AS9104/1 Transition and Oversight Assessment of Accreditation Bodies Tim Lee 12 March 2012

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

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

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?

Assessing AB AS9104/1 Transition 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?

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Hierarchy of Requirements Reminder Hierarchy of Requirements 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) Increasing Precedence

Oversight of ABs: Reminder 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

Oversight of ABs (AS9104/2): 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

AB Assessment: Reminder 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

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

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

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

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

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