Company Confidential 1

AS9104/1 Transition andOversight Assessment of

Accreditation Bodies

Tim Lee12 March 2012

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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

• 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

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Introducing AS9104/1 Section 16

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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?

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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?

Exercise

Questions?

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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)

Increasin

g

Preced

ence

Reminder

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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

Reminder

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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

Reminder

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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

Reminder

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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

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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

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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

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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

Questions?

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