INTRODUCTION

TO ISO 9001:2015
CISQ MANAGEMENT SERVICES
10 MARCH 2020
Objectives
 Understand and explain the purpose and benefits of
quality management system.
 Understand the operation of a quality management
system and its principal processes
Content
 Introduction to ISO 9001:2015

 Quality Management System Principles

 Risk Based Thinking

 Quality Objectives and Actions to achieved Quality Objectives

 Documented Information

 Operation – Planning & Control

 Continual Improvement
 Introduction to ISO 9001:2015

 ISO 9001:2015 is an international quality

management system standard use world wide.
 ISO 9001:2015 defines a set of quality management
requirements for a system that determines that a
company is able to provide international-quality
products and services consistently.
 Purpose of ISO 9001:2015

 The purpose of this standard is to help

organizations to provide products and services that
meet all relevant customer needs and expectations
and comply with all relevant regulatory and
statutory requirements
 Through the implementation of the standard, ISO
9001:2015 aims to improve customer experience
and satisfaction.

 This standard also aims to improve the internal system of a company so that it
is able to produce quality services and products while promoting a culture
that is aimed towards growth and continuous improvement.
 ISO 9001:2015 Background

 ISO 9001 was first published in 1987, and has

consistently been ISO’s most popular series of
standards.
 The standard first updated in 1994, and again in 2000
and 2008. This current version was published in
September of 2015 and is the fifth edition of the ISO
9001 standard. It cancels and replaces all previous
editions.
 Major and Minor Changes in
ISO 9001

MAJOR MINOR
CHANGE CHANGE

Inspection Based ISO 9001:1987 ISO 9001:1994

Process Based ISO 9001:2000

ISO 9001:2008

Risk Based ISO 9001:2015 ISO 9001:20??

 Quality Management System
 ISO 9001:2015 is a Quality Management System
Standard (QMS).
 A Quality Management System (QMS) is a set of
interrelated or interacting elements (PDCA
Cycle) that organizations use to formulate quality
policies and quality objectives and to establish
the processes that are needed to ensure that
these policies are followed and these objectives
are achieved.
 PDCA Cycle
PDCA (plan–do–check–act or plan–do–
check–adjust) is an iterative four-step
management method used in ISO 9001
for the control and continuous
improvement of processes and
products.
It is also known as the Deming
circle/cycle/ wheel, the Shewhart cycle,
the control circle/cycle, or plan–do-
study–,act (PDSA).
 PDCA Cycle in QMS
Quality Management System (4)
ORGANIZATION &
ITS CONTEXT (4)
SUPPORT &
OPERATION
(7,8) CUSTOMER
PLAN DO SATISFACTION

CUSTOMER PERFORMANCE RESULTS OF

REQUIREMENTS PLANNING LEADERSHIP
(6) EVALUATION (9) QMS
(5)

ACT CHECK
PRODUCTS
NEEDS & & SERVICES
EXPECTATIONS
OF RELEVANT IMPROVEMENT
INTERESTED (10)
PARTIES (4)
PDCA Cycle (Cont.)

The PDCA cycle can be briefly described as follows:

 Plan: establish the objectives of the system and its processes, and the resources
needed to deliver results in accordance with customers’ requirements and the
organization’s policies, and identify and address risks and opportunities;
 Do: implement what was planned;
 Check: monitor and (where applicable) measure processes and the resulting
products and services against policies, objectives, requirements and planned
activities, and report the results;
 Act: take actions to improve performance, as necessary.
Benefits of ISO 9001
ISO Quality Management System Standards
ISO has two kinds of quality management standards:
requirements and guidelines.
ISO 9001:2015 - Quality
Management System
Requirements. The
requirements are the
formal expectations that
must be met if we wish to
be officially certified or
registered. They are
compulsory.
ISO Quality Management System Standards (Cont.)

 ISO 9000:2015 – QMS

Fundamentals and vocabulary,
ISO 9004:2009 – QM Quality on
an Organization, Guidance to
achieve sustained success and
ISO 19011:2018 – Guidelines for
Auditing Management
These Guidelines are suggestions
and recommendations only.
They are voluntary.
Quality Management
Principles
Definition

 “ Quality Management Principles (QMP) ” are a set of fundamental

beliefs, norms, rules and values that are accepted as true and can be
used as a basis for quality management.
 The QMPs can be used as a foundation to guide an organization’s
performance improvement.
 The QMPs were developed and updated by international experts of
ISO/TC 176, which is responsible for developing and maintaining
ISO’s quality management standards.
Quality Management Principles
 QMP1. Customer Focus – The primary focus of Quality
management is to meet customer requirements and to strive to
exceed customer expectation.
 QMP2. Leadership – Leaders at all levels establish unity of
purpose and direction and create conditions in which people are
engaged in achieving the quality objectives of the organization.
 QMP3. Engagement of People – It is essential for the
organization that all people are competent, empowered and
engaged in delivering value.
Quality Management Principles
(Cont.)
 QMP4. Process Approach – Consistent and predictable results
are achieved more effectively and efficiently when activities
are understood and managed as interrelated processes that
function as coherent system.
 QMP5. Improvement – Successful organizations have an
ongoing focus on improvement.
 QMP6. Evidence based Decision Making – Decision based on
the analysis and evaluation of data and information are more
likely to produce desired result.
Quality Management Principles
(Cont.)

 QMP7. Relationship Management – For sustained success, organizations

manage their relationships with interested parties, such as suppliers.
Thank You