1. UNDERSTANDING
ISO 9001:2008

2. DISCUSSION TOPICS Definition and Introduction History of ISO
ISO Family & Standards in Pakistan
Quality Management Principles of ISO 9001:2008
ISO 9001:2008 Requirements/ Clauses
Process Flow for Implementing ISO 9001:2008
Benefits
Conclusions & Take-aways

3. DEFINITION & INTRODUCTION

4. What is ISO? ISO is the International Organization of Standardization
ISO is an organization that develops standards for use worldwide to help companies better manage themselves
ISO 9001:2008 outlines criteria for a Quality Management System (QMS)

5. What is ISO 9001?
ISO 9001 is the structural framework of a quality management system
ISO 9001 standards are generic standards that can be applied to any industry
It is important to note ISO 9000 is not a product standard; it is rather a system standard
It promotes standardization in processes and then measures performance

6. HISTORY OF ISO

7. History of ISO 9000
ISO was formed after world war II in Geneva to write quality standards to evaluate the quality management systems of potential suppliers.
First Edition
1987
First Revision
1994
Second Revision
2000
Third Revision
2008

8. ISO FAMILY & STANDARDS

9. ISO 9000 Family of Standards
ISO 9000:2008 (Quality Management Systems – Fundamentals and Vocabulary)
-Defines the fundamental terms & definitions used in ISO 9000
ISO 9001:2008 (Quality Management Systems – Requirements)
-Defines the requirements for assessing the ability to meet customer and applicable regulatory requirements and thereby address customer satisfaction
-Only standard in the ISO 9000 family against which third-party certification can be carried out
ISO 9004:2008 (Quality Management Systems – Guidance for Performance Improvement)
-Provides guidance for continual improvement of the quality management system to benefit all parties through sustained customer satisfaction

10. Famous ISO Standards in Pakistan
ISO Environmental Management Standards in production environments
OHSAS Occupational health and safety management system specifications
ISO Food safety management systems Requirements for any organization in the food chain
ISO Information security management systems Requirements

11. QUALITY MANAGEMENT PRINCIPLESOF
ISO 9001:2008

12. 08 QMPs of ISO 9001:2008

13. 08 quality management principles of ISO 9001:2008
Customer Focus
What, where, how and when do your customer require?
If you ensure it, it will ascertain in return that they would buy (or continue to buy) from you
2. Leadership
Leadership establishes environment, culture and direction
Good leadership creates an environment where people can become fully involved in achieving the organization’s objectives for quality
3. Involvement of people
People at all levels are the essence of an organization and their full involvement enables maximum utilization of individual abilities for the organization’s benefit
To educate, train and motivate employees to ensure their competence in performing tasks affecting quality, environment, health and safety

14. 08 quality management principles of ISO 9001:2008
4. Process approach
A desired result is achieved more efficiently when activities and related resources are managed as a process
5. System approach to management
Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives
6. Continual improvement
Continual improvement of the organization’s overall performance should be the permanent objective of the organization

15. 08 quality management principles of ISO 9001:2008
7. Factual approach to decision making
Effective decisions are based on the analysis of data and information
8. Mutually beneficial supplier relationship
An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.
Promote quality, environmental, health and safety principles.
Requiring suppliers to improve their practices and encouraging wider adoption of these principles by suppliers.

16. ISO 9001:2008 CLAUSES

17. ISO 9001:2008 Structure Scope Section 1 Normative References Section 2
Terms & Definition Section 3
Quality Management System Section 4
Management Responsibility Section 5
Resource Management Section 6
Product Realisation Section 7
Measurement, Analysis and
Improvement Section 8

18. QMS-Section 4 Clause-4, Quality Management System
4.1 General Requirements
(Process Approach)
4.2 Documentation Requirements
Determine what processes?
General- Quality Policy, Objectives, Quality Manual, Procedures, Documents & Records
Sequence & Interaction of processes
Quality Manual
Control methods for processes
Control of Documents
Provided resources for processes
Control of Records
Measure and analyze processes
Improve Processes

19. QMS Documentation Requirements
Commitment &
Goals
Policy &
Objectives
Overall summary and system str.
Quality Manual
Procedures related to QMS
Quality System Procedures
(Auditing, Document Control, Corrective Action etc.)
Technical Procedures
Process Procedures, Plans
(Operation procedures, plans, test methods, specifications etc.)
Records, Reports/ Logs
(Test Reports, Defect Reports, Training records etc.)
Proofs, Evidences

20. Management Responsibility-Section 5
Management commitment - evidence of commitment to the development and improvement of QMS
Customer focus - ensure customer needs and expectations are understood and satisfied
Quality policy - appropriate for company, communicated and reviewed
Planning - quality objectives and planning
Administration - responsibility and authority, management representative and internal communication
Review - QMS to be reviewed at planned intervals

21. Resource Management-Section 6
General – Required and competent resources
Competence, Training & Awareness
Infrastructure- Building, workspace, process equipment & other services
Facilities - workspace, equipment and supporting services
Work environment

22. Product Realization-Section 7
Product realisation is the sequence of processes and sub-processes required to achieve the product - must be planned
Customer-related processes - identification of requirements, product obligations and communication
Design and/or development - planning, inputs and outputs, review, verification and changes control
Purchasing - control and purchasing information
Production and service operations - operations control, traceability, preservation and verification
Control of measuring and monitoring devices

23. Measurement, Analysis & Improvement-Section 8
Measurement, analysis and improvement (Processes, Customer satisfaction, Product & Equipment)
- Planning
- Customer satisfaction
- Internal audit
- Control of nonconformity
- Analysis of data
- Improvement (CA & PA)

24. Conclusion (Sequencing & Interaction)

25. Continual Improvement
Effectiveness of QMS must continually be improved by:
Quality Policy
Objectives (KPIs)
Audit Results
Analysis of data
Corrective Actions
Preventive Actions
Management Reviews

26. PROCESS FLOW FOR
ISO 9001:2008 IMPLEMENTATION

27. ISO 9001 Implementation –Flow Chart
Selection of External QA Consultants for ISO9001 training and advisory
Implement corrective actions to meet ISO9001:2008 requirements
ISO9001 High level Training / Awareness Sessions
Mock Audit
Gap Analysis between Existing systems & ISO9001 standards
External 3rd Party Audit & ISO9001:2008 Certification
System Development and Document Processes, SOPs and Work Instructions
Surveillance Audits
System implementation according to the documented Processes, SOPs and Work Instructions
Perform Internal Audits

28. Steps to Implement ISO 9001:2008 QMS
Management Decision and Commitment
Establishment of Quality Council
Appoint your Management Representative
Establish Quality Policy and Objectives
Establish QMS Organization
Provide Infrastructure and other Resources
Review of Current QMS (Gap Analysis)
Documentation Process (Technical & QA)
Implementation of Processes and Monitoring through KPIs
Perform Internal Audit
Improve performance by corrective and preventive actions
Perform Assessment
External Audit and Certification

29. ISO 9001 Implementation and Certification Process
Activities
Gap Analysis
System Design
& Documentation
Certification
Activities
Audit
Corrective Actions
Award of Certificate
Maintenance
Activities
Surveillance Audits
6~12 Months
1~3 Months
After each year

30. Some Reasons of Failure
Over Documentation
Emphasis on adherence and not adequacy
Just get the certificate!
Loss of direction and credibility
Short term Corrective/ Preventive Actions
Weak auditing system

31. Benefits of ISO Certification
Financial benefits:
Profits are enhanced because of increased acceptability
More work is done in less time thus increasing production rate
Cost of quality comes down as a whole
For the Organization:
Products are of consistent quality
Production is more efficient with less reworks
Export marketing is easier
Increased market share
Customer confidence is enhanced as they expect products of consistent quality
For Employees:
Better understanding of their work.
Reduced stress level because of an efficient management system
New staff learns their job quickly because it's written down

32. Quality is the result of a carefully constructed cultural environment
Quality is the result of a carefully constructed cultural environment. It has to be the fabric of the organization, not part of the fabric (Philip B. Crosby)