Checklist ISO/IEC 17021: 2006. Conformity assessment ... - Sanas

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ISO/IEC 17021 Requirement CB’s References COMMENT BY ASSESSORcustomer organization, the scope and complexity ofits management system, products and processes aswell as demonstrated level of management systemeffectiveness and the results of any previous audits?Where a CB is taking account of certification or otheraudits already granted to the customer, does it collectsufficient, verifiable information to justify and recordany adjustments to the audit programme?F 155-029.1.2 Is an audit plan established for each audit to providethe basis for agreement regarding the conduct andscheduling of the audit activities? Audit plan drawnup in accordance with the relevant guidanceprovided in ISO 19011?9.1.3 Process in place for selecting and appointing theaudit team taking into account the competenceneeded to achieve the objectives of the audit?Process in accordance with the relevant guidanceprovided in ISO 19011?9.1.4 Does the CB have documented procedures fordetermining audit time?Does the procedure include or make reference to therelevant Annexes in the IAF GD2 and GD6documents?Note: Guidance in respect of multi-sites remains applicableeven if it appears in the main body of the guidancedocument until such time that specific IAF ApplicationGuidance is publishedIs the audit time determined by the CB, and thejustification for the determination, recorded?In determining the audit time, does the CB consider,among other things, the following aspects:a) the requirements of the management systemstandard?b) size and complexity?c) technological and regulatory context?d) Any outsourcing?e) The results of any prior audits?f) number of sites and multi-site considerations?.2008-07-25 ©SANAS Page 14 of 34
ISO/IEC 17021 Requirement CB’s References COMMENT BY ASSESSOR9.1.5 Where multi-site sampling is utilized, did the CBdevelop an adequate sampling programme to ensureproper audit of the management system?Is the rationale for the sampling plan documented?(IAF guidance applies)F 155-029.1.6 Are the tasks given to the audit team defined andmade known to the customer? Does the audit team:a) examine and verify the structure, policies, processes,procedures, records and related documents of thecustomer organization relevant to the managementsystem?b) determine that these meet all the requirementsrelevant to the intended scope of certification?c) determine that the processes and procedures areestablished, implemented and maintained effectively,to provide a basis for confidence in the customermanagement system, and?d) communicate to the customer, for its action, anyinconsistencies between the customer’s policy,objectives and targets and the results?9.1.7 Does the CB provide the name and, whenrequested, make available background information ofeach member of the audit team, with sufficient timefor the customer organization to object to theappointment of any particular auditor or technicalexpert and for the CB to reconstitute the team inresponse to any valid objection?9.1.8 Is the audit plan communicated and the dates of theaudit agreed upon, in advance, with the customerorganization?9.1.9 Does the CB have a process for conducting on-siteaudits defined in documented requirements drawnup in accordance with the relevant guidanceprovided in ISO 19011? See Notes9.1.10 Does the CB provide a written report for each audit?Is the report based on relevant guidance provided inISO 19011?2008-07-25 ©SANAS Page 15 of 34
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Checklist ISO/IEC 17021: 2006. Conformity assessment ... - Sanas

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