UNDERSTANDING the ISO 9001 QMS

UP MANILA 24 November 2014

UPIEAA Associate Professor Nestor O. RanesesDirector , Institute for Small Scale Industries

Affiliate Faculty on Total Quality ManagementTechnology 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

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GREETINGS

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• 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

Total Quality Management

WHY TQM?WHY TQM?

“Do the right things right the first time,

every time.”

TQM •

T = TIME •Q = QUALITY •M = MONEY

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QUALITY • Quickly • Understand &• Act On • Losses • Innovatively • Technical ( Theoretical ) • Yield

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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 BASISEXECUTIVE ORDER NO.

60523 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 ENVIRONMENTQUALITY MANAGEMENT SYSTEM

QMS LEGAL BASIS DBM CIRCULAR LETTER

NO. 2011-05MAY 19,2011

“PHILIPPINE GOVERNMENT INTERNAL AUDIT (PGIAM) ”

Generic Module on Controls in QMS

GCG Circular No. 2013-02April 29,2013

No. 6 letter e “ Government Quality Management System Standards (GQMSS) pursuant

to E.O. No. 605 s. 2007

MANAGEMENT SYSTEMS • To be really efficient 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 9000CERTIFICATION

• 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

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Continual Improvement of the quality management system

ProductProductRealization

ManagementResponsibility

ResourceManagement

Measurement, Analysis & Improvement

CUSTOMERS

REQUIREMENTS

CUSTOMERS

SATISFACTION

Input Output

Value-adding activities

Information flow

PROCESS

WITH WHO(Eqpt/Installations) (Training, Knowledge, Skills)

WITH WHAT

REQUIREMENTS

REQUIREMENTS

INPUT OUTPUTWhat

should we

receive?

What should

we deliver?

HOW MANY HOW(Performance

Indicators)(Instructions, procedures,

methodsCONTINUAL IMPROVEMENT

OF THE QMS

CUSTOMER

REQUIREMENTS

CUSTOMER

SATISFACTIONMgt. Responsibility

ProductRealization

Measurement Analysis &

Improvement

ResourceMgt.

OUTPUT

DEVELOPING A QUALITY SYSTEMDEVELOPING A QUALITY SYSTEM

Quality Policy

Quality Strategy

Quality Manual

Procedures

Work Instructions

VISION/ MISSION/COREVALUES / QUALITY POLICY STATEMENTS

VISION/ MISSION/COREVALUES / QUALITY POLICY STATEMENTS

HOW POLICY IMPLEMENTED.HOW POLICY IMPLEMENTED.

QP+QS +Quality System&Standards Are Applied.

QP+QS +Quality System&Standards Are Applied.

How Processes Which Affect Quality Are Carried Out.

How Processes Which Affect Quality Are Carried Out. How Specific Jobs/Tasks Are Carried Out & Recorded

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

May 2013 CD(Committee Draft)

February 2014 DIS (Draft International Standard)

February 2015 FDIS (Final Draft International Standard)

September 2015 Published IS (International Standard)

201520142013

+ Transition period for certification

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 .comnestor.raneses@upd.edu.ph

nestorraneses@yahoo.com

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