AS9104/1 Transition and Oversight Assessment of Accreditation Bodies

1. AS9104/1 Transition andOversight Assessment ofAccreditation Bodies Tim Lee 12 March 2012

2. Introducing AS9104/1 Section 5 • AS9104/1 section 5 contains requirements for Accreditation Bodies (ABs) • Section 5 split into some main areas: • General requirements (5.1) • Organisational requirements for ABs (5.2) • Quality Management System requirements (5.3) • Long clause with 11 sub-clauses • Accreditation Body Personnel requirements (5.4) • Take 15 mins and read AS9104/1 section 5 • Any questions

3. Introducing AS9104/1 Section 16 • AS9104/1 section 16 contains requirements for ABs and the SMS regarding cross frontier oversight assessment • Cross frontier means conducting oversight on CBs operating in countries other than the home country in which the AB accreditation or CB lead office is located • Please take 5 minutes and read: • Sections 16.2 to 16.4: Requirements for when an AB wishes to subcontract assessment to another AB • Sections 16.5 to 16.8: Requirements for when an RMC makes a decision to coordinate an OP assessment to another SMS / CBMC

4. AS9104/1 Transition for ABs • Turn to SR-002 clause 2.5: • Read what is required for AS9104/1 transition • Question: What is required? • Office Assessment ? • Witnessed Assessment ? • Any Assessment?

5. Exercise Assessing AB AS9104/1 Transition • In groups: • Look at AS9104/1 section 5 and SR-002 • On your flip charts and individual sheets, make a list answering the question • What requires to be assessed?

6. Questions?

7. Reminder Hierarchy of Requirements Increasing Precedence • Approval of ABs to perform accreditations of CBs includes: • ISO 17011:2004 • IAF membership • In Europe EA MLA signatory • In addition the ICOP process adds: • IAF MLA signatory • For 91XX:2009 – 9101 Rev D requirements • 9104 series (AS9104/1, AS9104/2 & AS9104/3) • IAQG OPMT Supplemental Rules • ICOP Resolutions (IAQG and EAQG OPMT)

8. Reminder Oversight of ABs: • Oversight of Accreditation Bodies (ABs) is described in AS9104/2 clause 8 • AB Oversight is conducted by industry only OP Assessor oversight • AS9104/2 requires that oversight of each AB each year comprising a minimum of one each of : • AB Office Assessment (8.3.2) • AB Witness Assessment (8.2) • Oversight of ABs is essentially the same processes that as when assessing a CB

9. Reminder Oversight of ABs (AS9104/2): • AB Office Assessment (8.3.2) includes: • A review of AB activity to ensure conformance with EN 9104 and applicable industry standards (ISO 17011) • Verification that the AB has a letter of recognition from their respective SMS or CBMC • A review of the last IAF peer evaluation • Review of the last AB oversight office assessment reports, including actions taken • AB Witness Assessment (8.2) assesses: • Team competence • Conformity to established requirements • The effectiveness of the audit program • Conformity of the audit team with the AB procedures and processes

10. Reminder AB Assessment: • OP Assessor Requires: • EN AS9104/2 Forms • Annex K - Oversight Assessment Summary Report • Annex J – Oversight Nonconformity Record • Annex E - AB Office Assessment Check Sheet • Annex G - AB Witness Assessment Check Sheet • Standards and Reference Documents: • EN 9104 series (9104, AS9104/1, AS9104/2, AS9104/3) • ISO / IEC 17011 and ISO / IEC 17021 • IAF Mandatory Documents 1 to 5 inclusive • IAQG Supplemental Rules (e.g. SR 001, SR 002) • IAQG and EAQG OPMT Resolutions Log • Audit Plan • Copy of previous assessment and oversight reports including verification evidence for any nonconformities

11. AS9104/2 Check sheets: Annex E & G • The AS9104/2 check sheets are out of date • They will be updated by the IAQG OPMT • Unlikely to be available until 30th March 2012 • Until then, use the existing checklists • Recommended that, if possible, oversight be delayed until new checklists are available and AS9104/1 is implemented • If you need to conduct oversight: • Be very cautious with requirements • Is the oversight to 9104:2006 or AS9104/1? • If needed for AS9104/1 oversight, amend the check sheet to reflect AS9104/1 requirements

12. AS9104/2 Annex E Check Sheet: • AB Office Assessment Check Sheet: • Use the check sheet with caution • Know your check sheet: • Refers to 9104 without the underlying 17011 references • No references to AS9104/1 - if needed amend the check sheet to reflect AS9104/1 requirements • Not all questions are fully accurate • Split into two sections – management system and accreditation process • Use of a check sheet is mandatory but you can change it – it is guidance

13. AS9104/2 Annex G Check Sheet: • AB Witness Assessment Check Sheet: • Use the check sheet with caution • Know your check sheet: • Common check sheet with CB Witness Assessment • Know which questions refer to AB and which to CB • Refers to ISO / IEC Guide 61 which is obsolete – do you know the ISO 17011 references? • Refers to 9104 without the underlying 17011 references • No references to AS9104/1 - if needed amend the check sheet to reflect AS9104/1 requirements • Not all references are accurate • Use of a check sheet is mandatory but you can change it – it is guidance

14. AS9104/1 Transition and Oversight: • Remember: • No specific assessment activity required for AB AS9104/1 transition, but • Must assure each AB has: • Updated its management system in accordance with AS9104/1 and SR-002 • A documented and implemented a risk mitigation plan • Don’t forget to check that the AB has implemented all the competence requirements • The RMC must approve the AB before the AB can transition CBs • Oversight may be more effective after transition to AS9104/1

15. Questions?