ISO 9001:2008

1. International Community & Management Certification ISO 9001:2008 Cont. +91-9818-42-7848 E-mail: icmc.iso@gmail.com Web: www.icmcertifications.com

2. Objective Introduce the concept of new ISO 9001 Standard Highlight important areas and changes of the new standard Briefly introduce the system requirements of the new standard ISO 9001::2008

3. What is ISO 9001: 2008 2nd revision of Quality Management System Requirement Standard from International Organization for Standards Replacement for previous ISO 9001 / 9002 and 9003 standards of 1994 Introduced considerable conceptual changes Applicable to all types of Organizations with possible permissible omissions of certain requirements ISO 9001:2008

4. General requirements General requirements New ISO 9001 QMS Management Responsibility Resource management Measurement, analysis & improvements Product Realization Continual Improvement cycle ISO 9001::2008

5. ISO 9001:2008 – Model Continual Improvement of the Quality Management System Quality Management System 5.Management Responsibility 8. Measurement Analysis and Improvement 6. Resource Management CUSTOMERS CUSTOMERS Satisfaction 7. Product Realization Requirements Product Consumption ISO 9001::2008

6. Principles of new standard Leadership Customer focus Mutual beneficial supplier relationship Involvement of people Based on eight quality management principles Factual approach to decision making Process approach System approach to Management Continual improvement ISO 9001::2008

7. Principles of new standard • Customer focus • Organization depends customers • Understand current & future customer needs. • Meet / exceed customer expectations • Leadership • Leaders establish purpose & direction of the organization • Should create & maintain environment to achieve organization’s objectives • Involvement of People • People of all levels are essence of an organization • Their full involvement for organization’s benefit • Process approach • Desired results are achieved more efficiently when activities and resources are managed as process ISO 9001::2008

8. Principles of new standard • System approach to Management • Identifying, understanding and managing interrelated process as a system contributes to the organization’s effectiveness & efficiency • Continual improvements • Continual improvement of the organization’s overall performance should be a permanent objective of the organization • Factual approach to decision making • Effective decisions are based on the analysis of data and information • Mutually beneficial supplier relationships • An organization & its suppliers are interdependent • Mutually beneficial relationship enhances the ability of both to create value ISO 9001::2008

9. Expectations of the new Standard Avoid the application of systems that are separate from the organization’s business process Enable the development of a Quality system that is fully integrated into the normal operations of organization’s business Enable Continual improvements of the system for enhanced customer satisfaction Enable compliance to statutory & regulatory requirements ISO 9001::2008

10. Criteria Previous version New Version Main focus Products Customer satisfaction Approach 20 quality elements Value adding processes Product requirements Requirements specified by customer / organization + Statutory & regulatory requirements Involvement of people What to do, When, Whom & How to do + Why it is to be done Improvements Maintain the system requirements Continual improvements should be achieved Important changes ISO 9001::2008

11. Identify the processes Identify the Inputs & outputs Identify the Interactions to other processes Establish measuring criteria Process approach • Process definition • Set of interrelated or interacting activities which transforms inputs into outputs Ensure continual improvements Do it for all value adding processes ISO 9001::2008

12. Process approach – Continual improvements of Process Understandings & meeting requirements PLAN PDCA Cycle Processes in terms Of Added Value DO Continual improvements of Processes based on objective measurements ACTION Measure results of process Performance and effectiveness - Objective Measurements CHECK ISO 9001::2008

13. Purchasing Procedure • Inputs • Required item / quantity / date • Applicable specs • Supplier source • Suppliers capability to meet our requirements • Interactions to • Storage • Inspection and Testing • Manufacturing • Finance E.g. - Purchasing Process • Outputs • Receipt of Material on right condition • Right Quality Right Quantity • Right Time • Performance Measurements • Delivery status – On-time, On spec, NCP etc • Supplier evaluation ISO 9001:2008

14. System Requirements / Structure of the Standard 5 Management Responsibility 6 Resource Management 7 Product Realization 8 Measurement Analysis & improvement General requirements Management Commitment Provision of resources Planning General Customer related processes Monitoring & measurement Documentation Requirements Customer focus Human resources Quality policy Control of NCP Infrastructures Design & development Planning Analysis of data Work environment Purchasing Responsibility, authority & communication Improvements Production & service provision Management Reviews 4 Quality Management System ISO 9001:2008

15. 4 - Quality management system Identification of processes required Continual improvements 4.1 General requirements Criteria and methods to ensure Operation & control Monitoring and Measuring of processes Availability of information & resources for operation & control ISO 9000:20008

16. 4 - Quality management system 4.2 Document requirements Quality Policy Quality Objectives Quality Manual Procedures required by the Standard Procedures required for planning, operation & control of Organization activities Records ISO 9001:2008

17. 5.2 Customer focus 5.3 Quality policy 5.4 Planning 5.6 Responsibility authority & communicate 5.7 Management Review Quality objectives Responsibility & authority General Review inputs QMS planning Management representative Review outputs Internal communication 5 - Management Responsibility 5.1 Management commitment - ISO 9000:2008

18. Development, implementation and continually improvement of QMS • Establishment of • Quality Policy • Quality Objectives Identification of Customer requirements • Communication of importance of • Regulatory & statutory requirements • Meeting customer requirements • Quality Policy & Quality objectives • Responsibilities & authorities • Appointment of Management Representative • Conducting Management Reviews • Providing required resources 5 - Management Responsibility Top Management’s commitment ISO 9001:2008

19. 5 - Management Responsibility Evidence must be provided to show that the Management is committed to the above requirements Auditors could speak to and audit Top Management (E.g. MD / Directors) to establish their commitment to the management system New Development ISO 9000:2008

20. 6.2 Human Resources 6.3 Infrastructures 6.4 Work Environment General Competence, awareness & training 6 - Resource Management 6.1 Provision of resources ISO 9000:2008

21. Resources required to • Implementing, monitoring & continual improvements • Enhance Customer satisfaction by meeting customer requirements Human Resources • Infrastructures • Infrastructures needed to achieve product conformity • Work environment • Work environment needed to achieve product conformity 6 - Resource Management Resource Management ISO 9000:2008

22. Enhanced Competent on the basis of appropriate education, skill and experience Define competencies for people performing work affecting product quality Provide training or actions Evaluate effectiveness of the training / actions Employees should aware importance of the activity being performed 6 - Human Resources 6.2 Human Resources ISO 9000:2008

23. 7.2 Customer related processes 7.3 Design and development 7.4 Purchasing 7.6 Control of monitoring measuring devices 7.5 Production & service provision Identification of customer requirement Purchasing process Design planning Control Validation of processes Design inputs Purchasing information Review of customer requirement Design outputs Identification & traceability Verification of purchased products Design review Customer communication Customer property Design verification Preservation of product Design validation Design Changes 7 - Product Realization 7.1 Planning of product realization ISO 9000:20008

24. Quality objectives of Products – Specs • Processes, procedures to realize product • Verification, validation, monitoring, inspection and testing of product • Record to demonstrate conformance 7 - Product Realization 7.1 Planning of Product realization ISO 9001:2008

25. Identification of Customer / Market requirements • Specified by customer • Requirements taken for granted • Statutory / Regulatory requirements • Review of requirements related product prior to acceptance / commitment to customers - ability to meet customer requirements • Effective communication with customer in relation to • Product information • Sales order handling • Customer feedback • Customer complaints 7 - Product Realization 7.2 Customer related processes – (Sales) ISO 9001:2008

26. Planning • Effective & efficient • Expectations of interested parties • EHS • Design inputs and outputs • Review and verification, validation and control of changes • Accuracy • Potential hazards & faults • Corrections • Evaluations against lessons learned 7 - Product Realization 7.3 Design and Development – (Product) ISO 9001:2008

27. Degree of control depends on effects of subsequent processes and effect on final product • Supplier evaluation • Verification of purchased product – Inspection and testing 7 - Product Realization • 7.4 • Purchasing • Purchasing is done in controlled manner to ensure that purchased products conforms to specific requirements ISO 9001:2008

28. Product characteristics (Specs) • Procedures and work instructions • Suitable equipments to manufacture. Monitoring and inspection & testing • Product release, delivery and post delivery • Process validation • Identification and traceability • Customers property • Material supplied by customers – e.g.. 3rd party blending 7 - Product Realization 7.5 Production and service provision Manufacturing / service provision under controlled condition to ensure conformity of product ISO 9001:2008

29. 7 - Product Realization • 7.6 Control of monitoring and measuring devices • Control and Calibration of equipments used for monitoring, inspection and testing ISO 9001:2008

30. 8.2 Monitoring & measurements 8.3 Control of non conforming product 8.4 Analysis of data 8.5 Improvement Customer satisfaction Continual improvements Internal audits Corrective action Measurement of processes Preventive action Measurement of product 8 - Measurement, analysis and improvement 8.1 General ISO 9001:2008

31. 8 - Measurement, analysis and improvement • To demonstrate • Conformity of the product • Conformity to QMS requirements • Continually improvements and the effectiveness of the system • 8.1 - To demonstrate • Conformity of the product • Conformity to QMS requirements • Continually improvements and the effectiveness of the system • 8.2 - Monitoring and Measurements • Customer satisfaction / perception • Internal audits - conformity planned arrangements of QMS and ISO9001 • Monitoring and measurements of processes – to determine / demonstrate ability of processes to achieve required results • Monitoring and measurements of product – Conformity to product requirements • 8.3 - Control of NCP • To assure that NCP products are identified and controlled to prevent unintended use / delivery ISO 9001:2008

32. 8 - Measurement, analysis and improvement 8.4 - Analysis of data Collection and analysis of data generated through QMS activities to verify suitability, effectiveness and continual improvement of the system • Analysis shall provide information related to • Customer satisfaction / perception • Conformity to specs, requirements • Trends of processes and products • Opportunities for preventive actions • Suppliers ISO 9001:2008

33. 8 - Measurement, analysis and improvement • 8.5 - Improvements • Continual Improvements • QMS needed to be continually improved • Corrective action • Actions to prevent recurrence of NCP, NCR etc • Includes reviews, determination of causes, need of action, implementation of action, review of action and maintenance of relevant records • Preventive action • Actions against potential non conformities to avoid their occurrence • Includes identification of potential non conformities, cause, need for action, implementation of action, review of action and maintenance of records ISO 9001:2008

34. Satisfaction surveys for customers and other interested parties • Feedback on products • Customer & market requirements • Financial measurements • Prevention cost • Non conforming / failure cost • Lifecycle cost Self assessment • Internal audits • Effectiveness & efficiency of processes • Opportunities for improvements • Use of data / information • Effective & efficient use of resources • Adequacy, accuracy and performance of measurements • Relationships with customers/ suppliers/ other interested parties Criteria for measurements System performance ISO 9001:2008

35. Process capability / process validation • Reaction time • Cycle time / throughput (Capacity) • Utilization of technology • Waste reduction • Cost reduction • Inspection and testing of incoming, in process and final product • Product verification • Product validation Criteria for measurements Processes Products ISO 9001::2008

36. Pros and Cons More business oriented. Less procedure oriented Company wide involvement Mutual benefit to all interested parties Customer focus than product focus Continual improvements Less emphasis on documentation Demanding more resources ?? ISO 9001:2008

37. Management Support Encouragement New ISO Communication Other employee Support Challenges in implementing new standard ISO 9001:2008

38. 1st visit 2nd visit 3rd visit Review of QMS & Product realization Review of Measurement, analysis & improvements Review of Management responsibility Review of Resource management 2 years ISO 9001:2008 Transition Process 4th visit ISO 9001:2008

39. ICMC Cont.+91-9818-42-7848 Email.- icmc.iso@gmail.com ISO 9001:2008