Part 1 - Introduction To ISO 9001 (For USE ONLY)

Workshop For ISO 9001:2000 (Appreciation and application)
Quality Services & SME Development Department
Session 1
INTRODUCTION TO ISO 9001: 2000 & ITS REQUIREMENTS

SIRIM Berhad YOUR PARTNER TO GLOBAL TRADE
Introduction to ISO 9001:2000 Who is ISO? International Organisation for Standardisation
ISO is a worldwide federation of national standards bodies (ISO member bodies). It is like the world's largest developer of standards and is a nongovernmental organisation, acting as the coordinator for standardisation of national standards that institutes of more than 150 countries in the world as members, on the basis of one member per country. The Central Secretariat is in Geneva, Switzerland. Malaysia has been the member of ISO since 1970s.
Introduction to ISO 9001:2000

ISO 9000 refers to a set of generic QMS Generic - because it can be applied to any organization, regardless of type of industries (manufacturing, service, construction) and sizes (small, medium or big) Purpose of ISO to help international trades by providing a set of standards where everyone can recognise and respect its recognition.
D-4
Published in December 2000 Contains significant revisions
1111 P h a s e II R e v is io n t a t t a in q u a lit y im p r o v e m e n t a n d c u s t o m e r v a lu e
Shift in ISO 9000 Focus
1111
1111
P h a s e I R e v is io n t o p r o v id e c o m p lia n c e f o r t h ir d - p a r t y r e g is t r a t io n
F ir s t In t r o d u c t io n t o a c h ie v e c o n f id e n c e f o r tw o -p a rty c o n tra c ts

An International Standard on Quality Management System It demonstrates an organizations quality assurance capability through quality audit and process review It had been developed by ISO / TC 176 i.e. Technical Committee Focuses on less documentation and more on effective control Continual improvement of the company performances A process-based approach to Quality Management System development
Introduction to ISO 9001:2000 Why do we need ISO 9001:2000? It can control quality It can save money Customer expectation Competitors adopt it
WORLDWIDE RECOGNITION OF PRACTICE

Malaysia
ISO 9000 ENVIRONMENT

Accredits
Accreditation Agency
Accredits Certifies
Guide 62
Registers
Technical Training
Trains
Certification Body
Registers
Auditors
Asses Assist Asses Assist
ISO 9001: 2000

Service Company
Assure
Product Company
Assure
Consultant
Customers
NATIONAL STANDARDISATION AND ACCREDITATION BODY In Malaysia is DSM (Department of Standards Malaysia)
Accredited Certification bodies in Malaysia; (1) SIRIM QAS International Sdn Bhd - 2 Dec.1996 (2) Moddy International Certification Sdn Bhd (AOQC Moddy (Malaysia) Sdn Bhd ) - 10 August 1998 (3) CI Certification (Malaysia) Sdn Bhd - 5 June 03 (4) SGS (Malaysia) Sdn Bhd - 18 Nov. 03 (5) RWTUV (Malaysia) Sdn Bhd - 16 Dec. 03 (6) Lloyd Register Quality Assurance - 12 Feb. 04 (7) Independent European Certification (Malaysia) Sdn Bhd - 8 Dec.05 (8) AJA EQS Certification (M) Sdn Bhd - 29 July 05
(By 31 December, 2005)
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For QMS certification : A Certification body is required to comply to :
ISO/IEC Guide 62
General Requirements for bodies operating assessment and certification/registration of Quality Systems
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12
13
ISO 9001:2000 STANDARD REQUIREMENTS

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0 Introduction 0.1 General 0.2 Process approach 0.3 Relationship with ISO 9004 0.4 Compatibility with other management systems 1. Scope 1.1 General 1.2 Application 2. Normative reference 3. Terms and definitions 4. Quality Management System 4.1 General requirements 4.2 General documentation requirements 5. Management Responsibility 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning 5.5 Responsibility and authority and Communication 5.6 Management Review
ISO 9001:2000 Clauses

6. Resource Management 6.1 Provision of resources 6.2 Human resources 6.3 Facilities 6.4 Work environment 7. Product Realization 7.1 Planning of realization processes 7.2 Customer-related processes 7.3 Design and/or development 7.4 Purchasing 7.5 Production and service operations 7.6 Control of measuring & monitoring devices 8. Measurement, Analysis and Improvement 8.1 Planning 8.2 Measurement and monitoring 8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement
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ISO 9001:2000 Requirements ISO 9001:2000 Requirements :

(1) Quality Management Systems (2) Management Responsibility (3) Resource Management (4) Product Realization (5) Measurement, Analysis and Improvement (Clause 4) (Clause 5) (Clause 6) (Clause 7) (Clause 8)
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DOCUMENTATION REQUIREMENTS HIERACHY OF DOCUMENTS

Level-1 Level-2 Level-3 Level-4 QUALITY MANUAL (Policy, Objectives,
Organisation Structure, Q.System Outlines
PROCEDURES (Specified Way to

Carry Out an Activity)
SUPPORT DOCUMENTS
(References, Standards, WI, Q.Plan)
FORMS/RECORDS
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QUALITY SYSTEM DOCUMENTATION STRUCTURE

QUALITY MANUAL
PROCEDURES
REFERENCE DOCUMENTS
REFERENCE STANDARDS
SPECIFICATION OF PRODUCTS/ TECHNICAL DOCUMENTS
WORK INSTRUCTIONS
SUPPORT DOCUMENTS FORMS/RECORDS

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ISO 9001:2000 Requirements Required Documented Procedures : 1) Control of Documents (Cl. 4.2.3) 2) Control of Records (Cl. 4.2.4) 3) Control of Non-Conformity (Cl. 8.3 ) Products 4) Corrective Action (Cl. 8.5.2) 19
Quality Standards to ISO 9001:2000

Currently, four available Quality Standards: 1) ISO 9001:2000 (QMS - Requirements) 2) ISO 9000:2000 (QMS - Fundamental and Vocabulary) 3) ISO 9004:2000 (QMS - Guidelines for Performance Improvements) 4) ISO 19011:2002 (QMS - Guidelines for Quality and/or Environmental Management Systems Auditing)
20
Module 3 : Understanding Quality
ISO 9000 : 2000 Family of Standards V.2000 V.1994

ISO 9001 : 1994
ISO 9001 : 2000 ISO 9000 : 2000 ISO 9004 : 2000 ISO 19011 : 2000
ISO 9002 : 1994 ISO 9003 : 1994 ISO 8402 : 1994 ISO 9004 : 1994 ISO 10011 : Part 1 ISO 10011 : Part 2 ISO 10011 : Part 3
21
Session 2
UNDERSTANDING ISO 9001:2000 & ITS APPLICATION

22
General QMS Requirements

It refers to a specific requirements of QMS for an organisation; a) To demonstrate the ability to provide product that meets customer and applicable regulatory requirements b) to enhance customer satisfaction through effective application of the system, including;
Continual improvement of the system Assurance of conformity to customer and applicable regulatory
D-4
ISO 9000 is concerned with Quality Management System
ISO 9001:2000 Standard Requirements
This means that what an organization does is to enhance the customer satisfaction by meeting and exceeding the customer and applicable regulatory requirements and continually improving its performance
D-4
BASIC CONCEPT
CUSTOMER
Quality Policy, Quality Objectives
ISO 9001:2000 REQUIREMENTS
Q.MANUAL, PROCEDURES & SUPPORT DOCUMENTS
RECORDS / EVIDENCES
25
What do we need to understand

Introduction to QMS ISO 9001:2000 Concept of Quality Model of Quality Management System Approach System to Quality Management
8-Management Principles Interpretation to ISO 9001:2000

Session 4
WHAT IS THE MEANING OF QUALITY?

27
UNDERSTANDING OF QUALITY
Quality can be safely derived as the sum of :
Knowing the customers needs Designing to meet them Faultless construction Reliable Certified performance and safety Clear instruction manuals Suitable packaging Punctual delivery Efficient back-up service Feedback of field experience
28
DEFINITION OF QUALITY
The word quality has many meanings :
A degree of excellence Conformance with requirements The totality of characteristics of an entity that bear on its ability to satisfy stated or implied needs Fitness for use Fitness for purpose Freedom from defects imperfections or contamination Delighting customers
29
QUALITY ...
s DEGREE TO WHICH A SET OF INHERENT CHARACTERISTICS FULFILS REQUIREMENTS (MS ISO 9000:2000, clause 3.1.1) TAHAP DIMANA satu set CIRICIRI/SIFAT-SIFAT SEMULAJADI YANG MEMENUHI KEPERLUAN
30
GRADE
An indicator of category or rank related to features or characteristics that cover different sets of needs for products or services intended for the same functional use
e.g. : Grade differentiates between a Mercedes and a Toyota or between a budget hotel and a 5 star hotel.
31
QUALITY CHARACTERISTIC Service Product

Appearance Cleanliness Odor Reliability Safety Size Strength Weight Taste Interchangeability Function ability Courtesy Comfortable Competence Credibility Efficiency Effectiveness Flexibility Honesty Promptness Reliability Security
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QUALITY DEFINITION (ISO 9000:2000)
i.e : Ability of set of inherent characteristics of a product, system or process to fulfill requirements of the customers and other interested parties Keupayaan untuk merekabentuk ciri-ciri produk, system atau proses yang memenuhi keperluan pelanggan dan pihak yang berkepentingan
(Terjemahan)
33
QUALITY MEANS .
W Classic definition of Quality : MEMENUHI KEPERLUAN PELANGGAN (Meeting customers requirements) W Modern definition of Quality : MEMENUHI DAN MELEBIHI KEPERLUAN PELANGGAN (Meeting and Exceeding Customers Requirements)
34
UNDERSTANDING ON QUALITY
Quality is a composite of 3 parameters:
Quality of design is the extent to which the design reflects a product or service that satisfies customer needs and expectations. Quality of conformance is the extent to which the product or service conforms to the design standard. Quality of use is the extent by which the user able to secure continuity of use from the product and service. Products need to have a low cost of ownership, be safe and reliable, maintainable in use and easy to use.
35
SERVICE SECTOR
ENHANCEMENT OF SERVICE EFFICIENCY
(MENINGKATKAN KECEKAPAN PERKHIDMATAN)
Dimension of Quality Service :

Masa (time), Cukup pada masa ketikanya berlaku (timeliness), Kesempurnaan (completeness), Kesopanan/budi bahasa (courtesy), Ketekalan/kesamaan yang menerus (consistency), Hal mudah diperolehi (accessibility) Kelesaan/kesenangan (convenience) Ketepatan (accuracy), Perihal membalas atau menyambut (responsiveness)
36
WHO IS OUR CUSTOMER?

Understand Customer will help You to provide Good Service of Quality
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WHO IS CUSTOMER Semua yang terlibat dengan sesuatu proses dan barangan
(All who are impacted by our processes and products)
Dalaman dan luaran

(Internal and External)
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QUESTIONS
What do customers need? What are their expectations? Why are they so important to us? Why is it meeting their requirements is so important? What are the consequences if not meeting their requirements?
39
COMMON SUPPLIED-CHAIN FOR COMMON SUPPLIED-CHAIN FOR GOODS/SERVICES GOODS/SERVICES ORGANISATION
SUPPLIER
CUSTOMER
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QUALITY ASSURANCE
OUR C U S T O M E R
S U P P L I E R
BROKEN?
Dont Take ! Dont Do ! Dont Deliver !
41
UNDERSTANDING ON QUALITY WHY IS QUALITY IMPORTANT ?

BEST VALUE FOR MONEY QUALITY, RELIABILITY AND COST IMPACT BY REDUCING REJECT, REWORK AND WARRANTY REPLACEMENT
42
QUALITY AND PROFIT

Quality
Conformance to requirements
Meets customer expectations
Exceeds customer expectations
Superiority to competitors
Reduced rework/repair Reduced returns, complaints, warranty
Avoids customer dissatisfaction
Reputation
Increased productivity
Customer satisfaction
Reduced costs
Increased market
Premium prices
Increased profit
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COST OF POOR QUALITY

Traditional Quality Costs
4-8%
Rejects
Inspection Warranty
Scrap Rework
(Easily Identified)
(tangible)
Engineering change orders Lost sales
Additional Costs of Poor Quality

(Difficult or impossible to measure)
Long cycle times More Setups Expediting costs
25-35%
(intangible)
Late delivery Lost Customer Loyalty
Lost Opportunity
Excess inventory
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Session 5
APPROACH TO QUALITY MANAGEMENT SYSTEM

45
QUALITY MANAGEMENT SYSTEM
What is ?
Management Managemet System Quality Management System
46
Management
coordinated activities to direct and control an organisation
(ISO 9000:2000, clause 3.2.6)
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Management System
system to establish policy and objective and to achieve those objective
(ISO 9000:2000, clause 3.2.2)
48
Quality Management System

management system to direct and control an organisation with regard to quality
(ISO 9000:2000, clause 3.2.3)
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ILLUSTRATION QUALITY - MANAGEMENT - SYSTEM

Quality Management System Quality Management System Organisation
Product
Policy
????
Direct, control with regard to quality
Objective
Continual Improvement
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ORGANISATION STRUCTURE RESOURCE
QMS
PROCESSES PROCEDURES
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Positive Impact of QMS :
Produce and provide a produce / service which consistently conforms to an agreed specification A reduction in administration, manufacturing and production costs because of less wastage and fewer rejects Market driven Pro-active management system A greater involvement and motivation within an organizations workforce Improved customer relationship Reduce multiple audit Upgrade management leadership Upgrade the staff competence
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Process-based approach - QMS

Process : Any activity that receives inputs and converts them to outputs. Often, the output from one process will directly form the input into the next process. Process Approach : The systematic identification and management of the processes employed within an organization (and particularly the interactions between such processes) is referred as Process Approach.
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Process-based approach - QMS

Materials Procedures Methods Information (including Specification) People Skills Knowledge Training Equipment Products
Process
Input Output
Services Information
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CONTINUAL IMPROVEMENTOF THE QUALITY MANAGEMENT SYSTEM
Customers (and other Interested Parties)
Management Responsibility Measurement, analysis, improvement Product Realization OUTPUT
Customers (and other Interested Parties) Satisfaction
Resource Management Requirements
INPUT
Value-adding activities Information flow
Product
ISO 9000:2000 PROCESS-BASED MODEL QMS

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Part 1 - Introduction To ISO 9001 (For USE ONLY)

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Workshop For ISO 9001:2000 (Appreciation and application)

Quality Services & SME Development Department

INTRODUCTION TO ISO 9001: 2000 & ITS REQUIREMENTS

Quality Services & SME Development Department

Introduction to ISO 9001:2000 Who is ISO? International Organisation for Standardisation

Quality Services & SME Development Department

Introduction to ISO 9001:2000

Quality Services & SME Development Department

Introduction to ISO 9001:2000

Published in December 2000 Contains significant revisions

Shift in ISO 9000 Focus

SIRIM Berhad YOUR PARTNER TO GLOBAL TRADE

Quality Services & SME Development Department

Introduction to ISO 9001:2000

Quality Services & SME Development Department

SIRIM Berhad YOUR PARTNER TO GLOBAL TRADE

Quality Services & SME Development Department

WORLDWIDE RECOGNITION OF PRACTICE

SIRIM Berhad YOUR PARTNER TO GLOBAL TRADE

Quality Services & SME Development Department

ISO 9000 ENVIRONMENT

ISO 9001: 2000

Quality Services & SME Development Department

SIRIM Berhad YOUR PARTNER TO GLOBAL TRADE

Quality Services & SME Development Department

Introduction to ISO 9001:2000

SIRIM Berhad YOUR PARTNER TO GLOBAL TRADE

Quality Services & SME Development Department

SIRIM Berhad YOUR PARTNER TO GLOBAL TRADE

Quality Services & SME Development Department

SIRIM Berhad YOUR PARTNER TO GLOBAL TRADE

Quality Services & SME Development Department

ISO 9001:2000 STANDARD REQUIREMENTS

Quality Services & SME Development Department

ISO 9001:2000 Clauses

SIRIM Berhad YOUR PARTNER TO GLOBAL TRADE

Quality Services & SME Development Department

ISO 9001:2000 Requirements ISO 9001:2000 Requirements :

SIRIM Berhad YOUR PARTNER TO GLOBAL TRADE

Quality Services & SME Development Department

DOCUMENTATION REQUIREMENTS HIERACHY OF DOCUMENTS

PROCEDURES (Specified Way to

SIRIM Berhad YOUR PARTNER TO GLOBAL TRADE

Quality Services & SME Development Department

QUALITY SYSTEM DOCUMENTATION STRUCTURE

SPECIFICATION OF PRODUCTS/ TECHNICAL DOCUMENTS

SUPPORT DOCUMENTS FORMS/RECORDS

Quality Services & SME Development Department

SIRIM Berhad YOUR PARTNER TO GLOBAL TRADE

Quality Services & SME Development Department

Quality Standards to ISO 9001:2000

SIRIM Berhad YOUR PARTNER TO GLOBAL TRADE

Quality Services & SME Development Department

Module 3 : Understanding Quality

ISO 9000 : 2000 Family of Standards V.2000 V.1994

Quality Services & SME Development Department

UNDERSTANDING ISO 9001:2000 & ITS APPLICATION

Quality Services & SME Development Department

General QMS Requirements

SIRIM Berhad YOUR PARTNER TO GLOBAL TRADE

Quality Services & SME Development Department

ISO 9000 is concerned with Quality Management System