Introduction to ISO 9001-2008

Introduction to ISO9001-2008 Quality Management Systems – Requirements

1. INTRODUCTION TO ISO 9001:2008 AD SARWAR

2. 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 good Quality Management System (QMS) ISO 9001 standards are generic standards that can be applied to any industry

3. ISO 9000 Family of Standards ISO 9000:2000 (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 9004:2000 (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

4. 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

5. Changing Scope of Quality (‘q’ to ‘Q’) Product Quality “q” Organizational Quality “Q” Focus has been shifting from product quality to Assurance From To

6. Quality Control Vs Quality Assurance Material Receiving Sorting Cutting Marking Final Inspection Galvanizing Washing Acid Cleansing q q q q Quality of each process (q) ensures that system produces the required product that meets customer requirements (Q) q q q Q

7. Quality is: Meeting customer expectations and satisfaction Freedom from defects Quality and Quality Management Systems (QMS) QMS is: Set of policies and procedures to ensure that desired levels of quality are met, reviewed, monitored and improved

8. 08 quality management principles of ISO 9001:2008

9. THE PDCA CYCLE                                                                                                                                                                                                                                                                                                              This classification of tools into sections of the PDCA Cycle is not meant to be strictly applied, but it is a useful prompt to help you choose what to do at each critical stage of your improvement efforts. Other references Many authors have written about the PDCA Cycle or variations of it. For a sample of the different approaches see the books listed below. `Out of the Crisis', W Edwards Deming, MIT 1989 `Kaizen', Masaaki Imai, McGraw-Hill, 1986 `The Team Handbook', Peter R. Scholtes, Joiner Assoc, 1988   Check this site for translations of this article in languages other than English .   back to ARTICLES Etc Contents to HCi Services                 PLAN Policy Resources Objectives DO Processes Indicators Prod. Real. ACT Cont. Impr . Prev. Actions Corr. Actions CHECK Audits Validations Verifications P A C D (The Deming Wheel)

10. 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

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

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

13. 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

14. 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

15. 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

16. 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)

17. Steps to Implement ISO 9001:2008 QMS Establish a quality policy Set your quality objectives Establish QMS organization Establish communication channels Product design and development Purchasing & supplier management Product monitoring & measurement Monitoring equipment management Customer satisfaction measurement Internal Audit Product Conformity Measure performance Analyse performance Improve performance by corrective and preventive actions

18. 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

19. 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

20. ISO9001:2008 focuses on process improvement and better management Documented processes & procedures ( SOPs ) Performance Measurement ( KPIs development ) Continual development ( Corrective Action & Implementation ) To improve internal operational efficiency to enhance quality What processes are required to documented and controlled?? Management Responsibility Resource Management Product Realization Measurement, Analysis & Improvement Conclusion

21. 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)

22. Queries : Questions : Concerns