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TWO DAYS SHORT COURSE

ON
ISO 9001:2000
QUALITY MANAGEMENT SYSTEM
24-25 May, 2008

CONTENTS
1

Background

Eight Quality Management Principles

ISO 9001:2000 Requirements

How to implement ISO 9001:2000

DAY-1
SESSION-1

1
BACKGROUND

What is ISO 9001?


ISO
The word iso or
International Organization for
Standardization

9001
The series allocated for
Quality System standards

ISO 9001 is a series of standards


describing the requirements for
establishing and maintaining a quality
management system in an organization

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 Standardization
Email: central@iso.ch
Web: 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


ISO 9001:87
ISO 9001:94
ISO 9001:2000
BS5750
1979
AQAP1
(NATO)
1970s
MIL-STD-9858
(1940s)

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

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
ISO 10006:2003
ISO 10007:2003
ISO 10012
ISO 10013:2001
ISO/TR 10014:1999
ISO/TR 10015:2000
ISO/TR 10017:2003
ISO 19011:2003
ISO 10002:2004
ISO 10001
ISO 10003

Guidelines for Quality Plans


Guidelines for Project Management
Guidelines for Configuration Mgt
Measurement Management System
Documentation
Economics Of Quality
Training
Statistics
Auditing
Complaint handling
Market based Code of Conduct
External Dispute Resolution System

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 9001:1994

Applies to organizations involved in design and development of


products/services, production of products/provision of services, and
delivery of products/services

ISO 9002:1994

Applies 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 9003:1994

Applies 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

Elements of ISO 9001:1994


Clause Title
Clause #
Management Responsibility
4.1
Quality System
4.2
Contract Rev iew
4.3
Design Control
4.4
Document and Data Control
4.5
Purchasing
4.6
Customer-supplied products
4.7
Identification & Traceability
4.8
Process Control
4.9
4.10 Inspection and Testing
4.11 Inspection and Test Equipment
4.12 Inspection and Test Status
4.13 Control of Non-conforming Product
4.14 Correctiv e and Prev entiv e Action
Handling, Storage, Preserv ation, Packing
4.15
and Deliv ery
4.16 Control of Records
4.17 Internal Quality Auditing
4.18 Training
4.19 Serv icing
4.20 Statistical Analysis

9001:1994 9002:1994 9003:1994


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ADVANTAGES OF
ISO-9001

For your employees:


1. Staff gets a better understanding of their role and
objectives, by having a documented management
system.
2. They benefit from reduced stress levels, because they are
using an efficient management system and because they
know what is expected of them.
3. They get increased morale and a sense of pride through
achieving the goals of registration and customer
satisfaction.

4. New staff can immediately learn their job, because the


details are in writing.

For your organization:


1. Your products will be of a more consistent quality, and you
will produce fewer rejects.
2. 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.
3. You can improve the quality of your raw materials by
requiring your suppliers to have a ISO 9001 system.

4. Export marketing is easier, because some foreign buyers


recognize ISO 9001 (BS 5750).

5. You can expect preferential treatment from potential


customers who have ISO 9001 certification. This means an
increase in new business.
6. 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.
7. You can use ISO 9001 in your publicity to win more sales.

8. ISO 9001 helps you minimize the risk of producing unsafe


products. It may also give you some protection law
against product liability claims.
9. Being first in your area or industry may put you ahead of
your rivals by 18 months to two years.

For your customers:


1. Your customers get a known level of quality that is
independently audited.
2. They get a means of choosing between competing
suppliers.
3. They can have more confidence in your goods.
4. ISO 9001 minimize their risk, by publishing responsibility on
to their supplier (i.e. you).
5. They can manage you, their supplier, better by specifying
that you must have a ISO 9001 system.
6. They can assess your quality system, and thus check your
ability to produce satisfactory goods and services.

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


to

from

Only

Product
Quality

Organizational
Quality
Dept.-Wise
Performance

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?

Quality Control vs Inspection


MIXED
PRODUCT

ADMIN,
TESTING
MARKETING
PRODUCTION
FINANCE
PROCESS
MAINT.
QA
LABS

Measurement
PRODUCT/ Cycle A
SERVICE
FIXING

Process and/or
Systems
Fixing

Cycle B

C/A

OK

Not
OK

Actions

data

Quality
Assurance

PROCESS
Performance

DESIGN

Market
Customer
Legal
Benchmarks
Process
Financial

Customers
PRODUCT

PROCESSES

Performance

Product
Fixing

Actions

Actions

Product, Process or
Systems Fixing &
Improvement
Product , Process or
Systems Fixing
& Improvement

OK

Not
OK

data

FIELD
Performance

data

Actions

data

QMS

PROCESS
Performance

DESIGN

Market
Customer
Legal
Benchmarks
Process
Financial

Customers
PRODUCT

PROCESSES

Performance

Product
Fixing

Actions

Actions

Product, Process or
Systems Fixing &
Improvement
Product , Process or
Systems Fixing
& Improvement

OK

Not
OK

data

FIELD
Performance

data

Evolution of Quality Field

TQM+
6 Sigma

TQM
HRM

QA

GROUP
ISO9000

QC
SPC

Inspection/
Testing

Quality
Circles

Metrology
Product Insp. to Process to
Control

Knowledge
Mgt.
IT

DYNAMICS
Teams

JAR145

Efficiency

OPR MGT.

BPR
TPM
JIT/MRP

System to Culture to Performance


(Opr Mgt )
Change

Four Levels of QM
QM Levels

IV
III
II
I

0
No Measures

Basic
Measures

QC

QA
(ISO9000)

CQI

1st Stage of QC

ADMIN

MANUFACTURING

PRODUCTION

QC

FINANCE

HRD

STORES
PURCHASING

MIS /
SEC /

PLANNING

Internal Mnt.

PRODUCT

2nd Stage of QC
ADMIN

MANUFACTURING

PRODUCTION

QC

FINANCE

HRD

STORES QC

Internal Mnt.

QC
PURCHASING QC

MIS /
SEC /

QC

PLANNING QC

PRODUCT

3rd Stage of QC

ADMIN

MANUFACTURING

QC
PRODUCTION

QC

FINANCE

QC
HRD

QC
MIS /
SEC /

QC

STORES QC

Internal Mnt.

QC
PURCHASING QC

PLANNING QC

PRODUCT

Quality Evolution through National


Quality Awards

Japan
Deming Quality Award

USA
Malcolm Baldrige National Quality Award

European Union
European 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.

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

FACTORS AFFECTING QUALITY

Human Resource
Financial Resources
Work Environment
Technical Resources.
Management System
Communication System
Motivation
Organizational Quality
Individual Quality

2
Eight Quality
Management Principles

8 QUALITY MANAGEMENT
PRICINIPLES
Customer-focus

Mutually beneficial
supplier relationship

Factual Approach
to Management

Leadership

8 QUALITY
MANAGEMENT
PRINCIPLES

Continual
Improvement

Involvement of
People

Process Approach
System approach to
management

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

Leaders should:
establish unity of purpose (vision and mission)
provide direction to the organization (policy and
objectives)
provide resources to achieve organizations
objectives

Corporate
Goal

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 organizations benefit

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
Inputs

Transformation

Outputs

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

Continual improvement should be


a permanent objective of the
organization
Continual
Improvement
Act

Plan
Results

Check

Do

Measure/Monitor Results
against Objectives

Improve Process, and


QMS

Change QMS as needed to


achieve and sustain Desired
Results
Baseline Performance

7. FACTUAL APPROACH TO
DECISION MAKING

Effective decisions should be


based on:
the analysis of data and information

COLLECTION
OF DATA

ANALYSIS

DECISION

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

+
ORGANIZATION

PRODUCT
OR
SERVICE

Five
dimensions of Service Quality
Accuracy
dependably

Physical
Infrastructure
image

Promptness
Helping
attitude

Reliability

Responsiveness
Tangibles

Access
Communication
Understanding
needs
Empathy

Assurance

Competence
Courtesy
Credibility
security

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

3
ISO 9001:2000
Requirements

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

Clause 4:
Quality System

Clause 7:
Product Realization

Clause 6:
Resource
Management
Clause 5:
Management
Responsibility

Clause 8:
Measurement,
Analysis &
Improvement

Permissible Exclusions from Clause 7 only if it does not apply

Contents
1 Scope
2 Normative Reference
3 Terms and Definitions

1.1 General
1.2 Application

Contents (cont.)
4
5

Quality Management
System
Management
Responsibility

Resource Management

Product Realization

4.1 General Requirements


4.2 Documentation Requirements
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
6.1 Provision of resources
6.2 Human resources
6.3 Infrastructure
6.4 Work environment
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

Contents (cont.)
Analysis
8 Measurement,
and Improvement

8.1 General
8.2 Monitoring and measurement
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement

DEMINGS CYCLE
Analyze the Gaps
Take corrective and
preventive actions to
fill the gap

PLAN

ACT

Define Policy
Set Objectives & Targets
Assign Responsibilities
Provide Resources

DEMINGS
CYCLE
CHECK
Monitor and Measure
the actual
implementation against
the planned
Identify the Gaps

DO
Implement according
to planned
arrangements

Process Model
CONTINUAL IMPROVEMENT OF THE
QUALITY MANAGEMENT SYSTEM

C
U
S
T
O
M
E
R

R
e
q
u
i
r
e
m
e
n
t
s

Management
responsibility
Resource
management
Input

Product
realization

Measurement,
analysis and
improvement

Product

Output

U
S
T
O
M
E
R

S
a
t
i
s
f
a
c
t
i
o
n

Scope
Consistency of products/services
Compliance with requirements including
customer and regulatory requirements
Enhanced Customer Satisfaction
Continual Improvement

BREAK

DAY-1
SESSION-2

4 QUALITY SYSTEM
4.1: General Requirements
4.2: Documentation Requirements
Policy/
Objectives

Quality Manual

4.2.3 Control of Documents

Quality System Procedures

Process Procedures, Plans

Records/Reports/Logs

4.2.4 Control of Records

4.2.2 Quality Manual


TRAINING
MATRIX

SCOPE
DISTRIBUTION
LIST

MASTER
DOCUMENT
LIST

Justification of
Any EXCLUSION

MASTER
RECORDS
LIST

POLICY
OBJECTIVES &
TARGETS

SYSTEM
PROCEDURES

ORGANIZATIONAL
CHART
ROLES &
RESPONSIBILITIES
LEGAL
REQUIREMENTS

OPERATIONAL
PROCEDURES
WORK
PRACTICES

4.4.5 DOCUMENT CONTROL


Review & Approval

Obsolete Document
Control

Distribution
Control

DOCUMENT
CONTROL

External Document
Control

Change Control

4.5.3 CONTROL OF RECORDS


Retrieval
Identification

Disposition

Indexing

RECORDS
CONTROL

Retention

Filing

Maintenance
Storage

5 MANAGEMENT
RESPONSIBLITY
New
5.1: Management Commitment

New
5.2: Customer Focus

5.3: Quality Policy


5.4: Quality Objective & Planning

New

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

New

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

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


IDENTIFY &
REVIEW

C
U
S
T
O
M
E
R

R
e
q
u
i
r
e
m
e
n
t
s

MONITOR &
MEASURE
Complaints

Feedback

Inputs

Organization
s
Processes
Product

C
U
S
T
O
M
E
R

S
a
t
i
s
f
a
c
t
i
o
n

5 MANAGEMENT RESPONSIBILITY

5.1 Management Commitment


5.2 Customer Focus

5.3 Quality Policy


5.4 Quality Planning

Define the organizations


quality policy.
Manage the
organizations quality
policy.
Quality Policy

5.5 Responsibility, Authority &


Communication
5.6 Perform Management
Reviews

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

CONTINUAL
IMPROVEMENT

MEETING
REQUIREMENTS

QUALITY
POLICY

COMMITMENT

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.
EMPLOYEES 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 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
Employees development & involvement
________________________
Chief Executive

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

Rejection Rate = ??
Rework rate = ??
Failure rate = ??

TIME-BOUND

REALISTIC

ACHIEVABLE

MEASURABLE

SPECIFIC

QUALITY
OBJECTIVES

5 MANAGEMENT RESPONSIBILITY

5.1
5.2
5.3
5.4

Management Commitment
Customer Focus
Define responsibilities,
Quality Policy
authorities and
Quality Planning
communicate them.

5.5 Responsibility, Authority & Appoint a management


Communication
representative.
5.6 Perform Management
Reviews

Establish internal
communications.

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.

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


5.6.1 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 REVIEW


INPUTS

OUTPUTS

Results of Audits
Complaints/Feedback
Product Quality Status
Pending Actions

Top
Management
Review
Meeting

Resource needs
Revision of policy
Revision of objectives
Corrective Actions

External Market Status


Improvement Actions
Improvement Suggestions

6 RESOURCE MANAGEMENT
6.1: General
6.2: Human Resources

New
New
6.3: Infrastructure

6.2.1: General

New
6.2.2: Awareness & Training

6.4: Work Environment

6.2 HUMAN RESOURCES


COMPETENCE

Education

Experience

Skills

Identify training needs

TRAINING &
AWARENESS

Provide training
Evaluate the
effectiveness of training

Maintain records of
training

Training

6.3/6.4 INFRASTRUCTURE &


WORK ENVIRONMENT
WORK ENVIRONMENT

INFRASTRUCTURE

Equipment
(hardware, software)

Temperature

Humidity

Noise

Dust

Ventilation

Work
Space

Health &
Safety

Cleanliness

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 requirementsNew

7.5.3 Identification and Traceability

7.2.2 Review of requirements

7.5.4 Customer Property

7.2.3 Customer Communication

7.3: Design & Development


7.4: Purchasing

New

7.5.5 Preservation

7.6: Control of Monitoring &


Measurement Equip.

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

CUSTOMERS SPECIFIED
REQUIREMENTS

CUSTOMERS INTENDED
REQUIREMENTS

STATUTORY & REGULATORY


REQUIREMENTS

ORGANIZATIONS INTERNAL
REQUIREMENTS

7.2.2 REVIEW OF
REQUIREMENTS
Product requirements are defined

Records of review
are maintained

Review of
Requirements

Organization has the ability to


meet the requirements

Differences/ conflicts
are resolved

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


DESIGN & DEVELOPMENT PLAN
DESIGN REVIEW

Requirements

- Customer
- Technical
- Legal

INPUT

Design &
Development

VERIFICATION

VALIDATION

OUTPUT

7.4 PURCHASING
Procedure

Purchasing Process
(Evaluation and selection
of suppliers)

Purchasing Information

Complete product specs.


Personnel qualifications
Approval of purchase
documents

Records

Verification
of Purchased
Product

7.5.1 CONTROL OF
PRODUCTION
Product Specifications
Availability of
work Instructions

Production planning

CONTROL OF
PRODUCTION

Production
records

Maintenance of
equipment

Availability of
monitoring equipment

Use of suitable
Equipment

In-process
monitoring &
measurement

7.5.3 IDENTIFICATION &


TRACEABILITY

IDENTIFICATION

TRACEABILITY

Article #/Model #/
Item #/Design #

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

INSPECTION
& TEST STATUS

Tags/Stickers/Trays for
rejected/reworked items

7.5.4 CUSTOMER PROPERTY

CUSTOMER
PROPERTY

Segregation & Maintenance

7.5.5 PRESERVATION
Handling

Delivery

Storage

PRESERVATION

Protection

Packing

DAY-2
SESSION-1

8 MEASUREMENT, ANALYSIS
& IMPROVEMENT
8.1: General

8.4: Analysis of Data

8.2: Monitoring and Measurement


8.2.1: Customer Satisfaction

New

8.2.2: Internal Audit


8.2.3: Measurement of ProcessesNew
8.2.4: Measurement of Products

Customer feedback
Product Performance
Product & Process Trends

Suppliers

8.5: Improvement

New

8.5.1: Continual Improvement


8.5.2: Corrective Action

8.3: Control of Nonconformity

New

8.5.3: Preventive Action

8.2.2 QUALITY AUDITS


Procedure

AUDIT
PLANNING

AUDIT
EXECUTION

Records

AUDIT
REPORTING

CORRECTIVE
ACTION &
FOLLOW UP

8.2.3/8.2.4 Monitoring of
Processes & Products
Quality Plan or Inspection/Test Plans

Test records

INSPECTION &
TESTING
Receiving
In-process
Final

Inspection and Test Methods

Availability of
specifications

8.3 CONTROL OF
NONCONFORMITY
Procedure

Alternative
use

Reject/
Rework

Control
of nonconformity

Accept-as-is

Records

Re-grade

8.4 ANALYSIS OF DATA


Analysis of
Customer Data

Analysis of
Suppliers Data

Analysis of
Product Data

Analysis of
Process Trends

8.5.1 CONTINUAL
IMPROVEMENT
Quality Objectives

Management
Review

Data Analysis

CONTINUAL
IMRPROVEMENT

Corrective/
Preventive Action

Quality Audits

8.5 CORRECTIVE &


PREVENTIVE ACTION
Identify the problem

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

PREVENTIVE
ACTION
Action taken to
eliminate the
potential
problems to
avoid their
occurrence

AUDITS:
TYPE AND PHASES

1.

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.

2.

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, documented and effectively implemented;

in accordance with specified requirements.

3. TYPES
FIRST PARTY (I), SECOND PARTY (II), THIRD PARTY (III)

DEFINITION

OBJECTIVE

By the organization of its own Assure maintenance,


systems and procedures.
development and
improvement of QMS.

II

By the organization of its


suppliers and subcontractors.

Determine suitability of
suppliers;
Appraise supplier/
subcontractors performance.

III

By a body which is
commercially and
contractually independent
of the organization, its
suppliers and customers.

Determine whether an
organizations QMS has been
documented and
implemented as per
specified standard.

4.

PHASE OF AN AUDIT (applicable to all types)

Planning

Independent but Overlapping

Preparation

Performance

Reporting and follow-up


PROPER PLANNING AND PREPARATION
PREVENT POOR PERFORMANCE.

AUDIT PLANNING

Basis of Planning
Points for
Planning

First Party

Second Party Third Party

Frequency

previous
as agreed /
performance; required
criticality,
complexity;
change, etc.

as agreed with
client/ required
by the
Accreditation
Body (NACCB,
RAB, act)

Responsibility

qualified
auditor i.e.
Trained
Auditor.

as for internal
audits

Registered Lead
assessor who will
select teams as
necessary

Expertise

technical
knowledge

technical
knowledge of
industry essential

Basis of Planning
Points for
Planning

First Party

Second Party Third Party

Criteria

organizations
own procedures/
standards/ ISO9000

as specified by ISO-9001:2000
contract or
and applicable
purchasing
regulatory
conditions
requirements

Scope

usually a
procedure,
related group of
procedure or a
department

usually
activities
directly
affecting
products or
service quality,
delivery etc.

Duration

typically a day or typically one


less
day

as specified by
the client in
terms of
processes,
products,
services, sites
affected by many
variables

5. OTHER PLANNING ACTIVITIES:


periodically review program;
review contracts, standards, regulatory requirements;

obtain organizations 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

1. The preparation phase will include the following:


a)

Obtaining

and

evaluating

the

latest

applicable

documentations against the stated criteria (i.e. the

documentation review or desk study).


b)

Reporting the results to the person responsible.


Domestic and travel arrangements.

c)

Review previous audit records where applicable.

d)

Compiling the site audit itinerary as necessary.

e)

Compiling checklist from procedure to be audited.

2. The checklist is a valuable aid to auditing and is


used as:

a working document, and

a record;

useful analysis during desk study.

3. 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.

Auditors main tool.

4. 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

1.

INTRODUCTION
The on-site audit process:

Opening meeting.

Conduct of the actual audit.

Auditors review.

Closing meeting.

Follow-up, if necessary.

2.

OPENING MEETING (2nd and 3rd Party)


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

good communications;
cooperation;
openness.

2.1 Agenda

introduction;

attendance list;

assessors log and complaints procedure;

objectives of audit (quality standard);

scope of audit;

report on desk study;

explanation of method/sampling;

explanation of
classification;

timetable/itinerary;

meeting room/domestic arrangements;

escorts;

closing meeting;

nature of report and follow-up;

confidentiality;

short tour of premises.

non-compliances

and

their

The above list is neither prescriptive nor exhaustive.


Keep it brief and concise, keep control.

2.2 Opening Meeting for Internal Audits:

3.

informal;

simple introduction;

Escorts, representatives, formal opening


and closing may not be necessary.

CONDUCT OF THE AUDIT


3.1 Keep 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:

people;

procedure;

equipment, tools, materials;

documentation.

3.3 It 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.

5.2 Ask efficient, open-ended


Exceptions allowed:
Open-ended question:

questions

Where do you keep your copy of the preferred


suppliers 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?


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.

or What

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.

6.

CONTROLS BY AUDITOR:
6.1 Do not:

be side tracked;

be led or misled;

get bogged down;

let the auditee dictate the pace of the audit;

make assumptions or presumptions.

6.2 Do:

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.

6.3 Auditor 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

DAY-2
SESSION-2

AUDIT REVIEW

1.

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

2.

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.

3.

Short statement a description


objective evidence found.

of

the

4.

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

5.

A non-compliance may be failure to:

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.

6.

When are non-compliance statements written?

Immediate.

Representatives 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.

7.

Example of non-compliance statement:

Standard:

ISO 9001:1994
(Clause 4.6.2 Evaluation of Subcontractors)

Procedure: QP6 Issue 2

Area: Purchasing Dept

i.

A new supplier of electric motors was not


selected on their ability to meet specified
requirements, but on price (for example:
PO1122 to EM Suppliers refers).

ii.

Suppliers and subcontractors must be


selected on the basis of their ability to
meet
specified
requirements,
in
accordance with procedure QP6 issue 2.

8.

9.

Corrective Action Request (CAR) (Ref.)

Form used by many organizations.

Describe a non-compliance and request action.

Raised after careful consideration at the auditors


private review.

Gives the level or classification of the noncompliance

Classification of the non-compliances:

MAJOR

MINOR

10.

Classification of Corrective Action Request


MAJOR CAR
Raised where:

Total breakdown of a procedure or work instruction


critical to product quality;

Total breakdown in
organizations QMS;

Total absence of a procedure required by the


Standard in the organizations 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.

the

operation

of

the

MINOR CAR:
Deficiency or deficiencies identified in:

a procedure or work instruction;

the operation of the organizations 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.

11.

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 noncompliance and its resolution should be noted in the
audit records.

12.

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

1.

2.

3.

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


challenging by the auditee

for

4.

For a 3rd party audit:

Very formal.

Client expects comprehensive, detailed


constructive presentation of findings.

Some auditors stick rigidly to the findings and


the CAR.

Some support them with constructive comments


and observations but no consultancy.

and

5.

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 representatives signature on
CAR;

explain significance of sample technique;


report on observations;
explain reporting and follow-up;

obtain attendance list and log;


thank the client;

6.

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.

REPORTING
7.

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;

contract identification number;

QA Standard;

Key personnel contacted;

Assessment team members;

CARs issued;

attendees at meeting;

position statement or conclusion;

distribution list;

attachments.

8.

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

FOLLOW-UP AND CLOSE-OUT


9.

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 clients
premises.

10.

The action relating to the verification and


acceptance of corrective action by the auditor
is called close-out.

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 auditees management
must, in conjunction with the management
representative:

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

4
HOW TO IMPLEMENT
ISO 9001:2000

1.

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.

2.

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.

3.

AWARENESS TRAINING LINE STAFF:


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

4.

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.

5.

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.
6.

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

CONTROL OF DOCUMENTS
ISO 9001 REQUIREMENTS

STATUS

All QMS documents are controlled


A documented procedure is established
to define the controls needed to:

Approve documents for adequacy


prior to issue.

Review and update as necessary


and re-approve documents.

Ensure that changes and


current
revision
status
documents are identified.

the
of

ACTION/
COMMENTS

ISO 9001 REQUIREMENTS

Ensure that relevant versions of


applicable documents are available
at points of use.

Ensure that documents remain


legible and readily identifiable.

Ensure that documents of external


origin are identified and their
distribution controlled.

Prevent the unintended use of


obsolete documents, and to apply
suitable identification to them if
they are retained for any purpose.

STATU
ACTION/
S
COMMENTS

7.

DEFINE QUALITY POLICY:

8.

PREPARE QUALITY MANUAL:


It should be done by the senior staff.

9.

PREPARE QUALITY PROCEDURES & WORK INSTRUCTION


AND OTHER RECORD FORM:
It should be done by the senior staff.

10. CONDUCT SYSTEM TRAINING:


It should be done by the senior staff.
11. IMPLEMENT SYSTEM AND KEEP REVIEWING

12. CONDUCT INTERNAL AUDIT AFTER ONE/TWO MONTHS OF


WORKING THE SYSTEM AND ASSIGN CORRECTIVE ACTION

13. CONTACT CERTIFICATION COMPANY


It should be done by the senior staff.
14. PRE-ASSESSMENT AUDIT

15. CERTIFICATION
APPOINTING A CONSULTANT, IF NECESSARY

1.

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.

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.

References:
1. Some of the material presented in these lectures has been
taken from different websites
2. Slides no 22-29 has been taken from PIQC Inst of Quality
Management

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