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Minden Orientation To Iso[1]

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  • 1. ISO 9001:2008 QUALITY MANAGEMENT SYSTEM PRESENTED BY: Wendy Stein, International Contract Compliance Auditor
  • 2. QUALITY MANAGEMENT SYSTEM ORIENTATION & AWARENESS (QMS) QUALITY – Degree to which a set of inherent characteristics fulfils requirements* – *ANSI/ISO/ASQ Q9000-2008 Level to which the existing quality system satisfies our customer’s requirements The ability of a product or service to meet or exceed customer expectations 2 SOC Proprietary
  • 3. QUALITY MANAGEMENT SYSTEM ORIENTATION & AWARENESS (QMS) QUALITY ASSURANCE – The part of Quality Management that focuses on providing confidence that quality requirements will be fulfilled QUALITY CONTROL – The part of Quality Management that focuses on fulfilling quality requirements* 3 SOC Proprietary
  • 4. QUALITY MANAGEMENT SYSTEM ORIENTATION & AWARENESS (QMS)  PROACTIVE – PLANNING  PROVIDES FOR INSPECTION & MEASUREMENT  PREVENTATIVE IN NATURE WHERE DEFECTS AND/OR  AIMED AT DETECTING DEFICIENCIES ARE DEFECTS CONCERNED  IS A MEASURE OF THE  PROVIDES FOR SUCCESS OF QUALITY CUSTOMER SATISFACTION ASSURANCE (QA) 4 SOC Proprietary
  • 5. QUALITY MANAGEMENT SYSTEM ORIENTATION & AWARENESS (QMS)  Ensure YOUR Work is Accurate  Verify the Work of Your Co-Workers – ASK SOMEONE TO CHECK YOUR WORK TOO!  Do Not Accept Deviations from ESTABLISHED Written Procedures Without Communication – AND APPROVAL 5 SOC Proprietary
  • 6. QUALITY MANAGEMENT SYSTEM ORIENTATION & AWARENESS (QMS) The standards originated in manufacturing process Now they are employed across several types of organizations A quot;productquot;, in ISO vocabulary, can mean a physical object, OR a service 6 SOC Proprietary
  • 7. QUALITY MANAGEMENT SYSTEM ORIENTATION & AWARENESS (QMS) ISO – INTERNATIONAL STANDARDIZATION ORGANIZATION 9001-2008 - The latest revision to the Quality Management System Standard 7 SOC Proprietary
  • 8. QUALITY MANAGEMENT SYSTEM ORIENTATION & AWARENESS (QMS) A SYSTEMATIC approach to QM which emphasizes the importance of: Identification of Requirements, Understanding them and Meeting Our Goals The Need to Consider Processes in Terms of “IS THIS VALUE ADDED?” 8 SOC Proprietary
  • 9. QUALITY MANAGEMENT SYSTEM ORIENTATION & AWARENESS (QMS) Obtaining the Results of Process Performance & Effectiveness and Analyzing Your Findings (ROOT CAUSE) Continual Improvement of Processes Based on Objective Measurement & Evidence 9 SOC Proprietary
  • 10. QUALITY MANAGEMENT SYSTEM ORIENTATION & AWARENESS (QMS) QUALITY MANUAL – Written, Endorsed and Driven by the Management of SOC Minden that will state how we will achieve our business and quality goals & objectives. Quality Management IS NOT SEPARATE FROM General Management – Quality Management SHOULD be an integral part of our organizations overall management approach 10 SOC Proprietary
  • 11. QUALITY MANAGEMENT SYSTEM ORIENTATION & AWARENESS (QMS) SOC team members are committed to achieving and maintaining Total Customer Satisfaction by supplying the highest quality services, while maintaining commitment to our core values. Our success as an enterprise is a direct reflection of the promises we keep to our customers and their respect for SOC. We must first keep our promises to one another and demonstrate mutual respect to fellow team members, supply partners, and our customers. We willingly accept the responsibility of leadership to achieve our quality goals, which will be reached through innovation, education, teamwork, and the desire for continuous improvement. 11 SOC Proprietary
  • 12. QUALITY MANAGEMENT SYSTEM ORIENTATION & AWARENESS (QMS)  CONTROL OF DOCUMENTS  Controlling Documents ensures we utilize only current business practices and/or customer requirements  Includes both internally produced and externally obtained documents 12 SOC Proprietary
  • 13. QUALITY MANAGEMENT SYSTEM ORIENTATION & AWARENESS (QMS)  CONTROL OF RECORDS  Ensure Current Forms are Used  Ensure the SAME Forms is Used  Completed Forms become Records and are Retained to Provide Objective Evidence to the Customer – We are in fact doing what we say we are doing  Provides for objective evidence to ensure conformance to the standard 13 SOC Proprietary
  • 14. QUALITY MANAGEMENT SYSTEM ORIENTATION & AWARENESS (QMS)  CONTROL OF RECORDS FORM NUMBER TITLE OWNER E-1 Letter of Authorization Operations E-2 Travel Profile Human Resources E-3 Expense Reimbursement Request Financial Management 14 SOC Proprietary
  • 15. QUALITY MANAGEMENT SYSTEM ORIENTATION & AWARENESS (QMS)  A Document will change and evolve to reflect our current business practices  A Record does not change and is a history of our past business practices 15 SOC Proprietary
  • 16. QUALITY MANAGEMENT SYSTEM ORIENTATION & AWARENESS (QMS)  Both can and should be used to perform documented quality and performance trends  Compare our data to competitors’’ data and/or quality benchmarks  Both can be used to solve customer related problems & issues  Both support status reviews, decision making and long term planning initiatives 16 SOC Proprietary
  • 17. QUALITY MANAGEMENT SYSTEM ORIENTATION & AWARENESS (QMS)  CONTROL OF NON-CONFORMING PRODUCT/SERVICE – How do we react and intervene when our process doesn’t meet our own requirements or the requirements of the customer 17 SOC Proprietary
  • 18. QUALITY MANAGEMENT SYSTEM ORIENTATION & AWARENESS (QMS)  INTERNAL AUDITING & SELF ASSESSMENT – Looking into the way we conduct business from the inside, analyzing our processes to ensure we are doing things 18 SOC Proprietary
  • 19. QUALITY MANAGEMENT SYSTEM ORIENTATION & AWARENESS (QMS)  Ask Yourself & Others – “WHAT CAN GO WRONG?”  Then Write Your Process Plan (PROCEDURES) Accordingly 19 SOC Proprietary
  • 20. QUALITY MANAGEMENT SYSTEM ORIENTATION & AWARENESS (QMS) 1. IDENTIFY YOUR PROCESSES 2. INVOLVE ALL OF THE STAKEHOLDERS IN DEVELOPMENT 3. DOCUMENT YOUR PROCESSES 4. LISTEN TO YOUR CUSTOMERS AND IMPLEMENT CORRECTIVE &/OR PREVENTATIVE MEASURES ACCORDINGLY 20 SOC Proprietary
  • 21. QUALITY MANAGEMENT SYSTEM ORIENTATION & AWARENESS (QMS) INTERMEDIATE RESULT CAUSE • Error Detection Corrective Machine Work • Deviation from Action or Procedure Established Implementation Human Error Procedures END RESULT ZERO DEFECT MODIFY/CHANGE PROCEDURES ANALYZE ACTION FOR FOR PREVENTATIVE ACTION EFFECTIVENESS 21 SOC Proprietary
  • 22. QUALITY MANAGEMENT SYSTEM ORIENTATION & AWARENESS (QMS)  The design is too complex – too many parts (KISS METHOD)  The design is inadequate – Not enough direction in the written standards  The process does not flow logically  Too much repetition and/or too many adjustments  Critical mission essential information is left out  YOU do not know ENOUGH about the process in and of it’s self for a process you are attempting to document – call in the SME!! 22 SOC Proprietary
  • 23. QUALITY MANAGEMENT SYSTEM ORIENTATION & AWARENESS (QMS)  Question the Individuals involved in performing the actual work - then document the process accordingly  Keep in mind adjustments may need to be made to ensure compliance to customer/client requirements – BUT BE FLEXIBLE & CREATIVE in your problem solving – BUT BE SURE TO INCLUDE ALL OF THE PLAYERS. Cause Result ERROR DEFECT 23 SOC Proprietary
  • 24. QUALITY MANAGEMENT SYSTEM ORIENTATION & AWARENESS (QMS) Prevention of Defects Benchmark Pride, Confidence Performance and Personal Customer Standards Satisfaction Satisfaction Global Procedural and Enhanced Customer Recognition Regulatory Process Confidence Compliance Reliability Process Productivity Reduction in Ownership Process Wasted Effort Consistency 24 SOC Proprietary
  • 25. QUALITY MANAGEMENT SYSTEM ORIENTATION & AWARENESS (QMS) WHAT IS THE SCOPE OF REGISTRATION? • The Scope of Our Registration – Tells Our Customers Exactly What We are Good, GREAT at doing 25 SOC Proprietary