Quality Management System
- 1. QMS-ISO9001:2008 QUALITY MANAGEMENT SYSTEM Dr Kalpesh Parikh, Director
- 2. QMS-ISO9001:2008 System is for the organisation, and not organisation for the system. AIM Enhancing Customer Satisfaction Same Result irrespective of Person Performing it.
- 3. QMS-ISO9001:2008 What is Quality? “DEGREE TO WHICH A SET OF INHERENT CHARACTERISTICS FULFILS REQUIREMENTS” Quality of a product is denoted by its • Market Acceptance • Appearance • Usage • Consistency • Lasting Value
- 4. QMS-ISO9001:2008 H/W S/W Humanware MS IT Solution Infrastructure System What is Management System? “set of interrelated or interacting elements to establish policy and objectives and to achieve those objectives”
- 5. QMS-ISO9001:2008 Quality definitions Deming: A predictable degree of uniformity and dependability at low cost and suited to the market. Crosby: Conformance to the requirements. ISO 8402: A totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs. Source: www.intellisenseit.com
- 6. QMS-ISO9001:2008 Quality Management System Quality Assurance : “Part of Quality Management System, focused on providing confidence that quality requirements will be fulfilled” Quality Management Coordinated activities to direct and control organization Wrt Quality Quality Control : “Part of Quality Management, focused on fulfilling quality requirements” QMS requirements are complementary to technical requirements for product
- 7. QMS-ISO9001:2008 • System Approach • Continual Improvement • Factual Approach to Decision Process • Mutually beneficial Supplier Relationship • Process Approach • Factual Approach • Organization and Personal Learning (Knowledge) • Agility (To react Change) • Creating Customer Value • Focus on Social Value • Visionary Leadership • Understanding Core Competence (profound knowledge of business) • Involvement of People • Collaboration with partners • Total optimization of system • Autonomy (Empowerment) Quality Management Principles
- 8. QMS-ISO9001:2008 Introduction to ISO 9000 ISO : International Organization for Standardization ISO 9000 : International Quality Management System Standard : Applies to Quality Management System and not to the Products : They are generic and not specific to any Industry • These are developed to effectively document the quality elements to be implemented in order to maintain an efficient quality system in company. • Do not specify the technology to be used for implementing quality system elements. • They tell what you ought to consider doing when you manage your organization, not how precisely you should do.
- 9. QMS-ISO9001:2008 What is Standard ? A Written document detailing minimum features, specifications and requirement of product. These are required to (a) Prescribe the minimum requirements for Quality (b) Ensure safety of operations both for workmen and users (c ) Promote interchangeability of the product. (d) Achieve variation reduction ISO 9000 QMS Manual PROCEDURE FORMS RECORDS WORK INSTRUCTION ISO Requirements
- 10. QMS-ISO9001:2008 C U S T O M E R C U S T O M E R Management responsibility Resource management Measurement, analysis, improvement ProductProduct realisation Quality Management System Continual Improvement R e q u i r e m e n t s S a t i s f a c t i o n Input Output The QMS Model
- 11. QMS-ISO9001:2008 Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization's policies Do: implement the processes Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results Act: take actions to continually improve process performance;" PDCA Cycle The Deming Cycle
- 12. QMS-ISO9001:2008 Process ProcessProcess ActivitiesActivities ++ ResourcesResources InputInput OutputOutput ControlsControls (e.g.procedure)(e.g.procedure) An activity using resources and managed in order to enable the transformation of input into outputs can be considered as process. ISO 9000:2000 clause 3.4.1 defines a "Process" as: "Set of interrelated or interacting activities which transforms inputs into outputs”
- 13. QMS-ISO9001:2008 Process Approach The application of a system of processes within organization, together with the identification and interactions of these processes and their management can be referred to as the “Process Approach” Processes - understand interactions ProcessProcess AA ProcessProcess DD ProcessProcess BB ProcessProcess CC InputInput OutputOutput ControlsControls
- 14. QMS-ISO9001:2008 Why Process Approach If processes are right Product/Service is supposed to be ‘right’ A desired result is achieved more efficiently when activities and related resources are managed as a process. Knowledge is input to Process and not output From Process Person Dependent to Process Driven Organization
- 15. QMS-ISO9001:2008 Process Integration Process Dimensions Proof of Process Performed Process Verification Process Validation Process Monitoring Process Owner Process Measurement
- 16. QMS-ISO9001:2008 Process Performance •Skill and Knowledge to Perform the Process •What is to be done (Procedure) •How it is to be done (Work Instruction) This is irrespective of Technology and Technicality of process, irrespective of infrastructure used, tools used. •Effectiveness of Process •Efficiency of Process Institutionalization of Processes Person is incidental to Organization Tools & Technology also should be incidental to Organization
- 17. QMS-ISO9001:2008 Effectiveness “producing or capable of producing desired effect” “extent to which planned activities are realized and planned results are achieved” Efficiency “Acting or Producing effectively with a minimum of waste, expense, or unnecessary effort” “Exhibiting high ratio of output to input” “relationship between the result achieved and the resources used” Effectiveness and Efficiency
- 18. QMS-ISO9001:2008 Better Product Quality • Cost Effectiveness • Transparency in operations • System dependent rather than person dependent Advantages to Employees • Simple Standard Instruction • Less blaming & finger pointing • Pride • Training to newcomers becomes easy • Enhance confidence of customer • Demonstrates company is committed to Quality •Less stress at work •Better work environment Advantages to Company
- 20. QMS-ISO9001:2008 •Apex Manual • Policy and Objectives •Mandatory Process Documentation •Business Process Documentation (What is to done) •Procedure Documentation (How it is to be Done) •Record Formats / Templates (Proof of Process Performed) •Training – Awareness, Internal Audit and MR •Implementation •Internal Audit •Management Review •Invite Certification Body for Initial Audit •Surveillance Audit •Re-Certification Audit QMS Certification Process
- 21. QMS-ISO9001:2008 SHANTIKRUPA ESTATES PVT LTD Icons Who Trusted us Hashmukh Shah Group Government Agencies UGC-AICTE-INFLIBNET-AMC Government Corporations GSFC-GIIC-GAIC-GIDC GHB Gujarat Housing Board
- 22. QMS-ISO9001:2008 Think Techknowlogically MSWH-new Generation ERP Technology KnowledgeLogic ownership SolutionTechnique Techknowlogical Quality Seekers are Too BUSY to be SAD Too POSITIVE to be DOUBTFUL Too OPTIMISTIC to be FEARFUL Too DETERMINED to be DEFEATED