Iso9000-2000-final

ISO 9001:2000

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Process OUT PUT IN PU T

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Inputs. Raw Material Production Plan Machinery Men Procedure Specifications Infra structure Quality Plan

Production Process

Out Puts Product. Production. Quality. Wastes. Byproducts.

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The Basics of ISO Say What You Do This means document your systems so you will consistently do the job the same way every time. We must make sure we have appropriate documentation.

Do What You Say This is what the auditors want to see. Objective evidence that what you say you are doing in your documentation is what you are doing in practice. 5

ISO is a network of the national standards institutes of 156 countries, on the basis of one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. ISO is a non-governmental organization: its members are not, as is the case in the United Nations system, delegations of national governments. Nevertheless, ISO occupies a special position between the public and private sectors. This is because, on the one hand, many of its member institutes are part of the governmental structure of their countries, or are mandated by their government. On the other hand, other members have their roots uniquely in the private sector, having been set up by national partnerships of industry associations. Therefore, ISO is able to act as a bridging organization 6 in which a consensus can be reached on solutions that

ISO standards are developed by national delegations of experts from business, government and other relevant organizations. They are chosen by the ISO members - the national standards institutes participating in the technical committee concerned - and are required to present a national consensus position based on the views of stakeholders in their country. ISO's national members pay subscriptions that meet the operational cost of ISO's Central Secretariat. The subscription paid by each member is in proportion to the country's Gross National Income and trade figures. Another source of revenue is the sale of standards the operations of ISO Central Secretariat represent only about one fifth of the cost of the system's operation. The main costs are borne by the member bodies which manage the specific standards' development projects and the business organizations which provide experts to participate in the technical work. These organizations are, in effect, subsidizing the technical work by paying the travel costs of the experts and allowing them time to work on their ISO assignments 7

ISO 9000 Standards • The success in war was attributed to the systems adopted and they were maintained as Military secrets. • In 1976, British Standard 5750 was introduced. • In 1987, ISO 9000 standards were adopted by 92 countries • First amendment was taken place in 1994 • In Dec 2000, the system was completely reviewed and new standards ISO 9000:2000 series was released. 8

ISO 9000:1987 vs. ISO 9000:2000 • ISO 9000:1987 • There were 3 standards Viz. ISO 9001, ISO 9002 and ISO 9003. • There were 4 main clauses and 20 sub clauses in Clause No 4

• ISO 9000:2000 • All have to go for ISO 9001 only, and can get exemption for any clause from Clause No 7, provided it is not affecting the ability to meet customer and regulatory requirements. • There are 8 clauses in ISO 9001:2000. 9

Objective Introduce the concept of new ISO 9001 Standard

Highlight important areas and changes of the new standard

Briefly introduce the system requirements of the new standard

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What is ISO 9001: 2000 2nd revision of Quality Management System Requirement Standard from International Organization for Standards

Replacement for previous ISO 9001 / 9002 and 9003 standards of 1994

Introduced considerable conceptual changes

Applicable to all types of Organizations with possible permissible omissions of certain requirements

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New ISO 9001 Management Responsibility

General requirements

Resource management

QMS

Measurement, analysis & improvements

General requirements

Product Realization

Continual Improvement cycle 12

ISO 9001:2000 – Model Continual Improvement of the Quality Management System

CUSTOMERS

Requirements

Quality Management

8. Measurement

6. Resource Management

Analysis and Improvement

Satisfaction

CUSTOMERS

5.Management Responsibility

System

7. Product Realization

Product

Consumption

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Principles of new standard Customer focus Mutual beneficial supplier ip relationsh

Factual to approach decision making

p

Leadershi

eight n o d e s a B quality ent managem principles

nt Involveme of people

Process approach Continual ent improvem

System to approach en Managem t 14

Principles of new standard Customer focus

•Organization depends customers •Understand current & future customer needs. •Meet / exceed customer expectations

Leadership

•Leaders establish purpose & direction of the organization •Should create & maintain environment to achieve organization’s objectives

Involvement of People

•People of all levels are essence of an organization •Their full involvement for organization’s benefit

Process approach

Desired results are achieved more efficiently when activities and resources are managed as process 15

Principles of new standard System approach to Management

Identifying, understanding and managing interrelated process as a system contributes to the organization’s effectiveness & efficiency

Continual improvements

Continual improvement of the organization’s overall performance should be a permanent objective of the organization

Factual approach to decision making

Effective decisions are based on the analysis of data and information

Mutually beneficial supplier relationships •An organization & its suppliers are interdependent •Mutually beneficial relationship enhances the ability of both to create value 16

QMS PRINCIPLES 1. Customer focus • To identify and understand customer needs • To satisfy customer requirements • To meet customer expectations 2. Leadership • Leaders establish unity of purpose, direction • and internal environment of the organization • Leaders establish the context in which staff • becomes involved 17

QMS PRINCIPLES Contd..

3. Involvement of staff • Full involvement of staff at all levels • for the benefit of the organization 4. Process approach • Managing resources and activities processes • to achieve desired results 18

QMS PRINCIPLES Contd..

5. System approach management • Understanding and managing a system of • interrelated processes • as a contribution to the organization’s • effectiveness and efficiency 6. Continual improvement • Must become the organization’s permanent objective 19

QMS PRINCIPLES Contd..

7. Factual and documented approach to decision making: • Effective decisions are based on the analysis of data, information and indicators 8. Mutually beneficial relationships with suppliers • Allows both organizations to create value

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Expectations of the new Standard Avoid the application of systems that are separate from the organization’s business process

Enable the development of a Quality system that is fully integrated into the normal operations of organization’s business

Enable Continual improvements of the system for enhanced customer satisfaction

Enable compliance to statutory & regulatory requirements

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Important changes Criteria

Previous version

New Version

Main focus

Products

Customer satisfaction

Approach

20 quality elements

Value adding processes

Product requirements

Requirements specified by customer / organization

+ Statutory & regulatory requirements

Involvement of people What to do, When, Whom & How + Why it is to be done to do Improvements

Maintain the system requirements

Continual improvements should be achieved

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Process approach Process definition Set of interrelated or interacting activities which transforms inputs into outputs

Identify the processes

Identify the Inputs & outputs

Identify the Interactions to other processes

Establish measurin g criteria

Ensure continual improvements

Do it for all value adding processes 23

Process approach – Continual improvements of Process Understandings & meeting requirements PLAN

Processes in terms Of Added Value DO

PDCA Cycle

Continual improvements of Processes based on objective measurements ACTION

Measure results of process Performance and effectiveness - Objective Measurements CHECK 24

E.g. - Purchasing Process Inputs • Required item / quantity / date • Applicable specs • Supplier source • Suppliers capability to meet our requirements

Purchasing Procedure

Interactions to

•Storage •Inspection and Testing •Manufacturing •Finance

Outputs • Receipt of Material on right condition • Right Quality Right Quantity • Right Time

Performance Measurements

•Delivery status – On-time, On spec, NCP etc •Supplier evaluation 25

System Requirements / Structure of the Standard 4 Quality Management System

General requirements Documentation Requirements

5 Management Responsibility

Management Commitment Customer focus

6 Resource Management

Provision of resources Human resources

7 Product Realization

Planning

General

Customer related processes

Monitoring & measurement

Quality policy Infrastructures Planning

Responsibility, authority & communication

Work environment

8 Measurement Analysis & improvement

Design & development

Control of NCP Analysis of data

Purchasing Improvements Production & service provision

Management Reviews 26

4 - Quality management system Identification Continual

of processes

improvements

required

4.1 General Criteria and

requirements Monitoring and

methods to ensure

Measuring of

Operation & control

processes Availability of information & resources for operation & control

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4 - Quality management system 4.2 Document requirements Quality Policy Quality Objectives Quality Manual Procedures required by the Standard Procedures required for planning, operation & control of Organization activities

Records 28

5 - Management Responsibility 5.1 Management commitment

5.2 Customer focus

5.3 Quality policy

5.4 Planning

5.6 Responsibility authority & communicate

Quality objectives

Responsibility & authority

QMS planning

Management representative Internal communication

5.7 Management Review

General Review inputs Review outputs

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5 - Management Responsibility Development, implementation and continually improvement of QMS Establishment of

Top Management’s commitment

•Appointment of Management Representative •Conducting Management Reviews

•Quality Policy •Quality Objectives

Identification of Customer requirements

Communication of importance of •Regulatory & statutory requirements •Meeting customer requirements •Quality Policy & Quality objectives •Responsibilities & authorities

•Providing required resources 30

5 - Management Responsibility

Evidence must be provided to show that the Management is committed to the above requirements

Auditors could speak to and audit Top Management (E.g. MD / Directors) to establish their commitment to the management system

New Development

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6 - Resource Management 6.1

6.2

Provision of resources

Human Resources

6.3 Infrastructures

6.4 Work Environment

General

Competence, awareness & training

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6 - Resource Management Resources required to Implementing, monitoring & continual improvements Enhance Customer satisfaction by meeting customer requirements

Human Resources Resource Managemen t

Infrastructures Infrastructures needed to achieve product conformity

Work environment Work environment needed to achieve product conformity 33

Enhanced

6 - Human Resources Competent on the basis of appropriate education, skill and experience

Define competencies for people performing work affecting product quality

6.2 Human Resources

Provide training or actions

Evaluate effectiveness of the training / actions

Employees should aware importance of the activity being performed 34

7 - Product Realization 7.1

7.2

7.3

7.4

7.5

7.6

Planning of product realization

Customer related processes

Design and development

Purchasing

Production & service provision

Control of monitoring measuring devices

Purchasing process

Control

Identification of customer requirement

Design planning Design inputs

Review of customer requirement

Design outputs

Customer communication

Design verification

Design review

Design validation

Purchasing information Verification of purchased products

Validation of processes Identification & traceability Customer property Preservation of product

Design Changes 35

7 - Product Realization Quality objectives of Products – Specs

Processes, procedures to realize product

7.1 Planning of Product realization

Verification, validation, monitoring, inspection and testing of product

Record to demonstrate conformance

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7 - Product Realization Identification of Customer / Market requirements •Specified by customer •Requirements taken for granted •Statutory / Regulatory requirements

7.2 Customer related processes – (Sales)

Review of requirements related product prior to acceptance / commitment to customers - ability to meet customer requirements

Effective communication with customer in relation to •Product information •Sales order handling •Customer feedback •Customer complaints 37

7 - Product Realization Planning •Effective & efficient •Expectations of interested parties •EHS

7.3 Design and Development – (Product)

Design inputs and outputs

Review and verification, validation and control of changes •Accuracy •Potential hazards & faults •Corrections •Evaluations against lessons learned 38

7 - Product Realization Degree of control depends on effects of subsequent processes and effect on final product

7.4 Purchasing Purchasing is done in controlled manner to ensure that purchased products conforms to specific requirements

Supplier evaluation

Verification of purchased product – Inspection and testing

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7 - Product Realization Product characteristics (Specs)

Procedures and work instructions

Suitable equipments to manufacture. Monitoring and inspection & testing

7.5 Production and service provision Manufacturing / service provision under controlled condition to ensure conformity of product

Product release, delivery and post delivery

Process validation

Identification and traceability Customers property Material supplied by customers – e.g.. 3rd party blending 40

7 - Product Realization 7.6 Control of monitoring and measuring devices Control and Calibration of equipments used for monitoring, inspection and testing

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8 - Measurement, analysis and improvement 8.1

8.2

General

Monitoring & measurements

8.3 Control of non conforming product

8.4

8.5

Analysis of data

Improvement

Customer satisfaction

Continual improvements

Internal audits

Corrective action

Measurement of processes

Preventive action

Measurement of product

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8 - Measurement, analysis and improvement To demonstrate 8.1 - To demonstrate •Conformity of the product •Conformity to QMS requirements •Continually improvements and the effectiveness of the system

8.2 - Monitoring and Measurements •Customer satisfaction / perception •Internal audits - conformity planned arrangements of QMS and ISO9001 •Monitoring and measurements of processes – to determine / demonstrate ability of processes to achieve required results

•Monitoring and measurements of product – Conformity to product requirements

8.3 - Control of NCP (Non Conforming Products) •To assure that NCP products are identified and controlled to prevent

unintended use / delivery

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8 - Measurement, analysis and improvement 8.4 - Analysis of data Collection and analysis of data generated through QMS activities to verify suitability, effectiveness and continual improvement of the system

Analysis shall provide information related to •Customer satisfaction / perception •Conformity to specs, requirements •Trends of processes and products • Opportunities for preventive actions •Suppliers

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8 - Measurement, analysis and improvement 8.5 - Improvements Continual Improvements •QMS needed to be continually improved

Corrective action •Actions to prevent recurrence of NCP, NCR etc •Includes reviews, determination of causes, need of action, implementation of action, review of action and maintenance of relevant records

Preventive action •Actions against potential non conformities to avoid their occurrence •Includes identification of potential non conformities, cause, need for action, implementation of action, review of action and maintenance of records 45

Criteria for measurements –Satisfaction surveys for customers and other interested parties •Feedback on products •Customer & market requirements

System performanc e

–Financial measurements •Prevention cost •Non conforming / failure cost •Lifecycle cost Self assessment

–Internal audits •Effectiveness & efficiency of processes •Opportunities for improvements •Use of data / information •Effective & efficient use of resources •Adequacy, accuracy and performance of measurements •Relationships with customers/ suppliers/ other interested parties 46

Criteria for measurements

Processes

–Process capability / process validation –Reaction time –Cycle time / throughput (Capacity) –Utilization of technology –Waste reduction –Cost reduction

Products

–Inspection and testing of incoming, in process and final product –Product verification –Product validation

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Pros and Cons More business oriented. Less procedure oriented Company wide involvement Mutual benefit to all interested parties Customer focus than product focus Continual improvements Less emphasis on documentation

Demanding more resources ??

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Challenges in implementing new standard Management Support

Encouragement

New ISO

Communication

Other employee Support 49

ISO 9001:2000 Transition Process

1st visit

2nd visit

3rd visit

4th visit

Review of QMS & Product realization

Review of Measurement, analysis & improvements

Review of Management responsibilit y

Review of Resource management

2 years

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Mission

Purpose for which we are working?

What we would like to be?

Policy

Vision

Which path we need to adopt?

What we should achieve?

Objectives

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Five golden questions. • 1. A re we havi ng a pr ocedure? • 2. H ow do we ensure it as the best? • 3. H ow it is i mplem ented? • 4. W hether we got the resul ts as anti ci pated? • 5. H ow do we com pare wi th our competi tors? 52

Reasons for implementing ISO 9000 • • • • • •

To operate efficiently To achieve customer satisfaction To improve financial results To satisfy stakeholders, employees and partners To secure sustainability 53

ISO 9000 implementation hints An 8 step approach An 8 step approach 1. Determination of customer needs and expectations 2. Establishment of the organization's quality policy and objectives 3. Determination of processes and responsibilities to achieve the quality objectives 4. Determination and provision of resources to achieve the quality objectives 54

ISO 9000 implementation hints An 8 step approach An 8 step approach (contd..) 1.

Definition of methods for measuring process effectiveness and efficiency

6.

Implementation of measurement methods

7.

Determination of means for dealing with complaints and non conformities

8.

Establishment and implementation of a process for the continual improvement of the Quality Management System QMS

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ISO 9000 implementation hints Role of top management Role of top management • • • •

Establish and maintain policy and set objectives Promote the quality policy in the organization Ensure focus on customer requirements Ensure the implementation of appropriate processes to enable achievement of objectives and customer requirements • Ensure the availability of the needed resources • Review the QMS periodically • Decide on improvement actions 56

ISO 9000 Reminders • • • • •

Does NOT define quality Is NOT a one-time process Is NOT easy Requires commitment Requires resources 57

Standards and guidelines

Purpose

ISO 9000:2000, Quality management systems - Fundamentals and vocabulary

Establishes a starting point for understanding the standards and defines the fundamental terms and definitions used in the ISO 9000 family which you need to avoid misunderstandings in their use.

ISO 9001:2000, Quality management systems - Requirements

This is the requirement standard you use to assess your ability to meet customer and applicable regulatory requirements and thereby address customer satisfaction. It is now the only standard in the ISO 9000 family against which third-party certification can be carried.

ISO 9004:2000, Quality management systems - Guidelines for performance improvements

This guideline standard provides guidance for continual improvement of your quality management system to benefit all parties through sustained customer satisfaction.

ISO 19011, Guidelines on Quality and/or Environmental Management Systems Auditing (currently under development)

Provides you with guidelines for verifying the system's ability to achieve defined quality objectives. You can use this standard internally or for auditing your suppliers.

ISO 10005:1995, Quality management - Guidelines for quality plans

Provides guidelines to assist in the preparation, review, acceptance and revision of quality plans.

ISO 10006:1997, Quality management - Guidelines to quality in project management

Guidelines to help you ensure the quality of both the project processes and the project products.

ISO 10007:1995, Quality management - Guidelines for configuration management

Gives you guidelines to ensure that a complex product continues to function when components are changed individually.

ISO/DIS 10012, Quality assurance requirements for measuring equipment Part 1: Metrological confirmation system for measuring equipment

Give you guidelines on the main features of a calibration system to ensure that measurements are made with the intended accuracy.

ISO 10012-2:1997, Quality assurance for measuring equipment - Part 2: Guidelines for control of measurement of processes

Provides supplementary guidance on the application of statistical process control when this is appropriate for achieving the objectives of Part 1.

ISO 10013:1995, Guidelines for developing quality manuals

Provides guidelines for the development, and maintenance of quality manuals, tailored to your specific needs.

ISO/TR 10014:1998, Guidelines for managing the economics of quality

Provides guidance on how to achieve economic benefits from the application of quality management.

ISO 10015:1999, Quality management - Guidelines for training

Provides guidance on the development, implementation, maintenance and improvement of strategies and systems for training that affects the quality of products.

ISO/TS 16949:1999, Quality systems - Automotive suppliers - Particular requirements for the application of ISO 9001:1994

Sector specific guidance to the application of ISO 9001 in the automotive industry. 58

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