/ records (4.2.3/4)
Preventive maintenance Continual improvement results (8.5) 31
Audit records (8.2.2)

Session 2:

ISO 9001: 2008 Overview

32

Mohamed Ghorab, June 2010 16

 ISO 9001:2008 overview

The structure of ISO 9001:2008

Scope and application of ISO 9001:2008

ISO 9001:2000 Clause 4:

Quality management system

• General requirements

• Documentation requirements

33

The structure of ISO 9001:2008

Comprises 8 clauses:

Scope

Normative reference

Terms and definitions

Quality management system

Management responsibility

Resource management

Product realization

Measure, analysis and improvement
34

Mohamed Ghorab, June 2010 17

 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

35

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
36

Mohamed Ghorab, June 2010 18

 ISO 9001; clause 4

4
Quality Management System

4.1 4.2
General requirements Documentation requirements

4.2.1 4.2.2 4.2.3 4.2.4

General Quality Manual Control of documents Records

37

The End of Day 1

Mohamed Ghorab
Mohamed.ghorab@sgs.com
38

Mohamed Ghorab, June 2010 19

 Session 3:

ISO 9001: 2008: Clause 5, 6

39

ISO 9001:2008 clause 5, Management responsibility

Management commitment

Customer focus

Quality Policy

Planning

Responsibility, authority and communication

Management review

40

Mohamed Ghorab, June 2010 20

 ISO 9001; clause 5 (1)

5
Management responsibility

5.1
Management commitment

5.2
Customer focus

5.3
Quality policy

41

ISO 9001; clause 5 (2)

5
Management responsibility

5.5
5.4 5.6
Responsibility, authority
Planning Management review
and communication

5.5.1 5.6.1
5.4.1 Responsibility and General
Quality objectives authority

5.5.2 5.6.2
Management Review input
5.4.2 representative
Quality management
system planning 5.6.3
5.5.3 Review output
Internal communication

42

Mohamed Ghorab, June 2010 21

 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.
43

ISO 9001:2008 clause 6, Resource management

Provision of resources

Human resources

Infrastructure

Work environment

44

Mohamed Ghorab, June 2010 22

 ISO 9001; clause 6

6
Resource management

6.1 6.2
6.3
Provision of Human
Infrastructure
resources resources

6.2.2
6.2.1
Competence, awareness
General
and training

45

Session 4:

ISO 9001: 2008: Clause 7, 8

46

Mohamed Ghorab, June 2010 23

 ISO 9001:2008 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

47

ISO 9001; clause 7 (1)

7
Product realization

7.1 7.2
Planning of Customer–related
Product realization processes

7.2.1 7.2.2 7.2.3

Determination of requirements Review of requirements Customer
related to the product related to the product communication

48

Mohamed Ghorab, June 2010 24

 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

49

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

50

Mohamed Ghorab, June 2010 25

 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

51

ISO 9001:2008 clause 8

Measurement, analysis and improvement

General

Monitoring and measurement

Control on nonconforming product

Analysis of data

Continual improvement

52

Mohamed Ghorab, June 2010 26

 ISO 9001; clause 8 (1)

8.1 General

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

53

ISO 9001; clause 8 (2)

8.3 Control of nonconforming product

8.4 Analysis of data

8.5 Improvement

8.5.1
Continual improvement

8.5.2
Corrective action

8.5.3
Preventive action

54

Mohamed Ghorab, June 2010 27

 The End of Day 2

Mohamed Ghorab
Mohamed.ghorab@sgs.com
55

Session 5:

Internal Auditor Qualification

56

Mohamed Ghorab, June 2010 28

 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.

57

Auditor Competence defined in ISO 19011

Quality Environment
Generic
system Knowledge System
knowledge knowledge

Education Work Experience Auditor training Audit Experience

Personnel attributes

58

Mohamed Ghorab, June 2010 29

 Current techniques

What is your organizations current

process for qualifying internal
auditors?

How is competence maintained?

59

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
60

Mohamed Ghorab, June 2010 30

 Auditor Qualification Criteria

Education

Training in ISO 9001: 2008

Work Experience

Quality management experience

Demonstrated ability to apply knowledge and
skills

61

Audits parties’ levels

Accreditation Body 4th p

Certification Body

S O
C
U 3rd p 3rd p R U
G 3rd p
P A S
N
P I
T
L
Z U
A
I T M
I
E O E
R 1st p N 1st p R 1st p

2nd p
2nd p 2nd p 62

Mohamed Ghorab, June 2010 31

 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.
63

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.

64

Mohamed Ghorab, June 2010 32

 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: 2008

65

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?
66

Mohamed Ghorab, June 2010 33

 ISO 9000: 2008 definitions

Conformity:
Fulfillment of requirement

Nonconformity:
Non fulfillment of a requirement

67

Reporting Findings

Evidence gathered should be evaluated against

requirements defined in ISO 9001: 2008,
customer requirements, and organizations
management system

Confirm decisions:
(Conformity, Non conformity or Observation)

Where found, prepare written nonconformities /
Observation.

68

Mohamed Ghorab, June 2010 34

 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

69

The End of Day 3 & the Course

THANKS

Mohamed Ghorab
Mohamed.ghorab@sgs.com
70

Mohamed Ghorab, June 2010 35