6. iso 9000 - implementation.ppt

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    ISO 9000

    ImplementationImran Hussain

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    ISO 9000: 1994 Clauses

    1. Management Responsibility

    2. Quality System

    3. Contract Review

    4. Design Control5. Document Control

    6. Purchasing

    7. Purchaser Supplied Product

    8. Product Identification and Traceability9. Process Control

    10. Inspection and Testing

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    ISO 9000: 1994 Clauses

    11. Inspection Measuring and Test Equipment

    12. Inspection and Test Status

    13. Control of Non-Conforming Product

    14. Corrective Action15. Handling, Storage, Packaging and Delivery

    16. Quality Records

    17. Internal Quality Audits

    18. Training19. Servicing

    20. Statistical Techniques

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    ISO 9000:2000 Clauses

    1. Quality Management System

    2. Resource Management

    3. Product or Service Realization4. Management Responsibility

    5. Measurement, Analysis and Improvement

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    ISO 9000: 2000

    Quality Management System

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    Quality Management System

    DocumentationStandard

    ISO 9000

    Quality Manual

    Quality System Procedures

    Work Instructions

    Forms

    LEVEL 1

    LEVEL 2

    LEVEL 3

    LEVEL 4

    Policy Statement, Commitment,

    Organisation, Responsibilities

    Company Practices, Interfaces

    Written Instructions

    to Control Tasks

    Quality

    Records

    Sales Design Purchasing Manufacturing Accounts Personnel After Sales

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    Why have a Quality Policy?

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    Need for Quality Policy

    All organizations have in mind some principles,beliefs which are their broad guides tomanagerial conduct

    These guides rest on a philosophical and ethicalbase

    They concern important issues and are intended

    to have a long life, i.e. to act as a stabilizer Such principles and beliefs are referred to as a

    Quality Policy

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    Need for Quality Policy

    When organizations grow, there are different managers

    working under which various employees are working

    Things need to be defined at that stage as things start

    becoming ambiguous As the unwelcome incidents accumulate, there arises a

    growing urge to think through, write out, and publish

    quality policies to serve as guides to managerial action

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    Advantages of Policies

    It provides insiders and outsiders with a new, superiorform of predictability, i.e. a written guide to managerialaction

    It forces the organization to think about quality

    problems to a depth never before achieved. before youwrite it down, you must think it out

    It establishes legitimacy and can be communicated in anauthoritative, uniform manner

    It permits practices to be audited against that policy

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    Disadvantages of Policies

    Major disadvantage is work involved

    Some managers think that written policies tend

    to restrict innovation and to narrow the range of

    action available to adapt to changing conditions

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    Corporate Quality Policies

    As a company grows, it becomes evident that no oneset of quality policies can fit all company activities

    This problem is solved by creating several levels ofquality policy out of which one is corporate policy

    which usually consists of The purpose of writing and publishing quality policies

    A brief statement of corporate intent

    The minimal actions to be taken by the company divisionswith respect to quality

    Interdivisional relationships concerning quality

    Relationship of quality policies to other company policies

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    Corporate Quality Policies

    A delegation of authority to subordinate company

    organization units to establish subsidiary quality policies

    appropriate to their needs

    Summary statement It is the policy of the company to provide products and

    services of a quality that meet the initial and continuing needs

    and expectations of customers in relation to the price paid

    and to the nature of competitive offerings, and in doing so, tobe the leader in product quality reputation

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    Corporate Quality Policies

    Importance of quality

    Leadership in quality has top priority

    Quality shall be given equal priority to costs and delivery

    Quality competitiveness Equal or exceed competitive quality

    Be of the highest quality

    Customer relations Provide customer satisfaction

    Meet customer perception of good quality

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    Corporate Quality Policies

    Internal Customers

    We regard the receivers of our work results as customers

    whose needs are important to understand and satisfy

    Work Force Involvement Our policy is to foster a spirit of pride among employees

    regarding the companys quality performance

    Quality improvement

    Resources will be allocated primarily to the prevention of

    defects and corrective action will be focused on rot-cause

    identification and elimination

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    Divisional Quality Policies

    The same design shall be used in all factories

    making a specific product.

    Quality of design shall be used in all factories

    making a specific product

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    Quality Policies for Functional Areas

    Many of the policies are prepared to provide guidance

    to managers in specific functional departments such as

    product development, manufacturing and marketing

    New product introduction Design reviews shall be conducted with customer, market

    and regulatory bodies in order to ensure the compliance of

    the design for quality

    Suppliers We seek to establish long-term, open relations with our

    suppliers

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    Quality Policies for Functional Areas

    Manufacturing

    Manufacturing process capability must be verified during the

    product development cycle

    Production Involvement and a spirit of pride will be fostered among

    employees by encouraging ideas and resolutions regarding the

    companys quality performance

    Customer service Service operations shall be conducted so as to minimize

    customers shutdowns

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    Quality Objectives

    An objective is an aimed-at-targetan

    achievement toward which effort is extended.

    Quality objective is an aimed-at-quality target

    Quality objectives should be quantifiable in

    nature (measurable) - SMART

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    Objectives vs. Policies

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    Objectives vs. Standards

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    Implementing ISO 9000:2000

    Awareness Training

    Establish a Team

    Establish ISO 9000 Status

    Prepare Action Plan

    Track Action Plan

    Present Status of Action Plan

    ISO 9000 Readiness Assessment

    Contact Registrar (Certification Body)

    Official ISO 9000 Audit

    Continuous Improvement

    Celebrate!

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    ISO 9000:2000 Clauses

    1. Quality Management System

    2. Resource Management

    3. Product or Service Realization4. Management Responsibility

    5. Measurement, Analysis and Improvement

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    Quality Management System (QMS)

    Concerned with the documentation and

    management of the QMS

    Sub-clauses:

    Quality Manual

    Control of documents

    Control of records

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    Management Responsibility

    Concerned with the responsibility of management in

    the implementation of the quality system

    Sub-clauses:

    Management commitment Customer focus

    Quality policy

    Planning

    Responsibility, authority, and communication

    Management review

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    Resource Management

    Concerned with the provision of resources

    needed to implement the QMS

    Sub-clauses:

    Provision of resources

    Human resources

    Infrastructure

    Work environment

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    Product or Service Realization

    Concerned with the provision of processes to implement the product orservice

    Sub-clauses: Planning of product realization

    Customer related processes

    Customer requirements Customer communication

    Design and development

    Control of changes

    Purchasing process

    Production and service provision

    Validation of processes Identification and traceability

    Customer property

    Preservation of product

    Control of measuring and monitoring devices

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    Measurement, Analysis and

    Improvement

    Concerned with the establishment of a measurement program tomeasure QMS performance and to identify problems

    Sub-clauses: Measurement of customer satisfaction

    Internal audits Measurement and monitoring of processes

    Measurement and monitoring of product

    Control of nonconformity

    Analysis of data

    Continual improvement Corrective action

    Preventive action

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    References

    Software Quality Management and ISO 9001, by

    Michael Jenner, Ch. 1, 2

    A Practical Approach to Software Quality, by

    Gerard ORegan, Ch. 3