Application Of ISO/IEC 17020:2012 For The Accreditation Of .

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Application of ISO/IEC 17020:2012 forthe Accreditation of Inspection BodiesILAC-P15:06/2014

ILAC – International Laboratory Accreditation CooperationILAC is the international authority on laboratory and inspection body accreditation, with a membershipconsisting of accreditation bodies and stakeholder organisations throughout the world.ILAC provides the infrastructure that supports the world-wide demonstration of competence andequivalence of testing (including medical) and calibration laboratories, inspection bodies and other typesof bodies serving or supporting laboratories and inspection bodies through accreditation. Accreditation oflaboratories and inspection bodies supports activities within and between economies including trade,protection of health, safety and the environment for the public benefit. Its fundamental purpose is toprovide confidence in the competence of bodies supporting these activities.The ILAC Arrangement is an international, multilateral mutual recognition arrangement for accreditationbodies. Participating accreditation bodies agree to promote acceptance of the equivalence of calibration,test and inspection reports produced by accredited facilities. Each accreditation body undergoes peerevaluation according to ILAC rules and procedures prior to becoming a signatory to the ILACArrangement.ILAC values the critical complementary and supportive activities of its Regional Cooperation Bodymembers in the realisation of its vision, mission, goals and associated strategies. The RegionalCooperation Body members through the implementation of their multilateral mutual recognitionarrangements provide all of the peer evaluation resources and much of the technical inputs to ILACdocuments. Copyright ILAC 2014ILAC encourages the authorised reproduction of its publications, or parts thereof, by organisations wishingto use such material for areas related to education, standardisation, accreditation, or other purposesrelevant to ILAC’s area of expertise or endeavour. The document in which the reproduced materialappears must contain a statement acknowledging ILAC’s contribution to the document.Organisations seeking permission to reproduce material from ILAC publications must contact the ILACChair or Secretariat in writing for example via email. The request for permission should clearly detail:1)2)3)4)the ILAC publication, or part thereof, for which permission is sought;where the reproduced material will appear and what it will be used for;whether the document containing the ILAC material will be distributed commercially, where it willbe distributed or sold, and what quantities will be involved;any other background information that may assist ILAC to grant permission.ILAC’s permission to reproduce its material only extends as far as detailed in the original request. Anyvariation to the stated use of the ILAC material must be notified in advance in writing to ILAC foradditional permission.ILAC reserves the right to refuse permission without disclosing the reasons for such refusal. ILAC shallnot be held liable for any use of its material in another document.Any breach of the above permission to reproduce or any unauthorised use of ILAC material is strictlyprohibited and may result in legal action.To obtain permission or for further assistance, please contact:The ILAC SecretariatPO Box 7507Silverwater NSW 2128AustraliaPhone: 61 2 9736 8374Email: ilac@nata.com.au Website: www.ilac.org

ILAC P15:06/2014Application of ISO/IEC 17020:2012 for the Accreditation of Inspection BodiesLIST OF CONTENTS1.INTRODUCTION . 42.AUTHORSHIP . 43.IMPLEMENTATION. 44.TERMINOLOGY. 45.APPLICATIONS OF ISO/IEC 17020:2012 . 5Terms and definitions. 5General requirements – Impartiality and independence . 5Structural requirements – Administrative requirements . 5Structural requirements – Organisation and management . 6Resource requirements – Personnel. 6Resource requirements – Facilities and equipment. 8Resource requirements – Subcontracting . 10Process requirements - Inspection methods and procedures . 10Process requirements - Inspection records . 11Process requirements - Inspection reports and inspection certificates. 11Management system requirements – Options . 11Management system requirements – Management system documentation (Option A). 12Management system requirements – Control of records (Option A) . 12Management system requirements – Management review (Option A) . 12Management system requirements – Internal audits (option A). 12Management system requirements – Preventive actions (Option A) . 13Annex A Independence requirements for inspection bodies . 136.REFERENCES . 14Page 3 of 13

ILAC P15:06/2014Application of ISO/IEC 17020:2012 for the Accreditation of Inspection Bodies1.INTRODUCTIONThis document provides information for the application of ISO/IEC 17020:2012Conformity assessment – Requirements for the operation of various types of bodiesperforming inspection for the accreditation of inspection bodies. It is intended to be usedby accreditation bodies assessing inspection bodies for accreditation as well as byinspection bodies seeking to manage their operations in a manner fulfilling therequirements for accreditation.For ease of reference, each application note is identified by the relevant clause number ofISO/IEC 17020 and an appropriate suffix, e.g. 4.1.4a would be the first application noteon the requirements of clause 4.1.4 of the standard.The term “shall” is used throughout this document to indicate those provisions which,reflecting the requirements of ISO/IEC17020, or in a few cases requirements for theoperation of accreditation bodies in ISO/IEC 17011, are considered to be mandatory.The term “should” is used throughout this document to indicate those provisions which,although not mandatory, are provided by ILAC as a recognized means of meeting therequirements. The term “may” is used to indicate something which is permitted. The term“can” is used to indicate a possibility or a capability. Inspection bodies whose systems donot follow the “should” guidance in this ILAC document will only be eligible foraccreditation if they can demonstrate to the accreditation body that their solutions meetthe relevant clause of ISO/IEC 17020 in an equivalent or better way.Individual inspection schemes may specify additional requirements for accreditation. Thisdocument does not try to identify what such requirements may be or how they shall beimplemented.When using ISO/IEC 17020 and this application document the accreditation bodiesshould neither add to, nor subtract from, the requirements in ISO/IEC 17020. Note,however, that accreditation bodies must still fulfill the requirements of ISO/IEC 17011.2.AUTHORSHIPThis publication was prepared by the ILAC Inspection Committee (IC) and endorsed forpublication following a successful ballot of the ILAC voting membership in 2014.3.IMPLEMENTATIONIn order to comply with the provisions of IAF/ILAC A2 clause 2.1.1, signatories to theILAC MRA shall implement this document within 18 months from the date ofpublication.4.TERMINOLOGYFor the purposes of this document the terms and definitions given in ISO/IEC 17000 andISO/IEC 17020 apply.Page 4 of 14

ILAC P15:06/2014Application of ISO/IEC 17020:2012 for the Accreditation of Inspection Bodies5.APPLICATIONS OF ISO/IEC 17020:2012Terms and definitions3.1aThe term “installation” may be defined as “a collection of componentsassembled to jointly achieve a purpose not achievable by the componentsseparately”.General requirements – Impartiality and independence4.1.3aRisks to the impartiality of the inspection body shall be considered wheneverevents occur which might have a bearing on the impartiality of the inspectionbody or its personnel.4.1.3bThe inspection body should describe any relationships that could affect itsimpartiality to the extent relevant, using organisational diagrams or othermeans.Examples of relationships that could influence the impartiality include:-Relationship with a parent organisationRelationships with departments within the same organisationRelationships with related companies or organisationsRelationships with regulatorsRelationships with clientsRelationships of personnelRelationships with the organisations designing, manufacturing , supplying,installing, purchasing, owning, using or maintaining the items inspected4.1.5aThe inspection body should have a documented statement emphasising itscommitment to impartiality in carrying out its inspection activities, managingconflicts of interest and ensuring the objectivity of its inspection activities.Actions emanating from the top management should not contradict thisstatement.4.1.5bOne way for the top management to emphasise its commitment to impartiality isto make relevant statements and policies publicly available.Structural requirements – Administrative requirements5.1.3aThe inspection body should describe its activities by defining the general fieldand range of inspection (e.g. categories/sub-categories of products, processes,services or installations) and the stage of inspection, (see note to clause 1 of thestandard) and, where applicable, the regulations, standards or specificationscontaining the requirements against which the inspection will be performed.5.1.4aThe level of provisions should be commensurate with the level and nature ofliabilities that may arise from the inspection body’s operations.Page 5 of 14

ILAC P15:06/2014Application of ISO/IEC 17020:2012 for the Accreditation of Inspection BodiesStructural requirements – Organisation and management5.2.2aThe size, structure, composition and management of an inspection body, takentogether, shall be suitable for the competent performance of the activities withinthe scope for which the inspection body is accredited.5.2.2b“To maintain the capability to perform the inspection activities” implies that theinspection body shall take steps to keep it appropriately informed aboutapplicable technical and/or legislative developments concerning its activities.5.2.2cInspection bodies shall maintain their capability and competence to carry outinspection activities performed infrequently (normally with intervals longerthan one year). An inspection body may demonstrate its capability andcompetence for inspection activities performed infrequently through ‘dummyinspections’ and/or through inspection activities conducted on similar products.5.2.3aThe inspection body shall maintain an up-to-date organisational chart ordocuments clearly indicating the functions and lines of authority for staff withinthe inspection body. The position of the technical manager(s) and the memberof management referenced in clause 8.2.3 should be clearly shown in the chartor documents.5.2.4aIt may be relevant to provide information concerning personnel which carry outwork tasks for both the inspection body and for other units and departments.5.2.5aIn order to be considered as “available”, the person shall be either employed orotherwise contracted.5.2.5bIn order to ensure that the inspection activities are carried out in accordancewith ISO/IEC 17020, the technical manager(s) and any deputy(ies), shall havethe technical competence necessary to understand all significant issues involvedin the performance of inspection activities.5.2.6aIn an organization where the absence of a key person causes the cessation ofwork, the requirement for having deputies is not applicable.5.2.7aThe position categories involved in inspection activities are inspectors and otherpositions which could have an effect on the management, performance,recording or reporting of inspections.5.2.7bThe job description or other documentation shall detail the duties,responsibilities and authorities for each position category referred to in 5.2.7a.Resource requirements – Personnel6.1.1aWhere appropriate, inspection bodies shall define and document competencerequirements for each inspection activity, as described in 5.1.3a.6.1.1bFor “personnel involved in inspection activities”, see 5.2.7a.Page 6 of 14

ILAC P15:06/2014Application of ISO/IEC 17020:2012 for the Accreditation of Inspection Bodies6.1.1cCompetence requirements should include knowledge of the inspection body’smanagement system and ability to implement administrative as well as technicalprocedures applicable to the activities performed.6.1.1dWhen professional judgment is needed to determine conformity, this shall beconsidered when defining competence requirements.6.1.2aAll requirements of ISO/IEC 17020 apply equally for both employed andcontracted persons.6.1.5aThe procedure for formally authorising inspectors should specify that therelevant details are documented, e.g. the authorised inspection activity, thebeginning of the authorisation, the identity of the person who performed theauthorisation and, where appropriate, the termination date of the authorisation.6.1.6aThe “mentored working period” mentioned in item b normally includesactivities where inspections are performed.6.1.7aIdentification of training needs for each person should take place at regularintervals. The interval should be selected to ensure fulfilment of clause 6.1.6item c. The results of the review of training, e.g. plans for further training or astatement that no further training is required, should be documented.6.1.8aA major aim of the monitoring requirement is to provide the inspection bodywith a tool to ensure the consistency and reliability of inspection outcomes,including any professional judgments against general criteria. Monitoring mayresult in the identification of needs for individual training or needs for review ofthe inspection body’s management system.6.1.8bFor “other personnel involved in inspection activities”, see 5.2.7a.6.1.9aTo be considered sufficient, the evidence that the inspector is continuing toperform competently should be substantiated by a combination of informationsuch as;- satisfactory performance of examinations and determinations,- positive outcome of report reviews, interviews, simulated inspections andother performance assessments (see note to clause 6.1.8),- positive outcome of separate evaluations to confirm the outcome of theinspections (this may be possible and appropriate in the case of e.g. theinspection of construction documentation),- positive outcome of mentoring and training,- absence of legitimate appeals or complaints, and- satisfactory results of witnessing by a competent body, e.g. a certificationbody for persons.6.1.9bAn effective program for the on-site observation of inspectors may contribute tofulfil the requirements in clauses 5.2.2 and 6.1.3. The program should bedesigned considering;- the risks and complexities of the inspections,Page 7 of 14

ILAC P15:06/2014Application of ISO/IEC 17020:2012 for the Accreditation of Inspection Bodies- results of previous monitoring activities, and- technical, procedural or legislative developments relevant to the inspections.The frequency of on-site observations depends on the issues listed above, butshould be at least once during the accreditation re-assessment cycle, howeversee application note 6.1.9a. If the levels of risks or complexities, or the resultsfrom previous observations, so indicate, or if technical, procedural or legislativechanges have occurred, then a higher frequency should be considered.Depending on the fields, types and ranges of inspection covered by theinspector’s authorisations, there may be more than one observation per inspector necessary to adequately cover the whole range of required competencies.Also, more frequent on-site observations may be necessary if there is lack ofevidence of continuing satisfactory performance.6.1.9cIn inspection areas where the inspection body has only one technicallycompetent person the internal observation on-site cannot take place. In suchcases the inspection body shall have arrangements in place for externalobservations on-site, unless other sufficient supporting evidence that theinspector is continuing to perform competently is available (see 6.1.9a).6.1.10a Records of authorisation should specify the basis on which authorisation wasgranted (e.g. the on-site observation of inspections).6.1.11a Remuneration methods that provide incentives to perform inspections quicklyhave the potential to negatively affect the quality and outcome of inspectionwork.6.1.12a Policies and procedures should assist inspection body personnel in identifyingand addressing commercial, financial or other threats or inducements whichcould affect their impartiality, whether they originate inside or outside theinspection body. Such procedures should address how any conflicts of interestsidentified by personnel of the inspection body are reported and recorded. Note,however, that while expectations for inspector integrity can be communicatedby policies and procedures, the existence of such documents may not signal thepresence of integrity and impartiality required by this clause.Resource requirements – Facilities and equipment6.2.1aEquipment required to carry out inspection in a safe manner may include e.g.personal protective equipment and scaffolding.6.2.3aIf controlled environmental conditions are needed, e.g. for the correctperformance of the inspection, the inspection body shall monitor these andrecord the results. If conditions were outside acceptable limits for theinspection to be performed, the inspection body shall record what action wastaken. See also clause 8.7.4.6.2.3bContinued suitability may be established by visual inspection, functional checksand/or re-calibration. This requirement is particularly relevant for equipmentthat has left the direct control of the inspection body.Page 8 of 14

ILAC P15:06/2014Application of ISO/IEC 17020:2012 for the Accreditation of Inspection Bodies6.2.4aIn order to enable tracking when items are replaced, the unique identification ofan item of equipment may be appropriate even when there is only one itemavailable.6.2.4bWhen controlled environmental conditions are needed, the equipment used tomonitor such conditions should be considered as equipment that significantlyinfluences the result of inspections.6.2.4cWhen appropriate (normally for the equipment covered by clause 6.2.6) thedefinition shall include the required accuracy and measurement range.6.2.6aThe justification for not calibrating equipment that has a sig

ISO/IEC 17020 and an appropriate suffix, e.g. 4.1.4a would be the first application note on the requirements of clause 4.1.4 of the standard. The term “shall” is used throughout this document t o indicate those provisions which, reflecting the requirements of ISO/IEC17020, or in a few cases requirements for the operation of accreditation bodies in ISO/IEC 17011, are considered to be .

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