ISO 9001 Internal Auditor Course - Part 1.pdf

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ISO 9001:2015
Interpretation and Internal
Auditor Training
All Rights Reserved.
No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic,
mechanical, photocopying, recording or otherwise, without prior permission.

Trainer
Carlos Roberto Coutinho, Industrial Mechanical Engineer, graduated at University São Francisco
(Brazil), Certified ISO 9001:2015 Lead Auditor and Implementer by PECB – Canada and Iternal Auditor
IATF 16949, ISO 14001, ISO 45001 and ISO IEC 17025. 29 years of experience, 18 in quality
management. Industrial Engineering – Mechanics. Leadership and teamwork spirit. result oriented with
global business view. Successfully implemented several world class quality and management
methodologies to address the high level of performance in international companies. Achievements
recorded with direct impact on customer satisfaction and bottom line result. Knowledge and experience
on ISO 9001, IATF 16949, ISO 14001, Lean, Theory of Constraints and WCM and BIQS. Highly
experienced in industrial and people management (headed teams up to 60 people. Quality responsible
for supplier, manufacturing, customer and after sales services. Worked with OEM’s like Coca-Cola,
AMBEV, VW, GM, Ford, Renault, PSA, Toyota, etc. More than 6 thousands hours experience with
industrial and business consultancy. Expert in core tools and methodologies like BIQS, APQP, PPAP,
FMEA, MSA, SPC. Fluency in English and Spanish. Basic French.
“Hi! I am
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SantaISO friend!”

Consider that we are just going to a place
30 miles away from where we are. In this
context which of those cars would you
consider with best quality for this trip?
BMW
Beetle
What is Quality for you?

What is Quality in this case?
It dependes on the customer specifications!
• How long do we want to get there?
• What are the road conditions?
• How many people will travel?
The product or service quality level is the
one adequate to the intended use!

What is Quality?
Definition from ISO 9000, clause 3.1.1 and 3.1.2.

Then!?
Quality happens when our customers are
satisfied and show up again...
But where is
ISO from?

ISO EVOLUTION
London, 1946
Genéve, 1949
1951
1952
London, 1955
1960, “Units” standard

ISO EVOLUTION
London, 1968
1971, Environmental Committee
1975, more adhesions
1987, 9000 Family
1995, first website
1996, ISO 14001

ISO EVOLUTION
2010, ISO 26001
2011, ISO 50001
2018, ISO 45001
2005, ISO 27001

Basic Principles – ISO Standards
1. Equal representation: 1 vote per country
2. Voluntary membership: ISO does not have the authority to force
adoption of its standards
3. Business orientation: ISO only develops standards for which a
market demand exists
4. Consensus approach: looking for a large consensus among the
different stakeholders
5. International cooperation: over 160 member countries plus liaison
bodies
Basic
principles of
ISO
standards

Management System Standards
ISO 9001
Quality
ISO 14001
Environment
OHSAS 18001
Health and Safety
at work
ISO 20000
IT Service
ISO 22000
Food Safety
ISO 22301
Business
continuity
ISO 27001
Information
security
ISO 28000
Supply Chain
Security

Definition of QMS
ISO 9000, clause 2.11

Integrated Management System
Common structure of ISO standards

History of the ISO 9001 Series
Important dates
1979
1981
1994
2008
2014
ISO 9001
amended
ISO/DIS
9001 Major
revision and
new
requirements
. Annex SL
introduced.
ISO starts
work on
ISO 9001
ISO 9000
series
published
BS 5750
published
ISO 9000
amended
ISO 9000
series
published
moving from a
quality
inspection
based
standard to a
management
system
standard.
1987
2000
2015
Publication of
ISO
9001:2015
2009
ISO 9004
encourages
business
sustainability

ISO 9004: Guidelines for performance
improvements

Link between ISO 9001 and ISO 9004

ISO 9001 Benefits
Top 5 Reasons

Structure of the ISO 9001 Standard

Content of the ISO 9001
Foreword
Introduction
1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement
Annex A
Annex B
Bibliography

Important
Principles and
Concepts

Shall, Should, May, Can
ISO 9001:2015, clause 0.1:

Seven ISO Management Principles
ISO 9001:2015, clause 0.2:
Customer focus
Relationship
management
Process Approach
Engagement and competence
of people
Leadership
Improvement
Informed decision
making

Process Approach
ISO 9001:2015, Figure 1.

Plan-Do-Check-Act cycle (PDCA)

Risk-Based Thinking
ISO 9001:2015, clause 0.3.3:

Risk-Based Thinking
ISO 9001:2015, clause 0.1:
“Risk-based thinking enables an organization to determine
the factors that could cause its processes and its quality
management system to deviate from the planned results, to
put in place preventive controls to minimize negative effects
and to make maximum use of opportunities as they arise”.
We will see
that in more
detail in the
Section 6

ISO 9001:2015 Requirements
What is the
standard
for?

Aids for a
better
understanding

4. Context of the
Organization

4. Context of the organization

ISO 9001
does not offer
a practical
approach for
that.

But I will give
you a
practical
advice.
SWOT ANALYSIS

Tip!
A table can be used indicating who and how monitors
each of the interested party in the organization.

QMS Scope Definition

Boundary of the QMS
Tree
Dimensions
to consider...

Defining the Organizational Boundaries of the Scope:

Define Physical Scope and Boundaries :

Change in Scope:

How does
the system
interact?

That’s really
important!

Example of Process Mapping
Define all
necessary
processes and
indicate their
interactions.

Examples of process approach tools: Turtle and SIPOC Diagrams
Turtle Diagram

A great deal of
responsibilities!
NOTE: Reference to
“business” in this
International Standard
can be interpreted broadly
to mean those
activities that are core to
the purposes of the
organization’s existence,
whether the organization
is public, private,
for profit or not for profit.

In short:

Keep in mind:
quality is made for
the customer!

Definition of Quality Policy – ISO 9000, clause 3.2.4

Types of Policies

Policy Example
Take a look at
that example...

5.3. Organizational roles, responsibilities and authorities

Tools to represent roles, responsibilities and authorities
Organizational
chart is a good
tool to represent
responsibilities
and authorities...

Responsibility
Matrix is a good
tool to represent
responsibilities and
assignments...

Job description and
procedures may
also be used to
define roles,
responsibilities and
authorities...

ISO 31000: the Generic Framework on Risk Management

Risk Management Process

Selecting an Approach to Risk Assessment – ISO 31010

Quantitative vs Qualitative – Advantages and Disadvantages

Residual Risk Acceptance

6.2 Quality Objectives

Performance Indicators - Examples

Change Management

ISO 9001, Section 7

ISO 9001, clause 7.1 – Resources / 7.1.1 General

ISO 9001, clause 7.1 - Resources

ISO 9001, clause 7.1.2 - People

ISO 9001, clause 7.1.3 - Infrastructure

Contingency actions
Contingency
actions is a good
practice to keep
infrastrucuture
continuity!

ISO 9001, clause 7.1.4 – Environment for the operation of processes

Personnel safety

Cleanliness of premises

5S: Sort – Set – Shine – Standardize - Sustain

ISO 9001, clause 7.1.5

ISO 9001, clause 7.1.6

ISO 9001, clause 7.2 & 7.3
NOTE Applicable
actions can include,
for example, the
provision of training
to, the mentoring of,
or the reassignment
of currently
employed persons;
or the hiring or
contracting of
competent persons.

ISO 9000, clause 3.1.6 & ISO 10015, clause 3.2

Training, Awareness and Communication

Defining Training Needs - ISO 10015, clause 4.2
Other needs
Competence-
related needs
Other needs
Training
needs
Need for
improvement
Analysis of
organization’s needs
Training

Assessment of the required Skills
Document specified training needs by function

Designing and Planning Training

Training Program
Types of program and their objectives

Awareness Program

Awareness Program
Main areas:

Providing the Training

Evaluating the Outcome of Training

Principles of a Efficient Communication Strategy

Quality Communication Process

Performing a Communication Activity

7.5 Documented information
7.5.1 General

7.5.2 Creating and updating

7.5.3 Control of documented information

Summary

QMS Documentation
Types of documents

Value of Documentation
Important notes

Creation of Templates
Hi! I’m back! This
are some types
of documents
you can use in
QMS.

Documentation Management

Implementing a Document Management System

Control of Records

Registration of Records
Examples

Master List of Documents

Document Management
Most Common Issues

8 Operation
8.1 Operational planning and control

As the general framework
of the QMS has been
defined it is up to the
organization now to plan
its operational processes!

8.2 Requirements for products and services

8.2.1 Customer communication

8.2.2 Determining the requirements for products and services
it is normally up to
the commercial team
to work on it prior to
any commercial
offer..

8.2.3 Review of the requirements for products and services
it is normally up to
the commercial team
to work on it prior to
any commercial
offer...

8.2 Requirements for products and services
House of Quality is a
diagram, resembling a
house, used for defining
the relationship between
customer desires and the
firm/product capabilities

8.2.4 Changes to requirements for products and services

8.3 Design and development of products and services

8.3.1 General
The organization shall establish, implement
and maintain a design and development
process that is appropriate to ensure the
subsequent provision of products and
services.
This is a crucial moment
where the organization will
formally define the project
of its product or service,
with its requirements and
specifications.

8.3.2 Design and development planning

8.3.3 Design and development inputs / 8.3.5 Design and development outputs

8.3.4 Design and development controls

Verification

Validation

8.3.6 Design and development changes

8.4 Control of externally provided processes, products and services

8.4.1 General & PMBOK

8.4.2 Type and extent of control
The organization shall:
a) ensure that externally provided processes remain within the
control of its quality management system;
b) define both the controls that it intends to apply to an external
provider and those it intends to apply to the resulting output;
c) take into consideration:
1) the potential impact of the externally provided processes,
products and services on the organization’s ability to
consistently meet customer and applicable statutory and
regulatory requirements;
2) the effectiveness of the controls applied by the external
provider;
d) determine the verification, or other activities, necessary to
ensure that the externally provided
processes, products and services meet requirements.

8.4.3 Information for external providers

8.5. Production and service provision
The organization shall implement production and service provision
under controlled conditions.

8.5. Production and service provision

8.5.1 Control of production and service provision
Very important
requirements that
will influence a lot
the effectiveness
of the QMS.

8.5.2 Identification and traceability

8.5.3 Property belonging to customers or external providers

8.5.4 Preservation

8.5.5 Post-delivery activities

8.5.6 Control of changes
The control of
changes should have
the same rigor as the
initial process
planning.

8.6 Release of products and services

8.7 Control of nonconforming outputs

9.1 Monitoring, measurement, analysis and evaluation / 9.1.1 General

9.1 Monitoring, measurement, analysis and evaluation
Some definitions:

The main goal is the improvement of the QMS

Determination of measurement objectives

What minimally needs to be monitored and measured?

Performance Indicators – Examples:

How and when to monitor and measure?

Reporting results – Example of Dashboard

Operational Dashboard – Example:

Tactical Dashboard – Example:

Strategic Dashboard – Example:

9.2 Internal audit
We will see more
on how to plan
and conduct an
internal audit a
little later.

9.2 Internal audit
We will see
how to do that
according to
ISO 19011
guidance.

9.3 Management review
9.3.1 General

9.3.2 Management review inputs / 9.3.3 Management review outputs

10. Improvement
10.1 General
The organization shall determine and select opportunities for improvement
and implement any necessary actions to meet customer requirements and
enhance customer satisfaction.
These shall include:
a) improving products and services to meet requirements as well as to
address future needs and expectations;
b) correcting, preventing or reducing undesired effects;
c) improving the performance and effectiveness of the quality management
system.
NOTE Examples of improvement can include correction, corrective action, continual
improvement, breakthrough change, innovation and re-organization.

10. Improvement

ISO 9000 - Definitions

Define a Process to Resolve Problem and Nonconformities:
Example of the Eight Disciplines Problem Solving method

Root-cause Analysis Tool:
Cause-and-effect-diagrams

Asking the Right Questions:
Needed for the analysis of any problem

Corrective Action Procedure

Actions to prevent occurrence

Drafting Action Plans

Action Plans - Examples

ISO 9001 Internal Auditor Course - Part 1.pdf

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