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TWO DAYS SHORT COURSE ON ISO 9001:2000 QUALITY MANAGEMENT SYSTEM 24-25 May, 2008 PowerPoint PPT Presentation


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TWO DAYS SHORT COURSE ON ISO 9001:2000 QUALITY MANAGEMENT SYSTEM 24-25 May, 2008. CONTENTS. 1. Background. 2. Eight Quality Management Principles. 3. ISO 9001:2000 Requirements. How to implement ISO 9001:2000. 4. DAY-1 SESSION-1. 1. BACKGROUND. What is ISO 9001?. ISO.

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TWO DAYS SHORT COURSE ON ISO 9001:2000 QUALITY MANAGEMENT SYSTEM 24-25 May, 2008

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Two days short course on iso 9001 2000 quality management system 24 25 may 2008

TWO DAYS SHORT COURSE

ON

ISO 9001:2000

QUALITY MANAGEMENT SYSTEM

24-25 May, 2008


Contents

CONTENTS

1

Background

2

Eight Quality Management Principles

3

ISO 9001:2000 Requirements

How to implement ISO 9001:2000

4


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

DAY-1

SESSION-1


Background

1

BACKGROUND


What is iso 9001

What is ISO 9001?

ISO

  • “ISO 9001” is a series of standards describing the requirements for establishing and maintaining a quality management system in an organization

9001

The word “iso” or International Organization for Standardization

The series allocated for Quality System standards


What is iso

What is ISO?

  • International Organization for Standardization

  • Develop standards and not to certify companies

  • Around 148 countries members

  • Around 13000 standards produced

  • Technical Committees are formed to produce standards

  • TC 176 for ISO 9001

  • International Organization for StandardizationEmail: [email protected]: http://www.iso.ch http://www.bsi.org.uk/iso-tc176-sc2.

  • First Pakistani company certified in 1994

  • More than 3,000 companies certified to ISO 9001 in Pakistan

  • More than 220 Certification (Auditing) Agencies throughout the world of which around 15 have offices in Pakistan

  • Established in 23 February 1947

  • ISO Systems:ISO 9001-2000, ISO-14000, ISO 17025, etc.


Origin of iso 9001

Origin of ISO 9001

ISO 9001:87

ISO 9001:94

ISO 9001:2000

BS5750

1979

AQAP1

(NATO)

1970’s

MIL-STD-9858

(1940’s)


Application of iso 9001

Application of ISO 9001

  • ISO 9001 is applicable to any type and any size of organization

    • It is not an industry specific or product specific standard

  • ISO 9001 involves third party certification

    • an independent auditing agency audits the organization against the requirements of the standard and issues certificate on successful compliance

  • ISO 9001 Certification is valid for three years

    • initial certification audit

    • yearly or half-yearly surveillance audits


Iso 9001 2000 family of standards

ISO 9001:2000 Family of Standards

  • CORE STANDARDS

    • ISO 9000:2000 Fundamentals and Vocabulary

    • ISO 9001:2000 QMS Requirements

    • ISO 9004:2000 Guidelines for Performance Improvement

  • SUPPORTING STANDARDS

    • ISO 10005:1995 Guidelines for Quality Plans

    • ISO 10006:2003 Guidelines for Project Management

    • ISO 10007:2003 Guidelines for Configuration Mgt

    • ISO 10012 Measurement Management System

    • ISO 10013:2001 Documentation

    • ISO/TR 10014:1999 Economics Of Quality

    • ISO/TR 10015:2000Training

    • ISO/TR 10017:2003 Statistics

    • ISO 19011:2003Auditing

    • ISO 10002:2004Complaint handling

    • ISO 10001Market based Code of Conduct

    • ISO 10003External Dispute Resolution System


Revisions of iso 9001

Revisions of ISO 9001

Second revision named as ISO 9001:2000

2000

First revision named as ISO 9001:1994

1994

Originally released as ISO 9001:1987

1987

ISO 9001 is revised after five years


Iso 9001 1994 models

ISO 9003:1994Applies to organizations that do not design/develop and produce their products or services but are only involved in final inspection and delivery of the finished product

ISO 9002:1994Applies to organizations that do not design/develop their products or services but are only involved in production of products/ provision of services and delivery of products/services

ISO 9001:1994Applies to organizations involved in design and development of products/services, production of products/provision of services, and delivery of products/services

ISO 9001:1994 Models


Elements of iso 9001 1994

Elements of ISO 9001:1994


Advantages of iso 9001

ADVANTAGES OF ISO-9001


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

  • For your employees:

    • Staff gets a better understanding of their role and objectives, by having a documented management system.

    • They benefit from reduced stress levels, because they are using an efficient management system and because they know what is expected of them.

    • They get increased morale and a sense of pride through achieving the goals of registration and customer satisfaction.

    • New staff can immediately learn their job, because the details are in writing.


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

  • For your organization:

    • Your products will be of a more consistent quality, and you will produce fewer rejects.

    • You gain cost savings, because your production will be more efficient. There are economies in production (because your systems are controlled from start to finish), and economies in time that was formerly spend re-doing work.

    • You can improve the quality of your raw materials by requiring your suppliers to have a ISO 9001 system.

    • Export marketing is easier, because some foreign buyers recognize ISO 9001 (BS 5750).


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

  • You can expect preferential treatment from potential customers who have ISO 9001 certification. This means an increase in new business.

  • You secure greater customer loyalty, because you continuously satisfy their needs and give them no cause to seek another supplier. That means you suffer fewer customer losses.

  • You can use ISO 9001 in your publicity to win more sales.

  • ISO 9001 helps you minimize the risk of producing unsafe products. It may also give you some protection law against product liability claims.

  • Being first in your area or industry may put you ahead of your rivals by 18 months to two years.


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

  • For your customers:

    • Your customers get a known level of quality that is independently audited.

    • They get a means of choosing between competing suppliers.

    • They can have more confidence in your goods.

    • ISO 9001 minimize their risk, by publishing responsibility on to their supplier (i.e. you).

    • They can manage you, their supplier, better by specifying that you must have a ISO 9001 system.

    • They can assess your quality system, and thus check your ability to produce satisfactory goods and services.


What is quality

WHAT IS QUALITY?

  • Degree of Excellence

  • Fitness for Purpose

  • Meeting Requirements

  • Meeting Customer/community Needs

  • Delighting Customers

  • Right First Time, All The Time


Changing scope of quality

Changing Scope of “Quality”

to

Organizational

Quality

Dept.-Wise

Performance

from

Only

Product

Quality


Quality management is

Quality Management is ….

a process of identifying and solving problems, followed by improving performance….

OCCASIONAL QUALITY ISSUES

CHRONIC QUALITY ISSUES


What is the difference between quality control and quality assurance

What is the difference between

Quality Control

and

Quality Assurance?


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

Quality Control vs Inspection

MIXED

PRODUCT

MARKETING

ADMIN,

QA

PRODUCTION

FINANCE

MAINT.

TESTING

LABS

PROCESS

Measu-

rement

OK

Cycle A

PRODUCT/

SERVICE

FIXING

Not

OK

Process and/or

Systems

Fixing

Cycle B

C/A


Quality assurance

PROCESS

Performance

Actions

data

Market

Customer

Legal

Benchmarks

Process

Financial

FIELD

Performance

data

Product , Process or

Systems Fixing

& Improvement

Actions

Quality Assurance

DESIGN

Customers

PROCESSES

PRODUCT

Performance

OK

Product

Fixing

Not

OK

Product, Process or

Systems Fixing &

Improvement

data

Actions


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

QMS

PROCESS

Performance

Actions

data

DESIGN

Customers

PROCESSES

PRODUCT

Performance

Market

Customer

Legal

Benchmarks

Process

Financial

OK

Product

Fixing

Not

OK

Product, Process or

Systems Fixing &

Improvement

data

Actions

FIELD

Performance

data

Product , Process or

Systems Fixing

& Improvement

Actions


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

TQM+

6 Sigma

Knowledge

Mgt.

IT

TQM

HRM

GROUP

DYNAMICS

Teams

Efficiency

BPR

TPM

JIT/MRP

QA

ISO9000

JAR145

OPR MGT.

QC

SPC

Quality

Circles

Inspection/

Testing

Metrology

Evolution of Quality Field

Product Insp. to Process to System to Culture to Performance

Control (Opr Mgt ) Change


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

Four Levels of QM

QM Levels

IV

III

II

I

0

No Measures

Basic

Measures

QC

QA

(ISO9000)

CQI


1 st stage of qc

1st Stage of QC

ADMIN

MANUFACTURING

QC

PRODUCTION

PRODUCT

FINANCE

HRD

Internal Mnt.

STORES

PURCHASING

MIS /

SEC /

PLANNING


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

2nd Stage of QC

ADMIN

MANUFACTURING

QC

PRODUCTION

PRODUCT

FINANCE

QC

HRD

Internal Mnt.

STORES

QC

QC

PURCHASING

QC

MIS /

SEC /

PLANNING

QC


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

QC

QC

QC

QC

3rd Stage of QC

ADMIN

MANUFACTURING

QC

PRODUCTION

PRODUCT

FINANCE

HRD

Internal Mnt.

STORES

QC

QC

PURCHASING

QC

MIS /

SEC /

PLANNING

QC


Quality evolution through national quality awards

Quality Evolution through National Quality Awards

  • JapanDeming Quality Award

  • USAMalcolm Baldrige National Quality Award

  • European UnionEuropean Quality Award

  • A large number of countries have initiated such efforts, some organized and some unorganized.

  • In Pakistan, an effort was initiated in 1999 but did not take-off.


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

Levels of Quality:

Poor- Angry- Fighting/Good- Happy- Glad

Dimension of Product Quality

Good looking (Appearance)

Reliable

Durable

Easy to operate

Made of best Materials

Affordable

Available

Low Maintenance cost

Size / Weight


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

  • FACTORS AFFECTING QUALITY

    • Human Resource

    • Financial Resources

    • Work Environment

    • Technical Resources.

    • Management System

    • Communication System

    • Motivation

    • Organizational Quality

    • Individual Quality


Eight quality management principles

2

Eight Quality Management Principles


8 quality management priciniples

8 QUALITY MANAGEMENT PRICINIPLES

Customer-focus

Mutually beneficial supplier relationship

8 QUALITYMANAGEMENTPRINCIPLES

Leadership

Factual Approach to Management

Involvement ofPeople

ContinualImprovement

Process Approach

System approach to management


1 customer focused

1. CUSTOMER FOCUSED

  • Organizations depend on their customers and therefore should:

    • understand current and future customer needs,

    • meet customer requirements, and

    • strive to exceed customer expectations.


2 leadership

2. LEADERSHIP

  • Leaders should:

    • establish unity of purpose (vision and mission)

    • provide direction to the organization (policy and objectives)

    • provide resources to achieve organization’s objectives

Corporate

Goal


3 involvement of people

3. INVOLVEMENT OF PEOPLE

  • People at all levels are the essence of an organization. Therefore,

    • their full involvement enables their abilities to be used for the organization’s benefit


4 process approach

4. PROCESS APPROACH

  • Organizations need to do more than simply monitor process outputs,(typically through inspection activities)

    • they must also control all process inputs,(people, facilities/equipment, material and methods)

    • and, they must establish appropriate controls over the transformation activities,(if desired results are to be achieved consistently and efficiently)

Resources

Transformation

Inputs

Outputs


5 system approach to management

5. SYSTEM APPROACH TO MANAGEMENT

  • Organizations must understand a system is a set of interrelated processes, and

    • the output of one process is the input to one or more subsequent processes, so …

    • It is critical to manage the “white space” (or interface) between processes to ensure that the overall system is effective


6 continual improvement

6. CONTINUAL IMPROVEMENT

  • Continual improvement should be a permanent objective of the organization

ContinualImprovement

Act

Plan

  • Measure/Monitor Results against Objectives

  • Improve Process, and

  • Change QMS as needed to achieve and sustain Desired Results

Results

Check

Do

QMS

Baseline Performance


7 factual approach to decision making

7. FACTUAL APPROACH TO DECISION MAKING

  • Effective decisions should be based on:

    • the analysis of data and information

DECISION

COLLECTION OF DATA

ANALYSIS


8 mutually beneficial supplier relationships

8. MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIPS

  • An organization and its suppliers are interdependent. Therefore:

    • a mutually beneficial relationship should be established between them to enhance the ability of both to create value

VENDORS

PRODUCT

OR

SERVICE

+

ORGANIZATION


Five dimensions of service quality

Accuracy

dependably

Five dimensions of Service Quality

Physical

Infrastructure

image

Promptness

Helping attitude

Reliability

Responsiveness

Tangibles

Access

Communication

Understanding

needs

Competence

Courtesy

Credibility

security

Assurance

Empathy


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

1. Reliability: ability to perform a service reliably and dependably; it means the customer expectations are met consistently

2. Responsiveness: the willingness to help customers and provide prompt service (speed)

3. Assurance: the ability to communicate to the customer a level of competence and to provide the service with the necessary courtesy

4. Empathy: the approachability and the ability to communicate with an understanding the customer’s needs

5. Tangible: the appearance of the physical facilities, equipment, personnel, and communication materials.


Iso 9001 2000 requirements

3

ISO 9001:2000 Requirements


Iso 9001 2000

ISO 9001:2000

  • ISO 9002:1994 & ISO 9003:1994 dropped and merged into a single ISO 9001:2000 standard

  • New Standards

  • ISO 9000:2000 Fundamentals and Vocabulary

  • ISO 9001:2000 QMS Requirements

  • ISO 9004:2000 Guidelines for Performance Improvement


New structure

NEW STRUCTURE

20 Clauses have been abandoned and merged into 5 sections with additional requirements

Clause 4:Quality System

Clause 7:Product Realization

Clause 6:ResourceManagement

Clause 8:Measurement, Analysis & Improvement

Clause 5:Management Responsibility

Permissible Exclusions from Clause 7 only if it does not apply


Contents1

1

1.1 General

1.2 Application

Scope

2

Normative Reference

3

Terms and Definitions

Contents


Contents cont

4

Quality Management System

4.1 General Requirements

4.2 Documentation Requirements

5

5.1 Management Commitment

5.2 Customer focus

5.3 Quality Policy

5.4 Planning

5.5 Responsibility, authority and communication

5.6 Management Review

Management Responsibility

6

6.1 Provision of resources

6.2 Human resources

6.3 Infrastructure

6.4 Work environment

Resource Management

7

7.1 Planning of product realization

7.2 Customer-related processes

7.3 Design and development

7.4 Purchasing

7.5 Production and service provision

7.6 Control of monitoring and measuring devices

Product Realization

Contents (cont.)


Contents cont1

8

8.1 General

8.2 Monitoring and measurement

8.3 Control of nonconforming product

8.4 Analysis of data

8.5 Improvement

Measurement, Analysis and Improvement

Contents (cont.)


Deming s cycle

DEMING’S CYCLE

  • Define Policy

  • Set Objectives & Targets

  • Assign Responsibilities

  • Provide Resources

  • Analyze the Gaps

  • Take corrective and preventive actions to fill the gap

PLAN

ACT

DEMING’SCYCLE

CHECK

DO

  • Monitor and Measure the actual implementation against the planned

  • Identify the Gaps

  • Implement according to planned arrangements


Process model

Process Model

CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM

C

U

S

T

OME

R

C

U

S

T

OME

R

S

a

t

i

s

f

a

c

t

i

o

n

R

e

q

u

i

r

e

m

e

n

t

s

Management responsibility

Measurement, analysis and improvement

Resource management

Input

Product realization

Output

Product


Scope

Scope

  • Consistency of products/services

  • Compliance with requirements including customer and regulatory requirements

  • Enhanced Customer Satisfaction

  • Continual Improvement


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

BREAK


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

DAY-1

SESSION-2


4 quality system

4 QUALITY SYSTEM

4.1: General Requirements

4.2: Documentation Requirements

Policy/Objectives

4.2.3 Control of Documents

Quality Manual

Quality System Procedures

Process Procedures, Plans

4.2.4 Control of Records

Records/Reports/Logs


4 2 2 quality manual

4.2.2 Quality Manual

TRAINING MATRIX

MASTER DOCUMENT

LIST

MASTER RECORDS

LIST

SCOPE

DISTRIBUTION

LIST

Justification of

Any EXCLUSION

MANUAL

POLICY

OBJECTIVES & TARGETS

SYSTEM

PROCEDURES

OPERATIONAL

PROCEDURES

WORK

PRACTICES

ORGANIZATIONAL

CHART

ROLES &

RESPONSIBILITIES

LEGAL

REQUIREMENTS


4 4 5 document control

4.4.5 DOCUMENT CONTROL

Review & Approval

DOCUMENT

CONTROL

Obsolete Document Control

Distribution Control

External Document Control

Change Control


4 5 3 control of records

4.5.3 CONTROL OF RECORDS

Retrieval

RECORDSCONTROL

Identification

Indexing

Disposition

Retention

Filing

Maintenance

Storage


5 management responsiblity

New

New

New

New

5 MANAGEMENT RESPONSIBLITY

5.1: Management Commitment

5.2: Customer Focus

5.3: Quality Policy

5.4: Quality Objective & Planning

5.5: Responsibility, Authority and Communication

5.5.1: Responsibility & Authority

5.5.2: Management Representative

5.5.3: Internal Communication

5.6: Management Review


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

5 MANAGEMENT RESPONSIBILITY

5.1 Management Commitment

5.2 Customer Focus

5.3 Quality Policy

5.4 Quality Planning

5.5 Responsibility, Authority & Communication

5.6 Perform Management Reviews

Setting Quality Policy

Establishing Quality

Objectives

Participating in Quality Reviews & Meetings

Motivating & Involving people

Providing Resources

Supporting Quality Initiatives & Programs


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

5 MANAGEMENT RESPONSIBILITY

5.1 Management Commitment

5.2 Customer Focus

5.3 Quality Policy

5.4 Quality Planning

5.5 Responsibility, Authority & Communication

5.6 Perform Management Reviews

  • Identify customer requirements.

  • Meet customers’ requirements.

  • Enhance customer satisfaction.


5 2 customer focus

5.2 CUSTOMER FOCUS

IDENTIFY &

REVIEW

MONITOR &MEASURE

C

U

S

T

OME

R

R

e

q

u

i

r

e

m

e

n

t

s

C

U

S

T

OME

R

S

a

t

i

s

f

a

c

t

i

o

n

Organization’s

Processes

Complaints

Feedback

Inputs

Product


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

5 MANAGEMENT RESPONSIBILITY

5.1 Management Commitment

5.2 Customer Focus

5.3 Quality Policy

5.4 Quality Planning

5.5 Responsibility, Authority & Communication

5.6 Perform Management Reviews

  • Define the organization’s quality policy.

  • Manage the organization’s quality policy.

Quality Policy

All staff of TMA understand and meet or exceed, community requirements so as to provide timely, services, thereby assisting our government to better serve the people.

Signature


5 3 quality policy

5.3 QUALITY POLICY

QUALITY POLICY

MEETING REQUIREMENTS

CONTINUAL IMPROVEMENT

COMMITMENT


Quality policy

QUALITY POLICY

  • We, at <XYZ>, fully realize and recognize the importance of achieving maximum satisfaction and confidence of our customers by consistently providing quality fabrics in accordance with their needs and expectations.

  • Our commitment to quality is driven by the following guiding principles:

  • MEETING OR EXCEEDING CUSTOMERS’ NEEDS & EXPECTATIONS: Customer requirements and expectations will be determined, reviewed, and incorporated in our products & processes, and customer satisfaction will be regularly monitored.

  • COMPLIANCE WITH LEGAL & REGULATORY REQUIREMENTS: We will strictly adhere to any legal and regulatory requirements that subscribe to our products or activities.

  • CONTINUAL IMPROVEMENT: We will continually strive to minimize our rejections and wastage, and improve the efficiency and effectiveness of our processes and services.

  • EMPLOYEE’S DEVELOPMENT & INVOLVEMENT: Every employee is responsible for maintaining and improving quality in his work function. Employees assigned to the job will be competent on the basis of their relevant qualification and experience, and will be regularly trained to enhance their skills. Understanding of Quality Policy and awareness of compliance with requirements and procedures will be communicated to all employees.

    ________________________

    Chief Executive


Quality policy1

QUALITY POLICY

We, the TMA DG Khan are fully committed to achieve maximum satisfaction of our community by delivery quality service, right the first time, on time, in accordance with their needs and expectations.

Our commitment to quality excellence is based on the following guiding principles:

  • Meeting or exceeding community’ needs & expectations

  • Compliance with all legal & regulatory requirements that apply to our service

  • Reduction in wastage

  • Continual improvement

  • Employee’s development & involvement

    ________________________

    Chief Executive


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

5 MANAGEMENT RESPONSIBILITY

5.1 Management Commitment

5.2 Customer Focus

5.3 Quality Policy

5.4 Quality Planning

5.5 Responsibility, Authority & Communication

5.6 Perform Management Reviews

  • Formulate quality objectives.

  • Plan quality management system.


5 4 planning

5.4 PLANNING

On-time delivery = ??Response time = ??Complaints = ??

Rejection Rate = ??Rework rate = ??

Failure rate = ??

QUALITYOBJECTIVES

SPECIFIC

MEASURABLE

ACHIEVABLE

REALISTIC

TIME-BOUND


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

5 MANAGEMENT RESPONSIBILITY

5.1 Management Commitment

5.2 Customer Focus

5.3 Quality Policy

5.4 Quality Planning

5.5 Responsibility, Authority & Communication

5.6 Perform Management Reviews

  • Define responsibilities, authorities and

  • communicate them.

  • Appoint a management representative.

  • Establish internal communications.


5 5 responsibility authority communication

5.5 Responsibility, Authority & Communication

  • Defining responsibilities & authorities in the form of:

    • Organizational Charts

    • Job Descriptions

Appointing the ISO 9001 Project Coordinator, called Management Representative (MR)

  • Establishing Internal Communication Channels, which may include:

    • intranet, memos, internal meetings, emails, phones, etc.


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

5 MANAGEMENT RESPONSIBILITY

5.1 Management Commitment

5.2 Customer Focus

5.3 Quality Policy

5.4 Quality Planning

5.5 Responsibility, Authority & Communication

5.6 Perform Management Reviews

  • Review quality management system.

  • Examine management review inputs.

  • Generate management review outputs.


5 6 management review

5.6 Management review

5.6.1 General

Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.

Records from management reviews shall be maintained (see 4.2.4).


5 6 management review1

5.6 MANAGEMENT REVIEW

INPUTS

TopManagement ReviewMeeting

OUTPUTS

Results of Audits

Resource needs

Complaints/Feedback

Revision of policy

Product Quality Status

Revision of objectives

Pending Actions

Corrective Actions

External Market Status

Improvement Actions

Improvement Suggestions


6 resource management

New

New

New

6 RESOURCE MANAGEMENT

6.1: General

6.2: Human Resources

6.3: Infrastructure

6.2.1: General

6.4: Work Environment

6.2.2: Awareness & Training


6 2 human resources

6.2 HUMAN RESOURCES

Education

Experience

Skills

Training

COMPETENCE

Identify training needs

TRAINING & AWARENESS

Provide training

Evaluate the effectiveness of training

Maintain records oftraining


6 3 6 4 infrastructure work environment

6.3/6.4 INFRASTRUCTURE & WORK ENVIRONMENT

WORK ENVIRONMENT

INFRASTRUCTURE

Temperature

Humidity

Support Facilitates(Comm., transport)

Noise

Dust

Building & Facilities

Ventilation

Work Space

Health &

Safety

Cleanliness

Equipment(hardware, software)


7 product realization

New

New

7 PRODUCT REALIZATION

7.5: Production

7.1: Planning of Realization Processes

7.5.1 Control of Production

7.2: Customer-related processes

7.5.2 Validation of Processes

7.2.1 Determination of requirements

7.5.3 Identification and Traceability

7.2.2 Review of requirements

7.5.4 Customer Property

7.2.3 Customer Communication

7.5.5 Preservation

7.3: Design & Development

7.6: Control of Monitoring & Measurement Equip.

7.4: Purchasing


7 1 planning of realization processes

7.1 PLANNING OF REALIZATION PROCESSES

QUALITY PLAN

  • Process stages

  • Inspection and test stages

  • Parameters to be controlled/checked

  • Reference standards

  • Related records

  • Responsible persons


7 2 customer related processes

7.2 CUSTOMER-RELATED PROCESSES

CUSTOMER’S SPECIFIED REQUIREMENTS

CUSTOMER’S INTENDED REQUIREMENTS

STATUTORY & REGULATORY REQUIREMENTS

ORGANIZATION’S INTERNAL REQUIREMENTS


7 2 2 review of requirements

7.2.2 REVIEW OF REQUIREMENTS

Product requirements are defined

Review ofRequirements

Differences/ conflicts are resolved

Records of review are maintained

Organization has the ability to meet the requirements


7 2 3 customer communication

7.2.3 CUSTOMER COMMUNICATION

Service Information

Customer

Communication

Community feedback, including Community complaints (Community Service)

Enquiries, Orders, contracts(meetings, visits, phone, fax)


7 3 design development

7.3 DESIGN & DEVELOPMENT

DESIGN & DEVELOPMENT PLAN

DESIGN REVIEW

Requirements

- Customer- Technical- Legal

INPUT

Design &

Development

OUTPUT

VERIFICATION

VALIDATION


7 4 purchasing

7.4 PURCHASING

Procedure

Verificationof PurchasedProduct

Purchasing Process

(Evaluation and selectionof suppliers)

  • Purchasing Information

  • Complete product specs.

  • Personnel qualifications

  • Approval of purchase documents

Records


7 5 1 control of production

7.5.1 CONTROL OF PRODUCTION

Product Specifications

Availability of work Instructions

CONTROL OFPRODUCTION

Production planning

Use of suitable Equipment

Production records

In-process monitoring & measurement

Maintenance of equipment

Availability of monitoring equipment


7 5 3 identification traceability

7.5.3 IDENTIFICATION & TRACEABILITY

IDENTIFICATION

TRACEABILITY

INSPECTION

& TEST STATUS

Tags/Stickers/Trays forrejected/reworked items

Article #/Model #/ Item #/Design #

Lot #/Batch #/ Serial #/Mfg. date


7 5 4 customer property

7.5.4 CUSTOMER PROPERTY

CUSTOMER PROPERTY

Reporting of damage / loss

Verification

Segregation & Maintenance


7 5 5 preservation

7.5.5 PRESERVATION

Handling

PRESERVATION

Delivery

Storage

Packing

Protection


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

DAY-2

SESSION-1


8 measurement analysis improvement

New

New

New

New

8 MEASUREMENT, ANALYSIS& IMPROVEMENT

8.1: General

  • 8.4: Analysis of Data

    • Customer feedback

    • Product Performance

    • Product & Process Trends

    • Suppliers

8.2: Monitoring and Measurement

8.2.1: Customer Satisfaction

8.2.2: Internal Audit

8.2.3: Measurement of Processes

8.5: Improvement

8.2.4: Measurement of Products

8.5.1: Continual Improvement

8.5.2: Corrective Action

8.3: Control of Nonconformity

8.5.3: Preventive Action


8 2 2 quality audits

8.2.2 QUALITY AUDITS

Procedure

AUDITPLANNING

AUDITEXECUTION

AUDITREPORTING

CORRECTIVEACTION &FOLLOW UP

Records


8 2 3 8 2 4 monitoring of processes products

8.2.3/8.2.4 Monitoring of Processes & Products

Quality Plan or Inspection/Test Plans

  • INSPECTION & TESTING

  • Receiving

  • In-process

  • Final

Availability of specifications

Test records

Inspection and Test Methods


8 3 control of nonconformity

8.3 CONTROL OF NONCONFORMITY

Procedure

Reject/Rework

Alternative use

Control of non-conformity

Re-grade

Accept-as-is

Records


8 4 analysis of data

8.4 ANALYSIS OF DATA

Analysis of Customer Data

Analysis of Product Data

Analysis of Suppliers Data

Analysis of Process Trends


8 5 1 continual improvement

8.5.1 CONTINUAL IMPROVEMENT

Quality Objectives

CONTINUALIMRPROVEMENT

Management Review

Data Analysis

Quality Audits

Corrective/ Preventive Action


8 5 corrective preventive action

8.5 CORRECTIVE & PREVENTIVE ACTION

Identify the problem

PREVENTIVE ACTION

Action taken to eliminate the potential problems to avoid their occurrence

CORRECTIVE ACTION

Action taken to eliminate the problems occurred to avoid their recurrence

Investigate the root causes

Propose solutions

Implement solution

Evaluate the effectiveness of solution


Audits type and phases

AUDITS:TYPE AND PHASES


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

  • Definition - ISO

    “A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives.”

  • Alternative Definition

    • an independent documented activity;

    • in accordance with written checklists and procedures;

    • to verify, by examination and evaluation of objective evidence;

    • that applicable elements of a quality system have been developed, documentedand effectively implemented;

    • in accordance with specified requirements.


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

  • TYPES

    • FIRST PARTY(I), SECOND PARTY(II), THIRD PARTY(III)


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

  • Planning

  • Preparation

  • Performance

  • Reporting and follow-up

    “PROPER PLANNING AND PREPARATION PREVENT POOR PERFORMANCE”.

Independent but Overlapping

  • PHASE OF AN AUDIT (applicable to all types)


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

AUDIT PLANNING


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

Basis of Planning


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

Basis of Planning


Other planning activities

OTHER PLANNING ACTIVITIES:

  • periodically review program;

  • review contracts, standards, regulatory requirements;

  • obtain organization’s details (3rd party);

  • consider multi-site implications;

  • establish costs and timescale (2nd & 3rd Party);

  • conduct pre-audit visit (3rd party);

  • determine past quality record;

  • vary auditors

  • consider procedure/authority for aborting audit;

  • consider procedure/authority for stopping work.


Audit preparation

AUDIT PREPARATION


The preparation phase will include the following

The preparation phase will include the following:

  • Obtaining and evaluating the latest applicable documentations against the stated criteria (i.e. the documentation review or “desk study”).

  • Reporting the results to the person responsible. Domestic and travel arrangements.

  • Review previous audit records where applicable.

  • Compiling the site audit itinerary as necessary.

  • Compiling checklist from procedure to be audited.


The checklist is a valuable aid to auditing and is used as

The checklist is a valuable aid to auditing and is used as:

  • a working document, and

  • a record;

  • useful analysis during desk study.

  • Purpose of Check List:

  • Ensure that the objectives and scope of the audit are met.

  • Ensure that every part of the audit is completed.

  • Acts as a guide for the auditor.

  • Auditor’s main tool.


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

  • Preparation of Check List

  • Consider the processes which are taking place.

  • The relevant procedure.

  • The documents and records.

  • The requirements of the standard.

  • The complexity or detail on a checklist will depend on the experience of the auditor.

  • Type of questions – open ended question.


Audit performance

AUDIT PERFORMANCE


Introduction

INTRODUCTION

The on-site audit process:

  • Opening meeting.

  • Conduct of the actual audit.

  • Auditors review.

  • Closing meeting.

  • Follow-up, if necessary.


Opening meeting 2 nd and 3 rd party

OPENING MEETING (2nd and 3rd Party)

Chaired by Lead Assessor, first step. Prepares the way for:

  • good communications;

  • cooperation;

  • openness.

2.1Agenda

  • introduction;

  • attendance list;

  • assessors log and complaints procedure;

  • objectives of audit (quality standard);

  • scope of audit;


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

  • report on desk study;

  • explanation of method/sampling;

  • explanation of non-compliances and their classification;

  • timetable/itinerary;

  • meeting room/domestic arrangements;

  • escorts;

  • closing meeting;

  • nature of report and follow-up;

  • confidentiality;

  • short tour of premises.

    The above list is neither prescriptive nor exhaustive.

    Keep it brief and concise, keep control.


3 conduct of the audit

3.CONDUCT OF THE AUDIT

2.2Opening Meeting for Internal Audits:

  • informal;

  • simple introduction;

  • Escorts, representatives, formal opening and closing may not be necessary.

3.1Keep Objectives in View i.e. to Verify that the Quality System:

  • exists and is complete;

  • operates correctly;

  • is effective.

    With the amount of work and information to be handled by an auditor it is easy to lose sight of these aims.


3 2 information about the following required

3.2Information about the following required:

  • people;

  • procedure;

  • equipment, tools, materials;

  • documentation.

3.3It must be the objective of the audit function and in particular, the auditor, to adopt a positive, professional and constructive approach. In common with this, the auditor should also try to obtain a cooperative, open and honest approach from the auditee.


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

5.2Ask efficient, open-ended questions – Exceptions allowed:

Open-ended question:

  • “Where do you keep your copy of the preferred supplier’s list?” elicits an answer; “in the file”. This shows that the auditee knows there should be one and knows where it is.

  • “How were you trained for this?” or “What training did you receive?”

  • “Where is the record kept while not in use?” establishes storage and filing.

  • “What do you do with the paperwork and items when inspection is complete?” will encourage an answer which will provide information on documentation flow.


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

  • “Show me your preferred suppliers list

  • Show me what you do.

  • Where is that kept?

  • How is that carried out?

  • When would you do this?

  • What happens after this is completed?

  • Who will do that?

Phrased carefully these all help to elicit information and keep conversation flowing.

Close-ended question:

  • Have you been trained for the job you do?”

Non-Question or “leading question”:

  • “I see that once your job is completed you file the record in the depository, am I right?”

    This will only get a yes, no or nod.


Controls by auditor

CONTROLS BY AUDITOR:

6.1Do not:

  • be side tracked;

  • be led or misled;

  • get “bogged down”;

  • let the auditee dictate the pace of the audit;

  • make assumptions or presumptions.


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

6.2Do:

  • be prepared/planned;

  • be punctual;

  • insist on the person being questioned answer for themselves;

  • as little talking as possible;

  • avoid misunderstandings;

  • keep questions clear and concise;

  • be polite and calm;

  • give compliments.


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

6.3Auditor must be prepared of a range of possible occurrence. For example:

  • aggressive auditees;

  • timid auditees;

  • missing people;

  • missing documents;

  • pre-prepared samples (always choose your own);

  • emotional blackmail;

  • special cases.

    When faced with these situations, the auditor must act decisively, professionally and fairly, keeping in mind the objectives and purpose of the on-site audit


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

DAY-2

SESSION-2


Audit review

AUDIT REVIEW


Review the findings daily and at the end of audit performance points

Review the findings daily and at the end of audit performance. Points:

  • a review and completion of checklist;

  • a study of notes and comparison of notes (team);

  • listing of non-compliances


Non compliance is

Non-compliance is:

  • deficiency;

  • finding;

  • Non-conformance.

    ISO 9000 defines a non-conformity as:

    “The non-fulfillment of specific requirements.”

    Note:-

    “The definition covers the departure or absence of one more quality characteristics (including dependability characteristics) or quality system elements from specified requirements.”


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

  • Short statement – a description of the objective evidence found.

  • Statement also define the applicable procedure and its issue, area/ department/ function and the standard and clause number.

  • comply with the standard applicable to the organization;

  • implement quality manual, procedures or other documentation requirements specified by the organization;

  • implement a code of practice, regulation, contract, etc.

  • A non-compliance may be failure to:


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

  • When are non-compliance statements written?

  • Immediate.

  • Representative’s signature with objective evidence.

    Best Points:

  • go over the facts verbally and agree the nature of the non-compliance with the auditee;

  • make notes and consult these later to make a statement;

  • draft non-compliances during a working lunch or at the end of the day, then finalize at the private review.


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

  • Example of non-compliance statement:


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

  • Corrective Action Request (CAR) (Ref.)

  • Form used by many organizations.

  • Describe a non-compliance and request action.

  • Raised after careful consideration at the auditor’s private review.

  • Gives the level or classification of the non-compliance

  • Classification of the non-compliances:

  • MAJOR

  • MINOR


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

  • Classification of Corrective Action RequestMAJOR CAR Raised where:

  • Total breakdown of a procedure or work instruction critical to product quality;

  • Total breakdown in the operation of the organization’s QMS;

  • Total absence of a procedure required by the Standard in the organization’s QMS;

  • Many minor lapses when added leading to major;

  • Immediate hazard to the quality of the product or service being offered.

  • A Major CAR must be corrected and verified before registration can be recommended.


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

MINOR CAR:

Deficiency or deficiencies identified in:

  • a procedure or work instruction;

  • the operation of the organization’s QMS.

  • a Minor CAR allows registration to proceed. The corrective action taken is usually verified at the first surveillance visit.

The classification of CARs is based upon good judgment, expertise and experience of the auditor.Non-compliances may be grouped by function, procedure or Standard clause.


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

  • Classification of non-compliances is not necessary for internal audits. CARs are meant to assist management in improving the system and, in internal auditing, they can be supported by recommendations to correct and improve the situation.

The second/third party audit situation is much more formal and CARs must be raised as required. However, if management implement the corrective action during the assessment, a CAR should not be raised formally at the closing meeting. The non-compliance and its resolution should be noted in the audit records.


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

  • In conducting internal audit it is useful for the organization to maintain a status log of outstanding non-compliances. This could also include the status of CAR from second and third party bodies


Audit report and follow up

AUDIT REPORT AND FOLLOW-UP


Presentation of finding after review in an

Presentation of finding after review in an:

  • EXIT MEETING

  • EXIT CRITIQUE

  • CLOSE OUT MEETING

  • For 1st Party Audit:

  • Informal

  • Constructive

  • System Improvement

  • For 2nd Party Audit:

  • more care is needed as contracts at stake

  • emotive / sensitive situation

  • auditor must be prepared for challenging by the auditee


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

  • For a 3rd party audit:

  • Very formal.

  • Client expects comprehensive, detailed and constructive presentation offindings.

  • Some auditors stick rigidly to the findings and the CAR.

  • Some support them with constructive comments and observations but no consultancy.


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

  • Closing meeting agenda:

  • Can vary according to the type of audit conducted.

    Typical Solutions:

    • distribute attendance list;

    • have assessor log signed;

    • restate purpose and scope;

    • state decision and conclusion;

    • explain major and minor CARs;

    • explain CAR form completion;

    • obtain client representative’s signature on CAR;


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

  • explain significance of sample technique;

  • report on observations;

  • explain reporting and follow-up;

  • obtain attendance list and log;

  • thank the client;


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

  • During the closing meeting, the auditor/team must:

  • explain all findings and evidence carefully and precisely;

  • be prepared to support and justify findings;

  • avoid being drawn into an argument;

  • apologize if an error transpires and alter or withdraw the CAR if necessary;

  • avoid giving consultative recommendations. Comments should be limited to providing clarification on acceptance criteria/requirements;

  • refuse the “quick fix” as a sole solution to the finding. The management must investigate and attempt to correct the root cause of the problems.


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

REPORTING

  • After the audit and closing meeting:

  • a written report must be produced;

  • concise and easy to read;

  • only points stated at the closing meeting;

Points to be included in report (depending on type of audit).

  • name of organization;

  • assessment date(s);

  • assessment location;


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

  • contract identification number;

  • QA Standard;

  • Key personnel contacted;

  • Assessment team members;

  • CARs issued;

  • attendees at meeting;

  • position statement or conclusion;

  • distribution list;

  • attachments.


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

  • The report should not include:

  • deficiencies discovered and corrected during assessment;

  • confidential information given in interviews;

  • matters not raised or discussed at closing interviews;

  • matter not raised or discussed at closing meeting;

  • subjective opinions-verifiable facts only;

  • ambiguous statements;

  • antagonistic words of phrases


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

FOLLOW-UP AND CLOSE-OUT

  • The process of determining whether the corrective action requested has been implemented is called “follow-up”. This can be done by reviewing documentation submitted by the client or by visiting the client’s premises.

  • The action relating to the verification and acceptance of corrective action by the auditor is called “close-out”.


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

Methods of “close-out” will include re-audit of deficient areas, where physical evidence has to be send, or review of new and/or revised documentation. In the case of minor deficiencies, verification and close-out will take place at the next surveillance or visit.

In processing CARs, the auditor and auditee have specific responsibilities. The auditee’s management must, in conjunction with the management representative:


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

  • investigate and clearly identify the problem;

  • propose a program of long-term preventive corrective action;

  • agree a target date for completion;

  • introduce changes;

  • verify effectiveness by internal audit;

  • notify auditor of compliance;

The auditor must then verify the effectiveness of corrective actions by visiting the organization and/or by carrying out an audit of objective evidence


How to implement iso 9001 2000

4

HOW TO IMPLEMENT ISO 9001:2000


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

  • OBTAIN COMMITMENT OF TOP MANAGEMENT:

    This is very important as the decision to implement can only be successful of the top management after studying all the pros and cons fully commit themselves to ISO 9000.

  • AWARENESS & DOCUMENTATION AND INTERNAL AUDITING TRAINING OF EXECUTIVES/MANAGERS:

    In case of small/medium industry there may not be many executives/ but the Owner with one or two of the senior must train themselves by reading, attending seminar/ course or hiring Consultant. It would be very useful if atleast one person can qualify as lead assessor.

  • AWARENESS TRAINING LINE STAFF:

    This can be done by the senior staff of the company.


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

  • ESTABLISH STEERING GROUP:

    A steering group be created from the departmental/ heads to plan and monitor the ISO activity. Regular evaluation of work should be recorded. In case of SME (Small Medium Enterprise) Owner alongwith a senior person can look after the work.

  • APPOINTMENT OF MANAGEMENT REPRESENTATIVE:

    Identifying, understanding and managing a system of interrelated processes for a given objective contributes to the effectiveness and efficiency of the organization.

  • STATUS SURVEY:

    present activities as compared to the requirements of ISO-9000.


Control of documents

CONTROL OF DOCUMENTS


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

  • DEFINE QUALITY POLICY:

  • PREPARE QUALITY MANUAL:

    It should be done by the senior staff.

  • PREPARE QUALITY PROCEDURES & WORK INSTRUCTION AND OTHER RECORD FORM:

    It should be done by the senior staff.

  • CONDUCT SYSTEM TRAINING:

    It should be done by the senior staff.

  • IMPLEMENT SYSTEM AND KEEP REVIEWING

  • CONDUCT INTERNAL AUDIT AFTER ONE/TWO MONTHS OF WORKING THE SYSTEM AND ASSIGN CORRECTIVE ACTION


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

CONTACT CERTIFICATION COMPANY

It should be done by the senior staff.

PRE-ASSESSMENT AUDIT

CERTIFICATION

APPOINTING A CONSULTANT, IF NECESSARY

  • Review by management as to the need for a consultant.

    Factors Considered:

  • Human resource.

  • Availability of knowledge regarding ISO systems, awareness, documentation, internal auditing and implementation techniques.

  • Tasks to be assigned to consultant, what will a “GOOD” consultant deliver?

  • Speedy transfer of knowledge and skill.


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

  • Shall provide intermittent guidance to keep the program on track.

  • Training trainers.

    CAUTION!DO NOT ASSIGN THE RESPONISBILITY FOR DOCUMENTATION. COMPANY STAFF SHOULD RETAIN “OWNERSHIP”OF DOCUMENTATION

    EVALUATING CONSULTANTS:

  • Work knowledge of your processes.

  • Past experience.

  • Qualification especially related to ISO 9001.

  • Costs.

    CAUTION!

    • DO NOT HIRE INDIVIDUALS BUT ORGANIZATION.

    • DO NOT SHIFT ENTIRE RESPONSIBILITY FOR ESTABLISHING QUALITY MANAGEMENT SYSTEM.


Two days short course on iso 9001 2000 quality management system 24 25 may 2008

  • References:

  • Some of the material presented in these lectures has been taken from different websites

  • Slides no 22-29 has been taken from PIQC Inst of Quality Management


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