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9101:2009 RMC Workshop

9101:2009 RMC Workshop. Prepared by: Tony Marino 9101 Team Member July 31, 2009. Target. Situation Target Proposal. Situation.

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9101:2009 RMC Workshop

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  1. 9101:2009 RMC Workshop Prepared by: Tony Marino 9101 Team Member July 31, 2009

  2. Target Situation Target Proposal Situation • Provide requirements on process auditing and development of a 9100 series audit approaches and tools that has a focus on conformity and effectiveness of a Quality Management System (QMS). • Current mandatory use and completion of the 9101 Checklist drives undesirable results: • Inhibits process approach. • Focus of auditor becomes completing the checklist. • Time intensive. • Takes time away from actual auditing. • Not in alignment with ISO 17021 (Stage1 & 2) Proposal • Develop an enhanced audit process for evaluating process based management systems, including alignment with ISO 17021: • Process-based information gathering (Stage 1, Surveillance and/or Re-Certification). • Stage 1 Assessment/Analysis and Audit Planning (Stage 2, Surveillance and Re-Certification). • Development of a performance-based, process-oriented audit methods and techniques. • Capture objective evidence of process conformity and effectiveness.

  3. 9101 Major Changes • One document covering 9100/9110/9120 standards. • Elimination of “Scoring” and “Key Requirements” designation. • Use of Customer feedback concerning QMS Organization performance as an input for process oriented audits (e.g., OASIS, customer satisfaction/performance scores). • In addition to conformity, also determination of Effectivenessincluded. • More emphasis on performance measuring. • Use of the Objective Evidence Record or CB equivalent.

  4. What has not Changed • Determining conformity to the standard's. • Nonconformity’s discovered during the audit are to be documented. • Based on information collected during the audit, the auditor will have to draw conclusions on conformity and effectiveness of the organizations quality management system.

  5. Process-Based Auditing Development Model for Process Based Auditing - 9101 Process Approach Audit Records Tools Evidence of conformity Evidence of Effectiveness Inputs Output Core, Support & Management Processes Effectiveness Focused

  6. What is the Effectiveness of YourOrganization? • Planned activities are not realized and desired results not achieved – Is this Effective? • Planned activities are not realized but desired results achieved – is this is this Effective? • Planned activities are realized but desired results not achieved – is this Effective? • Planned activities are realized and desired results achieved – is this Effective?

  7. What is Effectiveness? Extent to which planned activities are realized and planned results achieved (Reference ISO 9000Quality management systems – Fundamentals and Vocabulary)

  8. What will this Mean to the Organization? The QMS Organization should be able to… • Demonstrate conformity of the QMS Organization to the standard. • Show process definition (identified, sequence and interaction). • Explain process measures identified: • Who reviews the data? • Targets defined? • Targets are met? • Are the measures actionable? • How is the data used? • Show actions taken when product quality and on-time delivery performance targets are not met. The ultimate measure of QMS Organizational effectiveness – Customer satisfaction

  9. The Gains • Emphasizes process approach with organizations, as well as audit. • Shifts energies from completing the questionnaires to determining and documenting conformity and effectiveness of processes. • Provides useful information to stakeholders concerning process performance and history.

  10. 9101 Release Schedule Dependent on Ballot outcome Jan., 2009 June 8, 2009 June 23-25, 2009 Sept 11 Apr. 8, 2009 Aug. 11 Apr. 20, 2009 Ballot Close Team Meeting Seattle WA. Ballot Close Ballot Start IAQG Phoenix 9100:2009 Publication 9101 IAQG Ballot start New 9101 Publication

  11. Questions

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