iso 9001 2000 awareness programme -...

ISO 9001 – 2000 AWARENESS PROGRAMME

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Evolution of Quality & Quality Management

System

Process Approach, PDCA Cycle

Quality Management Principles

ISO 9001 – 2000 – Terms & Definitions and QMS

Overview

ISO 9001 – 2000 QMS Requirements

Program contents:

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WHY QUALITY ?

To satisfy customers

To stay in the market

To survive at all times

To satisfy customers, stake holders &

other interested parties

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CONCEPT OF QMS

Reduction of variations and elimination of waste

Control of un-productive activities

Enhancing the effectiveness and efficiency of productive activities / processes

Customer satisfaction

Continual improvement

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Customers

(ISO9001)

and other

Interested

Parties

(ISO 9004)

Note : 1) Interested parties include Customer, stake holder & Society

2) Based on PDCA Methodology

Product

Continual Improvement

Of the Quality Management System

INPUTRequirements

Customers

(ISO9001)

and other

Interested

Parties

(ISO 9004)

Satisfaction

Management

Responsibility

Resource

Management

Product

realization

Measurement,

Analysis &

Improvement

OUTPUT

MODEL OF THE PROCESS APPROACH

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WHAT IS A PROCESS ?

Process is defined as a series of sequential actions

or tasks used to achieve an objective

A set of activities, inter linked together, to

achieve a single objective form a process.

Basic process elements include input, task &

output.

Task 1 Task 2 Task 3OutputInput

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WHAT IS A PROCESS ?

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8 - Quality Management Principles

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QUALITY MANAGEMENT PRINCIPLES

1. Customer Focused Organization

2. Leadership

3. Involvement of people

4. Process Approach

5. Systems Approach to Management

6. Continual Improvement

7. Factual approach to decision making

8. Mutually beneficial supplier relationships

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ISO 9000:2000 REVISIONSQUALITY MANAGEMENT PRINCIPLES (Contd.)

Principle 1 Customer focus

Organizations depend on their customers and therefore should understand current

and future customer needs, should meet customer requirements and strive to

exceed customer expectations

Key benefits:

• Increased revenue and market share obtained through flexible and fast responses to market

opportunities

• Increased effectiveness in the use of the organization's resources to enhance customer satisfaction

• Improved customer loyalty leading to repeat business

Applying the principle of customer focus typically leads to: • Researching and understanding customer needs and expectations

• Ensuring that the objectives of the organization are linked to customer needs and expectations

• Communicating customer needs and expectations throughout the organization.

• Measuring customer satisfaction and acting on the results

• Systematically managing customer relationships

• Ensuring a balanced approach between satisfying customers and other interested parties (such as

owners, employees, suppliers, financiers, local communities and society as a whole)

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Principle 2 Leadership

Leaders establish unity of purpose and direction of the organization. They should

create and maintain the internal environment in which people can become fully

involved in achieving the organization's objectives

Key benefits:• People will understand and be motivated towards the organization's goals and objectives.

• Activities are evaluated, aligned and implemented in a unified way.

• Miscommunication between levels of an organization will be minimized.

Applying the principle of leadership typically leads to: • Considering the needs of all interested parties including customers, owners, employees, suppliers,

financiers, local communities and society as a whole.

• Establishing a clear vision of the organization's future.

• Setting challenging goals and targets.

• Creating and sustaining shared values, fairness and ethical role models at all levels of the organization.

• Establishing trust and eliminating fear.

• Providing people with the required resources, training and freedom to act with responsibility and

accountability.

• Inspiring, encouraging and recognizing people's contributions.

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Principle 3 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

Key benefits: • Motivated, committed and involved people within the organization.

• Innovation and creativity in furthering the organization's objectives.

• People being accountable for their own performance.

• People eager to participate in and contribute to continual improvement.

Applying the principle of involvement of people typically leads to: • People understanding the importance of their contribution and role in the organization

• People identifying constraints to their performance

• People accepting ownership of problems and their responsibility for solving them

• People evaluating their performance against their personal goals and objectives

• People actively seeking opportunities to enhance their competence, knowledge and experience

• People freely sharing knowledge and experience

• People openly discussing problems and issues

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Principle 4 Process approach

A desired result is achieved more efficiently when activities and related resources are

managed as a process

Key benefits:Lower costs and shorter cycle times through effective use of resources

Improved, consistent and predictable resultsFocused and prioritized improvement opportunities

Applying the principle of process approach typically leads to:Systematically defining the activities necessary to obtain a desired result

Establishing clear responsibility and accountability for managing key activities

Analyzing and measuring of the capability of key activities

Identifying the interfaces of key activities within and between the functions of the organization

Focusing on the factors such as resources, methods, and materials that will improve key activities of

the organization

Evaluating risks, consequences and impacts of activities on customers, suppliers and other interested

parties

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Principle 5 System approach to management

Identifying, understanding and managing interrelated processes as a system

contributes to the organization's effectiveness and efficiency in achieving its

objectives

Key benefits: • Integration and alignment of the processes that will best achieve the desired results.

• Ability to focus effort on the key processes

• Providing confidence to interested parties as to the consistency, effectiveness and efficiency of

the organization

Applying the principle of system approach to management typically leads to:• Structuring a system to achieve the organization's objectives in the most effective and efficient

way

• Understanding the interdependencies between the processes of the system

• Structured approaches that harmonize and integrate processes

• Providing a better understanding of the roles and responsibilities necessary for achieving common

objectives and thereby reducing cross-functional barriers

• Understanding organizational capabilities and establishing resource constraints prior to action.

• Targeting and defining how specific activities within a system should operate

• Continually improving the system through measurement and evaluation

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Principle 6 Continual improvement

Continual improvement of the organization's overall performance should be a

permanent objective of the organization

Key benefits: • Performance advantage through improved organizational capabilities

• Alignment of improvement activities at all levels to an organization's strategic intent

• Flexibility to react quickly to opportunities

Applying the principle of continual improvement typically leads to:• Employing a consistent organization-wide approach to continual improvement of the

organization's performance

• Providing people with training in the methods and tools of continual improvement

• Making continual improvement of products, processes and systems an objective for every

individual in the organization

• Establishing goals to guide, and measures to track, continual improvement

• Recognizing and acknowledging improvements

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Principle 7 Factual approach to decision making

Effective decisions are based on the analysis of data and information

Key benefits: • Informed decisions

• An increased ability to demonstrate the effectiveness of past decisions through reference to

factual records

• Increased ability to review, challenge and change opinions and decisions

Applying the principle of factual approach to decision making typically leads to: • Ensuring that data and information are sufficiently accurate and reliable

• Making data accessible to those who need it

• Analyzing data and information using valid methods

• Making decisions and taking action based on factual analysis, balanced with experience and

intuition


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Principle 8 Mutually beneficial supplier relationships

An organization and its suppliers are interdependent and a mutually beneficial

relationship enhances the ability of both to create value

Key benefits:• Increased ability to create value for both parties

• Flexibility and speed of joint responses to changing market or customer needs and expectations

• Optimization of costs and resources

Applying the principles of mutually beneficial supplier relationships typically leads to: • Establishing relationships that balance short-term gains with long-term considerations

• Pooling of expertise and resources with partners

• Identifying and selecting key suppliers

• Clear and open communication

• Sharing information and future plans

• Establishing joint development and improvement activities

• Inspiring, encouraging and recognizing improvements and achievements by suppliers

Terminology and Definitions

as per

ISO 9000 : 2000

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ISO 9000:2000 REVISIONS SOME MAJOR CHANGES

Terminology:

Supplier changed to Organization

Subcontractor changed to Supplier

Scope: Permissible exclusions - limited to clause 7

Certain definitions are discussed in subsequent slides.

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ISO 9000:2000 REVISIONS DEFINITIONS

Quality:

degree to which a set of inherent Characteristics fulfills

requirements

Quality Policy:

Overall intentions and direction of an Organization related to

quality as formally expressed by the top management

Quality Objective:

Something sought or aimed for, related to quality

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Quality Control:

Part of quality management focused on fulfilling quality

requirements

Quality Assurance:

Part of quality management focused on providing confidence that

quality requirements are fulfilled

Quality Improvement:

Part of quality management focused on increasing the ability to fulfill

quality requirement.

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Effectiveness :

Extent to which planned activities are realized and

planned results achieved.

Efficiency:

Relationship between result achieved and resources

used.

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Conformity:

Fulfillment of a requirement.

Non-conformity:

Non fulfillment of a requirement.

Defect:

Non fulfillment of a requirement related to an intended or

specified use.

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Correction:

Action taken to eliminate a detected non-conformity

Corrective action:

Action taken to eliminate the cause of a detected non-conformity or other

undesirable situation

(to prevent recurrence. See note 2 )

Preventive action:

Action taken to eliminate the cause of a potential non-conformity or other

potentially undesirable situation

(to prevent occurrence. See note 2)

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Quality Manual:

Document specifying the QMS of an Organization.

Document:

Guidelines ,Information and its supporting medium these can be

revised

Record:

Document stating the results achieved or providing evidence of

activities performed. These can not be revised

ISO 9001:2000

Quality Management Systems

Requirements

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DOCUMENTED PROCEDURES

Following 6 documented procedures are required by the

Standard

Document Control ( 4. 2. 3 )

Quality Records ( 4. 2. 4 )

IQA Procedure ( 8. 2. 2 )

Nonconformity Control ( 8. 3 )

Corrective Action ( 8. 5. 2 )

Preventive Action ( 8. 5. 3 )

Other procedures / documents as required by the Organ. to

manage the processes & operation of QMS may be

documented

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ISO 9001:2000 Requirements

Clause 4 : Quality Management System

Sub-clause 4.2: Documentation Requirements

4 .2 .3 : Control of documents

Documents required for QMS shall be controlled. A documentedprocedure shall be established to address : -

Approve documents for adequacy prior to use

Review and update and re-approve documents

Identify the current revision status of the documents

Ensure that relevant versions of applicable documents are availableat points of use

Ensure that documents remain legible, readily identifiable andretrievable

Ensure that documents of external origin are identified and theirdistribution controlled

Prevent unintended use of obsolete documents

Issue control of QMS documents and control of records (Records arespecial type of document) as per Cl. 4. 2. 4.

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Clause 4 : Quality Management System

Sub-clause 4.2: Documentation Requirements

4.2.4 : Control of Records

Quality records shall be maintained to provide evidence ofconformance to requirements and of effective operation of the QMS

A documented procedure shall be established for the identification,storage, retrieval, protection, retention time and disposition ofquality records

Records shall be legible, identifiable, retrievable, and stored,protected and disposed off after retention period

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Clause 5: Management Responsibility

Sub-Clause 5.2: Customer focus

Intent:

To Achieve and enhance customer satisfaction

Requirements:

Customer needs and expectations are determined

Converted into requirements and fulfilled/met

Aim to enhance customer satisfaction

Consider obligations related to product includinglegal and regulatory requirements

A procedure is required to determine the needs and expectations andmethods to exist defining the frequency & methods adopted forcollection of such information. To be an ongoing work.

IQA to verify the compliance to the procedure and actions taken basedon the feedback.

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Sub-Clause 5.3: Quality Policy

Intent:

Provide direction to Organization for achievement of quality

Requirements:

Top management to define and document the Quality policy and shall

ensure that the Policy :

is appropriate to the purpose of the Organization

includes a commitment to meeting the requirements and to continually

improve effectiveness of QMS

provides a framework for establishing and reviewing quality objectives

is communicated and understood at appropriate levels in the organization

is reviewed for continuing suitability.

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Sub-Clause 5.4: Planning

5.4.1: Quality objectives : requirements

Top management shall ensure that quality objectives are:

established at relevant functions and levels in the organisation

measurable and consistent with the quality policy and commitment to

continuous improvement

to include those needed to meet the requirements for product

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Sub-Clause 5.5: Administration

5.5.1 Responsibility and authority

Functions and their interrelations within the Organization, includingresponsibilities and authorities of personnel who manage , perform &verify shall be defined and communicated in order to facilitateeffective quality management

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5.5.2 Management Representative

Top management shall appoint member's of the management who,irrespective of other responsibilities, shall have responsibility and authoritythat includes:

ensuring that processes of QMS are established, implemented andmaintained.

reporting to top management on the performance of the QMS includingneeds for improvement;

promoting awareness of customer requirements throughout the organization

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5. 5.3: Internal Communication

The organization shall ensure appropriate communication processes areestablished within the Organization (between its various levels and functions)and that communication takes place regarding the effectiveness of QMS

.

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Sub-Clause 5.6: Management Review

Intent:

Ensure continuing suitability, adequacy and

Effectiveness of QMS

Requirements:

General ( 5.6.1)

Review Input ( 5.6.2 )

Review Output ( 5.6.3 )

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Sub-Clause 5.6: Management Review

5.6.1: General

Top management shall review the QMS at planned intervals,

to ensure its continuing suitability, adequacy and effectiveness

The review shall identify opportunities for improvement and evaluate

the need for changes to the QMS including quality policy and

quality objectives

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Clause 6: Resource Management

Intent:

Provision of resources - people, facilities and work environment essential tothe implementation of QMS and address customer satisfaction

Requirements:

Provision of resources (6.1)

Human resources (6.2)

Infrastructure (6.3)

Work environment (6.4)

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Clause 6.1 Provision of resources

Requirement:

The organization shall determine and provide, the resources needed

to implement and maintain the quality management system and improve QMS Effectiveness

to enhance customer satisfaction by meeting customer requirements

Requirements can be identified on need basis or for new assignments or as a

proposal or in MRM etc.

Records of such communication to be verified in IQA

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Clause 6.2 Human resources

Intent:

Assign competent persons for the work

6.2.1 General

Requirement:

The organization to ensure that personnel performing the work affectingquality shall be competent

Competency can be based on any or a combination of qualification ,experience and training

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Clause 6.2 Human resources

6.2.2 Competence, awareness and training:

The Organization needs to

identify competency needs

provide training to satisfy these needs

evaluate the effectiveness of training provided

ensure that its employees are aware of the relevance

and importance of their activities and how they contribute to theachievement of the quality objectives

maintain appropriate records of education, experience,

training, and qualifications (see 4.2.4)

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Clause 6.3: Infrastructure

Intent:

Achieve the conformity of product

Requirement:

identify, provide and maintain

workspace and associated facilities

equipment, hardware and software

supporting services such as transport services

facilities used for the realization of product is to be verified in IQA

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Clause 6.4: Work environment

Intent:

enhance performance of the Organization by

creating a work environment

Requirement:

Determine and Manage work environment to achieve conformity, whichrequires review of

-Human factors

- Physical factors

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Clause 7.4 : Purchasing

7.4.1 Purchasing process

Requirements:

Control purchasing processes to ensure that purchased products conform tospecified requirements

Type and extent of control depends on the effect on subsequent processes andtheir output

Evaluate and select suppliers based on their ability to meet requirements.

Define criteria for selection and periodic evaluation Record results ofevaluation and follow-up action (4.2.4)

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Clause 7: Product Realization

Clause 7.4 Purchasing

7.4.2 Purchasing information

Requirements:

Purchasing documents to contain information including, as appropriate, anyrequirement for qualification or approval of process, procedures, equipmentand personnel and any Quality Management System requirements

Ensure the adequacy of the requirements contained in the purchasingdocuments prior to release.

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Clause 7.4 Purchasing

7.4.3 Verification of purchased product

Requirements:

Identify and implement the necessary verification activities

Whenever verification at supplier’s premises is envisaged, the same shall bespecified along with the method of product release in purchasing documents.

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Clause 7.5 Production and service operations

7.5.3 identification and traceability

Requirements:

Identify, where appropriate, product by suitable means throughoutproduction and service operations.

Identify the status of product with respect to measurement and monitoringrequirements

Where traceability is requirement, control and record unique identification(4.2.4)

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Clause 7.6 Control of Measuring & Monitoring Devices

Requirements :

Identify measurements to be made and the measurement andmonitoring devices required.

Use and control, to ensure that measurement capability isconsistent with the requirements.

Measurement and monitoring devices shall:

be calibrated periodically or prior to use.

be safeguarded from damage and deterioration duringhandling, maintenance and storage.

have the results of their calibration recorded ( 4.2.4)

have the validity of previous results re-assessed, if they arefound to be out of calibration and the corrective action take

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Clause 8: Measurement, analysis and improvement

Intent:

To measure and monitor the product, process and system in a planned wayand to analyze the resultant data and use the same for continual improvementof product, process and system

Requirements:

General (8.1)

Measurement and monitoring (8.2)

Control of nonconforming product (8.3)

Analysis of data (8.4)

Improvement (8.5)

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Clause 8.2 Monitoring and Measurement

8.2.1 Customer satisfaction

Requirements:

Monitor information on customer satisfaction and / or dissatisfaction

This is one of the measurements of performance of the quality managementsystem

Define the methodologies for obtaining and using this information

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8.2.2 Internal audit

Requirements:

Conduct periodic internal audits to determine whether the QMS:

conforms to the requirements of this International standard

has been effectively implemented and maintained

Plan the audits based on the status and importance of the activities of the

areas to be audited and the results of the previous audits

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8.2.2 Internal audit (contd)

Requirements :

Define audit scope, frequency and methodology

Shall be conducted by personnel independent of the area being audited.

Documented procedure shall include the responsibilities and requirements

for conduct of audits, independence, recording results and reporting

to management

Timely corrective action is taken on the deficiencies found by the Auditee.

Follow up actions include verification of the corrective action taken

and reporting of the results

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Clause 8.5 Improvement

8.5.1 Continual improvement

Requirements:

Plan and manage the processes necessary for the continual improvement ofthe QMS

Facilitate continual improvement through use of quality policy, objectives,audit results, analysis of data, corrective and preventive action andmanagement review

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Clause 8.5 Improvement

8.5.2 Corrective action

Requirements:

Take corrective action to eliminate causes of non conformities in order to

prevent recurrence. Corrective action shall be appropriate to the impact of the

problems encountered

Documented procedure for corrective action shall cover:

reviewing non conformities (including customer complaints)

determining causes of nonconformity

evaluating need for actions to ensure that non conformities do not recur

determining and implementing the corrective actions needed

recording results of action taken

reviewing of corrective actions taken for effectiveness

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IMPROVEMENTS IN ISO 9001:2000

Continual improvement emphasis

Increased emphasis on the role of top management

Consideration of legal and regulatory requirements

To establish measurable objectives at relevant functions and levels

Monitoring Customer satisfaction as well as dissatisfaction

Resources, Human resources, Facilities & Work environment

Management and Control

Competency and training

Measurements extended to System, Processes and Product

Analysis of data for initiating improvements

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