TWO DAYS SHORT COURSE ON ISO 9001:2000 QUALITY MANAGEMENT SYSTEM 24-25 May, 2008
CONTENTS 1 Background 2 Eight Quality Management Principles 3 ISO 9001:2000 Requirements How to implement ISO 9001:2000 4
What is ISO 9001? ISO • “ISO 9001” is a series of standards describing the requirements for establishing and maintaining a quality management system in an organization 9001 The word “iso” or International Organization for Standardization The series allocated for Quality System standards
What is ISO? • International Organization for Standardization • Develop standards and not to certify companies • Around 148 countries members • Around 13000 standards produced • Technical Committees are formed to produce standards • TC 176 for ISO 9001 • International Organization for StandardizationEmail: firstname.lastname@example.orgWeb: http://www.iso.ch http://www.bsi.org.uk/iso-tc176-sc2. • First Pakistani company certified in 1994 • More than 3,000 companies certified to ISO 9001 in Pakistan • More than 220 Certification (Auditing) Agencies throughout the world of which around 15 have offices in Pakistan • Established in 23 February 1947 • ISO Systems:ISO 9001-2000, ISO-14000, ISO 17025, etc.
Origin of ISO 9001 ISO 9001:87 ISO 9001:94 ISO 9001:2000 BS5750 1979 AQAP1 (NATO) 1970’s MIL-STD-9858 (1940’s)
Application of ISO 9001 • ISO 9001 is applicable to any type and any size of organization • It is not an industry specific or product specific standard • ISO 9001 involves third party certification • an independent auditing agency audits the organization against the requirements of the standard and issues certificate on successful compliance • ISO 9001 Certification is valid for three years • initial certification audit • yearly or half-yearly surveillance audits
ISO 9001:2000 Family of Standards • CORE STANDARDS • ISO 9000:2000 Fundamentals and Vocabulary • ISO 9001:2000 QMS Requirements • ISO 9004:2000 Guidelines for Performance Improvement • SUPPORTING STANDARDS • ISO 10005:1995 Guidelines for Quality Plans • ISO 10006:2003 Guidelines for Project Management • ISO 10007:2003 Guidelines for Configuration Mgt • ISO 10012 Measurement Management System • ISO 10013:2001 Documentation • ISO/TR 10014:1999 Economics Of Quality • ISO/TR 10015:2000 Training • ISO/TR 10017:2003 Statistics • ISO 19011:2003 Auditing • ISO 10002:2004 Complaint handling • ISO 10001 Market based Code of Conduct • ISO 10003 External Dispute Resolution System
Revisions of ISO 9001 Second revision named as ISO 9001:2000 2000 First revision named as ISO 9001:1994 1994 Originally released as ISO 9001:1987 1987 ISO 9001 is revised after five years
ISO 9003:1994Applies to organizations that do not design/develop and produce their products or services but are only involved in final inspection and delivery of the finished product ISO 9002:1994Applies to organizations that do not design/develop their products or services but are only involved in production of products/ provision of services and delivery of products/services ISO 9001:1994Applies to organizations involved in design and development of products/services, production of products/provision of services, and delivery of products/services ISO 9001:1994 Models
For your employees: • Staff gets a better understanding of their role and objectives, by having a documented management system. • They benefit from reduced stress levels, because they are using an efficient management system and because they know what is expected of them. • They get increased morale and a sense of pride through achieving the goals of registration and customer satisfaction. • New staff can immediately learn their job, because the details are in writing.
For your organization: • Your products will be of a more consistent quality, and you will produce fewer rejects. • You gain cost savings, because your production will be more efficient. There are economies in production (because your systems are controlled from start to finish), and economies in time that was formerly spend re-doing work. • You can improve the quality of your raw materials by requiring your suppliers to have a ISO 9001 system. • Export marketing is easier, because some foreign buyers recognize ISO 9001 (BS 5750).
You can expect preferential treatment from potential customers who have ISO 9001 certification. This means an increase in new business. • You secure greater customer loyalty, because you continuously satisfy their needs and give them no cause to seek another supplier. That means you suffer fewer customer losses. • You can use ISO 9001 in your publicity to win more sales. • ISO 9001 helps you minimize the risk of producing unsafe products. It may also give you some protection law against product liability claims. • Being first in your area or industry may put you ahead of your rivals by 18 months to two years.
For your customers: • Your customers get a known level of quality that is independently audited. • They get a means of choosing between competing suppliers. • They can have more confidence in your goods. • ISO 9001 minimize their risk, by publishing responsibility on to their supplier (i.e. you). • They can manage you, their supplier, better by specifying that you must have a ISO 9001 system. • They can assess your quality system, and thus check your ability to produce satisfactory goods and services.
WHAT IS QUALITY? • Degree of Excellence • Fitness for Purpose • Meeting Requirements • Meeting Customer/community Needs • Delighting Customers • Right First Time, All The Time
Changing Scope of “Quality” to Organizational Quality Dept.-Wise Performance from Only Product Quality
Quality Management is …. a process of identifying and solving problems, followed by improving performance…. OCCASIONAL QUALITY ISSUES CHRONIC QUALITY ISSUES
What is the difference between Quality Control and Quality Assurance?
Quality Control vs Inspection MIXED PRODUCT MARKETING ADMIN, QA PRODUCTION FINANCE MAINT. TESTING LABS PROCESS Measu- rement OK Cycle A PRODUCT/ SERVICE FIXING Not OK Process and/or Systems Fixing Cycle B C/A
PROCESS Performance Actions data Market Customer Legal Benchmarks Process Financial FIELD Performance data Product , Process or Systems Fixing & Improvement Actions Quality Assurance DESIGN Customers PROCESSES PRODUCT Performance OK Product Fixing Not OK Product, Process or Systems Fixing & Improvement data Actions
QMS PROCESS Performance Actions data DESIGN Customers PROCESSES PRODUCT Performance Market Customer Legal Benchmarks Process Financial OK Product Fixing Not OK Product, Process or Systems Fixing & Improvement data Actions FIELD Performance data Product , Process or Systems Fixing & Improvement Actions
TQM+ 6 Sigma Knowledge Mgt. IT TQM HRM GROUP DYNAMICS Teams Efficiency BPR TPM JIT/MRP QA ISO9000 JAR145 OPR MGT. QC SPC Quality Circles Inspection/ Testing Metrology Evolution of Quality Field Product Insp. to Process to System to Culture to Performance Control (Opr Mgt ) Change
Four Levels of QM QM Levels IV III II I 0 No Measures Basic Measures QC QA (ISO9000) CQI
1st Stage of QC ADMIN MANUFACTURING QC PRODUCTION PRODUCT FINANCE HRD Internal Mnt. STORES PURCHASING MIS / SEC / PLANNING
2nd Stage of QC ADMIN MANUFACTURING QC PRODUCTION PRODUCT FINANCE QC HRD Internal Mnt. STORES QC QC PURCHASING QC MIS / SEC / PLANNING QC
QC QC QC QC 3rd Stage of QC ADMIN MANUFACTURING QC PRODUCTION PRODUCT FINANCE HRD Internal Mnt. STORES QC QC PURCHASING QC MIS / SEC / PLANNING QC
Quality Evolution through National Quality Awards • JapanDeming Quality Award • USAMalcolm Baldrige National Quality Award • European UnionEuropean Quality Award • A large number of countries have initiated such efforts, some organized and some unorganized. • In Pakistan, an effort was initiated in 1999 but did not take-off.
Levels of Quality: Poor- Angry- Fighting/Good- Happy- Glad Dimension of Product Quality Good looking (Appearance) Reliable Durable Easy to operate Made of best Materials Affordable Available Low Maintenance cost Size / Weight
FACTORS AFFECTING QUALITY • Human Resource • Financial Resources • Work Environment • Technical Resources. • Management System • Communication System • Motivation • Organizational Quality • Individual Quality
2 Eight Quality Management Principles
8 QUALITY MANAGEMENT PRICINIPLES Customer-focus Mutually beneficial supplier relationship 8 QUALITYMANAGEMENTPRINCIPLES Leadership Factual Approach to Management Involvement ofPeople ContinualImprovement Process Approach System approach to management
1. CUSTOMER FOCUSED • Organizations depend on their customers and therefore should: • understand current and future customer needs, • meet customer requirements, and • strive to exceed customer expectations.
2. LEADERSHIP • Leaders should: • establish unity of purpose (vision and mission) • provide direction to the organization (policy and objectives) • provide resources to achieve organization’s objectives Corporate Goal
3. INVOLVEMENT OF PEOPLE • People at all levels are the essence of an organization. Therefore, • their full involvement enables their abilities to be used for the organization’s benefit
4. PROCESS APPROACH • Organizations need to do more than simply monitor process outputs,(typically through inspection activities) • they must also control all process inputs,(people, facilities/equipment, material and methods) • and, they must establish appropriate controls over the transformation activities,(if desired results are to be achieved consistently and efficiently) Resources Transformation Inputs Outputs
5. SYSTEM APPROACH TO MANAGEMENT • Organizations must understand a system is a set of interrelated processes, and • the output of one process is the input to one or more subsequent processes, so … • It is critical to manage the “white space” (or interface) between processes to ensure that the overall system is effective
6. CONTINUAL IMPROVEMENT • Continual improvement should be a permanent objective of the organization ContinualImprovement Act Plan • Measure/Monitor Results against Objectives • Improve Process, and • Change QMS as needed to achieve and sustain Desired Results Results Check Do QMS Baseline Performance
7. FACTUAL APPROACH TO DECISION MAKING • Effective decisions should be based on: • the analysis of data and information DECISION COLLECTION OF DATA ANALYSIS
8. MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIPS • An organization and its suppliers are interdependent. Therefore: • a mutually beneficial relationship should be established between them to enhance the ability of both to create value VENDORS PRODUCT OR SERVICE + ORGANIZATION
Accuracy dependably Five dimensions of Service Quality Physical Infrastructure image Promptness Helping attitude Reliability Responsiveness Tangibles Access Communication Understanding needs Competence Courtesy Credibility security Assurance Empathy
1. Reliability: ability to perform a service reliably and dependably; it means the customer expectations are met consistently 2. Responsiveness: the willingness to help customers and provide prompt service (speed) 3. Assurance: the ability to communicate to the customer a level of competence and to provide the service with the necessary courtesy 4. Empathy: the approachability and the ability to communicate with an understanding the customer’s needs 5. Tangible: the appearance of the physical facilities, equipment, personnel, and communication materials.
3 ISO 9001:2000 Requirements
ISO 9001:2000 • ISO 9002:1994 & ISO 9003:1994 dropped and merged into a single ISO 9001:2000 standard • New Standards • ISO 9000:2000 Fundamentals and Vocabulary • ISO 9001:2000 QMS Requirements • ISO 9004:2000 Guidelines for Performance Improvement
NEW STRUCTURE 20 Clauses have been abandoned and merged into 5 sections with additional requirements Clause 4:Quality System Clause 7:Product Realization Clause 6:ResourceManagement Clause 8:Measurement, Analysis & Improvement Clause 5:Management Responsibility Permissible Exclusions from Clause 7 only if it does not apply
1 1.1 General 1.2 Application Scope 2 Normative Reference 3 Terms and Definitions Contents
4 Quality Management System 4.1 General Requirements 4.2 Documentation Requirements 5 5.1 Management Commitment 5.2 Customer focus 5.3 Quality Policy 5.4 Planning 5.5 Responsibility, authority and communication 5.6 Management Review Management Responsibility 6 6.1 Provision of resources 6.2 Human resources 6.3 Infrastructure 6.4 Work environment Resource Management 7 7.1 Planning of product realization 7.2 Customer-related processes 7.3 Design and development 7.4 Purchasing 7.5 Production and service provision 7.6 Control of monitoring and measuring devices Product Realization Contents (cont.)
8 8.1 General 8.2 Monitoring and measurement 8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement Measurement, Analysis and Improvement Contents (cont.)