QMS Standard

ISO 9000:2000
ISO 9000:2000

Pakistan Institute of Quality Control

CONTENTS
1 2 ISO 9000 New Family of Standards Whats New in ISO 9000:2000 (Outline) ISO 9001:2000 New/Modified Requirements Audit Terms and Definitions

ISO 9000:2000

3
4

5
6 7

Principles of Auditing
Competence of Auditors Managing an Audit Program

Evolution of Quality Field

TQM+

TQM
QA
QC
SPC
Performance Measure Quality Circles ISO9000 HRM GROUP
DYNAMICS Teams

6 Sigma

Knowledge Mgt.
IT

JAR 145
OPR MGT.

Efficiency
BPR TPM JIT/MRP

Product Inspection

Process Control

System Opr Mgt.

Culture / Overall Performance Competitiveness

Quality Control

Airport Flight Marketing PROCESS MIS Services

Performance

OK

Cycle A Rework

Errors

Rootcause Analysis & Problem Solving

Cycle B

PROCESS
Measures

Quality Assurance

Customers
PROCESSES

OUTCOME

OK

Correction

Errors

Root-Cause Analysis & Problem solving

data

Root-Cause Analysis & Problem solving

FIELD
Performance

data

QA in PIA means QA in every Dept.

ENGG.

FINANCE

Flight Operations

Mkg

HRD

Flight Services

Airport Services

PURCHASING
MIS PLANNING

Performance Measures for Quality

1Appropriateness 2 Availability
The degree to which the service provided is relevant to The passenger needs The degree to which the appropriate service is available to meet the passengers needs

3 Continuity
The degree to which the service for the passenger is coordinated among providers among organizations, and over time

4 Effectiveness
The degree to which the service is provided in the correct manner

5 Safety
The degree to which the risk of an intervention and the risk in the service environment are reduced for passengers and others

6 Efficiency
The relationship between the outcome(s) and the resources used to deliver service

7 Timeliness
The degree to which service is provided to the Passenger at the most beneficial or necessary time

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

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

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Process Approach 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

C
U S T O M E R

Measurement, analysis and improvement

Output

Service realization

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

Product

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Contents

1 Scope
2 Normative Reference 3 Terms and Definitions

1.1 General 1.2 Application

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Contents (cont.)

Quality Management System Management Responsibility

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

Resource Management

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

Product Realization

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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

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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

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1.2 Application
Generic requirements; applicable to all organizations, regardless of type, size and product provided

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Documentation Structure (Example)

What How
QMS QMS QMS QMS QMS Dept A Procedures Dept B Procedures Dept C Procedures Dept D Procedures Dept E Procedures Relevant Records Relevant Records Relevant Records Relevant Records Relevant Records

QUALITY MANUAL
(SUMMARY)

Supporting Documents e.g. standards, Manuals

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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

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5.3 Quality Policy

Top management shall ensure that the quality policy: is appropriate to the purpose of the organization includes a commitment to comply with the requirements and continually improve the effectiveness of the QMS provides a framework for establishing and reviewing quality objectives communicated and understood in the organization is reviewed for continuing suitability
What broad Quality aspects should be Covered in the Quality Policy? 1. Fulfillment of Customer needs 2. Fulfillment of applicable national laws and regulations 3. Minimization of waste,errors and nonconforming 4. Continual improvement 5. Employees quality and organizational culture

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5.4 QMS Planning

Quality Objectives:
are established at relevant functions and levels, and are measurable and consistent with the quality policy

What does Quality objectives for each function means?

What does Quality objectives for each level means?

QMS Planning:
How to achieve the objectives

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5.5 Responsibility, Authority and Communication

Responsibility and Authority:

defined and communicated within the organization

Examples Job Descriptions QMRs 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

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 Internal Communication:
ensure effective communication regarding the effectiveness of the QMS

Examples Team briefing and meetings notice boards newsletter intranet employees surveys

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5.6 Management Review

INPUTS

QUALITY PROCESS

OUTPUTS Improvements in QMS

QUALITY REPORT covering Audit results Customer feedback process performance product conformity C/P Action follow-ups changes / follow-ups recommendations for improvements

Management Reviews

Improvements in Products/Processes

Resource Needs

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6.2 Human Resources

6.2.1 General

Right person for the right job

qualified managers? qualified supervisors? appropriate workers?

Qualified / Appropriate means 1. 2. 3. 4. Education Training Skills Experience

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6.3 Infrastructure

Provide necessary infrastructure for the QA program, e.g.

building, workspace, utilities process equipment (hardware/ software) supporting services, e.g. transport, communication,

Examples suitable machines, workspaces, software, hardware, information

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6.4 Work Environment

The organization shall determine and manage the work environment needed to achieve conformity to product requirements

Examples
work space heat, humidity, light airflow, hygiene, cleanliness, noise, vibration and pollution, etc.

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7. Service Realization

7.2 7.6 Customer Monitoring & Related Measuring Processes Devices PROCESS MANAGEMENT 7.3 7.5 Design & Service Development Provision 7.4 Purchasing

7.1 Planning

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7.1 Planning

Quality objectives and requirements for the services 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

Service Quality Plans?

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7.2 Customer-related Processes

7.2.1 Determination of requirements related to the Services

Determine:
customers requirements unstated but necessary requirements statutory and regulatory product reqt any additional requirement determined by the organization

Examples contracts customer surveys, focus groups applicable national regulations

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7.2 Customer-related Processes

7.2.2 Review of requirements related to the Services review contract before acceptance ensure service reqts are defined resolve issues before acceptance confirm organization capability maintain records ensure amendments properly
Examples Contract review review of results of surveys and focus groups, etc.

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7.2 Customer-related Processes

7.2.3 Customer Communication

Make effective arrangements for communicating with customers in relation to:

service information inquiries, order handling, including changes, and customer feedback, including customer complaints

Examples Printed information Telephonic info Mail info Web info Airport announcements. Aircraft announcements

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7.3 Development of New Services

Development Review
Customer Regulatory Professional Reqts.

Inputs

Review

Designing

Output

Verification

Validation

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7.4 Purchasing

PURCHASING

Verification of Purchased Product/Services

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7.5 Service Provision

7.5.1 Control of Service Provision

7.5.2 Validation of Processes

7.5.3 Identification and Traceability

7.5.4 Customer Property

7.5.5 Preservation of Luggage & products

7.5.6 Control of Monitoring and Measuring Devices

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8. Measurement, Analysis and Improvement

8.1 General 8.3 Control of non-conforming service

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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

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8 Measurement, Analysis and Improvement

8.2 Monitoring and Measurement
Examples of CS: Direct interfaces focus groups surveys sector and industry studies Examples of IA: Main objective is to check the correctness and performance of functions and processes

Customer Satisfaction
device a method to measure and monitor customer satisfaction from customer perception point of view

Internal Audit
regularly carry out internal audit to check conformity and effectiveness of the QMS design an effective audit program and plan, criteria competent auditors audit results and records follow-ups and timely C/A

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8 Measurement, Analysis and Improvement

8.2 Monitoring and Measurement
Examples use of SPC, especially control charts monitoring and supervision of process parameters daily morning reviews of quality by workers and their supervisors Appropriate product measurement scheme

Processes
apply suitable monitoring of processes where required C/A when deviation occurs

Services
measure service characteristics to confirm fulfillment of quality at appropriate stages in accordance with the quality plans define acceptance criteria authorize release and records

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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?

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8 Measurement, Analysis and Improvement

8.5 Improvement

Continual Improvement
identify opportunities of improvement from quality policy, objectives, audit results, analysis of data, C/P actions, and management reviews mobilize improvement programs

Clear evidence of improvement processes Clear evidence of improvements

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8 Measurement, Analysis and Improvement

8.5 Improvement

Corrective Action
take timely action to eliminate the cause of nonconformities. Review nonconformities determine causes evaluate determine and implement action records of results review and confirm results

What is the difference between Correction, Corrective Action and Preventive Action? Corrective Action Form Control of Corrective Actions

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8 Measurement, Analysis and Improvement

8.5 Improvement

Preventive Action
determine potential nonconformities current mistakes and future planning determine their causes device actions implement actions record results review action taken

Outputs of management reviews or corrective actions

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System Maturity Logic

An S-Curve Improvement

SYSTEM

Embryonic

1ST Year

2nd Year

3rd Year

Maturity

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System Maturity
Excellent Good Satisfactory Acceptable

After 1 1/2 years

B
A

6 9 12 Time (months)

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QUALITY ASSURANCE (ISO 9000)

Poor 60% Satisfa ctory 40%

Satisfa ctory

25%

Good

15%

1998 Survey Result by KM

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The End

Lets Create

QUALITY TRADITIONS

ISO 9000:2000

Thank You

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