QMS Standard

ISO 9000:2000
ISO 9000:2000

Pakistan Institute of Quality Control

 CONTENTS
1 ISO 9000 New Family of Standards
2 What’s New in ISO 9000:2000 (Outline)
3
ISO 9000:2000

ISO 9001:2000 New/Modified Requirements

4 Audit Terms and Definitions
5 Principles of Auditing
6 Competence of Auditors
7 Managing an Audit Program
Evolution of Quality Field

TQM+
6 Sigma

TQM Knowledge
Mgt.
HRM
QA IT
GROUP
ISO9000 DYNAMICS
QC Teams
SPC JAR 145 Efficiency
Quality OPR MGT. BPR
Performance Circles
Measure TPM

JIT/MRP

Product Process System Culture / Overall

Inspection Control Opr Mgt. Performance Competitiveness
Quality Control

Airport
Flight
Marketing
PROCESS
MIS
Services Performance OK

Cycle A Errors
Rework

Rootcause Cycle B
Analysis &
Problem
Solving
 Quality
PROCESS
Assurance
Measures

Customers

PROCESSES OUTCOME OK

Correction Errors

Root-Cause
Analysis & data
Problem solving

Root-Cause Analysis data

& FIELD
Problem solving Performance
QA in PIA means QA in every
Dept.

ENGG.

Flight Mkg
Operations
FINANCE

Flight Services Airport Services

HRD

PURCHASING

MIS
PLANNING
Performance Measures for Quality
1Appropriateness 2 Availability
The degree to which the
service provided is relevant to
The passenger needs
4 Effectiveness
The degree to which the
service is provided in the
correct manner
7 Timeliness
The degree to which
service is provided to the
Passenger at the
most beneficial or necessary
time
The degree to which the
appropriate service is available to
meet the passenger’s needs
5 Safety
The degree to which the risk of
an intervention and the risk in the
service environment are reduced
for passengers and others
8 Respect & Caring
The degree to which the patient
or designee is involved in his or
her own travel decisions and to
which those providing
service do so with sensitivity and
respect for the passengers
needs, expectations, and
Individual differences
3 Continuity
The degree to which the
service for the passenger is
coordinated among providers
among organizations, and over
time
6 Efficiency
The relationship between the
outcome(s) and
the resources used to deliver
service
9 Reliability
Errors during service
 Introduction to
ISO 9000 QMS
ISO 9000:2000
ISO 9000:2000 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 10006:1997 Guidelines for Project Management
– ISO 10007:1995 Guidelines for Configuration Mgt
– ISO 19011 on Auditing
– ISO 10012-1 & -2, Quality Assurance for Measuring Eqpt.
– ISO 10013:1995 Guidelines for Quality manuals
– ISO/TR 10014:1998 Guidelines for managing economics
of quality
– ISO 10015 Guidelines for Training
– ISO/TR 10017:1999 Guidelines on Statistical techniques
Process Approach Model

CONTINUAL IMPROVEMENT OF THE

QUALITY MANAGEMENT SYSTEM

C R
e Management C S
a
U q
responsibility U
t
i
u
S i
S s
r Measurement, f
T e Resource
analysis and T a
c
O m management improvement
e O t
i
M n
t M o
Input
E s Service Output
E
n

R realization Product
R
Contents

1 Scope 1.1 General

1.2 Application

2 Normative Reference

3 Terms and Definitions

Contents (cont.)

4 Quality Management
System 4.1 General Requirements
4.2 Documentation Requirements

5 Management 5.1 Management Commitment

Responsibility 5.2 Customer focus
5.3 Quality Policy
5.4 Planning
5.5 Responsibility, authority and communication
5.6 Management Review

6 Resource Management 6.1 Provision of resources

6.2 Human resources
6.3 Infrastructure
6.4 Work environment

7 Product Realization 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.)

8 Measurement, Analysis
and Improvement 8.1 General
8.2 Monitoring and measurement
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
1. Scope (applicability)
1.1 General

• Product meets customer and applicable regulatory

requirements

• to enhance customer satisfaction, including continual

improvement of the system and assurance of conformity to
customer and applicable regulatory requirements
1.2 Application

• Generic requirements; applicable

to all organizations, regardless of
type, size and product provided
Documentation Structure
(Example)

What How

Dept A Relevant
QUALITY QMS Procedures Records
MANUAL
(SUMMARY) Dept B Relevant
QMS Procedures Records

Dept C Relevant
QMS Procedures Records
Dept D Relevant
QMS Procedures Records

Dept E Relevant
QMS Procedures Records

Supporting Documents
e.g. standards, Manuals
5.2 Customer Focus
• Top management shall ensure
that customer requirements are
determined and fulfilled with the
aim of enhancing customer
satisfaction
Examples
• Customer needs
identification
procedure?
(e.g. surveys, focus
groups, contracts)
• Top management
verification (through
1st, 2nd, 3rd party
tests etc., that such
requirements are
fulfilled
5.3 Quality Policy
What broad Quality aspects
Top management shall ensure that the should be Covered in the
quality policy: Quality Policy?
• is appropriate to the purpose of the
organization 1. Fulfillment of Customer
needs
• includes a commitment to comply with
2. Fulfillment of applicable
the requirements and continually national laws and
improve the effectiveness of the QMS regulations
• provides a framework for establishing 3. Minimization of
and reviewing quality objectives waste,errors and
• communicated and understood in the nonconforming
organization 4. Continual improvement
• is reviewed for continuing suitability 5. Employees quality and
organizational culture
5.4 QMS Planning
• Quality Objectives: • What does Quality
– are established at relevant functions objectives for each
and levels, and are measurable and function means?
consistent with the quality policy
• What does Quality
• QMS Planning: objectives for each
– How to achieve the objectives level means?
5.5 Responsibility, Authority and Communication
• Responsibility and Authority: Examples
– defined and communicated within • Job Descriptions
the organization • QMR’s clear role
• Management Representative:
appoint a QMS Coordination role to a
management member
– ensure QMS is established,
implemented and maintained
– report the performance and the
need for improvement
– promote awareness
– liaison with external parties
• Internal Communication: Examples
ensure effective communication • Team briefing and
regarding the effectiveness of the meetings
QMS • notice boards
• newsletter
• intranet
• employees surveys
 5.6 Management Review

INPUTS
QUALITY
PROCESS OUTPUTS
QUALITY REPORT
covering Improvements in QM
•Audit results
•Customer feedback Management Improvements in
•process performance Reviews
•product conformity Products/Processes
•C/P Action
•follow-ups Resource Needs
•changes / follow-ups
•recommendations
for improvements
6.2 Human Resources

6.2.1 General

Right person for the right job

qualified managers? Qualified /

qualified supervisors? Appropriate means
appropriate workers? 1. Education
2. Training
3. Skills
4. Experience
6.3 Infrastructure
• Provide necessary infrastructure Examples
for the QA program, e.g. • suitable machines,
workspaces,
software, hardware,
– building, workspace, utilities
information
– process equipment (hardware/
software)
– supporting services, e.g. transport,
communication,
6.4 Work Environment
• The organization shall determine Examples
and manage the work
environment needed to achieve • work space
conformity to product • heat, humidity, light
airflow,
requirements
• hygiene, cleanliness,
noise, vibration and
pollution, etc.
7. Service Realization

7.1
7.6 Planning7.2
Monitoring & Customer
Measuring Related
Devices PROCESS Processes
MANAGEMENT
7.5 7.3
Service Design &
Provision Development
7.4
Purchasing
7.1 Planning

• Quality objectives and • Service Quality

requirements for the services Plans?

• establish processes, documents,

and provide resources specific to
the services
• required verification, validation,
monitoring, inspection and test
activities specific to the service
and the criteria for service
acceptance
• identification of relevant records
7.2 Customer-related Processes

7.2.1 Determination of requirements related to the Services

• Determine: Examples
– customer’s requirements • contracts
– unstated but necessary requirements • customer surveys,
– statutory and regulatory product req’t focus groups
– • applicable national
any additional requirement
determined by the organization regulations
7.2 Customer-related Processes

7.2.2 Review of requirements related to the Services

Examples
• • Contract review
review contract before acceptance
• review of results of
• ensure service reqts are defined surveys and focus
• resolve issues before acceptance groups, etc.
• confirm organization capability
• maintain records
• ensure amendments properly
7.2 Customer-related Processes

7.2.3 Customer Communication

• Make effective arrangements for Examples
communicating with customers in • Printed information
relation to: • Telephonic info
– service information • Mail info
– inquiries, order handling, including • Web info
changes, and • Airport
– customer feedback, including announcements.
customer complaints • Aircraft
announcements
7.3 Development of New
Services

Development Review

Customer
Regulatory
Professional Inputs Review Designing Output
Reqts.

Verification

Validation
7.4 Purchasing

Pu
ss
ce

rch
o
Pr

asi
ng
ing

In
as

for
ch

ma
PUR CH ASI NG
r
Pu

tio
n
Verification of
Purchased Product/Services
7.5 Service Provision

7.5.1
Control of 7.5.4
Service Customer
Provision Property 7.5.6
7.5.3
Control of
Identification
Monitoring and
and
7.5.5 Measuring
Traceability
7.5.2 Preservation Devices
Validation of of Luggage
Processes & products
8. Measurement, Analysis and
Improvement

8.1 8.4
General Analysis of
Data
8.3
Control of
non-conforming
service
8.2 8.5
Monitoring & Improvement
Measurement
8 Measurement, Analysis and
Improvement

8.1 General
• Ensure conformity of the service
• ensure conformity of the QMS
• ensure effectiveness and
continually improving the QMS
8 Measurement, Analysis and
Improvement

8.2 Monitoring and Measurement Examples of CS:

• Direct interfaces
• Customer Satisfaction
• focus groups
– device a method to measure and
monitor customer satisfaction from • surveys
customer perception point of view • sector and industry
studies
• Internal Audit Examples of IA:
– regularly carry out internal audit to • Main objective is to
check conformity and check the correctness
effectiveness of the QMS and performance of
– design an effective audit program functions and processes
and plan, criteria
– competent auditors
– audit results and records
– follow-ups and timely C/A
8 Measurement, Analysis and
Improvement

8.2 Monitoring and Measurement

Examples
• Processes • use of SPC,
– apply suitable monitoring of especially control
processes where required charts
– C/A when deviation occurs • monitoring and
supervision of
process parameters
• Services • daily morning reviews
– measure service characteristics to of quality by workers
confirm fulfillment of quality and their supervisors
– at appropriate stages in accordance • Appropriate product
with the quality plans measurement scheme
– define acceptance criteria
– authorize release and records
8 Measurement, Analysis and
Improvement
8.4 Analysis of Data
• Determine, collect and analyze
appropriate data from
measurement sources to check
conformance and analysis for
improvement in:
– customer satisfaction
– service conformance
– process
– suppliers
• Analysis is not
compiling of data
• Analysis is after
compiling of quality
data
• Analysis is part of
Quality Report
• Sources of data?
8 Measurement, Analysis and
Improvement

8.5 Improvement
• Continual Improvement • Clear evidence of
– identify opportunities of improvement improvement
from quality policy, objectives, audit processes
results, analysis of data, C/P actions, • Clear evidence of
and management reviews improvements
– mobilize improvement programs
8 Measurement, Analysis and
Improvement

8.5 Improvement
• Corrective Action • What is the
– take timely action to eliminate the difference between
cause of nonconformities. Correction,
Corrective Action
– Review nonconformities
and Preventive
– determine causes Action?
– evaluate • Corrective Action
– determine and implement action Form
– records of results • Control of Corrective
– review and confirm results Actions
8 Measurement, Analysis and
Improvement

8.5 Improvement
• Preventive Action • Outputs of
– determine potential nonconformities management
current mistakes and future planning reviews or corrective
actions
– determine their causes
– device actions
– implement actions
– record results
– review action taken
System Maturity Logic

An S-Curve

Improvement
Embryonic
SYSTEM

1ST Year 2nd Year Maturity

3rd Year
System Maturity After 1 1/2 years

Excellent C

Good
Maturity

Satisfactory

Acceptable B

3 6 9 12 18
Time (months)
QUALITY ASSURANCE (ISO 9000)

Poor
60%
Satisfa
ctory
Satisf
actory 25% Good

40% 15%

1998 Survey Result by KM

 The End

Lets Create
QUALITY
TRADITIONS
ISO 9000:2000

Thank You