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 IMPLEMENTING ISO 9001 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 Continuous Improvement 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

“Do the right things right the first time, every time.” WHY TQM? “Do the right things right the first time, every time.” Total Quality Management

TQM T = TIME Q = QUALITY M = MONEY

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

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”

DBM CIRCULAR LETTER NO. 2008-8 23 OCTOBER 2008 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 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

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. MANAGEMENT SYSTEMS

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.

Unifying base for industry sectors 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 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 C U S T O M E RS R E Q U I M N T S S A T I F C O N C U S T O M E RS Management Responsibility Measurement, Analysis & Improvement Resource Management Output Input Product Realization Product Value-adding activities Information flow

WITH WHO OUTPUT PROCESS HOW ISO TURTLE PROCESS DIAGRAM WITH WHAT INPUT (Eqpt/Installations) (Training, Knowledge, Skills) REQUIREMENTS REQUIREMENTS INPUT OUTPUT What should we receive? What should we deliver? PROCESS HOW MANY HOW (Performance Indicators) (Instructions, procedures, methods CONTINUAL IMPROVEMENT OF THE QMS CUSTOMER SATISFACTION Mgt. Responsibility CUSTOMER REQUIREMENTS Resource Mgt. Measurement Analysis & Improvement Product Realization OUTPUT

DEVELOPING A QUALITY SYSTEM VISION/ MISSION/COREVALUES / QUALITY POLICY STATEMENTS Quality Policy HOW POLICY IMPLEMENTED. Quality Strategy QP+QS +Quality System&Standards Are Applied. Quality Manual How Processes Which Affect Quality Are Carried Out. Procedures How Specific Jobs/Tasks Are Carried Out & Recorded Work Instructions

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 + Transition period for certification 2013 2014 2015 May 2013 CD (Committee Draft) February 2014 DIS (Draft International Standard) February 2015 FDIS (Final Draft International Standard) September 2015 Published IS (International Standard) + 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 .

Thank you for listening and have great day .

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