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8/2/2019 Training Iso 9001 Final
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WELCOME TO
AWARENESS TRAINING PROGRAMME
ISO 9001: 2000
Quality Management System
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Development of ISO 9001 Standard
AQAP (1969)
BS 5750 (1979)
MILQ-9858A (1963)
ISO9001 (1987)
ISO9001 (1994)
ISO9001 (2000)
ISO9001 (2008)
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ISO
INTERNATIONAL ORGANISATION
FOR STANDARDIZATION (I S O)
BASED IN GENEVA, SWITZERLAND
STARTED OPERATIONS IN 1947.
MORE THAN 140 NATIONAL BODIESINCLUDING INDIA ARE MEMBERS
MORE THAN 130 COUNTRIES HAVEADOPTED THIS STANDARD.
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WHY ISO ?
ISO CERTIFICATION IS IDENTIFIED AS A :
BEST IN CLASS INITIATIVE IN STRATEGIC
BUSINESS PLAN
-- MONITOR , ANALYZE AND IMPROVE PERFORMANCE AND
CONFORMANCE
-- PREVENT AND REDUCE PROBLEMS (NON CONFORMANCES)
-- OPERATIONAL EFFICIENCY THORUGH PROCESSCONSISTENCY.
COMITTMENT TO CONTINUAL IMPROVEMENT
-- 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.
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Road to ISO Certification
Start
ISO
Cert
ISO
Cert
3 yrs?
Decision
for ISO Cet.
INTRO.
ISO STD to
MGMT
SELECT
MR
INTERNAL
AWARENESS
MR
TRG
DOC.
CONTROL
MAKE
SOPTRG.
EMPLOYEES
DOC.
MANUAL
Q.POLICY
GAP
ANALYSIS.
INT.AUDITOR
TRAINING
PERFORM
INTERNAL
AUDIT
MGMT
REVIEWPRE-
ASSESSMENT
REGIST.
AUDIT
RE-
REGIST.
SURV.
AUDIT 3 YrsCycle
MGMT
REVIEW
PERFORM
INTERNAL
AUDIT
Yes
No
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The ISO Model
Continual Improvement of the QMS
ResourceManagement
Measurement,Analysis,
Improvement
ManagementResponsibility
ProductRealization Product
Inputs Outputs
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PDCA Cycle
2. DO
Try plan ona test basis
1. PLAN
Identify im-provements anddevelop plan
3. CHECK
Evaluate planto see if it
works
4. ACT
Permanentlyimplement
improvements
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Analysis of Data
Customer
RequirementsStatutory
Requirements
Defect Rate &
Customer Returns
QMS Control
Purchasing
Organizational
Results
Customer
SatisfactionStatutory
Compliance
QMS Metrices
Insp.& Testing
Supplier
Performance
OrganizationalObjectives
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QMS MODEL O ll
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ONIDAmay cause envyMIRC ELECTRONICS LTD
QMS MODEL Overall
QMSCertfy.
Body
Senior
MgmtHR
QAAudits for
Compliances
Reviews &
Evaluates
Certifies
Mfg
Sales /
Mktg
Customer
ServiceFinance
Finance
Accounts
Taxation
Personnel
Admin
HR
After
Sales
ServiceSales Marketing
Logistics
Prod. PurchasePlanning Maintenance
Stores
R &D
Design Developmen
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Typical Product Life Cycle
Marketing&FinalizingContract
DesigningProcurement
Process/Planning
Identifying
Inspection &Testing
Servicing
Handling,Storage,Packing &Delivery
Corrective/PreventiveAction
Nonconforming
Material Control
Mark Teststatus
ManagementResp & QSystem
Documents
Control of
Equipments
InternalAuditing/
Training
Statistics
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
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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 areknown 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
Innovation: A way To Remain Ahead
ISO 9000 / ISO 14000 FAMILY
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Management system" refers to theorganization's structure for managing its
processes - or activities - that transform
inputs of resources into a product orservice which meet the organization's
objectives,
Innovation: A way To Remain Ahead
ISO 9000 / ISO 14000 FAMILY
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ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
ISO FAMILY OF STANDARDS
ISO 9001 : 2000 -- Fundamentals & Vocabulary
ISO 9001 -- Requirements
ISO 9004 -- Guidelines for PerformanceImprovements
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ISO 9004 2000 SCOPE
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ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
ISO 9004 : 2000 SCOPE
Provides guidelines and recommendationsBeyond the requirements of ISO 9001:2000& is Published together as ISO 9004: 2000
Making them Consistent Pair .
C ti l I t
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Evaluate & Select
Solution
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
Continual Improvement
Analyze &
EvaluateData
Establish
Objectives
Search for solutionsTo achieve the
Objective
Implement theSelected Solution
Monitor ,Analyze &Evaluate Results
Formalize the
ChangesProcess
WHAT IS QUALITY ?
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QUALITY ISCONFORMANCE TO REQUIREMENTS
RIGHT FIRST TIME
ON TIME
EVERY TIME
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
WHAT IS QUALITY ?
CUSTOMER SATISFACTION
COST OF POOR PERFORMANCE REPEAT BUSINESS
INCREASED PROFITABILITY
WHY QUALITY ?
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MISCONCEPTIONS OF QUALITY
QUALITY MEANS LUXURY
QUALITY PROBLEMS ARE CAUSED BYOPERATORS
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 GOBESIDE
ITNA TO CHALTA HAI CONCEPTISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
TERMINOLOGY
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TERMINOLOGY
PRODUCT : RESULT OF A PROCESS.
NOTE: FOUR GENERIC CATEGORIES:
HARDWARE
SOFTWARE
SERVICES
PROCESSED MATERIALS
MAY ALSO BE A COMBINATION OF GENERICCATEGORIES.
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
TERMINOLOGY
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PROCESS:
A SET OF INTERRELATED OR INTERACTINGACTIVITIES WHICH TRANSFORMS INPUTSINTO OUTPUTS.
QUALITY:
QUALITY IS A DEGREE TO WHICH A SET OFINHERENT CHARACTERISTICS FULFILSREQUIREMENTS.
QUALITY CONTROL:
PART OF QUALITY MANAGEMENT FOCUSSEDON FULFILLING QUALITY REQUIREMENTS.
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
TERMINOLOGY
TERMINOLOGY
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QUALITY ASSURANCE:
PART OF QUALITY MANAGEMENT FOCUSSEDON PROVIDING CONFIDENCE THAT QUALITYREQUIREMENTS WILL BE FULFILLED.
QUALITY MANAGEMENT SYSTEM:
A MANAGEMENT SYSTEM TO DIRECT ANDCONTROL AN ORGANISATION WITH REGARDTO QUALITY.
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
TERMINOLOGY
DEFECT:
NON FULFILLMENT OF REQUIREMENT RELATEDTO AN INTENDED OR SPECIFIED USE.
TERMINOLOGY
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ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
TERMINOLOGY
QUALITY POLICY:Overall intentions and direction of an organization
related to quality as formally expressed by topmanagement.
QUALITY OBJECTIVE :Something sought, or aimed for, related to quality.
CONTINUAL IMPROVEMENT :RECURRING ACTIVITY TO INCREASE THE ABILITY TOFULFILL REQUIREMENTS
TERMINOLOGY
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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 UNDESIRABLESITUATION
PREVENTIVE ACTION :
ACTION TO ELIMINATE THE CAUSE OF A POTENTIAL
NON CONFORMITY OR OTHER UNDESIRABLEPOTENTIAL SITUATION
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
TERMINOLOGY
TERMINOLOGY
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DOCUMENTINFORMATION AND ITS SUPPORTING MEDIUM.
RECORD:DOCUMENT STATING RESULTS ACHIEVED
OR PROVIDING EVIDENCE OF ACTIVITIES PERFORMED
OBJECTIVE EVIDENCEDATA SUPPORTING THE EXISTENCE OR VERIFYINGSOMETHING
VALIDATION:
CONFORMATION THROUGH THE PROVISION OFOBJECTIVE EVIDENCE THAT THE REQUIREMENTS FOR
A SPECIFIC INTENDED USE OF APPLICATION HAVE
BEEN FULFILLED.
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
TERMINOLOGY
DOCUMENTS
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Innovation: A way To Remain Ahead
DOCUMENTS
What is a Document
a Procedure, WI, quality Manual.
Input to Quality System.
Can be revised
Controlled document
Responsibility of controller to ensureupdation as and when there is a revision
Need to have Issue stamp.
DOCUMENT STRUCTURE ISO 9001 : 2000
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Innovation: A way To Remain Ahead
DOCUMENT STRUCTURE ISO 9001 : 2000
LEVEL - I
LEVEL - II
LEVEL - III
LEVEL - IV
LEVEL - V
ManualProcedures
Work Instructions
External Documents Documents
Records
DOCUMENT FLOW ISO 9001 : 2000
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ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
Updation of Master Listof Documents Obsoletein Intranet
Document Preparation
Document Approval
Document submissionby dept to MR.
Updation of DocumentChange History Record& Master List ofDocuments
Note : The above flow is applicable for
1.Level 1: Manual
2.Level 2 : Procedures )3.Level 3 : Work Instructions
4.Level 4 : Formats
Disposal of Old(Obsolete Doc.)
MaintainIssuanceRecords
Document Issuance byMR.
DOCUMENT FLOW ISO 9001 : 2000
RECORDS
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Innovation: A way To Remain Ahead
RECORDS
What is a Record
Unfilled Format is a document butFilled 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.
E.g test result in the check sheets/soft copy in PC
RECORDS
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Innovation: A way To Remain Ahead
Records should have
-- Identification-- Storage
-- Retrieval
-- Retention (Time Interval)
-- Disposal-- Indexing
Records should be
-- Legible
-- Identifiable
-- Traceable
RECORDS
PROCESS MODEL APPROACH
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PROCESS MODEL APPROACH
THE APPLICATION OF A SYSTEM OF PROCESSES WITH INAN ORGANISATION, TOGETHER WITH THE
IDENTIFICATION AND INTERACTIONS OF THESEPROCESSES, AND THEIR MANAGEMENT.
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
Understand
Markets &
Customers
Develop
Vision &
Strategy
Design
Products &
Services
Market
&
Sell
Produce
Products /
Services
Customer
Service
Typical Process Flow
ISO1994 version & ISO 2000 version Comparisons
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APC case study
sno Parameter ISO9000: ISO 9001: Remarks
94 version 2000
1 Mandatory 20 6 6 mandatory Procedures
Procedures
2 Clauses 20 8 All 20 Clauses Merged with
Eight clauses
3 Focus What we have wrote, Follow
& write what we are following
More Focus on documentation Less focus on documentation
4 Internal audit More Focus on system follow
5 Management Only Internal audit review Internal Audit Review EMR/QMR,
Review Processes rejections & actions,
Customer feedback & actions, any change
All departments involvement6 Approach Generalised Continual improvement & how systematicallyTQM/QC/ Inovation scheme /
( Other than Normal corrective actions) Six sigma,Control charts required
Training focus & results
7 corrective Just Activity verification Corrective & Preventive actions details
& Preventive Records & results of actions should have
Actions Positive Trends if any abnormality.
In Trends then some constructive action plan
ISO 2000 for continual improvement rather then only documentation
Record of corrective & preventive
actions (Quality Record)
ISO1994 version & ISO 2000 version Comparisons
More Focus On Results, Corrective actions
action against normality.
Not only for the sake of document
but to highlight the week points
Continual improvement through
Innovations
Follow what ever we have written & Results are
more Important.
More Focus on corrective & PreventiveActivities
What is New in ISO 9001 : 2000 ?
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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
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
What is New in ISO 9001 : 2000 ?
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What is New in ISO 9001 : 2000 ?
PLANNING OF PRODUCT REALIZATION
EFFECTIVENESS OF TRAINING . FEWER DOCUMENTED PROCEDURES.
CUSTOMER SATISFACTION .
MONITORING , MEASURIMENT OFPROCESSES & PRODUCTS
CONTINUAL IMPROVEMENT
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
EIGHT MANAGEMENT PRINCIPLES
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CUSTOMER FOCUSLEADERSHIPINVOLVEMENT OF PEOPLEPROCESS APPROACHSYSTEM APPROACH TO MANAGEMENTCONTINUAL IMPROVEMENTFACTUAL IMPROVEMENT TO DECISION MAKINGMUTULALLY BENEFICAL SUPPLIER RELATIONSHIP
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
EIGHT MANAGEMENT PRINCIPLES
EIGHT MANAGEMENT PRINCIPLES
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1.CUSTOMERFOCUS
ORGANIZATIONS DEPEND ON THEIR CUSTOMERS& THEREFORE SHOULD UNDERSTAND CURRENTAND FUTURE CUSTOMERS NEEDS, SHOULD MEETCUSTOMER REQUIREMENTS AND STRIVE TOEXCEED CUSTOMER EXPECTATIONS.
2.LEADERSHIP
LEADERS ESTABLISH UNITY OF PURPOSE ANDDIRECTION OF THE ORGANIZATION. THEY
SHOULD CREATE AND MAINTAIN THE INTERNALENVIRONMENT IN WHICH PEOPLE CAN BECOMEFULLY INVOLVED IN ACHIEVING THEORGANISATIONS OBJECTIVES.
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
EIGHT MANAGEMENT PRINCIPLES
EIGHT MANAGEMENT PRINCIPLES
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3. INVOLVEMENT OF PEOPLE
PEOPLE AT ALL LEVELS ARE THE ESSENCE OF ANORGANIZATION AND THEIR FULLINVOLVEMENT ENABLES THEIR ABILITIES TO
BE USED FOR THE ORGANISATIONS BENEFIT.4.PROCESS APPROACH
A DESIRED RESULT IS ACHIEVED MORE
EFFICIENTLY WHEN ACTIVITIES AND RELATEDRESOURCES ARE MANAGED AS A PROCESS.
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
EIGHT MANAGEMENT PRINCIPLES
EIGHT MANAGEMENT PRINCIPLES
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5. SYSTEM APPROACH TO MANAGEMENT
IDENTIFYING, UNDERSTANDING AND MANAGINGINTERRELATED PROCESSES AS A SYSTEMCONTRIBUTES TO THE ORGANIZATIONSEFFECTIVENESS AND EFFICIENCY IN ACHIEVING ITS
OBJECTIVES.
6. CONTINUAL IMPROVEMENT
CONTINUAL IMPROVEMENT OF THE
ORGANISATIONS OVERALL PERFORMANCE SHOULDBE A PERMANENT OBJECTIVE OF THEORGANISATION.
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
EIGHT MANAGEMENT PRINCIPLES
EIGHT MANAGEMENT PRINCIPLES
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7. FACTUAL APPROACH TO DECISION MAKING
EFFECTIVE DECISIONS ARE BASED ON THEANALYSIS OF DATA AND INFORMATION.
8. MUTUALLY BENEFICIAL SUPPLIERRELATIONSHIPS
AN ORGANISATION AND ITS SUPPLIERS ARE
INTERDEPENDENT AND A MUTUALLYBENEFICIAL RELATIONSHIP ENHANCES THE
ABILITY OF BOTH TO CREATE VALUE.
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
EIGHT MANAGEMENT PRINCIPLES
QUALITY SYSTEM ELEMENTS- ISO 9001:2000
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QUALITY SYSTEM ELEMENTS ISO 9001:2000
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
ISO 9001 : 2000
4.0. Quality Management System
5.0.Management Responsibility
6.0.Resource Management
7.0.Product Realization
8.0.Measurement Analysis & Improvement
1.0. Scope
2.0. Normative Reference
3.0. Terms and Definitions
QUALITY SYSTEM ELEMENTS- ISO 9001:2000
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Q
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
4.1.General Requirement
4.0. Quality Management System
4.2.Documentation.Requirement
5.0.Management Responsibility
5.1.Management Commitment
5.2.Customer Focus
5.3.Quality Policy
5.4.Planning
4.2.1.General Requirement
4.2.2. Quality Manual4.2.3 Control of Documents
4.2.4. Control of Records
5.4.1.Quality Objectives
5.4.2 Quality ManagementSystem Planning
QUALITY SYSTEM ELEMENTS- ISO 9001:2000
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Q
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
5.0.Management Responsibility
5.5. Responsibility ,Authority &Communication
5.6.Management Review
5.5.1.Responsibility & Authority
5.5.2. Management Representative
5.5.3 Internal Communication
5.6.1. General
5.6.3 Review Output
5.6.2 Review Input
QUALITY SYSTEM ELEMENTS- ISO 9001:2000
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Q
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
6.0.Resource Management
6.1.Provision of Resources
6.2.Human Resources
6.3.Infrastructure
6.4.Work Environment
6.2.1. General
6.2.2. Competency , Awareness& Training
QUALITY SYSTEM ELEMENTS- ISO 9001:2000
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Q
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
7.0.Product Realization
7.1.Planning of ProductRealization
7.2.Customer RelatedProcess
7.3.Design & Development
7.4.Purchasing
7.6.Control of Monitoring &
Measuring Devices
7.5 Production & ServiceProvision
7.2.1.Customer Related Processes
7.2.2. Determination of
Requirements related to Product
7.2.3 Review of Requirements
7.3.1.Design and Development
7.3.2. Design and Development
Inputs
7.3.3 Design & Dev.Ouputs
7.3.4 Design & Dev.Review
7.3.5 Design & Dev. Verification
7.3.6 Design & Dev.Validation
QUALITY SYSTEM ELEMENTS- ISO 9001:2000
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ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
7.0.Product Realization
7.4.Purchasing
7.6.Control of Monitoring &
Measuring Devices
7.5 Production & Service
Provision
7.4.1.Purchasing Processes
7.4.2. Purchasing Information
7.4.3 Verification of PurchasedProduct
7.5.1. Control of Production &Service Provision
7.5.2. Validation of Processes forProduct & Service Provision
7.5.3 Identification & Traceability
7.5.4 Customer Property
7.5.5 Preservation of Product
QUALITY SYSTEM ELEMENTS- ISO 9001:2000
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Q
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
8.0.Measurement Analysis&Improvement
8.1. General
8.2. Monitoring &Measurement
8.3. Control of NonConforming Product
8.4. Analysis of Data
8.5. Improvement
8.5.1 Continual Improvement
8.5.2 Corrective Action
8.5.3 Preventive Action
8.2.1.Customer Satisfaction
8.2.2.Internal Audit
8.2.3 Monitoring and Measurementof Process
8.2.4 Monitoring and Measurementof Product
QUALITY POLICY-MIRC ELECTRONICS
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QUALITY POLICY-MIRC ELECTRONICS
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
Quality Policy
We are committed to qualityAnd
Strive for continuous improvementthrough
innovation and human development
to give the customerbetter value for money
always
Re- affirmed ( G. L. MIRCHANDANI )19. 07. 2001 CHAIRMAN & MANAGING
DIRECTOR
QUALITY OBJECTIVES-MIRC ELECTRONICS
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QUALITY OBJECTIVES MIRC ELECTRONICS
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
1.The product shall be designed and developed to meet thecustomers quality requirements including safety and reliability.
2.Material supply & delivery shall be in line with stated specificationwith continuous efforts to improve cost of procurement andreducing inventory level.
3.There shall be strict adherence to specifications duringmanufacturing and inspection with emphasis on statistical defectanalysis and pre vention in order to continuously improveoperational efficiency in the areas of cost of manufacturing , qualityand capacity utilization .
4.The sales and distribution network and logistics shall be organizedsuch that there is easy and timely availability of the products to thecustomer while reducing working capital deployment in FG inventoryand debtor.
QUALITY OBJECTIVES-MIRC ELECTRONICS
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QUALITY OBJECTIVES MIRC ELECTRONICS
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
5.There shall be constant endeavor to increasecustomer satisfaction by reducing field failure
rate continuously and by providing timely andefficient after sales service.
6.Feed back continuously obtained from customers ,
both internal and external, shall be used forimprovement of product, services and internalprocesses.
7.Employees shall be deployed with right competence whichshall be continuously upgraded with training to improve
overall performance.
PROCEDURES REQUIRED BY ISO 9001:2000
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Q
PROCEDURE FOR CONTROL OF DOCUMENTS (CL. 4.2.3)
PROCEDURE FOR CONTROL OF RECORDS (CL. 4.2.4)PROCEDURE FOR INTERNAL AUDITS (CL. 8.2.2)
PROCEDURE FOR CONTROL OF NONCONFORMING
PRODUCT (CL. 8.3)
PROCEDURE FOR CORRECTIVE ACTION (CL. 8.5.2)
PROCEDURE FOR PREVENTIVE ACTION (CL. 8.5.3)
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
SUPPORTING DOCUMENTS REQUIRED
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SUPPORTING DOCUMENTS REQUIREDBY ISO 9001:2000
a) PROCEDURES (THOUGH NOT SPECIFICALLYCALLED FOR)
b) WORK INSTRUCTIONS, STANDARDOPERATING PROCEDURES (SOPS)
c) FORMS, CHECKLISTS, GUIDELINES
d) WORKSHOP MANUALS
e) SERVICE LEVEL AGREEMENTS
f) DRAWINGSg) FLOW CHARTS, PROCESS MAPS
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
CODIFICATION DOCUMENTS ISO 9001 2000
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CODIFICATION DOCUMENTS ISO 9001:2000
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
C. Codification
Level - I 6 digitalphanumeric code
QMS-MIRC
Level - II 6 digit
alphanumeric code
GP / XX / XX
Gen. Proce./ Dept. Code /Sr.no
Level - III 7 digitalphanumeric code
WI / XX / XXXWork Instruction / Dept. code /Sr No.
Level - IV 10 digit
alphanumeric codeXX / XXX / A / YY / MM
Dept.code/Sr.no/ Rev status/Year & month of issue
DEPARTMENT CODING
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ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
DEPT. CODE DEPT. CODE
R&D
PURCHASE
EXPORTS
P & A
MKTG. & SALES
SERVICE
FINANCE
CALIBRATION
AUTO INSERTION
PRODUCTION
HRD
RD
PR
EX
PA
MK
SC
FN
CL
AI
PRD
HR
CKD
SKD
ENGINEERING
QC/QA
STORES
PLANNING
MAINTENANCE
ACCOUNTS
MANAGEMENTREPRESENTATIVE
ENGINEERING
CD
SD
EN
QA
ST
PN
MN
AC
MR
ENGG
Why Quality Management System?
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y Q y g y
Reduction of Rejection
Facilitate continuous Improvement
Identification of existing and potential problems inproduct, process and system
Root Cause Analysis
Product Liability & Market Acceptance
Better Work Place and Innovative cultureatmosphere
Cross Functional cooperation
Productivity High,Lead time reduction
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
Why Quality Management System?
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What do I do?
How do I do?
Am I able to do it?
How well it hasbeen done?
Can I affect it?
Do I want to do it?
Can I Prove job hasbeen doneproperly?
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
y Q y g y
Specs, Drg, Pur requisitions,
Contracts
Procedures, Instructions,
experience, qualification,
Training
Resources, Material, Eqpt, info,
Experience, attributes
Measurement and comparison
Feedback, Involvement, C/S
MotivationRecords, certification, Audits
Need to Look for.
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Need to Look for. Quality Policy & Objectives Documented, understood,
implemented and maintained.
Responsibility, Authority and interrelation of personnel. Work Instruction, Test Engineering Procedures, Flow charts
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
Identification & Traciability .
Parts stored in the area is identified with appropriate part no.
Component storage is as per Min./Max system
Rejected material is stored in Red bin and designated area
Rejected material is Identified with appropriate markings
Failed Product or PCB is stored with Test Failure slip
Material handling through tracibility
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
Need to Look for.
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7S & Mind Innovation- Shop floor neat &clean-no unwanted material near our places
-Clear Gangways-Clear identification-Visual factory-positive attitude
-First accept problem ,Analyze &then come back
-we are part of problem or part of solution .
Measurements in data-Data integrity
-Data collection mechanism
Corrective & Preventive actions- Foolproof actions &systems in place
Team spirit & system follow
ISO 9001:2000 VERSION FOR CONTINUAL IMPROVEMENT
QUALITY MANUAL
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Q
PURPOSE
TO PROVIDE AN ADEQUATE DESCRIPTION OF THEQUALITY MANAGEMENT SYSTEM
SERVE AS A PERMANENT REFERENCE IN THEIMPLEMENTATION & MAINTENANCE OF THE
SYSTEM. THE REQUIREMENTS AND CONTENTS OF THE
QUALITY SYSTEM TO BE STRUCTURED TO ITSRELEVANT STANDARD AND DEFINED IN THEQUALITY MANUAL.
USES OF QUALITY MANNUAL
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Q
EFFECTIVE IMPLEMENTATION OF THE QUALITY
SYSTEM
COMMUNICATION OF THE COMPANYS QUALITYPOLICY, STANDARDS OR REQUIREMENTS
PROVIDING IMPROVED CONTROL OF PRACTICES
AND FACILITATING MANAGEMENT OF ACTIVITIES
PROVIDING A BASIS FOR AUDITING
PROVIDING FOR CONTINUITY OF QUALITY SYSTEM,ITS REQUIREMENTS AND METHODS DURING
CHANGING CIRCUMSTANCES