Quality Management Quality Management

Agenda
      

Quality Management Introduction to ISO 9000 Introduction to QS 9000 & TS 16949 Comparison of ISO 9001 & TS 16949 Requirements Documentation Requirement Types of Audits Need for Certification

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Quality Management Quality Management

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Quality Management Quality Management

What is Quality
Quality :
Degree to which a set of inherent characteristics fulfils requirements (As per ISO 9000)
Inherent Characteristics means permanent characteristics E.g. Reliability – the mean time between failure Durability - how long the product lasts Aesthetics – how the product looks Cost, Serviceability

Requirement : - Need or expectation that is stated or implied - Requirements can be different for end user.

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Quality Management Quality Management

What is Quality
Quality :

The quality of something can be determined by comparing a set of inherent characteristics against a set of requirements. If those inherent characteristics meet all requirements, good quality is achieved. If those characteristics do not meet all requirements, a low or poor level of quality is achieved. According to this definition, quality is a relative concept. Quality is always relative to a set of requirements.

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distribution.Quality is determined by every process. as well as in the event of applications for industrial property rights. . editing. and subproduct and Customer Satisfaction. exploitation.Quality is everyone’s job. function.Quality Management Quality Management What is Quality Quality Concepts:   OLD . All rights reserved. on every task to perform  5 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009.Quality is the responsibility of the Quality Assurance department NEW . reproduction. also regarding any disposal.  OLD .Quality relates only to the final product NEW .

Coordinated activities to direct and control an organization with regard to quality. Coordinated activities include . reproduction. exploitation.Establishment of Quality Objectives . All rights reserved. 6 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. . distribution. as well as in the event of applications for industrial property rights.Quality Management Quality Management Quality Management  Quality management .Establishment of Quality Policy .Quality Planning .Quality Control & Improvement  Quality management means what the organization does to ensure that its products or services satisfy the customer's quality requirements. editing. also regarding any disposal.

as well as in the event of applications for industrial property rights. Give MANAGEMENT CERTAINTIY that quality is being maintained and improved. editing. not about solving or accommodating the same problem over and over again” A Quality Management System will:  Meet stated or implied CUSTOMERS NEEDS. reproduction. All rights reserved.  7 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. distribution. . also regarding any disposal.Quality Management Quality Management Quality Management “QM is about removing the reasons for problems. Give CUSTOMERS CONFIDENCE that intended quality will be achieved. exploitation.

exploitation. as well as in the event of applications for industrial property rights. reproduction. editing.Quality Management Quality Management 8 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. All rights reserved. . distribution. also regarding any disposal.

000 International Standards. ISO Was established in 1947. Its Head Quarters is at Geneva. distribution. ranging from standards for activities such as agriculture. Switzerland.Quality Management Quality Management What is ISO  ISO Stands for International Organization for Standardization. The Object of ISO is to promote the development of standardization and related activities in the world with a view to facilitating the international exchange of goods and services. medical devices. ISO has published more than 17. NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. as well as in the event of applications for industrial property rights. editing. construction. ISO is the world largest standards developing organization. mechanical engineering. exploitation.    9 . All rights reserved. information technology etc. ISO is a worldwide federation of National Standards Bodies (ISO member bodies) from over 150 countries. also regarding any disposal. reproduction.

10 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. as well as in the event of applications for industrial property rights. . also regarding any disposal.Quality Management Quality Management ISO In Figures Members 157   Technical Committees - 208  International Standards Developed 08) - 17 765 (Till Dec. editing. All rights reserved. distribution. reproduction. exploitation.

as well as in the event of applications for industrial property rights.Quality Management Quality Management ISO Standard Development Process  International Standards are drafted in accordance with the rules given in ISO Directive  Draft International Standards adopted by the technical committees are circulated to the member bodies for voting  Publication as international Standard requires approval by at lease 75% of the member bodies casting a vote. exploitation. . 11 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. also regarding any disposal. distribution. All rights reserved. reproduction. editing.

(It does not specify how to control your product. also regarding any disposal.e. All rights reserved. . as well as in the event of applications for industrial property rights. Structure of the QMS should remain same thought the world.) 12 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. reproduction. distribution. exploitation.Quality Management Quality Management What is ISO 9000  ISO 9000 contains the basic requirements of the quality management for all industries It is important to note ISO 9000 is not a Product Standard. Rather it is a System Standard. (i. editing. It specifies to control processes by means of a System)   Its primary purpose is to provide organizations with useful internationally recognized models for operating a quality management system.

ISO 9002 & ISO 9003 (All are Certification Standards) ISO 9000 Series (2000) – ISO 9000. All rights reserved.Quality Management Quality Management What is ISO 9000  ISO 9000 was released in 1987 ISO 9000 was developed by ISO Technical Committee TC 176 The first update in ISO 9000 Series published in 1994 known as ISO 9000:1994. as well as in the event of applications for industrial property rights. ISO 9001 & ISO 9004 (ISO 9001 is the Certification Standards)     13 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. ISO 9000 Series (1994) – ISO 9001. the Second revision released in December 2000. editing. reproduction. now referred to as ISO 9000:2000 series. distribution. also regarding any disposal. exploitation. .

development. ISO 9002 installation Model for quality assurance in production.   ISO 9003 testing. installation and Servicing. and Servicing. Model for quality assurance in final Inspection and 14 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. . reproduction. also regarding any disposal. production. All rights reserved.Quality Management Quality Management ISO 9000 : 1994 Series Standard  Description ISO 9001 Model for quality assurance in design. exploitation. as well as in the event of applications for industrial property rights. distribution. editing.

6 .9 . .8 .18 . Packing .7 .19 .Inspection and Test Status 4.11 .Management Responsibility 4.14 .3 .Control of Inspection.Statistical Techniques 15 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009.16 . exploitation.Internal Quality Audits 4.2 . also regarding any disposal. Preservation and Delivery 4. distribution.Training 4.1 .Contract Review 4.17 .Inspection and Testing 4. Measuring & Test Equipments 4. editing.Corrective and Preventive Action 4.Control of Quality Records 4. Storage .12 .4 .Document and Data Control 4.Product Identification and Traceability 4.13 .Handling .20 .Quality System 4.Purchasing 4. as well as in the event of applications for industrial property rights.10.Quality Management Quality Management ISO 9001 : 1994 (20 Elements) 4.Servicing 4. All rights reserved.Process control 4.Design Control 4.15 . reproduction.Control of Customer Supplied Product 4.Control of Nonconforming Product 4.5 .

. editing. exploitation. reproduction. as well as in the event of applications for industrial property rights. also regarding any disposal.Quality Management Quality Management ISO 9000 : 2000 Family of Standards ISO 9000 : Quality Management Systems – Fundamentals and Vocabulary ISO 9001 : Quality Management Systems – Requirements ISO 9004 : Quality Management Systems – Guidelines for Performance Improvement 16 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. All rights reserved. distribution.

as well as in the event of applications for industrial property rights. also regarding any disposal. All rights reserved. authority & communication Management Reviews Production & service provision 17 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009.Quality Management Quality Management System Requirements – ISO 9001:2000 4 Quality Management System 5 Management Responsibility 6 Resource Management 7 Product Realization 8 Measurement Analysis & improvement General requirements Management Commitment Customer focus Provision of resources Human resources Infrastructures Work environment Planning Customer related processes Design & development Purchasing General Monitoring & measurement Control of NCP Analysis of data Improvements Documentation Requirements Quality policy Planning Responsibility. exploitation. distribution. . reproduction. editing.

also regarding any disposal. All rights reserved.Quality Management Quality Management Why Revision ?  ISO has a standard review cycle for every Five Year. To focus on customer satisfaction. as well as in the event of applications for industrial property rights. To simplify the structure of QMS and to develop an unique standard that will be equally applicable to small as well as medium and large organizations To reduce amount and detail of documentation and allow flexibility for documentation. reproduction. exploitation. editing.    18 . distribution. NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. process approach & continual improvement.

exploitation. reproduction. distribution. as well as in the event of applications for industrial property rights. also regarding any disposal.Quality Management Quality Management ISO 9000 : 2000  Released on 15th December 2000. . 2nd revision of Quality Management System Requirement Standard from International Organization for Standards Standard Known as ISO 9001 – “Quality Management System – Requirements Applicable to all organization with possible permissible omissions of certain requirements    19 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. All rights reserved. editing.

Quality Management Quality Management Important Changes ISO 9000:1994 1.8 Identifies greater management involvement More focus on CIP More focus on Customer Satisfaction Only 6 Mandatory procedures required ISO 9000:2000 Only ISO 9001 (Exclusions in Cl.5. Procedure required for all processes 20 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009.7 7.20 4.4.6. distribution.1 . . exploitation. All rights reserved. 9002. Management Role not descriptive 5. Core standard ISO9001. also regarding any disposal. “Product” based approach 3. 6. as well as in the event of applications for industrial property rights.7. Requirements detailed in Clauses 4. Requirements detailed in Clauses 4. editing. reproduction. ------permitted) “Process” based approach Clauses rearranged. 9003 2.

Improvement Inputs Product Realization Outputs Product 21 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. reproduction. as well as in the event of applications for industrial property rights.Quality Management Quality Management Continual Improvement of the Quality Management System Management Responsibility Resource Management Measurement. exploitation. also regarding any disposal. distribution. Analysis. . All rights reserved. editing.

Use resources and transforms Input to output is referred to as a Process. All rights reserved. Resources PROCESS INPUTS Cust. distribution. reproduction.g. Machining. exploitation.Quality Management Quality Management Process Process Any Activity or Set of Activities which takes input. . editing. Grinding) Inspection & Testing Product of processes 22 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. as well as in the event of applications for industrial property rights. also regarding any disposal. Order Product is the output receiving OUTPUTS Product Purchasing Manufacturing (E.

All rights reserved.C. •To inspect incoming •To inspect incoming goods goods 23 •Storage •Storage •Inspection and •Inspection and Testing Testing •Manufacturing •Manufacturing •Finance •Finance Interactions to Interactions to Outputs Outputs • Receipt of • Receipt of Material in Material in Right Quality Right Quality & Quantity at & Quantity at Right Time Right Time Resources Resources •Manpower •Manpower •Stationary / /Invoice •Stationary Invoice •Measuring equipments •Measuring equipments •P. also regarding any disposal. distribution.Quality Management Quality Management Purchasing Process – Process Approach • Purchasing • Purchasing Need // Need Purchase Purchase Indent Indent Inputs Inputs Purchasing Purchasing Process Process Set of Activities Set of Activities •To select suppliers •To select suppliers •To prepare P. supp. exploitation. reproduction. •To prepare P.O.O.C. Phone NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. as well as in the event of applications for industrial property rights. •To prepare GRN •To prepare GRN •To communicate to •To communicate to supp. / /Phone •P. editing. .

Tools. Trained Operators. Inspection 24 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. reproduction. Working Space Raw Material TURNING Turned Component Interaction Purchase. exploitation. also regarding any disposal. editing. Power. Instruments. All rights reserved. . as well as in the event of applications for industrial property rights. Maintenance. distribution. Machines.Quality Management Quality Management Turning Process – Process Approach Resources : Consumables.

Quality Management Quality Management
Training Process – Process Approach

Trainer, LCD Projector, Computer, Sitting Arrangement, Backup Power etc.

Training Need

Training Process

Implementation of New learning

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Quality Management Quality Management
Internal Audit Process – Process Approach Resources : Train Auditor, PC, Audit Observation sheet, Audit Checklist

Audit Plan

Internal Audit

Audit findings, Audit Report

Interaction Management Review, Training, Customer Communication

Set of Activities
•To do Audit as per checklist •To communicate audit findings •To prepare audit report.

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Quality Management Quality Management

Process Approach
Process Approach The application of a system of processes within an organization, Together with the identification, interactions and management Of the Processes can be referred to as the Process Approach Process approach is to be applied for managing organization in order to meet customer requirements and enhance customer satisfaction.

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Quality Management Quality Management

Process Approach
Maintenanc e

Receive Order

Identify Purchase Needs

Purchasing

Production

Storage

Inspection & Testing

Logistics

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. as well as in the event of applications for industrial property rights. distribution.Quality Management Quality Management QMS Principles stomer Cuustomer C us foccus fo tual Muutual M cial enefi bbeneficial upplier ssupplier onship relatitionship rela adershi Leeadershi L p p olvement Invvolvement In eople P of f People o actual FFactual ppr r ach to aappooach to ecision ddecision king maaking m n Based on Based oity eighttqual lity eigh quaent managem ent managem s prrnciple s p i inciple cess Proocess Pr ppr r ach aappooach ntinual Coontinual C ement r imppovvement im ro stem Syystem S ch to ppr r a aappooach to nagement Maanagement M 29 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. editing. exploitation. also regarding any disposal. reproduction. All rights reserved.

6. 7. also regarding any disposal.2. managed & improved By communicating customer requirements throught the organization by ensuring effective & efficient operation and control of processes and monitor and measure data to determine customer satisfaction Main Clauses – 5.2. 7. reproduction. Top Management should establish a customer oriented organization By defining systems & processes that can be clearly understood.1 30 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. should meet customer requirements and strive to exceed customer expectations.2. 7. distribution. as well as in the event of applications for industrial property rights. editing.2.Quality Management Quality Management QMS Principles Customer focus Organizations depend on their customers and therefore should understand current and future customer needs. All rights reserved.3. 8. exploitation.2.1.2. .

6.1 31 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. reproduction. Top Management should direct the organization to achieve customer satisfaction and continual improvement. Top Management should take leadership. as well as in the event of applications for industrial property rights. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.Quality Management Quality Management QMS Principles Leadership Leaders provide direction of the organization. should commit and involve in establishing and implementing Quality Management System. exploitation. Main Clauses – 5. also regarding any disposal. distribution. 5. editing. All rights reserved.1. .

as well as in the event of applications for industrial property rights. All rights reserved.1. 6. exploitation. editing. distribution.2 32 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. reproduction. also regarding any disposal.Quality Management Quality Management QMS Principles 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 organization’s benefit. . new methods & solutions creating an environment to encourage innovation using measurement of people’s satisfaction. Organization should encourage involvement & development of its people By By By By By defining their responsibilities and authorities providing ongoing training participating in improvement projects. Main Clauses – 5.2.5.

2. as well as in the event of applications for industrial property rights.2. reproduction. distribution.3. . editing. 8. 5.4 33 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. also regarding any disposal. exploitation. Main Clauses –8.6. All rights reserved.Quality Management Quality Management QMS Principles Process Approach A desired result is achieved more efficiently when activities and related resources are managed as a process.

5. The organization should define the system by identifying and developing the processes and their interactions towards continual improvement. Taking an example. also regarding any disposal. From an user’s angle. exploitation. . understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives. reproduction. seats. the important characteristics of a Bus is to carry out passengers from one place to other. 8. distribution. the engine body.1. editing. All rights reserved. as well as in the event of applications for industrial property rights. tyre & other parts all together carry out the aim.6.3 34 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. Nobody can say that only engine do this job.2. Main Clauses – 4.Quality Management Quality Management QMS Principles System Approach to Management Identifying.

exploitation. Quality Objectives.2 35 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. involvement of people. Main Clauses – 8.5. also regarding any disposal.Quality Management Quality Management QMS Principles Continual Improvement Continual improvement of the organization’s overall performance should be a permanent objective of the organization Management should continually seek to improve processes of the organization rather than wait for a problem to reveal opportunities for improvement. editing. Continual improvement should be make through establishing policy. . review of processes & taking corrective & preventive actions.5. All rights reserved. as well as in the event of applications for industrial property rights. reproduction.1. 8. distribution.

Competitive process benchmarking. editing.Quality Management Quality Management QMS Principles Factual Approach to decision making Effective decisions are based on the analysis of data and information. distribution. reproduction. This principle requires the organization to manage the information. . measuring customer satisfaction and similar actions can help the organization to take decisions based on facts. exploitation. as well as in the event of applications for industrial property rights. also regarding any disposal. All rights reserved.4 36 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. make decisions and take appropriate actions based on the results of analyses of data. Main Clauses – 8. measuring cost of quality.

reproduction. 7. editing.Quality Management Quality Management QMS Principles Mutually Beneficial Supplier Relationship An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value. .4. exploitation. Mutually Beneficial supplier relationship means benefits to the organization & suppliers This organization should establish relationship / partnership with suppliers to promote & Improve processes. The relationship should be developed by 1) Communicating customer requirements to the suppliers 2) Carry out supplier evaluation 3) to take part in supplier Main Clauses – 7.4. as well as in the event of applications for industrial property rights. distribution.1.3 37 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. also regarding any disposal. All rights reserved.

All rights reserved. editing. .Quality Management Quality Management 38 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. reproduction. distribution. as well as in the event of applications for industrial property rights. also regarding any disposal. exploitation.

. Ford and Chrysler’s Quality System Requirements QS 9000 was published in 1994 and based on ISO 9001:1994 QS 9000 = (ISO 9001:1994 + Automotive Quality System Requirements) QS 9000 has been withdrawn & replaced by ISO/TS 16949 (Validity of Standard has been expired after 14th Dec. 2006)     39 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. All rights reserved. reproduction.Quality Management Quality Management QS 9000 Approach  QS 9000 – Quality System Requirements QS 9000 is a harmonization of General Motor. editing. exploitation. distribution. as well as in the event of applications for industrial property rights. also regarding any disposal.

exploitation.Quality Management Quality Management QS 9000 QS-9000 W. editing. reproduction.e. distribution.f 15.f Dec’ 2006 ISO 9000:1994 W.e. also regarding any disposal.2003 ISO / TS16949 ISO 9000:2000 40 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. as well as in the event of applications for industrial property rights. All rights reserved.12. .

All rights reserved. also regarding any disposal. distribution. editing. 41 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. . reproduction. exploitation.Quality Management Quality Management QS 9000 Demerits  A lot of Documentation required in order to implement Standard  Focus of Product Quality as standard was based on ISO 9001:1994  Difficult to implement in small organization. as well as in the event of applications for industrial property rights.

distribution. also regarding any disposal. ISO/TS 16949:2002 was published in 2002 and based on ISO 9001:2001 ISO/TS 16949 = (ISO 9001:2000 + Automotive Quality System Requirements)  42 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. reproduction.Quality Management Quality Management ISO/TS 16949  ISO/TS 16949 – Technical Specification (Quality Management System Requirements for Automotive Production & Relevant Production & Service Part Organization)  The ISO/TS 16949 was prepared by IATF (International Automobile Task Force) and JAMA (Japan Automobile Manufacture Association) with Support from ISO/ TC 176. as well as in the event of applications for industrial property rights. editing. All rights reserved. exploitation. .

VDA (Germany). IATF Consists of an international group of Vehicle Manufacturers & national trade associations: .Fiat Auto .PSA .Ford .National Trade Associations such as AIAG (USA). distribution. editing. . exploitation.Daimler Chrysler .BMW Group . also regarding any disposal. as well as in the event of applications for industrial property rights.Quality Management Quality Management ISO/TS 16949  IATF is the International Automobile Task Force. SMMT (UK) & ANFIA (Italy) 43 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009.Renault . All rights reserved. reproduction.Volkswagen .General Motors Corporation .

but can not obtain stand alone Certification. editing. . exploitation. distribution.Quality Management Quality Management Eligibility Requirements for ISO/TS 16949  ISO/TS 16949:2002 is applicable to automotive production and service part organizations only. (A site is defined as a location at which value added manufacturing processes occur. It is applicable only to sites where production or service parts are manufactured. as well as in the event of applications for industrial property rights. reproduction. Corporate Headquarters & Distribution Centers. also regarding any disposal. All rights reserved.) Supporting functions whether on-site of remote such as Design Centers.   44 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. Form part of the site as they support the site.

All rights reserved. as well as in the event of applications for industrial property rights. Construction etc. Agricultural.)   45 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. exploitation. distribution. also regarding any disposal. Forestry.Quality Management Quality Management Eligibility Requirements for ISO/TS 16949  ISO/TS 16949 is applicable to the Automotive Supply Chain “Automotive” shall be understood as including the following : . editing. Trucks. . Off-Highway (Mining.Cars. reproduction. Buses & Motorcycles “Automotive” shall be understood as exclude the following : .Industrial.

All rights reserved. distribution.Quality Management Quality Management Eligibility Requirements for ISO/TS 16949  Organizations which have automotive and non-automotive product will require separate certification for these separate groups. They would have ISO/TS 16949 Certification for their automotive activities and ISO 9001:2000 for non-automotive business E. exploitation. editing. . as well as in the event of applications for industrial property rights. reproduction. Bearings for Automotive & Industrial Applications •For Automotive Application – TS 16949:2002 •For Industrial Application – ISO 9001:2000 46 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. also regarding any disposal.g. A company Mfg.

distribution. editing. exploitation. All rights reserved. as well as in the event of applications for industrial property rights. also regarding any disposal. . reproduction.Quality Management Quality Management 47 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009.

Quality Management Quality Management Comparison – ISO 9001:2000 & TS 16949:2002 Requirements ISO 9001:2000 4. distribution and to ensure current revision level TS 16949:2002 4. exploitation.2. changes. Timely review should be as soon as possible.  48 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. All rights reserved. and shall not exceed two working weeks. reproduction. editing. The organization shall maintain a record of the date on which each change is implemented in production. as well as in the event of applications for industrial property rights.3. distribution. review. distribution and implementation of all customer engineering standards/specifications and changes based on customer required schedule.2. also regarding any disposal. Implementation shall include updated documents.1 Engineering specifications  The organization shall have a process to assure the timely review.3 Control of documents   Documents required by the quality management system shall be controlled. . Updating. A documented procedure shall be established to define the controls needed to approve.

editing. also regarding any disposal. . TS 16949:2002 5. Production operations across all shifts shall be staffed with personnel in charge of for ensuring product quality.5. All rights reserved.5.Quality Management Quality Management Comparison – ISO 9001:2000 & TS 16949:2002 Requirements ISO 9001:2000 5.  49 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009.1.1 Responsibility for quality  Personnel responsible for product quality shall have the authority to stop production to correct quality problems.1 Responsibility and authority  Top management shall ensure that the responsibilities and authorities are defined and communicated within the organization. as well as in the event of applications for industrial property rights. exploitation. distribution. reproduction.

Quality Management Quality Management Comparison – ISO 9001:2000 & TS 16949:2002 Requirements ISO 9001:2000 5.2 Management representative  Top management shall appoint a member of management who. irrespective of other responsibilities.2 1 Customer representative  Top management shall designate personnel with responsibility and authority to ensure the customer requirements are addressed This includes selection of special characteristics. setting quality objectives and related training. product design and development. distribution. corrective and preventive actions. shall have responsibility and authority that includes a) ensuring that processes needed for the quality management system are established. All rights reserved. as well as in the event of applications for industrial property rights. editing.5.5. exploitation. and TS 16949:2002   5. reproduction. also regarding any disposal. . b) reporting to top management on the performance of the quality management system and any need for improvement. implemented and maintained. 50 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009.

Quality Management Quality Management Comparison – ISO 9001:2000 & TS 16949:2002 Requirements ISO 9001:2000 7.2 Supplier quality management system development  Suppliers to the organization shall be third party registered to ISO 9001 : 2000 by an accredited third party certification body.4.1. reproduction. . TS 16949:2002 7. All rights reserved. also regarding any disposal. distribution. editing. exploitation. as well as in the event of applications for industrial property rights.1 Purchasing process  The organization shall ensure that purchased product conforms to specified purchase requirements. (Priority of ISO 9001:2000 Certification depends upon Criticality of the Item Supplied and supplier quality performance) 51 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009.4. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.

as necessary.2 Work Instructions  52 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. as applicable a) the availability of information that describes the characteristics of the product. reproduction.1.Quality Management Quality Management Comparison – ISO 9001:2000 & TS 16949:2002 Requirements ISO 9001:2000 7.5. also regarding any disposal. exploitation.1 Control Plans  The organization shall develop Control Plans for Components / System / Product The organization shall prepare documented work instructions for all employees having responsibilities for the operation of processes that impact product quality 7. . as well as in the event of applications for industrial property rights. TS 16949:2002 7. distribution.1.5. All rights reserved. editing.5. Controlled conditions shall include.1 Control of production and service provision  The organization shall plan and carry out production and service provision under controlled conditions. b) the availability of work instructions.

distribution. . as well as in the event of applications for industrial property rights. All rights reserved. editing. exploitation. reproduction.Quality Management Quality Management 53 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. also regarding any disposal.

also regarding any disposal. editing. Some useful clarifications to existing requirements 54 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. Content of ISO 9001 (2008):    No new requirements introduced in ISO 9001:2000. exploitation. The purpose of the revision was specified to be limited to:  Enhance the clarity of ISO 9001:2000. as well as in the event of applications for industrial property rights. reproduction.Quality Management Quality Management ISO 9001: 2008 ISO 9001:2008 was developed (in 2005). All rights reserved. without introducing new requirements  ISO 9001:2008 was published November 15th. 2008. . distribution.

temperature. distribution.4 Work environment ISO 9001:2008  The organization shall determine and manage the work environment needed to achieve conformity to product requirements. All rights reserved. as well as in the event of applications for industrial property rights. environmental and other factors (such as noise.Quality Management Quality Management Changes ISO 9001: 2008  6. editing. . ISO 9001:2008 NOTE The term “work environment” relates to those conditions under which work is performed including physical. reproduction. 55 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. lighting or weather). exploitation. humidity. also regarding any disposal.

1 Customer satisfaction ISO 9001:2000  As one of the measurements of the performance of the quality management system. the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements.Quality Management Quality Management Changes ISO 9001: 2008  8. All rights reserved.2. lost business analysis. . editing. customer data on delivered product quality. as well as in the event of applications for industrial property rights. distribution. exploitation. 56 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. user opinion surveys. warranty claims and dealer reports. The methods for obtaining and using this information shall be determined. also regarding any disposal. reproduction. compliments. ISO 9001:2008 NOTE Monitoring customer perception can include obtaining input from sources such as customer satisfaction surveys.

2. . also regarding any disposal. editing. distribution.Quality Management Quality Management Changes ISO 9001: 2008  8. exploitation. ISO 9001:2008  Addition of a requirement that the management team in the area being audited is responsible for “necessary corrections and corrective actions.2 Internal Audits ISO 9001:2000 The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes.” 57 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. as well as in the event of applications for industrial property rights. reproduction. All rights reserved.

All rights reserved. 58 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. any existing certification issued to ISO 9001:2000 shall not be valid. . editing. as well as in the event of applications for industrial property rights. but preferably during a recertification audit to avoid additional costs.Quality Management Quality Management Transition Period ISO 9001: 2008 Changes 24 months after publication by ISO of ISO 9001:2008 (i. 15th 2010). exploitation.e. Transition can be done during any scheduled re-certification or periodical audit in the 24 months period. Nov. reproduction. also regarding any disposal. distribution.

.Quality Management Quality Management 59 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. also regarding any disposal. exploitation. All rights reserved. distribution. as well as in the event of applications for industrial property rights. editing. reproduction.

. A CD Containing Organization drawings is also a document) 60 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. exploitation. distribution. as well as in the event of applications for industrial property rights. editing. All rights reserved. reproduction. also regarding any disposal.Quality Management Quality Management Document  Document : Information and its supporting medium (ISO 9000) Information Procedure Specification Record Drawings Standard Medium Paper Magnetic Electronic Photographic Master Sample (Documents are not always in Paper Forms.

All rights reserved. exploitation.Generally Records need not be under revision control. . as well as in the event of applications for industrial property rights. Documents Control Plan Work Instructions Preventive Maintenance Plan Record Drawings TS Standard / Audit Checklist 61 Records Incoming Inspection Record SPC Chart Preventive / Breakdown Maintenance In Process Inspection Report System / Product Audit Report NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. also regarding any disposal. reproduction.Quality Management Quality Management Documents & Records Record : Document stating results achieved or providing evidence of activities performed (ISO 9000) . Records are one type of documents. editing. distribution.

distribution.g. All rights reserved. Customer Order (Customer – Mktg.Quality Management Quality Management Purpose of Documents Communication of information  It helps to communicate relevant information to different levels / functions. E. – Customer) Work Instructions (Production dept – Operator) 62 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. reproduction. – Production) Final Inspection Report (Quality Dept. . also regarding any disposal. editing. exploitation. as well as in the event of applications for industrial property rights.

. exploitation. distribution. editing.Quality Management Quality Management Purpose of Documents Evidence of Conformity  Provision of evidence that what was planned has actually been done. as well as in the event of applications for industrial property rights. Work Instruction / Preventive Maintenance Plan says when to do Preventive Maintenance of M/c Preventive Maintenance Record is the evidence of Maintenance done. also regarding any disposal. All rights reserved. E. 63 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. reproduction.g.

 64 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. distribution. which can be used as a base for design and development of a new product. as well as in the event of applications for industrial property rights. editing. Example: a technical specification. exploitation. reproduction. All rights reserved. also regarding any disposal.Quality Management Quality Management Purpose of Documents Knowledge Sharing  In order to increase awareness and preserve the organization’s experiences. .

All rights reserved. Standard. Drawings Provide Reference to process carry out Records Evidence of Result achieved 65 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. Exclusion. distribution. also regarding any disposal. reproduction. as well as in the event of applications for industrial property rights. exploitation. . editing. Process interaction Specified way to carry out processes Documents such as work instructions Control Plans.Quality Management Quality Management Typical QMS Documentation Structure Quality Manual Procedures QMS Scope.

Standards etc. . Control Plans. editing. operation and control of its processes (e. reproduction.) Records required by the international standard     66 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. distribution. also regarding any disposal.General Requirements  Documented statements of quality policy and quality objectives A quality manual Documented procedures required by the international standard Documents needed by the organization to ensure effective planning.1 .g. Work instructions. Drawings. exploitation. All rights reserved.Quality Management Quality Management Documents Required by ISO 9001:2000 Clause 4. as well as in the event of applications for industrial property rights.

Work environment Checklist for System.Quality Management Quality Management Additional Documents Required by TS 16949 Example . . distribution. Work instructions Product Approval Process (PPAP – As per customer requirement) MSA Study. reproduction. as well as in the event of applications for industrial property rights. competency of personnel. also regarding any disposal. All rights reserved. Risk Analysis .Additional Documents required – TS 11111 Control Plans. editing.FMEA Laboratory Scope (Defined methods. Process & Product Audit 67 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. exploitation.

.2.3)      68 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. editing.2) Preventive Action (Clause 8.2. reproduction. also regarding any disposal.5.Quality Management Quality Management Documented Procedures Required by ISO 9001:2000  Control of documents (Clause 4.4) Internal Audit (Clause 8.5. distribution.3) Corrective action (Clause 8.3) Control of records (Clause 4. as well as in the event of applications for industrial property rights. exploitation.2. All rights reserved.2) Control of nonconforming product (Clause 8.

2) Preventive Action (Clause 8.5.2. exploitation.2.2.3) Corrective action (Clause 8. reproduction.2)       69 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. . editing. distribution. also regarding any disposal.2) Control of nonconforming product (Clause 8.4) Internal Audit (Clause 8. as well as in the event of applications for industrial property rights.3) Control of records (Clause 4.5. All rights reserved.2.Quality Management Quality Management Documented Procedures Required by ISO/TS 16949:2002  Control of documents (Clause 4.2.3) Training (6.

.Quality Management Quality Management 70 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. editing. All rights reserved. also regarding any disposal. distribution. as well as in the event of applications for industrial property rights. reproduction. exploitation.

Quality Management Quality Management Why Audits ?  ISO 9001 and ISO/TS 16949 Systems contains a specific mandatory requirement for ‘ Internal Quality Audits ‘ to be conducted. as well as in the event of applications for industrial property rights. also regarding any disposal. The requirements is : The organization shall conduct internal audits at planned intervals to determine whether the quality management system  a) conforms to the planned arrangements and b ) is effectively implemented and maintained 71 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. . exploitation. reproduction. editing. All rights reserved. distribution.

as well as in the event of applications for industrial property rights. All rights reserved. also regarding any disposal. editing. ( Thus. distribution. . exploitation. Overall System Improvement ) 72 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. reproduction.Quality Management Quality Management Purpose of Audits FACT FINDING & NOT FAULT FINDING To Collect objective evidence on deficiencies observed ( Identify System Weakness ) To Facilitate auditee for initiating corrective action in order to ensure that nonconformities do not recur again.

. as well as in the event of applications for industrial property rights. exploitation. Process Audits & Product Audits  73 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. reproduction. are conducted by organization for internal system assessment and may form the basis for an organization's self-declaration of conformity. System Audits. All rights reserved. distribution. sometimes called first-party audits.Quality Management Quality Management Types of Audit First Party Audits  Internal audits. also regarding any disposal.g. E. editing.

All rights reserved. as well as in the event of applications for industrial property rights. reproduction. distribution.g. exploitation. . Mahindra conducts audit on Bosch OR Bosch conducts audit on suppliers  74 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. editing.Quality Management Quality Management Types of Audit Second Party Audits  Second-party audits are conducted by Customers to their Suppliers in order to verify system assessment. E. also regarding any disposal.

. also regarding any disposal. independent auditing organizations. ISO 9001.Quality Management Quality Management Types of Audit Third Party Audits  Third-party audits are conducted by external. ISO 14001.g. as well as in the event of applications for industrial property rights. distribution. TS 16949. exploitation. OHSAS 18001)  75 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. reproduction. editing. such as those providing registration or certification of conformity to the requirements of ISO 9001 or TS 16949 Conducted by Certification Body Only (E. All rights reserved.

)   76 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. Purchasing. Analysis of Data. also regarding any disposal. instructions . distribution. Design etc. . Meeting top management perceptions. Marketing. Servicing. reproduction. procedures. exploitation.. All rights reserved.Quality Management Quality Management Categories of Audit System Audits  System audit refers to the audits conducted to determine whether execution follows plans . Focus on Achievement of Quality Objectives. editing. policies . Customer Satisfaction & Continual Improvement & Process Interactions Conducted on All organization’s QMS Processes (Mfg. as well as in the event of applications for industrial property rights. etc.

Control Plan. Competence of Operator. also regarding any disposal. editing. exploitation. All rights reserved. Maintenance instructions adherence to the Process. Work Instructions. distribution.Quality Management Quality Management Categories of Audit Process Audits  Process Audit is conducted on Manufacturing Processes only and focused on manufacturing Process Control. Focus on Process Control Parameters. . as well as in the event of applications for industrial property rights. In depth QMS Audit for Manufacturing Processes   77 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. reproduction.

exploitation.g. . as well as in the event of applications for industrial property rights. Fit . reproduction. (e.Quality Management Quality Management Categories of Audit Product Audits  Product audit is an Independent evaluation of product quality to determine its fitness for use and conformance to specification. e.g. editing. Product Dimensions & Test Parameters) 78 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. also regarding any disposal. All rights reserved. distribution. form . function  Focus on Product Characteristics & Inspection & test parameters adherence to Drawing / Customer Specification.

distribution.Quality Management Quality Management 79 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. also regarding any disposal. as well as in the event of applications for industrial property rights. All rights reserved. editing. exploitation. . reproduction.

exploitation. distribution.   80 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. Only Certification Bodies having accreditation (national / international) can issue Certificate. . as well as in the event of applications for industrial property rights. All rights reserved. reproduction. also regarding any disposal. It means that an independent. editing. external body has audited an organization's management system and verified that it conforms to the requirements specified in the standard (ISO 9001 or ISO 14001).Quality Management Quality Management Certification  Certification is known in some countries as registration. ISO does not carry out certification and does not issue or approve certificates.

as well as in the event of applications for industrial property rights. exploitation. Checking Audit Reports of certification bodies)   Accreditation Body Certification Body Organization to be certified 81 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009.Quality Management Quality Management Accreditation  Accreditation is like certification/approval of the certification body. editing. distribution. Accreditation means the formal approval by a specialized body in order to ensure that a certification body is competent to carry out Certification (ISO 9001:2000 or ISO 14001:2004) in specified business sectors. Audit of Certification Bodies. . Accreditation body controls Certification Bodies (E. Audit at Client’s site.g. reproduction. All rights reserved. also regarding any disposal.

exploitation. distribution. .Quality Management Quality Management Accreditation Accreditation Bodies     UKAS (United Kingdom Accreditation Services) JAS (Japan Accreditation Services) ANAB (American National Accreditation Body) NABCB (National Accreditation Board for Certification & Training) ISO develops standards and guides to encourage good practice in accreditation and certification (ISO 17021). All rights reserved. also regarding any disposal. as well as in the event of applications for industrial property rights. editing. ISO does not approve or control certification bodies.  82 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. reproduction.

Thus common system to understand Organization’s QMS. exploitation. Competitive Advantage.g. All rights reserved. as well as in the event of applications for industrial property rights. editing.    83 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. TS 16949 organization requires their suppliers should be certified to ISO 9001) International Recognization to the organization. also regarding any disposal. Enhance Customer Satisfaction which in turn can lead to business needs.Quality Management Quality Management Need for Certification  Customer Requirement (E. reproduction. . distribution.

editing. All rights reserved.Quality Management Quality Management Journey to Certification STEP 1: Preparation  Preparation means Understanding of Standard requirements and implement in the organization. 84 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. distribution. as well as in the event of applications for industrial property rights. reproduction. STEP 4: Stage 2 Audit (Implementation Audit)  Audit Assessment covers audits of documents and QMS Processes. STEP 2: Application  After implementation & review found satisfactory. exploitation. . also regarding any disposal. STEP 3: Stage 1 Audit (Documentation Audit)  Stage 1 Audit to check completeness of documents related to QMS. can go for application for certification to a certification body.

reproduction. distribution. . editing. Certification body issue certificate to the Organization. also regarding any disposal. exploitation. Application Stage 1 Audit Stage 2 Audit Certification Contract Review •Scope •Time Scale for Audit •Audit Team Surveillance 85 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. Certification means Conformity of Organization’s QMS to Standard requirements. as well as in the event of applications for industrial property rights. STEP 6: Continual Assessment  Annual Surveillance audit in order to check whether quality management system is maintained and improved.Quality Management Quality Management Journey to Certification STEP 1: Registration & Certification  After Closure of all NCRs. All rights reserved.

Quality Management Quality Management 86 NaP/QMM 24 | 12/01/2009 | © Bosch Limited 2009. reproduction. exploitation. as well as in the event of applications for industrial property rights. also regarding any disposal. distribution. . editing. All rights reserved.

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