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

2. Situation Target Proposal
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 (Stage1 & 2)
Provide requirements on process auditing and development of a series audit approaches and tools that has a focus on conformity and effectiveness of a Quality Management System (QMS).
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 Effectiveness included.
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. Development Model for Process Based Auditing - 9101
Process Approach
Audit
Records
Tools
Process-Based Auditing
Evidence of conformity
Evidence of Effectiveness
Inputs
Output
Core, Support & Management
Processes
Effectiveness Focused

6. What is the Effectiveness of Your Organization?
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 9000 Quality 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 Apr. 8,
June 8,
2009
June 23-25,
2009
Aug. 11
Sept 11
9100:2009
Publication
9101
IAQG Ballot
start
IAQG
Phoenix
Ballot
Close
Team
Meeting
Seattle WA.
Ballot
Start
Ballot
Close
New 9101
Publication

11. Questions