ISO/IEC 17020:2012 Inspection Standard Application Document

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ISO/IEC 17020:2012 Inspection StandardApplication DocumentJune 2013

Copyright National Association of Testing Authorities, Australia 2013This publication is protected by copyright under the Commonwealth of AustraliaCopyright Act 1968.NATA’s accredited facilities or facilities seeking accreditation may use or copy thispublication or print or email this publication internally for accreditation purposes.Individuals may store a copy of this publication for private non-commercial use orcopy a reasonable portion of this publication in accordance with the fair dealingprovisions in Part III Division 3 of the Copyright Act 1968.You must include this copyright notice in its complete form if you make a copy of thispublication.Apart from these permitted uses, you must not modify, copy, reproduce, republish,frame, upload to a third party, store in a retrieval system, post, transmit or distributethis content in any way or any form or by any means without express written authorityfrom NATA.

ISO/IEC 17020:2012 Inspection Standard Application DocumentContentsISO/IEC 17020 Inspection Standard Application Document . 5Foreword . 5Introduction (Informative) . 6Basis of the Guidance . 64 General Requirements . 64.1 Impartiality and Independence . 64.2 Confidentiality . 85 Structural Requirements . 85.1 Administrative requirements . 85.2 Organisation and management . 86 Resource requirements. 96.1 Personnel . 9Staff competence. 9Management of Inspector and staff competence . 9Loss of staff . 10Corporate accreditations . 106.2 Facilities and equipment. 116.3 Subcontracting . 147 Process Requirements. 147.1 Inspection methods and procedures . 147.2 Handing inspection items and samples . 157.3 Inspection records . 15Record modification . 167.4 Inspection reports and inspection certificates . 167.4.2Inspection reports – content . 16Opinions . 18Use of client’s forms . 18Progress reports . 187.5 Complaints and appeals . 188 Management system requirements . 198.1 Options . 198.2 Management system documentation (Option A) . 208.3 Control of documents (Option A) . 218.4 Control of records (Option A) . 218.6 Internal audits (Option A) . 21Appendix A: Independence Requirements. 22June 2013Page 3 of 31

ISO/IEC 17020:2012 Inspection Standard Application DocumentAnnex A1 Requirements for inspection bodies (Type A) . 22Annex A2 Requirements for inspection bodies (Type B) . 22Annex A3 Requirements for inspection bodies (Type C) . 22Appendix B: Application to Modelling . 23Process background. 23Personnel (6.1) . 23Facilities and equipment (6.2) . 24Computers (6.2.13) . 24Inspection methods and procedures (7.1) . 24Choice of model . 24Selection of parameters . 25Relevance of data (7.1.6) . 25Output constraints . 25Iterations . 25Confirmatory testing . 25Records (7.3) . 26Inspection reports and inspection certificates (7.4) . 26Appendix C: Monitoring inspectors and assuring the quality of inspections . 27Introduction . 27Proficiency testing and inspection bodies. 27Quality assurance activities for inspection bodies . 27Implications for inspection bodies . 29References . 30Standards . 30APLAC Documents . 30ILAC and IAF Documents. 30NATA Publications . 30Amendment Table . 31June 2013Page 4 of 31

ISO/IEC 17020:2012 Inspection Standard Application DocumentISO/IEC 17020:2012 Inspection Standard ApplicationDocumentForewordThis document was mainly derived from the NATA Inspection Field ApplicationDocument (FAD) 2011 which was in turn derived from IAF/ILAC A4. It has beenmodified in line with the sources and influences in the development of ISO/IEC17020:2012. In line with NATA’s program for implementation of ISO/IEC17020:2012 as detailed in NATA Policy Circular 44, this document comes intoapplication from 1 July 2013.The requirements text of ISO/IEC 17020:1998 was the starting point for therequirements detailed in ISO/IEC 17020:2012, and the text was then: Modified in structure in accordance with ISO PAS documents that wereendorsed by CASCO; Modified in content in accordance with ISO PAS documents to ensurethat all conformity assessment (ISO/IEC 17000 series) standards hadidentical requirements where these are associated with commonelements of operation (e.g., independence, impartiality, managementsystems etc.); Additional requirements of IAF/ILAC A4 were included; Additional definitions were drawn from ISO/IEC 17000:2004 and ISO9000:2005; A thorough revision by the committee to incorporate experiences andinterpretations from operation to the 1998 document and to reflectcurrent expressions, arrangements and practices.In developing this application document the text of IAF/ILAC A4 was arrangedto the current structure and reconciled against clause numbers. Text that wasadopted in the 2012 edition of ISO/IEC 17020 was deleted, as was text thatbecame redundant due to clarifications in the requirements of the 2012standard.Additional gaps between the requirements of ISO 9001 and ISO/IEC17020:2012 have been identified and documented.The NATA Policy Circular that is relevant to Inspection relating to ProficiencyTesting has been included as an Appendix.ISO/IEC 17020:2012 is the first of the ISO/IEC 17000 series of standards to usethe PAS text, however ISO/IEC 17024:2004 uses similar text and so the IAF GD24 document that provides guidance to ISO/IEC 17024 was reviewed forpossible guidance relating to the relevant clauses.Please note that although the term “requirement” remains applicable to ISO andISO/IEC standards, NATA uses the term “criteria” to describe mandatorystatements.June 2013Page 5 of 31

ISO/IEC 17020:2012 Inspection Standard Application DocumentIntroduction (Informative)These criteria detail general principles of good inspection practice. Someclauses may not be relevant to particular industry groups or to small (e.g. oneperson) operations.There are many types of inspection activities that can be conducted. Theseinclude activities such as design verification, fabrication inspection, productinspection, installation inspection, commissioning inspection, in-serviceinspection, expediting, witnessing, consignment verification, quantity surveying,modelling and classification inspection. Inspection of processes includespersonnel, facilities, technology and methodology. Interested parties arereferred to the guidance documents identified in the opening paragraphs to thissection.Professional judgement is understood to entail decision making that issupported by a body of rigorous and objective analysis.Identification of what is inspected and where in the process professionaljudgement is exercised, enables inspection activities to be discriminated fromother activities, such as product approval schemes or personnel licensingsystems.Basis of the GuidanceThis section provides interpretation of the application of ISO/IEC 17020 thatapplicant and accredited facilities must comply with. The clause numbers in thissection follow those of ISO/IEC 17020 but, since not all clauses requireinterpretation, the numbering may not be consecutive.With the publication of ISO/IEC 17020:2012, requirements that were detailed inIAF/ILAC A4:2004 have been taken into the standard in whole or in a modifiedform. This document reflects the elements of IAF/ILAC A4 Guidance on theApplication of ISO/IEC 17020 and APLAC TC 006 Guidance notes on ISO/IEC17020 that were not taken into the 2012 edition, further modified by NATA’saccreditation criteria and assessment experience. At the time of publicationILAC is in the process of developing a guidance document on the application of17020:2012, however this document is still in draft form. As the status anddetailed content of the draft ILAC document was not confirmed at the time ofrelease, NATA has determined to implement ISO/IEC 17020 using thisguidance so as to meet the ILAC deadline for implementation of the standard,set at March 2015.4 General Requirements4.1 Impartiality and Independence4.1.2a) Where an inspection body is a legal entity which is itself part of a largerorganisation it should be able to demonstrate that no conflict of interest exists.Relevant information on activities performed by the other parts of the largerorganisation should be maintained up to date.b) Guidance should be provided, indicating to staff expected behaviours insituations where undue pressure is applied.June 2013Page 6 of 31

ISO/IEC 17020:2012 Inspection Standard Application Documentc)Records of situations where undue pressure (from any source) has beenapplied to inspectors should be kept.d)Requirements relating to impartiality are also applicable to subcontractors(See clause 6.1.12)4.1.3a) Inspection bodies should be able to demonstrate how they manage theirbusiness and any other activities so as to eliminate actual conflict of interestand minimize any identified risk to impartiality. This should cover all potentials

ISO/IEC 17020:2012 is the first of the ISO/IEC 17000 series of standards to use the PAS text, however ISO/IEC 17024:2004 uses similar text and so the IAF GD 24 document that provides guidance to ISO/IEC 17024 was reviewed for possible guidance relating to the relevant clauses.