QUALITY SYSTEMS

PTMG8651
TOTAL QUALITY MANAGEMENT
D.P. BALAKRISHNAN
TEACHING FELLOW
DEPARTMENT OF AUTOMOBILE ENGINEERING
MIT CAMPUS
ANNA UNIVERSITY
CHENNAI - 600044
 ISO 9000 SERIES CERTIFICATION
 Quality assurance certificate
 ISO (International Organisation for Standards)
ISO 9004 – Design, Production, Delivery.
ISO 9002 – Production & Delivery.
ISO 9003 – Service Industry [Marketing &
Service]
ISO 9004 – Guidelines for certification
Twenty Clauses to comply with ISO 9000
(1994)………. ISO 9000:2000
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 ISO 9000 SERIES CERTIFICATION
PROCEDURE
 Decide which certification & whether we are eligible.
 Formal training and education about audit systems & quality
management is essential.
 Appoint market representative from the industry He/She
should be a certified quality lead assessment officer.
 Market Representative should prepare the industry to receive
the certification. He has to check whether all the relevant
clauses are followed in process. Any non-confirming preset
are to be identified and set right.
 Third party audit is a must for certification.
 Then certifying body will come for Auditing.
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 ISO 9000 SERIES CERTIFICATION
PROCEDURE
 No non-conformities, certification will be awarded.
 Valid for 3 years and it has to be renewed.
 Surveilence and it must be done for every six months by the
certifying body
 Key points to be noted :
 No need for the entire industry. One department can go for
certification.
 Certification states that the company has the potential in terms of
processes to productivity quality goals.
 Insists on “Documentation”.
 Auditing checks only for correctness of documentation (not the
technology old & new).
 Auditing team may not contain experts and it is not mandatory.
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 DIFFERENT CLAUSES TO BE COMPILED
WITH FOR ISO 9000 CERTIFICATION
S.No SYSTEM ELEMENT ISO 9001 ISO 9002 ISO 9003
1 Management Responsibility √ √ +
2 Quality System √ √ +
3 Contract Review √ √ √
4 Design Control √ × ×
5 Document and Data Control √ √ √
6 Purchasing √ √ ×
7 Customer Supplied Product √ √ √
8 Product Identification and √ √ +
Traceability
9 Process Control √ √ ×
10 Inspection and Testing √ √ +

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- Mandatory; + - Requirement stated but not completed; X – Not Required
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 DIFFERENT CLAUSES TO BE COMPILED
WITH FOR ISO 9000 CERTIFICATION
S.No SYSTEM ELEMENT ISO 9001 ISO 9002 ISO 9003
11 Control of Inspection, Measuring and Test √ √ √
Equipment
12 Inspection and Test Status √ √ √
13 Control of non-conforming product √ √ +
14 Corrective and preventive action √ √ +
15 Handling, Storage, Packaging, Preservation and √ √ √
Delivery
16 Control of Quality Records √ √ +
17 Internal Quality Audit √ √ +
18 Training √ √ +
19 Servicing √ √ ×
20 Statistical Techniques √ √ +
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 QUALITY SYSTEM REQUIREMENTS
1. MANAGEMENT RESPONSIBILITES:
1. Quality Policy
1. Objectives
2. Commitment
3. Customers Need
2. Organization
1. Responsibilities and authority for personal who
1. Initiate Actions
2. Document
3. Provide Solutions
4. Implement Control
2. Resources for managing, working and verifying
3. Management Representative
1. Review at defined intervals
2. Reporting Authority
3. Managements Review
1. Review at defined intervals
2. To maintain continuing effectiveness
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 QUALITY SYSTEM REQUIREMENTS
2.QUALITY SYSTEM:
1. General
 Quality Manual.
 Incorporating structure of the document.
 Makes reference to quality system.
2. Quality System Procedure
 Documented procedures
 Implementation
3. Quality Planning
 Preparation
 Identification and Acquisition of equipment's etc
 Ensuring Compatibility of processes
 Updating Information
 Identification of verification methods
 Clarifications of standards of acceptability
 Preparation of quality records
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 QUALITY SYSTEM REQUIREMENTS
3.CONTRACT REVIEW:
1. General
 Maintain document procedure.
2. Review
 Review the contract,tender,etc.
 Capability to meet the contract requirements o be established.
3. Amendments to contract
 Any amendments to be incorporated.
4. Records
 All records to be maintained.

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 QUALITY SYSTEM REQUIREMENTS
4.DESIGN CONTROL
1. General
 Documentation procedure
2. Design and Development Plans
 Design responsibility
 Assign qualified personal
 Update Plans
3. Organizational and Technical Interfaces
 Interface between design groups to be specified
 Document the interfacing
4. Design Input
 Take into account any contractual requirement
 Other stationary and regulatory requirements to be complied together
 Check for adequacy
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 QUALITY SYSTEM REQUIREMENTS
4.DESIGN CONTROL
5. Design Output
 Should meet input requirements
 Identify crucial features – storage, disposal etc.
 Review before release
6. Design Review
 Review to be planned at regular intervals
7. Design Verification
 Do alternative calculation and verify.
 Compare with proven in practice.
 Undertake testing and demonstration.

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 QUALITY SYSTEM REQUIREMENTS
4.DESIGN CONTROL
8. Design Validation
 Validation is to check product conform to user needs.
 Validation under defined operating conditions.
 Even may be done prior to product completion
 Multiple validation may be done
9. Design Changes
 Design changes must be approved by authorised persons.

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 QUALITY SYSTEM REQUIREMENTS
5.DOCUMENTATION AND DATA CONTROL:
1. General
 Documented procedure
 External documents to be maintained
 It can be in any media, electronic or hard copy
2. Document and Data Approval and Issue
 Documents to be approved by authorized personnel
 Documents to be available at appropriate location
 Obsolete documents to be removed promptly
 Old documents to be labelled properly
3. Document and Data Changes
 Changes to be approved by same personnel who performed the original change
 Nature of change brought to be specified

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 QUALITY SYSTEM REQUIREMENTS
6.PURCHASING:
1. General
 Proof to be maintained
2. Evaluation of Sub-Contractors
 Evaluation procedure
 Define extent of control exercised by supplier own sub contractors
 Maintain Quality records of subcontractors
3. Purchasing Data
 Type, class, grade of product ordered are to be specified and
documented
 Raw material inspections instructs to be drawn out
4. Verification of Purchased Product
 Supplier verification avail sub contractors premises
 Customer verification of subcontracted product

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 QUALITY SYSTEM REQUIREMENTS
7.CONTROL OF CUSTOMER SUPPLIED PRODUCT
 Maintain documented procedure for control of verification, storage
and maintenance of customer supplied product.
8.PRODUCT IDENTIFICATION AND TRACEBILITY
 Method for identifying the product by suitable means from receipt
of raw materials to delivery of finished goods.
9.PROCESS CONTROL
 Production, installation and servicing to be planned and carried out
under controlled conditions.
 Suitable working environment to be provided
 Compliance with standards/codes to be checked
 Process parameters and product characteristics
 Validation of processes to be checked
 Criteria for workmanship
 Maintenance procedures for equipments
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 QUALITY SYSTEM REQUIREMENTS
10.INSPECTION AND TRAINING:
1. General
 To very that specified requirements for the product are not.
2. Reviewing Inspection and Testing
 Ensure that the incoming product is not used until it is inspected
 Inspection may take place at subcontractors premises, if so documents should be available
 Due to urgency, if the product is released prior to inspection, it has to be identified and
recorded.
3. In process Inspection and Testing
 Required inspection and testing to be done as per quality plan before the product moves to
meet process
4. Final Inspection and Testing
 Before the product moves out
 Signed by authorised person
5. Inspection and Test Records
 Maintain all inspection/test records to provide evidence

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 QUALITY SYSTEM REQUIREMENTS
11.CONTROL OF INSPECTION, MEASURING & TEST
EQUIPMENT
1. General
 All inspection, measuring and test equipment to be calibrated and kept in
good conditions
 To be checked at frequent intervals
2. Control Procedure
 Define accuracy of measurement required and select appropriate
instruments
 Calibration procedure to be documented
 Identification record to show the calibration status to be maintained
 Validity of previous inspection to be documented, in case the instrument
is found to be out of calibration
 Ensure suitable environment conditions for measurement, calibration etc
 Handling, storage procedure to be defined so as to maintain accuracy
 Safe guard the testing facilities to maintain calibration and testing
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 QUALITY SYSTEM REQUIREMENTS
12.INSPECTION AND TEST STATUS
To ensure that only product that has passed the required inspection
and test is depatched.
13.CONTROL OF NON-CONFROMING PRODUCT
14.CORRECTIVE AND PREVENTIVE ACTION
15.HANDLING, STORAGE, PACKAGING, PRESERVATION AND
DELIVERY
16.CONTROL OF QUALITY RECORDS
17.INTERNAL QUALITY AUDIT
18.TRAINING
19.SERVICING
20.STATISTICAL TECHNIQUES

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 MODEL OF A PROCESS-BASED QUALITY
MANAGEMENT SYSTEM

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 ISO 9000:2000 CERTIFICATION
 Now ISO 9000 : 2000 Quality Management principle behind
certification:
Customer focused organization
Leadership
Involvement of people
Process approach
Systems approach to management
Continued improvement
Factual approach to decision making
Mutual Beneficial Supplier Relationship

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 ISO 9000:2000 CERTIFICATION
ISO 9000 : 2000 – QMS fundamentals and vocabulary
ISO 9001 : 2000 – QMS requirements
ISO 9004 : 2000 – QMS guidance for performance improvement

OBJECTIVE ISO 9000 : 2000 CERTIFICATION

 To demonstrate the organization ability to provide a product that
meets customer requirements on a continuous and sustainable
manner.
 To address customer satisfaction through effective application of the
system, including processes continuous improvement and
prevention of non-conforming
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 ELEMENTS OF ISO 9000 : 2000
CERTIFICATION
1. Scope
1. General
2. Application
2. Normative reference
3. Terms and conditions
4. General requirements
1. General Requirements
2. General documentation requirements
1. General
2. Quality Mannual
3. Control Docuements
4. Control of records

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 ELEMENTS OF ISO 9000 : 2000
CERTIFICATION
5. Management Responsibility
1. Management commitment
2. Customer Focus
3. Quality Policy
4. Planning
1. Quality Objectives
2. Quality Management System Planning
5. Responsibility, Authority and communication
1. Responsibility and Authority
2. Management Representative
3. Internal Communication
6. Management Review
1. General
2. Review Input
3. Review Output
6. Resource Management
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 ELEMENTS OF ISO 9000 : 2000
CERTIFICATION
7. Product Realization
1. Planning of Product realization
2. Customer related processes
1. Determination of customer requirements related to product
2. Review of requirements related to the product
3. Customer Communication
3. Design and Development
1. Design & Development planning
2. Design & Development inputs
3. Design & Development outputs
4. Design & Development review
5. Design & Development verification
6. Design & Development validation
7. Design & Development charges
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 ELEMENTS OF ISO 9000 : 2000
CERTIFICATION
7. Product Realization
4. Purchasing
1. Purchasing process
2. Purchasing information
3. Verification of purchased product
5. Production and service provision
1. Control of production and service provision
2. Validation of processes for production & service provision
3. Identification & Traceability
4. Customer properly
5. Preservation of product
6. Control, Monitoring and measurement devices

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 ELEMENTS OF ISO 9000 : 2000
CERTIFICATION
8. Measurement, Analysis and Improvement
1. General
2. Monitoring and Measurement
1. Customer Satisfaction
2. Internal Audit
3. Monitoring & Measurement of process
4. Monitoring & Measurement of product
3. Control of Non-Conforming product
4. Analysis of Data
5. Improvement
1. Continual improvement
2. Corrective action
3. Preventive action

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 STEPS IN IMPLEMENTATION OF QMS
1. Top Management Commitment
2. Appoint the management representative
3. Awareness
4. Appoint as implementation team
5. Training
6. Time schedule
7. Select Element owners
8. Review the present system
9. Write the documents
10. Install the New system
11. Internal Audit
12. Management Review
13. Pre assessment (Optimal)
14. Registration
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 DOCUMENTATION PYRAMID
Define WHAT will be done
WHY - Stated once Policy
WHO

Procedures WHEN
WHERE

HOW Work Instructions EVIDENCE

[or] Practices
Records [or] Proof
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 ISO 14000 SERIES CERTIFICATION
 Developed by ISO for managing environmental impacts ISO
14000 consists of
 Specification standards
 Guidance standards
 ISO 14000 addresses six distinct but related subjects:
1. Environmental Management System (EMS)
2. Environmental Auditing (EA)
3. Environmental Performance Evaluation (EPE)
4. Environmental Labelling (EL)
5. Life Cycle Assessment (LCA)
6. Environmental Aspects in Product Standards (EAPS)

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 ISO 14000 SERIES CERTIFICATION
EL

PRODUCT ORIENTED
EAPS
STANDARDS
ISO 14000

LCA

EMS

PROCESS ORIENTED
EPE
STANDARDS

EA
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 ISO 14000 SERIES CERTIFICATION

 PROCESS STANDARDS
ISO 14001 – EMS [Specification with guidance for use]
ISO 14004 – EMS [General guidelines, systems & supporting
techniques]
ISO 14010 – GUIDELINES FOR EA [General principles]
ISO 14011 – GUIDELINES FOR EA [Audit procedures]
ISO 14012 – AUDIT CRITERIA
ISO 14031 - EPE

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 ISO 14000 SERIES CERTIFICATION
 PRODUCT STANDARDS
ISO 14020 – EL [Genreal principles]
ISO 14024 – EL [Guide for certification procedure]
ISO 14040 – ENVIRONMENTAL MANAGEMENT – LCA
[Principles & guidlines]
ISO 14042 – ENIVRONMENTAL MANAGEMENT LCA [Life
cycle impact assessment]
ISO 14060 – GUIDE FOR INCLUSION OF EAPS

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 ENVIRONMENTAL MANAGEMENT SYSTEM
MODEL

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 Requirements of ISO 14001
1. General Requirements
2. Environmental Policy
3. Planning
4. Implementation and Operation
5. Checking and Corrective Action
6. Management Review
[Six parts and 18 requirement clauses]

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 Benefits of EMS - Global
 Facilitate trade and remove barriers.
 Improve environmental performance of planet earth.
 Build consensus that there is a need for environmental
management and a common terminology for EMS.
 Unity countries in their approach to labelling, environment
management and life cycle assessment.
 It improves regulatory compliance.
 Help people in different countries in sharing improvement
ideas, prevention information and system problem.

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 QUALITY AUDITING
 Quality certification are issued after conducting quality
auditing in a systematic manner.
 Auditing procedure is aimed at checking if the practices
followed confirms with the quality management or not.
 Types of Quality Audit : [Based on type of Auditing]
 First Party Audit
 Second Party Audit : Conducted by purchases on the supplier of
goods
 Third Party Audit : Certifying Agents

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 QUALITY AUDITING
 Based on Area of Coverage:
 System Audit: Activities of Organization
 Process Audit : Manufacturing or Process Audit
 Product Audit : Products conform to specified standards
 Other types:
 Adequacy Audit : Documented procedures compliance with
requirements
 Compliance Audit : Document procedure implemented
certification valid
 Time Frame
 Initial Audit : Certification valid for 3 years
 Surveillance Audit : Once in Six months after certification
 Renewal Audit : For another 3 years
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 BENEFITS OF QUALITY AUDITING
 Make people know where they stand in quality.
 Adequacy and suitability of them to the projected objectives
is made known.
 Effectiveness of the system is found out.
 Non-conformities identified helps in analysing the process.
 Problem solving is taken up with high priority and system
once non-con formatted are projected.
 Helps in proper decision making.
 Brings employees together.
 Capabilities of the process and equipment are established.
 Helps in meeting legal and stationary requirements indirectly
it facilitates training.
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 ORGANIZATIONAL BENEFITS
 Assuring customers of a commitment to environmental
management.
 Meeting customer requirements, the primary reason for
organizations to become certified.
 Maintaining a good public/community relations image.
 Satisfying investor criteria and improving access to capital.
 Increasing market share that results from a competitive
advantage.
 Reducing incidents that results in liability.
 Improving defence posture in litigation.

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 ORGANIZATIONAL BENEFITS
 Conserving input materials and energy.
 Facilitating the attainment of permits and improving
industry/government relations, authorization.
 Cost effective
 Enhanced internal communication
 Enhanced decision making
 Improved team work
 Focus on prevention

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THANK YOU !!!