Iso 9001 - Et - 251108
Iso 9001 - Et - 251108
Iso 9001 - Et - 251108
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Presentation Outlines
Introduction to ISO Introduction to Quality Management System, Quality Principles of QMS Requirements of ISO 9001:2000 Quality Audits Process of Registration for ISO 9001:2000
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Introduction to ISO
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Who ISO is
Network of the national standards institutes of 156 countries Central secretariat in Geneva, Switzerland ISO is a non-governmental organization Meets the requirements of businesses & the broader needs of society
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Demings Cycle
PLAN DO Establish performance objectives and standards. Measure the ACTUAL performance against planned arrangements. Compare PERFORMANCE against planned arrangements (i.e objectives and standards) Gap measurement. Take necessary action to close gap by undertaking improvements.
CHECK -
ACT
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Management responsibility
Input Requirements
Key
Product realisation
Value-adding activities Information flow
Product
Output
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Quality
Quality is Conformance with requirements. Quality is fitness for purpose. Quality is fitness for use. Quality is user dependent. Quality is journey & not destination.
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Quality
Understand customer needs and expectations. and regulatory Understand applicable statutory requirements of the products.
Establish Policy and Objectives to meet the above. Design the processes and establish criteria to realize those objectives.
Provide adequate resources to realize and measure product and other quality objectives
Contd
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Quality (contd)
Ensure reliability of inputs purchased from suppliers. Realize product meeting criteria.
Measure realization of processes for effectiveness in meeting product needs and objectives satisfying customer and Interested parties. Provide Clear instruction manuals/ Customer needed Product information Adhere to safety, environmental and statutory requirements.
Contd
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Quality (Contd)
Provide suitable packaging. Ensure on-time delivery. Provide efficient back-up service. Use of feedback from customers and internal processes for continual improvement. Provide proper training to build on organisational learning and continual improvement To achieve consistency in output, it is Quality of everything that we do, which can be improved.
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Concept of Quality
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Quality
Degree to which a set of inherent characteristics fulfills requirements.
Requirements
Need or expectation that is stated, generally implied or obligatory.
System
Set of interrelated or interacting elements/processes put in sequence
Management System
System to establish policy and objectives and to achieve those objectives.
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CUSTOMER FOCUS
Organizations depend on customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations
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INVOLVEMENT OF PEOPLE
People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organizations benefit
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PROCESS APPROACH
A desired result is achieved more efficiently when activities and related resources are managed as a process
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CONTINUAL IMPROVEMENT
Continual improvement of the organizations overall performance should be a permanent objective of the organization
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Process Approach
Process approach to quality Management is encouraged by ISO 9000 standards, as a means to enhance customer satisfaction by meeting customer requirements. Introduces and explains process model as conceptual presentation of specified QMS requirements. The application of a system of processes within an organisation together with the identification and interactions of these processes and their management can be referred to as process approach.
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PROCESS
OUTPUT Product (Result of the process) Examples of output: - A cup of tea. - Computing software. - Liquid fuel. - Banking service - Intermediate product.
Examples of resources: - Materials (Raw materials, parts). - Manpower (Competent). - Machinery (Infrastructure). - Measurement (Testing equipment). - Environment (Work environment).
Monitoring and measurement opportunities before, during and after the process.
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Interaction of Processes
Process A
Process C
Process B
Process D
Input
Output
Controls
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Management responsibility
Input Requirements
Key
Product realisation
Value-adding activities Information flow
Product
Output
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Determining and providing resources necessary to attain the quality objectives; Contd
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Quality Control
It is focused on providing confidence that Quality requirements will be fulfilled. It is essentially a control loop based on monitoring, feedback and corrective action.
Quality Assurance
It is an anticipation & prevention of unfavorable events by the task performers.
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TERMINOLOGY
CONTINUAL IMPROVEMENT Recurring activity to increase the ability to fulfill requirements EFFECTIVENESS
Extent to which planned activities are realized and planned results achieved
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TERMINOLOGY
PRODUCT Result of a Process
TERMINOLOGY
CORRECTIVE ACTION Action to eliminate the cause of a detected non conformity or other undesirable situation. PREVENTIVE ACTION Action to eliminate the cause of a potential situation.
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TERMINOLOGY
VERIFICATION confirmation through the provision of objective evidence that specified requirements have been fulfilled. VALIDATION confirmation, through the provision of objective evidence , that the requirements for a specific intended use or application have been fulfilled.
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Background
To help expand world trade, provide confidence to the customers on the quality of products / services they buy, and help the industry to remain competitive by continual improvement, ISO published ISO 9000 series of standards for the first time in 1987. These standards are reviewed and revised periodically. The phase-I revision of ISO 9000 series of standards took place in July 1994. The phase-II revision took place in December 2000.
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ISO 9000:2000 & ISO 9004:2000 are intended as guidelines only & can not be used as ref. Standards to audit the adequacy of QMS. Contd
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ISO 9001:2000
ISO 9004:2000
ISO 19011:2002
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Quality Plans. Project Management. Configuration Management. Measurement Control System. Complaints handling. Selection of QMS consultants and use of their services.
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Brochures Quality Management Principles. Selection and use. Hand book for small businesses. * Under revision/preparation
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The terms product can comprise elements belonging to different generic product categories. Throughout, the Standard, wherever the term product occurs, it can also mean service
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ISO 9001:2000
Requirements Quality Management System Management Responsibility Resource Management Product Realization Scope General requirements, Documentation requirements. Commitment, Customer Focus, Quality Policy, Objectives, Planning, Responsibility, Authority and communication, Management review. Provision of resources: Human resources, Infrastructure and Work environment. Planning of product realization ,Customer related processes , Design & development, Purchasing, Production and service provision, Control of measuring & monitoring devices. Monitoring and measurement, Control of nonconforming product, Analysis of data, Improvement.
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ISO 9001:2000
REQUIREMENTS - CL.4 THE DESCRIPTION OF QMS - IDENTIFICATION, CONTROL, IMPROVEMENT OF PROCESSES INCLUDING THOSE
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ISO 9001:2000
THE DESCRIPTION OF QMS(CONTD.) REFERENCE FOR IMPLEMENTATION DOCUMENTS, CONTROL EVIDENCE FOR IMPLEMENTATION RECORDS, CONTROL
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ISO 9001:2000
THE DESCRIPTION OF QMS(CONTD.) Cl. 4.2.2: Quality Manual- contains regulatory requirements, Quality policy, Introduction of company (nature of work- marketing/manufacturing etc.), Justification of any exclusion of clause Any manual must consists the following: 1. Title 2. (i) Scope & Field of application, (ii) Structure i.e. level 3. Table of contents 4. Abbreviation list
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ISO 9001:2000
REQUIREMENTS CL. 5 MANAGEMENT RESPONSIBILITY - EVIDENCE - COMMITMENT: POLICIES; OBJECTIVES; EVIDENCE AKA_PMI_TAJ
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QUALITY POLICY
CHARACTERISTICS:
BASED ON BUSINESS PHILOSOPHY OF PROMOTERS HAVE VISION, MISSION & STRATEGY EASY TO REMEMBER: COINCISE & SIMPLE LANGUAGE AIM AT ERROR FREE PERFORMANCE CUSTOMER ORIENTED GUIDE SETTING OF PERFORMANCE STANDARDS SIGNED BY CHIEF EXECUTIVE OBJECTIVES FOR VISION
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ISO 9001:2000
REQUIREMENTS CL. 6 RESOURCE MANAGEMENT - PROVISION - COMPETENCE (HUMAN RESOURCES) - INFRASTRUCTURE
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ISO 9001:2000
REQUIREMENTS CL. 7 PRODUCT REALISATION (PROCESSES) - PLANNING - CUSTOMER RELATED (INCLUDING CUSTOMER
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ISO 9001:2000
REQUIREMENTS CL. 7 (CONTD.) DESIGN AND DEVELOPOMENT - PLANNING TO VALIDATION - CHANGES
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ISO 9001:2000
REQUIREMENTS CL. 7.4 PURCHASING - PRODUCT CONFORMITY - EXTENT OF CONTROLS - PURCHASING INFORMATION
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ISO 9001:2000
REQUIREMENTS CL. 7.5 PRODUCT AND SERVICE PROVISIONS - PRODUCT REQUIREMENTS(INFORMATION)
- PROCESS REQUIREMENTS, WIs
- MONITORING PROVISION
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ISO 9001:2000
REQUIREMENTS CL. 7.5 (CONTD.) - SPECIAL PROCESS VALIDATION IDENTIFICATION/TRACEABILIT
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ISO 9001:2000
REQUIREMENTS CL. 7.6 CONTROL OF MONITORING AND MEASURING DEVICES - CALIBRATION, VERIFICATION - TRACEABILITY - STATUS (FOR USE)
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REQUIREMENTS CL. 8
ISO 9001:2000
MEASURE, ANALYSE AND IMPROVE FOR MONITORING AND MEASUREMENT (CL.8.2) - CUSTOMER SATISFACTION - IQA - PROCESSES - INSPECTION AND TESTING
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ISO 9001:2000
REQUIREMENTS CL. 8 (CONTD.) - ANALYSIS OF DATA (CL.8.4)OBTAINED - IMPROVEMENT (CONTINUAL IMPROVEMENT) CORRECTIVE ACTION
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Quality Manual (Level A) Quality Management System Procedures (Level B) Work instructions , process maps and other documents for QMS (Level C) Forms and Records (Level D)
Note 1: The numbers and levels may be adjusted to meet the organisations needs. Note 2: Forms may be applicable at all levels of the hierarchy.
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List of Records
Results of management reviews (5.6.1). Records of education, experience, training and qualifications (6.2.2e). Records to provide evidence that realisation process and resulting product meet requirement (7.1d). Results of customer requirement reviews and actions arising from reviews (7.2.2). Design and development input relating to product requirement (7.3.2). Records of design and development reviews (7.3.4) Contd...
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Quality Audit
WHY DO AUDITS? 1. To ensure compliance with the standards 2. Check of current status 3. Facilitate improvement 4. Enhance quality awareness 5. Increased interdepartmental understanding & cooperation
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AUDIT PROCESS
SEEKS ANSWERS TO THREE BASIC QUESTIONS AT MOST, ANYTIME, ANYWHERE
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AUDIT PROCESS
THE THREE BASIC QUESTIONS: QUESTION 1. TO WHAT EXTENT IS THE QMS DOCUMENTED?
ADEQUACY OF QMS DOCUMENTS
AUDIT PROCESS
QUESTION 2. TO WHAT EXTENT IS THE DOCUMENTED QMS IMPLEMENTED?
COMPLIANCE OF QMS DOCUMENTS
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AUDIT PROCESS
QUESTION 3. TO WHAT EXTENT IS THE QMS PUT INTO PRACTICE IS EFFECTIVE? STATED OTHERWISE ARE THE STATED OBJECTIVES OBTAINED? CONCLUSIONS OF AUDIT
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AUDIT PROCESS
WHAT AUDIT IS? DEFINITION FROM ISO 9000:2000 SYSTEMATIC, INDEPENDENT AND DOCUMENTED PROCESS FOR OBTAINING EVIDENCE AND EVALUATING IT OBJECTIVELY TO
DETERMINE
WHY AUDITS ?
IT IS REQUIREMENT OF IS/IS0 9001:2000(CLAUSE 8.2.2) IT IS REQUIREMENT BY A CERTIFICATION BODY FOR THE PURPOSES OF CERTIFICATION IT IS AN EFFECTIVE MANAGEMENT TOOL TO KNOW, MONITOR AND IMPROVE ITS MANAGEMENT SYSTEMS
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WHY AUDITS ?
TWO QUESTIONS THAT NEED ANSWERS ARE :
ARE WE DOING THINGS RIGHT ? ARE WE DOING THE RIGHT THINGS ?
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LEVELS OF AUDITS
AUDITS ARE CARRIED OUT AT TWO LEVELS
1) TO EVALUATE IF THE PRESENT PROCEDURES ARE SUITABLE FOR ACHIEVING ORGANIZATIONAL GOALS AND OBJECTIVES 2) TO EVALUATE COMPLIANCE TO EXISTING PROCEDURES/CRITERIA
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TYPES OF AUDIT
First Party
ADEQUACY AUDIT
Second Party
COMPLIANCE AUDIT
Third Party
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Certification Bodies
An impartial body either governmental or non governmental, possessing the necessary competence and reliability to operate a certification system. BIS, NQA-QSR, STQC, LRQA, TUV, DNV, BVQI, KPMG, IRQS, SGS, QAS, UAL, ICL
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Accreditation Body
A national body which evaluates the competence of certification body. UKAS- United Kingdom Accreditation Services RAB- Registrar Accreditation Board in USA. RvA- RAAD VOOR ACCREDITATIE- Dutch Council JAS-ANZ- Joint Accreditation Services of Australia & NewZealand NACQS (Belgium), InMetro (Brazil), SCC (Canada), DAR PGA (German), SINCERT (Italy), SAS (Switzerland) INN (Chilly)
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Advantages
To Customers Product conforming to the requirements. Dependable and reliable product. Improved supply. Less noncompliance. Competitive pricing. Favorable response to changes.
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Advantages
To Organisation Reduced rejection rate Improved operational results Consistency in output Improved customer satisfaction Increased market share Increased return on investment
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Advantages
To Employees Defined roles & responsibilities. Increased job satisfaction. Improved morale. Better working conditions. Involvement. Pride.
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Advantages to Society
Fulfillment of legal & regulatory requirements Improved health and safety Reduced environmental impact
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vision,