Professional Documents
Culture Documents
ISO
INTERNATIONAL ORGANISATION FOR STANDARDIZATION (I S O)
BASED IN GENEVA, SWITZERLAND
STARTED OPERATIONS IN 1947. MORE THAN 140 NATIONAL BODIES
WHY ISO ?
ISO CERTIFICATION IS IDENTIFIED AS A :
BEST IN CLASS INITIATIVE IN STRATEGIC
-- QUALITY ,COST , DELIVERY, CUSTOMER SERVICE ETC, TO DISTINGUISH FROM ITS COMPETITOR
LEADING TO .
NEW BUSINESS , BETTER EFFICIENCY(SAFE , RELIABLE , ECONOMIC ,QUICKER) , IMPROVED RELATIONS WITH EMPLOYEES , CUSTOMERS , SUPPLIERS , STAKEHOLDERS & REGULATORS.
MR TRG
DOC. CONTROL
MAKE SOP
TRG. EMPLOYEES
GAP ANALYSIS.
INT.AUDITOR TRAINING
MGMT REVIEW
PREASSESSMENT
REGIST. AUDIT
ISO Cert
Yes
ISO Cert
REREGIST.
3 yrs?
No
SURV. AUDIT
MGMT REVIEW
3 Yrs Cycle
Resource Management
Inputs
Product Realization
Outputs
Product
PDCA Cycle
4. ACT
Permanently implement improvements
1. PLAN
Identify improvements and develop plan
3. CHECK
Evaluate plan to see if it works
2. DO
Try plan on a test basis
Analysis of Data
Organizational Organizational Results Customer Satisfaction Statutory Compliance QMS Metrices Insp.& Testing Supplier Performance
Objectives
Customer Requirements Statutory Requirements Defect Rate &
Customer Returns
QMS Control Purchasing
QMS MODEL
Overall
HR
Admin
Senior Mgmt
Reviews & Evaluates
Mfg
Prod. Purchase Planning Maintenance Stores Design
Personnel HR
Development
Certfy. Body
Certifies
QMS
After Sales Service
R &D
Sales Marketing
Finance
Customer Service
Logistics
Sales / Mktg
ONIDA
may cause envy
Designing
Procurement Identifying
Documents
Process /Planning
Statistics
Control of Equipments
ISO 9000 / ISO 14000 FAMILY The vast majority of ISO standards are highly specific to a particular product, material, or process. However, the standards that have earned the ISO 9000 and ISO 14000 families a worldwide reputation are known as Generic Management System Standards". "Generic" means that the same standards can be applied: -to any organization, large or small - including whether its "product" is actually a service, - in any sector of activity, whether it is a business enterprise,a public administration, or a government department
Management system" refers to the organization's structure for managing its processes - or activities - that transform inputs of resources into a product or service which meet the organization's objectives,
ISO 9001
ISO 9004
-- Requirements
-- Guidelines for Performance Improvements
ISO 9001 : 2000 SCOPE General - Needs to demonstrate consistency - Aims to enhance customer satisfaction
Application - Generic & intended to be applicable to all Organizations (type /size /product/service) - Requirements that are not applicable can be considered for exclusion
Provides guidelines and recommendations Beyond the requirements of ISO 9001:2000 & is Published together as ISO 9004: 2000 Making them Consistent Pair .
Continual Improvement
Analyze & Evaluate Data Establish Objectives Evaluate & Select Solution Implement the Selected Solution Monitor ,Analyze & Evaluate Results
Process
WHAT IS QUALITY ?
QUALITY IS
CONFORMANCE TO REQUIREMENTS
ON TIME
EVERY TIME
WHY QUALITY ? CUSTOMER SATISFACTION COST OF POOR PERFORMANCE REPEAT BUSINESS INCREASED PROFITABILITY
MISCONCEPTIONS OF QUALITY
QUALITY MEANS LUXURY QUALITY PROBLEMS ARE CAUSED BY OPERATORS QUALITY LEADS TO HIGHER COST QUALITY PROBLEMS BELONG TO THE QUALITY / INSPECTION DEPARTMENT HIGHER QUALITY MEANS LESSER OUTPUT FEAR OF INCREASED PAPER WORK FEAR OF NEED FOR MORE MANPOWER VERY RIGID AND CUMBERSOME QUALITY & PRODUCTIVITY CANNOT GO BESIDE ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT ITNA TO CHALTA HAI CONCEPT
TERMINOLOGY
TERMINOLOGY
PROCESS: A SET OF INTERRELATED OR INTERACTING ACTIVITIES WHICH TRANSFORMS INPUTS INTO OUTPUTS. QUALITY:
QUALITY IS A DEGREE TO WHICH A SET OF INHERENT CHARACTERISTICS FULFILS REQUIREMENTS. QUALITY CONTROL:
PART OF QUALITY MANAGEMENT FOCUSSED ON FULFILLING QUALITY REQUIREMENTS.
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
TERMINOLOGY
QUALITY ASSURANCE:
PART OF QUALITY MANAGEMENT FOCUSSED ON PROVIDING CONFIDENCE THAT QUALITY REQUIREMENTS WILL BE FULFILLED. QUALITY MANAGEMENT SYSTEM:
A MANAGEMENT SYSTEM TO DIRECT AND CONTROL AN ORGANISATION WITH REGARD TO QUALITY. DEFECT:
NON FULFILLMENT OF REQUIREMENT RELATED TO AN INTENDED OR SPECIFIED USE.
TERMINOLOGY
QUALITY POLICY:
Overall intentions and direction of an organization related to quality as formally expressed by top management.
QUALITY OBJECTIVE
CONTINUAL IMPROVEMENT
TERMINOLOGY
NON CONFORMITY:
NON FULFILLMENT OF A REUIREMENT.
CORRECTION :
ACTION TO ELIMINATE NON CONFORMITY
CORECTIVE 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 NON CONFORMITY OR OTHER UNDESIRABLE POTENTIAL SITUATION
TERMINOLOGY
DOCUMENT
INFORMATION AND ITS SUPPORTING MEDIUM.
RECORD:
DOCUMENT STATING RESULTS ACHIEVED OR PROVIDING EVIDENCE OF ACTIVITIES PERFORMED
OBJECTIVE EVIDENCE
DATA SUPPORTING THE EXISTENCE OR VERIFYING SOMETHING
VALIDATION:
CONFORMATION THROUGH THE PROVISION OF OBJECTIVE EVIDENCE THAT THE REQUIREMENTS FOR A SPECIFIC INTENDED USE OF APPLICATION HAVE BEEN FULFILLED.
DOCUMENTS
What is a Document
a Procedure, WI, quality Manual. Input to Quality System. Can be revised
Controlled document
Responsibility of controller to ensure
LEVEL - I Manual
LEVEL - II
LEVEL - III LEVEL - IV LEVEL - V
Procedures
Work Instructions
Records External Documents Documents
Document Approval
Note : The above flow is applicable for 1.Level 1: Manual 2.Level 2 : Procedures ) 3.Level 3 : Work Instructions 4.Level 4 : Formats
Filled Format is a Record Shows compliance to QMS Documents Out put of quality system e.g Test report, training report, production report Can not be revised
What is data
Test parameters.
Customer Service
sno
ISO9000: 94 version 20
Clauses
20
Eight clauses
3
Focus
Follow what ever we have written & Results are more Important. Continual improvement through Innovations More Focus on corrective & Preventive Activities
Internal audit
More Focus On Results, Corrective actions action against normality. Internal Audit Review EMR/QMR, Processes rejections & actions, Customer feedback & actions, any change All departments involvement
Not only for the sake of documents but to highlight the week points
Management Review
Approach
Generalised
Continual improvement & how systematically TQM/QC/ Inovation scheme / ( Other than Normal corrective actions) Six sigma,Control charts required Training focus & results
Corrective & Preventive actions details Records & results of actions should have Positive Trends if any abnormality. In Trends then some constructive action plan
What is New in ISO 9001 : 2000 ? CLAUSE STRUCTURE & TERMINOLOGY COMMON SYSTEM PRINCIPLES WITH EMS. 9001 & 9004 CLAUSE COMPATABILITY GENERIC REQUIREMENT FOR ALL INDUSTRIES . 9004 TAKES IT BEYOND ISO 9001 PROCESS APPROACH VISIBLE TOP MANAGEMENT INVOLVEMENT
What is New in ISO 9001 : 2000 ? PLANNING OF PRODUCT REALIZATION EFFECTIVENESS OF TRAINING . FEWER DOCUMENTED PROCEDURES. CUSTOMER SATISFACTION . MONITORING , MEASURIMENT OF PROCESSES & PRODUCTS CONTINUAL IMPROVEMENT
FOCUS
ORGANIZATIONS DEPEND ON THEIR CUSTOMERS & THEREFORE SHOULD UNDERSTAND CURRENT AND FUTURE CUSTOMERS NEEDS, SHOULD MEET CUSTOMER REQUIREMENTS AND STRIVE TO EXCEED CUSTOMER EXPECTATIONS. 2.LEADERSHIP LEADERS ESTABLISH UNITY OF PURPOSE AND DIRECTION OF THE ORGANIZATION. THEY SHOULD CREATE AND MAINTAIN THE INTERNAL ENVIRONMENT IN WHICH PEOPLE CAN BECOME FULLY INVOLVED IN ACHIEVING THE ORGANISATIONS OBJECTIVES.
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
4.PROCESS APPROACH
A DESIRED RESULT IS ACHIEVED MORE EFFICIENTLY WHEN ACTIVITIES AND RELATED RESOURCES ARE MANAGED AS A PROCESS.
6. CONTINUAL IMPROVEMENT CONTINUAL IMPROVEMENT OF THE ORGANISATIONS OVERALL PERFORMANCE SHOULD BE A PERMANENT OBJECTIVE OF THE ORGANISATION.
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
EFFECTIVE DECISIONS ARE BASED ON THE ANALYSIS OF DATA AND INFORMATION. 8. MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIPS
AN ORGANISATION AND ITS SUPPLIERS ARE INTERDEPENDENT AND A MUTUALLY BENEFICIAL RELATIONSHIP ENHANCES THE ABILITY OF BOTH TO CREATE VALUE.
5.0.Management Responsibility
6.0.Resource Management 7.0.Product Realization
5.0.Management Responsibility
5.1.Management Commitment 5.2.Customer Focus 5.3.Quality Policy
5.4.1.Quality Objectives
5.4.Planning
5.6.1. General 5.6.Management Review 5.6.2 Review Input 5.6.3 Review Output
6.3.Infrastructure
6.4.Work Environment
7.4.Purchasing
8.2.2.Internal Audit 8.2.3 Monitoring and Measurement of Process 8.2.4 Monitoring and Measurement of Product
8.5. Improvement
2.Material supply & delivery shall be in line with stated specification with continuous efforts to improve cost of procurement and reducing inventory level. 3.There shall be strict adherence to specifications during manufacturing and inspection with emphasis on statistical defect analysis and pre vention in order to continuously improve operational efficiency in the areas of cost of manufacturing , quality and capacity utilization . 4.The sales and distribution network and logistics shall be organized such that there is easy and timely availability of the products to the customer while reducing working capital deployment in FG inventory and debtor.
d) WORKSHOP MANUALS e) SERVICE LEVEL AGREEMENTS f) DRAWINGS g) FLOW CHARTS, PROCESS MAPS
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
Level - II
Level - III
GP / XX / XX Gen. Proce./ Dept. Code / Sr.no WI / XX / XXX Work Instruction / Dept. code / Sr No. XX / XXX / A / YY / MM Dept.code/Sr.no/ Rev status/ Year & month of issue
Level - IV
DEPARTMENT CODING
DEPT. CODE DEPT. CODE
R&D PURCHASE EXPORTS P&A MKTG. & SALES SERVICE FINANCE CALIBRATION AUTO INSERTION
RD PR EX PA MK SC FN CL AI
CKD SKD ENGINEERING QC/QA STORES PLANNING MAINTENANCE ACCOUNTS MANAGEMENT REPRESENTATIVE ENGINEERING
CD SD EN QA ST PN MN AC MR
PRODUCTION HRD
PRD HR
ENGG
product, process and system Root Cause Analysis Product Liability & Market Acceptance Better Work Place and Innovative culture atmosphere Cross Functional cooperation Productivity High,Lead time reduction
Am I able to do it?
How well it has been done? Can I affect it? Do I want to do it? Can I Prove job has been done properly?
Training .
Have been trained on the job you are performing If we are well competent for present Job if no Skill Up Example : During Joining Class room trainings, On the Job Trainings Or any additional training received
Corrective & Preventive actions - Foolproof actions &systems in place Team spirit & system follow
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
QUALITY MANUAL
PURPOSE TO PROVIDE AN ADEQUATE DESCRIPTION OF THE QUALITY MANAGEMENT SYSTEM SERVE AS A PERMANENT REFERENCE IN THE IMPLEMENTATION & MAINTENANCE OF THE SYSTEM. THE REQUIREMENTS AND CONTENTS OF THE QUALITY SYSTEM TO BE STRUCTURED TO ITS RELEVANT STANDARD AND DEFINED IN THE QUALITY MANUAL.