1

ISO 9001 Quality Management System

2

What is ISO?

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION

Established in 1947

Head Office is based in Geneva - Switzerland

Greek Word “isos” which means equal

3

Current ISO Standards

ISO 9001:2008 Quality Management System

ISO 14001Environmental Management System

ISO 22000 Food Safety Management System

ISO 27001Information Security Management System

4

History of ISO 9000

Second world war US military standards NATO British Standards Institute BS5750 ISO 9000:1987 Vocabulary Standard Revised in ISO 9000:1994 & ISO 9001:2000 QMS ISO 9001:2008 Current

5

Hierarchy / Chain of Monitoring

(ISO) International Organization for Standardization

Worldwide Accreditation Bodies

(Every Country)

Certification Bodies

6

World-wide Accreditation Bodies

UKAS United Kingdom

TGA DAR German

PNAC Pakistan

RvA Netherlands

ANSI RAB America

JAB Japan

COFRAC France

7

ISO 9001

CERTIFICATION BODIES

UKAS

BVC LRQAACS

RegistrarsMoody

International

8

Introduction to ISO 9001 QMS

ISO 9001 is the quality management system standard. Which addresses the basic requirements for a quality system.

It is equally applicable to manufacturing, servicing & inspection / testing organizations.

9

About ISO 9001:2008 Process Model

ManagementResponsibility

5

ResourceManagement

6

Product/ ServiceRealization

7

Measurement, AnalysisImprovement

8

Custome

sr

Output

Product& Service

Customer

Requirements

ISO9001/2008Process Model

Input

Satisfaction

Continual improvement of the quality management system

s

10

ISO 9001:2008QMS Process requirements

Five Key Activities (Paragraphs)4. Quality Management System

6 Resource Management7. Product Realization.8. Measurement, Analysis, Improvement

5. Management Responsibility

11

ISO 9001:2008

4.0 Quality Management System4.1 Requirements shall

Establish, Document, Implement,Maintain Continually improve its effectiveness

12

ISO 9001:20085. Management responsibility

5.1 Management Commitment

5.2 Customer focus

5.3 Quality Policy

5.4 Planning

5.5 Responsibility, authority and communication5.6 Management review

13

ISO 9001:2008

6. Resource Management

6.1 Provision of Resources

6.2 Human resources

6.3 Infrastructure

6.4 Work environment

14

ISO 9001:2008

7.6 Control of monitoring & measuring devices.

7. Product Realization

7.1 Planning of product realization7.2 Customer-related processes

7.3 Design and development

7.4 Purchasing7.5 Production and service provision

15

ISO 9001:2008

8.0 Measurement, analysis and improvement8.1 General8.2 Monitoring and measurement 8.3 Control of Non conformity product8.4 Analysis of data8.5 Improvement

16

Integrated Management System

Internal Systems

Statutory & Regulatory

RequirementsISO 9001 QMS

17

Training courses we can offer during system development & implementation

ISO 9001 QMS Introduction ISO 9001 QMS Internal Auditing ISO 14001 EMS Introduction ISO 14001 EMS Internal Auditing Occupational Health & Safety Basic Introduction Integration of ISO 9001, ISO 14001 & OHSAS 18001 ISO 22000 Food Safety

18

Benefits of ISO Standardization

Globally Recognized Improvement in Quality System Efficiency Controlled Wastages Better Motivation World-wide Acceptance Customer Satisfaction

19

Trained Work Force Better Working Environment Defined Roles & Responsibilities Better Coordination Environment Friendly Better Future Increased Competence & Commitment of Employees as

well as Vendors

20

STEPS TO GET YOUR COMPANY ISO CERTIFIED (Summary)

GAP Analysis Training Session Defining Quality Policy Developing & implementing Operating Procedures, Job

Descriptions and Work Instructions Setting Quality Objectives Training of Internal Auditors Pre-evaluation of QMS System Certification Audit Never Ending Improvement