1. IAQG 9101:2009 Revision IAQG General Assembly Munich, 15 Oct. 2009
Hans Luijt
9101 Team Leader

2. 9101 Revision Target
Define an enhanced audit process for evaluating “process based management systems” :
Definition of the audit process phases with assessment/analysis and audit planning (Pre-audit, Stage 1, Stage 2, Surveillance, Re-Certification)
Development of 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.
Introduction of a new Objective Evidence Record.

4. 9101 Major Changes
Introduction in the audit report of a new “Objective Evidence Record” OER which records :
the documents reviewed during the audit
the observations, opportunities for improvement

5. 9101 Major Changes
Introduction in the audit report of a “Process Effectiveness Assessment Report” Form (PEAR) which :
States on a 4 effectiveness levels,
if processes are defined and implemented, planned results are achieved and appropriate, actions are taken
Give objective evidence, observed conditions, data, and comments to support effectiveness determination.

6. What has not changed Determining conformity to the standard's.
Nonconformities 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.

7. 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

8. 9101 Publication : 9101 final for publication ready : November 2009
Deployment support materials :
Press Release, FAQs, Overview of changes Nov 2009
Examples of PEAR cases + filled-in Forms Dec 2009 & Rationale document (reasons for changes)
Guidance for auditors : Jan (what to look for, what to ask for)

9. Effectiveness of your organization
What is effectivess?
Is your company effective?
How do you determine effectiveness?

10. What is the Effectiveness of Your Organization?
ISO 9000: Extent to which planned activities are realized and planned results achieved (Reference ISO 9000Quality management systems –Fundamentals and
Vocabulary)
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?

11. What will this mean to You?
Your QMS Organization should be able to…:
Demonstrate conformity of the QMS Organization to the standard.
Show process determination (identified, sequence and interaction).
Explain process measures identified:
Targets defined?
Who reviews the data?
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 ?
Ouput Performance driven!
Customer satisfaction

12. Questions ??????