UNDERSTANDING
the ISO 9001 QMS
UP MANILA
24 November 2014
UPIEAA Associate Professor Nestor O. Raneses
Director , Institute for Small Scale Industries
Affiliate Faculty on Total Quality Management
Technology Management Center
University of the Philippines Diliman
Assistant Vice President for Administration
University of the Philippines
Former Senior Director Quality Asia, AMIS Semiconductor
Global Manufacturing Quality Manager , ON Semiconductor
GREETINGS
•
•
Creating and Empowering Filipino
Entrepreneurs Today & Tomorrow
National Institute for
Innovation and
Entrepreneurship
GREETINGS
ASEAN CENTER OF
EXCELLENCE for SME
DEVELOPMENT – PHL
• Usaping Pangnegosyo, Ilaw,
Salamin at Sandata ng
Industryang Pilipino
•
•
UP ISSI P
AGENDA
• QUALITY OVERVIEW
• QUALITY MANAGEMENT STANDARDS –
WHAT & WHY
• LEGAL BASIS FOR QMS
• ISO 9001 QMS – WHAT IS IT ?
• UNDERSTANDING ISO 9001
REQUIREMENTS
• IMPLEMENTING ISO 9001
• QUESTIONS AND ANSWERS
• NEXT STEPS
CUSTOMER FOCUS
DISCIPLINED PROCESSES
CONTINUAL IMPROVEMENT
MANAGING PROCESS CHANGE
STRUCTURED PROBLEM SOLVING
THE NATURE OF QUALITY
• Exceeding Customers’ and the
Organisation’s Needs
• DNA of an organization
• Assuring Quality Systematically
• Prevention Culture
• Right First Time
• Continuous Improvement
QUALITY TERMINOLOGY
• QUALITY CONTROL
=
CORRECTION
• QUALITY ASSURANCE = PREVENTION
• QUALITY MANAGEMENT = DESIGN
CUSTOMER SATISFACTION AND
CONTINUAL IMPROVEMENT
WHY TQM?
“Do the right
things right the
first time, every
time.”
Total Quality Management
•
TQM
T = TIME
•Q = QUALITY
•M = MONEY
11
QUALITY
• Quickly
•
•
•
•
•
•
Understand &
Act On
Losses
Innovatively
Technical ( Theoretical )
Yield
13
TOTAL QUALITY
 “ QUALITY is the transformation
in the way we think and work
together, in what we value and
reward, and in the way we
measure success. “
“All of us collaborate to
design and operate a
seamless value-adding
system– all optimizing for a
common purpose “
TOTAL
QUALITY
MODEL
TRANSFORMATIVE
Government
Quality
Management
System
Standards
(GQMSS)
QMS LEGAL BASES
REPUBLIC ACT NO. 9013
28 FEBRUARY 2001
“ AN ACT ESTABLISHING THE
PHILIPPINE QUALITY AWARD IN ORDER
TO ENCOURAGE ORGANIZATION IN
BOTH PRIVATE AND PUBLIC SECTOR TO
ATTAIN EXCELLENCE IN QUALITY IN
THE PRODUCTION AND/OR DELIVERY
OF THEIR GOODS AND SERVICE”
QMS LEGAL BASIS
EXECUTIVE ORDER NO.
605
23 FEBRUARY 2007
“INSTITUTIONALIZING THE
STRUCTURE,MECHANISMS AND
STANDARDS TO IMPLEMENT THE
GOVERNMENT QUALITY
MANAGEMENT PROGRAM”
QMS LEGAL BASIS
DBM CIRCULAR LETTER
NO. 2008-8
23 OCTOBER 2008
NATIONAL GUIDELINES ON INTERNAL
CONTROL SYSTEMS (NGICS)
CHAPTER 3, COMPONENTS OF
INTERNAL CONTROL, SECTION 3.1
CONTROL ENVIRONMENT
QUALITY MANAGEMENT SYSTEM
QMS LEGAL BASIS
DBM CIRCULAR
LETTER NO. 2011-05
MAY 19,2011
“PHILIPPINE GOVERNMENT
INTERNAL AUDIT (PGIAM) ”
Generic Module on Controls in QMS
GCG Circular No. 2013-02
April 29,2013
No. 6 letter e “ Government
Quality Management System
Standards (GQMSS)
pursuant to E.O. No. 605 s.
2007
• MANAGEMENT
To be really efficientSYSTEMS
and
effective, the organization should
do actions systematically .
• Nothing important is left out.
• Everyone is clear about who is
responsible for doing what, when,
how, why and where.
• Management system standards
provide the organization with an
international, state-of-the-art
model to follow.
QUALITY MANAGEMENT
SYSTEM – QMS
• Defines the framework in
establishing, monitoring and
improving satisfaction of customer
requirements in any organization
• Directs and control an organization
with regard to quality
• Assesses if a process is working, if
things are being done in the way
they are supposed to be done
WHAT IS ISO QMS ?
• An International Standard for
Quality Management Systems
• Covers the planning, the
management and operation of any
Organisation
• Assures customers of your
reliability and competence to
deliver what you promise
WHY ISO 9001 QMS ?
• International & expert consensus
on state-of-the-art practices for
quality management.
• Common language for dealing
with customers and suppliers
worldwide in B2B.
• Increase efficiency and
effectiveness.
• Model for continual improvement.
WHY ISO 9001 QMS ?
• Model for satisfying
customers and other
stakeholders.
• Build quality into products
and services from design
• Integrate with global
economy.
WHY ISO9001 QMS ?
• Sustainable business
• Unifying base for industry
sectors
• Qualify suppliers for
global supply chains
• Technical support for
regulations
WHAT ARE THE INTERNAL
BENEFITS OF ISO QMS ?
Less Waste of Time and Effort
Improved Efficiency and Effectiveness
Fewer Complaints
Culture of Problem Prevention,
Continuous Improvement
• Culture of innovation and excellence
• Focus on Customer Service and
Organizational Results
•
•
•
•
EIGHT 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
Relationships
•
•
•
•
•
•
•
The ISO 9001:2008
certification signifies a
global benchmark in
customer satisfaction,
product quality, and
leads to significant
reduction in defect
levels.
GENERAL STEPS TO ISO 9000
CERTIFICATION
•
•
•
•
•
•
•
•
•
•
•
Initial Audit and Review
Management Commitment
Management Steering Group
Quality Training for all staff
Write Quality Manual
Map Core Processes
Train QMR and Auditors
Implement and Test
Internal Audits
Management Review
External Accreditation
ISO is a worldwide
federation of national
standards bodies
ISO
International Organization
for Standardization
Adoption of a
Quality
Management is a
strategic
decision.
Process based Quality Management System
Model
Continual Improvement of the
quality management system
CR
U EQ
SU
TI
R
OE
MM
E EN
RT
SS
C
U
S
T
O
M
E
R
Management
Responsibility
Measurement,
Analysis &
Improvement
Resource
Management
Input
Value-adding
activities
Product
Realization
Information flow
Output
Product
S
S
A
T
I
S
F
A
C
T
I
O
N
39
WITH WHO
WITH WHAT
(Eqpt/Installations)
INPUT
What
should
we
receive
?
HOW MANY
R
E
Q
U
I
R
E
M
E
N
T
S
(Performanc
e Indicators)
(Training, Knowledge, Skills)
R
E
Q
U
I
R
E
M
E
N
T
S
PROCESS
CONTINUAL IMPROVEMENT
CUSTOMER
OF THE QMS
CUSTOMER
REQUIREMENTS
Mgt.
Responsibilit
y
Resource
Mgt.
SATISFACTIO
N
Measurement
Analysis &
Improvement
Product
Realization
OUTPUT
OUTPUT
What
should
we
deliver?
HOW
(Instructions,
procedures,
methods
DEVELOPING A QUALITY
SYSTEM
Quality
Policy
Quality Strategy
Quality Manual
Procedures
Work Instructions
VISION/ MISSION/COREVALUES
/ QUALITY POLICY
STATEMENTS
HOW POLICY
IMPLEMENTED.
QP+QS +Quality
System&Standards
Are Applied.
How Processes Which
Affect Quality Are
Carried Out.
How Specific Jobs/Tasks
Are Carried Out & Recorded
DOCUMENTATION
• Written Policies, Process
Maps and Training
Documents
• Standard Methods of Best
Practice
• Process Approach
• Authorisation and Control
• Evidence of Compliance
REASONS FOR
DOCUMENTING PROCESSES
• Defines clearly who are
responsible
• Assures work is done in a
consistent way
• Assures work is done to the
same high standard
• Useful for training new
personnel
Plan Do Check Act Cycle
 “Plan” what you will Do
 “Do” according to your Plan
 “Check” to see if you did what
you planned
 “Act”, change or improve the
part of your Plan or Do that
did not give you the results
you intended
KEY CONCEPT OF ISO
9001 QMS
“Say what you ,do
and do what you say,
show proof that you
do it, and
continuously
improve “
Thank you for listening
ISO 9001:2015 Timeline
2013
2014
May 2013 CD
2015
+ Transition period
for certification
(Committee Draft)
February 2014 DIS
(Draft International
Standard)
February 2015 FDIS
(Final Draft International
Standard)
September 2015
Published IS
(International Standard)
QUICK RECAP
• ISO stands for International
Organization for Standardization .
• ISO 9001 specifies requirements
for total quality management
system.
• Eight principles underpin
ISO9001 QMS.
• ISO 9001 QMS comprises 5 major
elements or clauses .
• QMS is a strategic decision .
nraneses @gmail .com
nestor.raneses@upd.edu.ph
nestorraneses@yahoo.com
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