Module 1

Overview of
ISO 9001
Overview of ISO 9001/GQMSS
o ISO 9001 Concepts
o The Seven Quality Management Principles
o Major Clauses

Module Objective
• Participants will have an appreciation on the basic concepts
and structure of the ISO 9001
• Participants are able to internalize the management
principles applied to ISO-QMS
Overview of ISO 9001:2015

QMS Concepts
What do we mean by quality?

Imagine
● Yourself as your consumer

● Your choice of quality products and services

Exercise
Find a partner
1. Get 1 product from your bag or pocket: identify the
quality characteristics you like in it.
2. Identify one product or service from your
organization: describe the quality service
characteristics you know you give to your
“customers”
3. Prepare to give a 1 minute result of your
discussion.

5
QMS Concepts

What is Quality for ISO 9001?

Quality degree to which a set of inherent characteristics of an object
fulfills requirements (3.6.2)

Characteristic distinguishing feature (e.g. physical, sensory, behavioral,

temporal, ergonomic, functional)(3.10.1)

Object anything perceivable or conceivable (entity, item) (3.6.1)

Requirement need or expectation that is stated, generally implied or
obligatory (3.6.4)
QMS Concepts

What is Quality for ISO 9001?

● Key characteristics that influence product/service
quality
◦ Design
◦ Management
◦ Resource
◦ Employee
◦ Communication
◦ Documentation
QMS Concepts

What is Management System?

Management Set of interrelated or interacting elements of an
System organization to establish policies and objectives, and
processes to achieve those objectives(3.5.3)
Organization Person or group of people that has its own functions with
responsibilities, authorities and relationships to achieve its
objectives(3.2.1)
Policies Intentions and direction of an organization as formally
expressed by its top management(3.5.8)
Objectives Result to be achieved(3.7.1)
Processes Set of interrelated or interacting activities that use inputs
to deliver an intended result.
QMS Concepts

Therefore:
Quality = Conforming Characteristics
= Fulfilled Requirements

● Quality Management System (QMS) –

part of a management system with regard to

quality (3.5.4)
QMS Concepts

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.

● Created by the International Organization for Standardization to

help organization effectively fulfill customer requirements and to
enhance customer satisfaction.
QMS Concepts

Process-based QMS
Leadership
(Planning & Review)
Customer/
Customer/
Stakeholder
Stakeholder

Support
Performance Satisfaction
(HR, Infrastructure,
Evaluation
environment, KM)

Requirements

INPUT OUTPUT
Operations
 Plan-Do Check-Act Cycle
Quality Management System (4)

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

Performance
Customer Planning (6) Leadership Results of
evaluation (9)
Requirements QMS

Products and
Needs and services
Act Check
expectations of
relevant interested Improvement
parties (10)
(4)

12
QMS Concepts

Starting point End point

Sources of Inputs Inputs Activities Outputs Receivers of Outputs

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

Possible controls and check

points to monitor and
measure performance
RISK-BASED THINKING

14
Risk-Based Thinking

Essential for achieving an

effective QMS

Plan and implement

actions to address risks
and opportunities

15
Opportunities & Risks
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

16
Opportunities & Risks

Risk is the effect of

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

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QMS/GQMS Concepts

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
QMS/GQMS Concepts

ISO 9001 adds value

◦ 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
 QMS/GQMS Concepts

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, including processes for improvement
of the system and the assurance of conformity to customer and
applicable statutory and regulatory requirements.
QMS/GQMS Concepts

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 quality management system with related management
system requirements.
QMS/GQMS Concepts

ISO 9000 Family of Standards

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

● ISO 9001:2015 specifies requirements for a quality

management system.
QMS/GQMS Concepts

ISO 9000 Family of Standards

ISO 9004:2009 gives guidance on a wider range of
objectives of a quality management
system. (Significant changes are planned for
2009 edition.)

ISO 19011:2011 gives guidance on quality and

environmental management system
auditing.
(New version expected in 2011.)
QMS/GQMS Concepts

Evolution of ISO 9001 Standard

2015 5th Edition
● ISO 9001 standard is th
2008 4 Edition
periodically reviewed
2000 ISO 9001 3rd Edition
every 3 years
1994 ISO 9001, 9002, 9003 2nd Edition

1987 ISO 9001, 9002, 9003 1st Edition

1979 BS 5750 Quality Management System

NATO – AQAPs and DEFSTAN

After
WWII
QMS/GQMS Concepts

Why are the standards being revised?

● ISO’s formal review process:
◦ Requires continual review to keep standards up to date. Must be initiated
within 3 years of publication of a standard.

● User inputs from:

◦ A global user questionnaire/survey
◦ A market Justification Study
◦ Suggestions arising from the interpretation process
◦ Opportunities for increased compatibility with ISO 14001
◦ The need for greater clarity, ease of use, and improved translation

● Current trends:
◦ Keeping up with recent developments in management system practices.
QMS/GQMS Concepts

What is the Government QMS?

A set of interrelated or interacting elements that
allows the public sector organization to establish
its policy and objectives and processes (related to
quality), to achieve those objectives
QMS Concepts

Process-based QMS
Leadership
(Planning & Review)
Citizen
Citizen

Support
Performance Satisfaction
(HR, Infrastructure,
Evaluation
environment, KM)

Requirements

INPUT OUTPUT
Operations
QMS/GQMS Concepts

What is GQMSS?
● Government Quality Management Systems Standards
◦ One of the components of the Government Quality
Management Program (GQMP) of the Executive Order
605 (E.O.605) Institutionalizing the Structure,
Mechanisms, and Standards to Implement the
Government Quality Management Program
QMS/GQMS Concepts

What is GQMSS?
◦ The drafting of the GQMSS was directed by the
Government Quality Management Committee
(GQMC), the policy making body of the GQMP
and is composed of the following agencies:
⚫Chairman – DBM
⚫Co-chairman – DTI
⚫Members – DILG, OP-IAO, DAP
 What is GQMSS?
Drafted by the Bureau of Product Standards
Technical Committee 71-GQMP considering
the International Workshop Agreement (IWA) 4,
Quality Management Systems-Guidelines for the
Application of ISO 9001 in Local Government,
and other legal requirements
 What is GQMSS?

It was approved by the GQMC after a series

of consultations with the Civil Service
Commission (CSC), Commission on Audit
(COA), and agencies which have undergone
or are currently pursuing ISO-QMS
certification.
QMS/GQMS Concepts

What is GQMSS?
It aims to “translate” the technical language of
ISO 9001 into a language that is more user-
friendly for people who are involved in
managing a public sector organization.
 QMS/GQMS Concepts

Terms and Definitions

● For the purposes of this standard, the terms and definitions
given in ISO 9000 /GQMSS apply
● Supply chain terminology

Supplier Public Citizen

Sector
Organization

● Throughout the text of ISO 9001/GQMSS, wherever the

term “product” occurs, it can also mean “service”.
 QMS Concepts

Scope of GQMSS
● It is the objective of GQMSS to provide public
sector organization with
guidelines for the application
of ISO 9001 on an integral basis.
● The guidelines do not, however, add, change or
modify the requirements of ISO 9001
QMS/GQMS Concepts

Scope of GQMSS
● Note:
to be consistent with statutory and regulatory
requirements such as EO 292, series of 1987 –
“achievement of more economy and efficiency
in the management of government
operations;” RA 9184, RA 9485, etc.
QMS/GQMS Concepts

Application of ISO 9001/GQMSS

● Requirements are generic and are intended to be
applicable to all organizations

● All requirements are to be applied. Certain requirements

may be excluded in particular situations:
◦ Exclusions are acceptable if they do not affect the
organization's ability, or responsibility, to provide service that
meets customer and applicable statutory and regulatory
requirements.
VOCABULARY
SOME IMPORTANT TERMS:

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

1-37
VOCABULARY
SOME IMPORTANT TERMS: (Per GQMSS)

PRODUCT
Output of an organization that can be produced without
any transaction taking place between the organization
and the customer
SERVICE
Output of an organization with at least one activity
necessarily performed between the organization and
the customer

CUSTOMER/CITIZEN SATISFACTION
Customer’s / Citizen’s perception of the degree to which
expectations have been fulfilled

1-38
VOCABULARY
SOME IMPORTANT TERMS: (Per GQMSS)

TOP MANAGEMENT
Person of group of people who directs and
control an organization at the highest level (of
the public sector organization)

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.

1-39
VOCABULARY
SOME IMPORTANT TERMS: (Per GQMSS)

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

1-40
VOCABULARY
SOME IMPORTANT TERMS: (Per GQMSS)

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

1-41
VOCABULARY
SOME IMPORTANT TERMS: (Per GQMSS)

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

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Overview of ISO 9001/GQMSS

2-43
QMS Principles
QMS Principles

Principle 1 – Customer Focus

The primary focus of quality

management is to meet
customer requirements and
strive to exceed customer
expectations.
QMS Principles

o Conformity o Service availability

o Dependability o Competitive price
o Availability o Easy, efficient order
o Delivery returns process
o Post realization activities o Helpful, friendly and
o Price and life-cycle cost efficient staff
o Product safety o Reliability
o Product liability o Good image
o Environmental impact o Stability and security
o Transparency
QMS Principles

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.

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
QMS Principles

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.
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
QMS Principles

Principle 4 – Process Approach

Consistent and INPUT
Requirements Specified
predictable results are (including resources)
achieved more
effectively and Interrelated or interacting
efficiently when activities and control methods
activities are
understood and
managed as OUTPUT Monitoring
interrelated processes Requirements Satisfied and
Measuring
(Result of a process)
that function as a
coherent system.
EFFECTIVENESS OF PROCESS
Ability to achieve EFFICIENCY OF PROCESS
desired results Results achieved
vs. resources used
 QMS Principles

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

Check Do
if implementation is what was
according to plan planned
QMS Principles

Principle 6 – Evidence-based Decision Making

Decisions based on the analysis and evaluation of data
and information are more likely to produce desired
results.
Fact Opinion
A fact is something concrete An opinion is less concrete. It's a
that can be proven. You can view formed in the mind of a
find facts in records, scientific person about a particular issue.
findings, encyclopedias, atlases, In other words it is what
etc. In other words, facts are someone believes or thinks, and
the truth and are accepted as is not necessarily the truth.
such.
QMS Principles

Principle 7 –Relationship Management

● For sustained success, organizations manage their relationships with
relevant interested parties, such as providers

Traditional Outsourcing Concept ISO 9001 Concept

• multiple sourcing strategy
• frequent switching of
suppliers
• lack of long term commitment
• the only job expected of the
supplier was to meet the
requirements at a
competitive price
• Managing the supply chain
• very rare switching of supplier
• strong, mutual long-term
commitment
• work together by opening up ,
talking about design
(departments) and supply
problems to selected suppliers
Overview of ISO 9001/GQMSS

Clauses
 Major Clauses

Major Clauses of ISO 9001:2015

4 5 6 7 8 9 10
Context of Leadership Performance Improvement
Planning Support Operation
the Evaluation
Organization

Actions to Resources Operation planning & Monitoring, General

Understanding Leadership &
address risks (7.1) control (8.1) measurement (10.1)
the Organization Commitment
and & evaluation
and its context ( 5.1)
opportunities Requirements for (9.1)
(4.1)
(6.1) Competence products & services
Policy (5.2) 7.2) (8.2)
Internal Non
Understanding
Quality Audit(9.2) conformity &
the needs and Design & development
Objectives 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 Management
responsibilitie them (6.2) Review (9.3)
s and Control of externally Continual
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 (8.6)