Iso awarness
- 1. BY : MR. JASMIN SUTHAR SR. ENGINEER – Q.A. GALAXY SIVTEK PVT. LTD.
- 2. The International Organization for Standardization (ISO) brought out in 1987 a set of standards called ISO 9000 series of standards on Quality Management System (QMS) This standard was brought in for the purpose of establishing a customer oriented quality discipline in all functions. (Marketing, Design, Engineering, Production, Procurement, In spection. Etc.)
- 3. In 1950s, after the world war US defence dept. established the MIL-Q- 9858 standard as contractual specification for procurement. In 1979, UK published quality system standard BS 5750 (3 parts) & BS 5781 In 1987, ISO Geneva published a series of quality system First amendment was taken in 1994 (ISO 9000 : 1994) In Dec. 2000, the system was completely reviewed and new standard ISO 9001 : 2000 series was released In 2008, ISO 9001 : 2008 series was released (Only introduced clarifications to the existing requirements of ISO 9001 : 2000 and some changes intended to improve consistency with ISO 14001 : 2004.
- 4. Meet customer requirement Ger more revenue and business from new customers Improve Company and Product Quality Increase Customer Satisfaction with our Product. Develop a Professional Culture and Better Employee Morale Improve the Consistency of our Operations Improve Efficiency, Reduce Waste and Save Money
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- 6. QMS PRINCIPLES 1. Customer focus To identify and understand customer needs To satisfy customer requirements To meet customer expectations 2. Leadership Leaders establish unity of purpose, direction of the organization Create and maintain the internal environment in which people can becomes fully involved in achieving the organization’s objective. 6
- 7. QMS PRINCIPLES Continue 3. Involvement of People Full involvement of people at all level enables their abilities to be used for the benefit of the organization. 4. Process approach Activities and related resources are managed as a process to achieve desired goal 7
- 8. QMS PRINCIPLES Continue 5. System approach to Management Identifying, understanding and managing a system of interrelated processes as a contribution to the organization’s effectiveness and efficiency. 6. Continual Improvement Must become organization’s permanent objective 8
- 9. QMS PRINCIPLES Continue 7. Factual and documented approach to decision making Effective decision are based on the analysis of data & information. 8. Mutually beneficial relationship with the suppliers Allows both the organization to create value 9
- 10. Say What You Do This means document your systems so you will consistently do the job the same way every time. We must make sure we have appropriate documentation. Do What You Say This is what the auditors want to see. Objective evidence that what you say you are doing in your documentation is what you are doing in practice. 10
- 11. 4 Quality 5 Management 6 Resource 7 Product 8 Management Responsibility Management Realization Measurement System Analysis & improvement Management General Commitment Provision of Planning General requirements resources Customer focus Customer Monitoring & Documentation Human related measurement Requirements resources processes Quality policy Infrastructures Control of NCP Design & development Planning Analysis of data Work environment Purchasing Responsibility, a Improvements uthority & Production & communication service provision Management Reviews Control of monitoring & measuring 11 equipment
- 12. 1. Determine the 5. Implement action, processes required Continual For QMS improvements 4.1 General requirements 2. Criteria and 4. Monitoring and methods to ensure Measuring of Operation & control Processes, Analysis the process 3. Availability of information & resources for operation & control 12
- 13. General • Documented statement & Quality policy • Quality Manual • Documented Procedure & records Quality Manual 4.2 Documentation Control of Documents requirement • Approve doc. For adequacy • Legible and identifiable • Review and update Control of records • Identification, storage, protection, retrieval, retention & disposition • Provide evidence of conformity 13
- 14. 5.1 5.2 5.3 5.4 5.5 5.6 Management Customer Quality Planning Responsibility Management commitment focus policy authority & Review communicate Quality Responsibility General objectives & authority Review QMS Management inputs planning representative Review Internal outputs communication 14
- 15. Development, implementation and Establishment of continually improvement of QMS •Quality Policy •Quality Objectives (measurable & consistent with Quality policy) Ensuring the availability of resources Top Management’s Identification of Customer requirements & commitment satisfaction Communication of importance of •Appointment of Management Representative •Regulatory & statutory requirements •Meeting customer requirements •Conducting Management Reviews •Quality Policy & Quality objectives •Providing required resources •Responsibilities & authorities 15
- 16. Processes needed for QMS are established, implemented & maintained Reporting to top management on the MR Performance of QMS (Responsibility & Authority) Need for improvement for QMS Liaison with external parties 16
- 17. 6.1 6.2 6.3 6.4 Provision of Human Infrastructures Work resources Resources Environment General Competence, awareness & training 17
- 18. Resources required to Implementing, monitoring & continual improvements Enhance Customer satisfaction by meeting customer requirements Human Resources Resource Management Infrastructures Infrastructures needed to achieve product conformity Work environment Work environment needed to achieve product conformity 18
- 19. Competent on the basis of appropriate education, skill and experience Define competencies for people performing work affecting product quality 6.2 Human Provide training or actions Resources Evaluate effectiveness of the training / actions Employees should aware importance of the activity being performed 19
- 20. 7.1 7.2 7.3 7.4 7.5 7.6 Planning Customer Design and Purchasing Production Control of of product related development & service monitoring & processes provision measuring realization equipment Determination D&D planning Purchasing Control of requirement process related to the D&D inputs Validation of product Purchasing processes D&D outputs information Review of Identification & requirement D&D review Verification of traceability related to the purchased product products D&D verification Customer property Customer communication D&D validation Preservation of product Control of D&D Changes 20
- 21. Quality objectives & requirement of Products Processes, procedures, resources to realize product 7.1 Planning of Product realization Verification, validation, monitoring, inspe ction and testing of product Record to demonstrate conformance 21
- 22. Identification of Customer / Market requirements • Specified by customer • Requirements taken for granted • Statutory and regulatory requirements 7.2 Customer related processes – (Sales) 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 •Enquiries, contracts or order handling, including amendments • Customer feedback, including Customer complaints 22
- 23. Planning (Determine) • stages • review, verification, validation (each stage) •Responsibility and authority 7.3 Design and Development Design inputs and outputs Review and verification, validation and control of changes •Accuracy •Potential hazards & faults •Corrections •Evaluations against lessons learned 23
- 24. Degree of control depends on effects of subsequent processes and effect on final product 7.4 Purchasing Purchasing is done in controlled manner to ensure that Supplier evaluation purchased products conforms to specific requirements Verification of purchased product – Inspection and testing 24
- 25. Product characteristics (Specs) Procedures and work instructions Suitable equipments to manufacture. 7.5 Monitoring and inspection & testing Production and service provision Manufacturing / Product release, delivery and post delivery service provision under controlled condition to ensure Process validation conformity of product Identification and traceability •Customers property (Identify, verify, protect and safeguard) •Preservation of product (during processing, storage, Handling, delivery) 25
- 26. • Calibrate and validate at specific interval • traceable to international measurement standard 7.6 Control of monitoring • Adjusted or re-adjusted as necessary and measuring • Protect from damage and deterioration equipment during handling, maintenance and storage Identification in order to determine its calibration status 26
- 27. 8.1 8.2 8.3 8.4 8.5 General Monitoring & Control of Analysis of Improvement measurement non data conforming product Customer Continual satisfaction improvements Internal audits Corrective action Monitoring & Measurement of Preventive processes action Monitoring & Measurement of product 27
- 28. To demonstrate 8.1 - To demonstrate •Conformity of the product •Plan & carried out inspection, testing, measurement, analysis & improvement •Conformity to QMS requirements processes. •Continually improvements and the effectiveness of the system •Demonstrate that products & services meet defined requirements. •Continually improve the effectiveness of the QMS 8.2 - Monitoring and Measurements •Measure Customer satisfaction / perception •Conduct Internal audits •Monitoring and measurements of processes – to demonstrate ability to meet planned results •Monitoring and measurements of product – Conformity to product requirements 8.3 - Control of NCP (Non Conforming Products) •To assure that NCP products are identified and controlled to prevent unintended use / delivery 28
- 29. 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 •Process data & product trends • Opportunities for preventive actions •Suppliers data 29
- 30. 8.5 - Improvements Continual Improvements •QMS needed to be continually improved Corrective action •Resolve complaints and nonconformities. •Investigate causes of nonconformities •Record results of investigation. •Corrective action is determined, carried out, effective & reviewed. Preventive action •Use information from many sources to detect, analyze & eliminate potential causes. •Identify steps needed to prevent problems •Ensure preventive action is effective •Action taken are recorded and reviewed. 30
- 31. Mission Purpose for which we are working? What we would like to be? Vision Policy Which path we need to adopt? What we should achieve? Objectives 31
- 32. • Does NOT define quality • Is NOT a one-time process • Is NOT easy • Requires commitment • Requires resources 32
- 33. BY : MR. JASMIN SUTHAR SR. ENGINEER – Q.A. GALAXY SIVTEK PVT. LTD. 33