1. ISO 9001: 2000 Certified Auditing Methods What is evidence?

2. Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07 2 ISO 9001: 2000 Certified Module Overview Outline basic audit definitions Needs for sampling while conducting audits Introduction of methods for collecting evidence Auditing of Documents and Records

3. Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07 3 ISO 9001: 2000 Certified Audit Criteria –Set of requirements that must be adhered to Policy Procedure Program Requirement Contract Regulation Audit Definitions

4. Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07 4 ISO 9001: 2000 Certified Audit Evidence –Items used to verify that audit criteria are being met or not –Appropriate audit evidence indicates conformance or non-conformance Records Interviews Observation Measurement Audit Definitions

5. Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07 5 ISO 9001: 2000 Certified Audit finding: conformance/non-conformance –Compare audit evidence to criteria/ requirements and generate an audit finding –Review conclusions with auditees to affirm accuracy of your findings –Resolve diverging opinions and record unresolved points Audit Definitions

6. Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07 6 ISO 9001: 2000 Certified Methods of Finding Evidence Observing Interviewing ListeningListening Reviewing –Documents & Records

7. Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07 7 ISO 9001: 2000 Certified Used when criteria and evidence pool is large –Statistical significance is not needed –Sample requirements: Like Random Sampling

8. Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07 8 ISO 9001: 2000 Certified Validus Sampling Types Field Samples Building Samples Animal Samples Interview Samples Document/Record Samples Other?

9. Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07 9 ISO 9001: 2000 Certified Observations Work area Records/Documents Present Conditions Process Equipment Use, Storage, Handling Animals

10. Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07 10 ISO 9001: 2000 Certified Interviews Questioning Techniques Questions that always work: How do you know to do that? Could you show me! What if…

11. Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07 11 ISO 9001: 2000 Certified Observation/Interview Audit Tips Check an employee’s awareness of WI Ask where they could find WI if needed Verify the process they are doing matches what is written in the version of the WI you have View any completed records (if referenced)

12. Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07 12 ISO 9001: 2000 Certified Auditing Documents/Records Documents to meet standard Records to meet documents Documents and Records that meet processes

13. Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07 13 ISO 9001: 2000 Certified Doc Review for Std. Conformance Process Locate each requirement in the standard or checklist Locate the part of the document that meets each requirement Check version information as needed

14. Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07 14 ISO 9001: 2000 Certified Document Review for Company Conformance Procedures not required Work Instructions Relevant Forms

15. Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07 15 ISO 9001: 2000 Certified Doc Review for Company Conformance Process Complete a careful review of each sentence for Audit point(s) Look for action statements Look for terms: always, everyone, all Do the entire document Ask/Write individual questions for each Audit point

16. Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07 16 ISO 9001: 2000 Certified Are Recs used correctly during the process? Ask to see docs/recs they are using Are records complete/dated/initialed Are records referenced in written procedures When done - where the records go Who keeps completed records Where do employees get a new copy of the record form

17. Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07 17 ISO 9001: 2000 Certified Note Taking for Evidence Document Name – Date – Wording Issues Position Title – Process Observing Observation Location - # times occurred

18. Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07 18 ISO 9001: 2000 Certified Following the audit trail… Audit trails are items that lead you to a requirement but were either: –Not the intention of your original verification plan –Open up a door to more clearly verify and document evidence on the verification plan that you intended Need to be used to determine you are writing the correct non-conformity

19. Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07 19 ISO 9001: 2000 Certified Summary Sampling methods are very important to creditability and repeatability Listening is a technique that is needed that no one can teach Good note taking is a must if defendable non-conformances are to be written ISO 9001: 2000 Certified

20. Copyright 2005, Validus Services, LLC. All rights reserved. Revision 05/15/07 20 ISO 9001: 2000 Certified Questions?