UNDERSTANDING ISO 9001:2008

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. Third Revision 2008 Second Revision 2000 First Revision 1994 First Edition 1987

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 • ISO14001 Environmental Management Standards in production environments • OHSAS 18001 Occupational health and safety management system specifications • ISO 22000 Food safety management systems Requirements for any organization in the food chain • ISO27001 Information security management systems Requirements

11. QUALITY MANAGEMENT PRINCIPLES OF 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 Implementation Activities • Gap Analysis • System Design • Implementation & 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. It has to be the fabric of the organization, not part of the fabric(Philip B. Crosby)