Module I: Introduction

Overview of the ISO 9001:2015 QMS

Module Outline
 ISO 9001 General Concepts
 The Seven (7) Quality Management
Principles
 Process Approach
 PDCA Cycle
 Risk-based thinking
 QMS Structure
ISO 9001
General
Concepts
Introduction to ISO 9001:2015 QMS
What is Quality?

 An organization focused
on quality promotes a
culture that results in the
behavior, attitude,
activities and processes
that deliver value through
fulfilling the needs and
expectations of
customers and other
interested parties.(2.2.1)
Introduction to ISO 9001:2015 QMS
What is Quality?

 Determined by the ability

to satisfy customers
and intended and
unintended impact on
relevant interested parties
 Includes not only the
intended function and
performance, but also
their perceived value
and benefit to the
customer (2.2.1)
Introduction to ISO 9001:2015 QMS
What is Quality?

If:
Quality = Conforming Characteristics
= Fulfilled Requirements

Therefore:

Quality Management System (QMS)

part of a management system with
regard to quality (3.5.4)
Introduction to ISO 9001:2015 QMS
What is Quality Management System?

 Comprises activities by
which the organization
identifies its objectives
and determines the
processes and resources
required to achieve desired
results
 Manages the interacting
processes and resources
required to provide values
and realize results for
(per ISO 9000:2015)
relevant interested parties
Introduction to ISO 9001:2015 QMS
What is Quality Management System?

 Enables top management

to optimize the use of
resources considering the
long and short term
consequences of their
decision
 Provides the means to
identify actions to address
identified and unintended
consequences in providing
(per ISO 9000:2015)
products and services
Introduction to ISO 9001:2015 QMS
What is ISO?

 An independent, non-governmental
international organization
 With membership of 163 national standards
bodies
 Formed on 23 February 1947
Introduction to ISO 9001:2015 QMS
What is ISO?

 NOT an acronym for the organization

 From the Greek word “isos” meaning equal
 Like, isobars (a line connecting points of equal
atmospheric pressure), isonomy (equality of
laws or of people before the law
Introduction to ISO 9001:2015 QMS
ISO IS NOT...

 ISO is NOT a product/ service quality label;

 ISO DOES NOT assess or audit management
systems to confirm that they conform to an
international standard;
 ISO DOES NOT issue ISO certificates;
 ISO DOES NOT approve ISO certificates.
Introduction to ISO 9001:2015 QMS
What is ISO 9001?

 ISO 9001 provides a model for

setting up a Quality
Management System.
 It’s a model that is certainly not
perfect, but one that, since
1987, has proven to be
valuable and applicable to all
types of organization.
Introduction to ISO 9001:2015 QMS
What is ISO 9001?

 QMS aims to increase an

organization’s awareness
of its duties and commitment
in fulfilling the needs and
expectations of its
customers and interested
parties, and in achieving
satisfaction with its products
and services
Introduction to ISO 9001:2015 QMS
ISO 9001 Potential Benefits

1. ABILITY to consistently provide products and

services that meet customer and applicable
statutory and regulatory requirements
2. FACILITATES opportunities to enhance
customer satisfaction
3. ADDRESSES risks and opportunities
associated with its context and objectives
4. ABILITY to demonstrate conformity to
specified QMS requirements
Introduction to ISO 9001:2015 QMS
ISO 9001 adds value

Organizations find that ISO 9001:

Improves their ability to fully understand
and meet customer requirements
consistently

Brings greater clarity to the goals and

objectives of the organization

Standardizes the way things are done,

reducing variability, and making it easier
to solve problems
Introduction to ISO 9001:2015 QMS
ISO 9001 adds value

Organizations find that ISO 9001:

Makes it easier to manage using facts
and data rather than opinions

Enhances communication throughout the

organization

Fosters continual improvement as an

institutionalized core value, and provides
a platform for moving to performance
excellence
Introduction to ISO 9001:2015 QMS
Scope of ISO 9001

 ISO 9001 specifies

requirements for a QMS where
an organization:

 Needs to demonstrate its

ability to consistently provide
product that meets customer
and applicable regulatory
requirements
 Aims to enhance customer
satisfaction through the
effective application of the
system
Introduction to ISO 9001:2015 QMS
Compatibility with other Management Systems

 ISO 9001 has been aligned with ISO 14001 for the benefit
of the user community.
 ISO 9001 does not include requirements specific to other
management systems.
 However, ISO 9001 enables an organization to align or
integrate its own QMS with related management system
requirements.
Introduction to ISO 9001:2015 QMS
ISO 9000 Family of Standards

● Contains the fundamentals and

ISO 9000: vocabulary used within the formal
2015 standards in order to ensure consistency
of interpretation

● Specifies requirements for a quality

ISO 9001: management system
2015
Introduction to ISO 9001:2015 QMS
ISO 9000 Family of Standards

● Gives guidance on a wider range of

ISO 9004: objectives of a quality management
2009 system.

● Gives guidance on quality and

ISO 19011: environmental management system
2011
auditing.
Introduction to ISO 9001:2015 QMS
Evolution of ISO 9001 Standard

● ISO 9001 standard is 2015 5th Edition

periodically reviewed
th
every 3 years 2008 4 Edition
2000 ISO 9001 3rd Edition

1994 ISO 9001, 9002, 9003 2nd Edition

1987 ISO 9001, 9002, 9003 1st Edition

1979 BS 5750 Quality Management System

After NATO – AQAPs and DEFSTAN
WWII
Introduction to ISO 9001:2015 QMS
Why are standards being revised?
● ISO’s formal review ● User inputs from:
process: ◦ A global user
◦ Requires continual questionnaire/survey
review to keep ◦ A market Justification
standards up to Study
date.
◦ Suggestions arising from
◦ Must be initiated the interpretation
within 3 years of process
publication of a
standard. ◦ Opportunities for
increased compatibility
with ISO 14001
◦ The need for greater
clarity, ease of use, and
improved translation
Introduction to ISO 9001:2015 QMS
Why are standards being revised?

● Current trends:
◦ Keeping up with recent
developments in
management system
practices.
Introduction to ISO 9001:2015 QMS
Vocabulary

QUALITY

Degree to which a set of inherent characteristics

of an object fulfills requirements (3.6.2)

REQUIREMENT

need or expectation that is stated, generally

implied or obligatory (3.6.4)
ISO 9000:2015

1-
24
Introduction to ISO 9001:2015 QMS
Vocabulary

PROCESS
Set of interrelated or interacting activities
that use inputs to deliver an intended
result (3.4.1)

NONCONFORMITY
Non-fulfillment of a requirement (3.6.9)

RISK
Effect of uncertainty(3.6.9)
ISO 9000:2015
1-
25
Introduction to ISO 9001:2015 QMS
Vocabulary
PRODUCT
Output of an organization that can be produced without
any transaction taking place between the organization
and the customer (3.7.6)
SERVICE
Output of an organization with at least one activity
necessarily performed between the organization and the
customer (3.7.7)
CUSTOMER
person or organization that could or does receive a product
or a service that is intended for or required by this
person or organization. (3.2.4)
ISO 9000:2015
1-
26
Introduction to ISO 9001:2015 QMS
Vocabulary

CUSTOMER SATISFACTION
Customer’s perception of the degree to
which expectations have been fulfilled
(3.9.2)
TOP MANAGEMENT
Person of group of people who directs and
control an organization at the highest level (of
the organization) (3.1.1)

ISO 9000:2015
1-
27
Introduction to ISO 9001:2015 QMS
Vocabulary

MANAGEMENT PROCESS
A process needed for oversight and governance
of the public sector organization in order to
comply with the applicable legislation, policies,
and standards
CORE PROCESS
A process that is needed in order to achieve the
overall mission and objectives of the public
sector organization
GQMSS
1-
28
Introduction to ISO 9001:2015 QMS
Vocabulary

OPERATIONAL PROCESS
Refers to the operational part of the core
process that allows the organization to provide
goods and services that meet the need and
expectations of the citizens

SUPPORT PROCESSES
A process needed to ensure the satisfactory
performance of the core processes
GQMSS
1-
29
Introduction to ISO 9001:2015 QMS
Vocabulary

QUALITY MANAGEMENT SYSTEM

A set of interrelated or interacting elements that
allow the organization to establish its policy and
objectives related to quality, and to achieve those
objectives (3.5.4)

ISO 9000:2015 1-
30
 The Seven
Quality
Management
Principles
“… fundamental rules for leading
and operating an organization.”
Aim: To facilitate
a successful
management 2Leadership
culture
1 Customer
Focus 3 Engagement
of People

7 Relationship
Management 4 Process
Approach
Evidence –

6 based
Decision
Making
5 Improvement
 2Leadership

1 Customer
Focus 3 Engagement
of People

7
Relationship
Management 4 Process
Approach
Evidence –

6 based
Decision
Making
5 Improvement
Introduction to ISO 9001:2015 QMS
Seven QM Principles – Customer Focus

Principle 1 – Customer Focus

 The primary focus of

quality management is to
meet customer
requirements and strive
to exceed customer
expectations.

1-
34
Introduction to ISO 9001:2015 QMS
Seven QM Principles – Customer Focus

Customer Needs / Expectations

o Conformity o Service availability
o Dependability o Competitive price
o Availability o Easy, efficient order
o Delivery returns process
o Post realization o Helpful, friendly and
activities efficient staff
o Price and life-cycle cost o Reliability
o Product safety o Good image
o Product liability o Stability and security
o Environmental impact o Transparency 1-
35
 2
Leadership

1 Customer
Focus 3 Engagement
of People

7
Relationship
Management 4 Process
Approach
Evidence –

6 based
Decision
Making
5 Improvement
Introduction to ISO 9001:2015 QMS
Seven QM Principles – Leadership

Principle 2 – Leadership
 Leaders at all levels
establish unity of
purpose and direction
of the organization and
create conditions in
which people are
engaged in achieving
the organization’s
quality objectives.
Introduction to ISO 9001:2015 QMS
Seven QM Principles – Leadership
What is a leader?
• is not the person who does
things right, but the person
who finds the right things to
do
• always give his people the
credit that is rightfully theirs
• is a person who takes a little
more than his share of the
blame and a little less than
his share of the credit
• believes in the premise that
the function of leadership is
to produce more leaders,
not more followers
 2
Leadership

1 Customer
Focus 3 Engagement
of People

7
Relationship
Management 4 Process
Approach
Evidence –

6 based
Decision
Making
5 Improvement
Introduction to ISO 9001:2015 QMS
Seven QM Principles – Engagement of People

Principle 3 – Engagement of People

 Competent,
empowered and
engaged people at all
levels throughout the
organization are
essential to enhance
the organization’s
capability to create
and deliver value.
Introduction to ISO 9001:2015 QMS
Seven QM Principles – Engagement of People

Principle 3 – Engagement of People

How to motivate employees?
• Treat them as individuals
• Acknowledge their
contributions
• Back them up
• Make time for them
• Explain why
• Let them work to their
strengths
• Praise in public, correct in
private
 2
Leadership

1 Customer
Focus 3 Engagement
of People

7
Relationship
Management
4 Process
Approach
Evidence –

6 based
Decision
Making
5 Improvement
Introduction to ISO 9001:2015 QMS
Seven QM Principles – Process Approach

Principle 4 – Process Approach

 Consistent and
predictable results
are achieved more
effectively and
efficiently when
activities are
understood and
managed as
interrelated
processes that
function as a
coherent system.
 2
Leadership

1 Customer
Focus 3 Engagement
of People

7
Relationship
Management 4 Process
Approach
Evidence –

6 based
Decision
Making
5 Improvement
Introduction to ISO 9001:2015 QMS
Seven QM Principles – Improvement

Principle 5 – Improvement
 Successful
organizations have Plan
Act
an ongoing focus on on shortcomings
what to do
how to do it

improvement
 Responding to
changes in the
internal and external
environment is Check Do
if implementation is what was planned
necessary if you want according to plan

to continue to deliver
value for your
customers.
 2
Leadership

1 Customer
Focus 3 Engagement
of People

7
Relationship
Management 4 Process
Approach
Evidence –

6 based
Decision
Making
5 Improvement
Introduction to ISO 9001:2015 QMS
Seven QM Principles – Evidence-based Decision Making
Principle 6 – Evidence-based
Decision Making
 Decisions based
on the analysis and
evaluation of data
and information are
more likely to
produce desired
results.
Introduction to ISO 9001:2015 QMS
Seven QM Principles – Evidence-based Decision Making

Principle 6 – Evidence-based
Decision Making
Fact Opinion
A fact is something An opinion is less
concrete that can be concrete. It's a view
proven. You can find facts formed in the mind of a
in records, scientific person about a particular
findings, encyclopedias, issue. In other words it is
atlases, etc. In other what someone believes
words, facts are the truth or thinks, and is not
and are accepted as necessarily the truth.
such.
 2
Leadership

1 Customer
Focus 3 Engagement
of People

7
Relationship
Management 4 Process
Approach
Evidence –

6 based
Decision
Making
5 Improvement
Introduction to ISO 9001:2015 QMS
Seven QM Principles – Relationship Management

Principle 7 – Relationship Management

 For sustained
success,
organizations
manage their
relationships with
relevant interested
parties, such as
providers
Introduction to ISO 9001:2015 QMS
Seven QM Principles – Relationship Management
Principle 7 – Relationship Management
Traditional Outsourcing
ISO 9001 Concept
Concept
• multiple sourcing strategy • Managing the supply chain
• frequent switching of • very rare switching of
suppliers supplier
• lack of long term • strong, mutual long-term
commitment commitment
• the only job expected of • work together by opening
the supplier was to meet up , talking about design
the requirements at a (departments) and supply
competitive price problems to selected
suppliers
The Process
Approach
Introduction to ISO 9001:2015 QMS
The Process Approach

 Involves systematic
definition and
management of
processes and their
interactions
 Enables control of the
interrelationships and
interdependencies
among processes in
the system
Introduction to ISO 9001:2015 QMS
The Process Approach

The use of process approach

enables:
 Understanding and consistency
in meeting requirements
 Consideration of processes in
terms of added value
 Achievement of effective
process performance
 Improvement of process based
on evaluation of data and
information
Introduction to ISO 9001:2015 QMS
The Process Approach

Schematic representation of the elements

of a single process
Starting point End point

Sources of Activities Receivers of

Inputs Outputs
Inputs Outputs

PREDECESSOR MATTER,
MATTER, SUBSEQUENT
PROCESSES ENERY,
ENERY, PROCESSES
e.g. at providers INFORMATIO
INFORMATION e.g. at customers
(internal or N
e.g. in the form (internal or
external) e.g. in the form
of product, external)
At customers, at of materials,
service, at other relevant
other relevant resources,
decisions interested parties.
interested parties. requirements

Possible controls and

check points to
monitor and measure
performance
 Plan-Do-Check-Act Cycle
Note: Numbers in brackets
Quality Management System (4) refer to the clauses in the
International Standard

Organization
and its context Support
(4) (7)
Operation
(8) Customer
satisfaction

<--------->
PLAN DO

Customer Results of the

Requirements QMS
Performance
Leadership Evaluation
Planning <---------> <--------->
(5) (9)
(6)
Products and
services
<--------->
ACT CHECK

Needs and
expectations of
relevant
interested Improve-
parties ment
(4) (10)

56
 What is Risk-based thinking
(RBT)?
ISO 9001:2015 (from ISO/TC 176/SC2)
 RBT is “something we all do automatically” and
“is already part of the process approach”.
 It has “always been in ISO 9001. This new
version of the standard makes risk more explicit
and “builds it into the whole management
system”.
 RBT ensures that risk is considered in full cycle
of the process approach. It brings preventive
action as an inherent part of the strategic and
operational planning.
 RISK-BASED THINKING

Essential for achieving an effective

QMS

Plan and implement actions to

address risks and opportunities

59
RISK-BASED THINKING
Addressing risks and
opportunities
establishes a basis for
increasing the
effectiveness of the
QMS, achieving
improved results and
preventing negative
effects
 RISKS AND OPPORTUNITIES

Risk is the effect of

uncertainty and any
Prevent the negative
such uncertainty can
effects of risk.
have positive or
negative effects.

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61
 RISK-BASED THINKING
Opportunities can arise as a result of a
situation favorable to achieving the
intended results:

Attract new customers/clients

Develop new products and

services

Reduce waste

Improve productivity
62
 QMS
STRUCTURE
Introduction to ISO 9001:2015 QMS
QMS Structure

Frequently-used Verbs in the ISO 9001:2015

SHALL SHOULD MAY

Requirement Recommendation Permission

CAN NOTE
Possibility or For guidance and
capability clarification
 Major Clauses of ISO 9001:2015
4 5 6 7 8 9 10
Improvement
Context of the Leadership Planning Support Operation Performance
Organization Evaluation

Actions to Resources Operation planning & Monitoring, General

Understanding Leadership & control (8.1)
address risks (7.1) measurement (10.1)
the Organization Commitment
and & evaluation
and its context ( 5.1)
opportunities (9.1)
(4.1) Requirements for
(6.1)
Competence products & services
Policy (5.2) 7.2) (8.2)
Non
Understanding Internal
Quality conformity &
the needs and Audit(9.2)
Objectives Design & development corrective
expectations of Awareness of products and
Organization and planning action (10.2)
interested (7.3) services(8.3)
parties (4.2) al roles, to achieve
them (6.2) Management
responsibilitie
Review (9.3)
s and Continual
Control of externally
authority Communica- Improvement
Determining the provided processes,
(5.3) tion (7.4) (10.2)
scope of the products & services
QMS (4.3) Planning of (8.4)
changes (6.3)
Documented
Information Production & service provision (8.5)
QMS and its (7.5)
processes (4.4)
Release of Products & services (8.6)

Control of non conforming outputs (8.7)

Introduction to ISO 9001:2015 QMS
QMS Structure

Introduction 0.1 General

0.2 QM Principles
0.3 Process Approach
0.3.1 General
0.3.2 PDCA Cycle
0.3.3 Risk-based thinking
0.4 Relationship with other
Management System Standards

1 Scope

2 Normative Reference

3 Terms and Definitions

Introduction to ISO 9001:2015 QMS
QMS Structure

4 Context of the
Organization
4.1 Understanding the
Organization and its
context
4.2 Understanding the
needs and
expectations of
interested parties
4.3 Determining the
scope of the QMS
4.4 QMS and its
processes

5 Leadership 5.1 Leadership and

Commitment
5.2 Policy
5.3 Organizational roles,
responsibilities and
authorities
Introduction to ISO 9001:2015 QMS
QMS Structure

6 Planning 6.1 Actions to address

risks and
opportunities
6.2 Quality Objectives
and planning to
achieve them
6.3 Planning of Changes

7 Support 7.1 Resources

7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented
Information
Introduction to ISO 9001:2015 QMS
QMS Structure

8 Operation 8.1 Operational planning and

control
8.2 Requirements for products and
services
8.3 Design and development of
products and services
8.4 Control of externally provided
processes, products and
services
8.5 Production and service
provision
8.6 Release of products and
services
8.7 Control of nonconforming
outputs
Introduction to ISO 9001:2015 QMS
QMS Structure

9 Performance
Evaluation
9.1 Monitoring,
measurement,
analysis and
evaluation
9.2 Internal Audit
9.3 Management Review

10 Improvement 10.1 General

10.2 Nonconformity and
corrective action
 - END -
Module I: Introduction
Overview of the ISO
9001:2015 QMS