1. Agenda Why this group exists Who is behind it
State of the ISO 9000 Certification Industry and lessons learned from the Transition
“New” ISO Documents
Official ISO/TC-176 interpretations
Not so official guidance documents
The ELSMAR Forum
Free for all

2. Why this group exists?
To spread knowledge on Management System Standards, in So Cal.
Remember, So-Cal is a POWERHOUSE. We are the strongest economic area of the 5th largest Economy in the World.

3. Who is behind it?
Me and
You

4. The current state of affairs
Generally speaking the ISO 9000 Certification Sector is still strong
Reduced rate of new Registrations
High % of organizations MADE the transition; ≥ 90%
Market is very fragmented and diverse for both Consulting and Certification
Accreditation Bodies also under pressure and promise tougher policing

5. Lessons from the transition
Most misunderstood and ineffectively implemented sections are:
4.1 Outsourced processes
5.4.1 Quality objectives for all relevant functions and levels
8.2.3 Monitoring and measurement of processes

6. “New” ISO Documents

7. Official ISO TC 176 interpretations

8. Official ISO TC 176 interpretations

9. RFI’s

10. RFI’s

11. RFI’s

12. RFI’s

13. RFI’s

14. RFI’s

15. RFI’s

16. RFI’s

17. RFI’s

18. RFI’s

19. RFI’s

20. RFI’s

21. RFI’s

22. RFI’s

23. Not so official Guidance

24. Not so official Guidance
The need for a 2-stage approach to auditing
Measuring QMS effectiveness and improvements
Identification of processes
Understanding the process approach
Determination of the “where appropriate”
Auditing the “where appropriate” requirements
Demonstrating conformity to the standard
Linking an audit of a particular task, activity or process to the overall system
     

25. Not so official Guidance
Auditing continual improvement
Auditing a QMS which has minimum documentation
How to audit top management processes
The role and value of the audit checklist 
Scope of ISO 9001:2000, Scope of Quality Management System and Defining Scope of Certification
Value-added auditing
Auditing competence and the effectiveness of actions taken

26. The need for a 2-stage approach to auditing
Activities performed at a preliminary 1st stage audit include:
Identification of the key risks of the business and related statutory, regulatory aspects and compliance
An assessment of whether the auditee's defined processes are adequate to meet its objectives and customer requirements
Conducting a Documentation Review
Drafting the future certification documentation, including the Scope statement
Planning the certification (stage 2) audit, including the requirements for audit team selection

27. The need for a 2-stage approach to auditing
Obtaining evidence that internal audits and management reviews are being planned, or performed, effectively
Checking that the QMS is implemented and ready for the stage 2 audit, including appropriate level of documents and supporting records.
If the system is lacking in any way, the auditor should note this in the audit report, so that the organisation has an opportunity to rectify deficiencies prior to its certification (2nd stage) audit.
Agreeing a date for the stage 2 audit

28. Value Added Audits A “value-added third-party audit” should be useful:
to the certified organization
by providing information to top management regarding the organization’s ability to meet strategic objectives
by identifying problems which, if resolved, will enhance the organization’s performance.
by identifying improvement opportunities and possible areas of risk
to the organization’s customers by enhancing the organization’s ability to provide conforming product
to the certification body, by improving the credibility of the third party certification process.

29. Value Added Audits
Understand the auditee’s expectations/corporate culture
Any specific concerns to be addressed (output from previous audits)?
Risk analysis of industry sector / specific to organization.
Pre-evaluation of statutory/regulatory requirements
Appropriate audit team selection to achieve audit objectives
Adequate time allocation

30. Value Added Audits

31. Use of checklists Conclusion
There are advantages and disadvantages in using audit checklists. It depends on many factors, including customer needs, time and cost restraints, auditor experience and sector scheme requirements. Auditors should assess the value of the checklist as an aid in audit process and consider its use as a functional tool.

32. The ELSMAR website