Insp Fad

ISO/IEC 17020 Application Document

Inspection

Supplementary requirements for accreditation

December 2011

© Copyright National Association of Testing Authorit ies, Australia 2011 This publication is protected by copyright under the Commonwealth of Australia Copyright Act 1968. NATA’s accredited facilities or facilities seeking accreditation may use or copy this publication or print or email this publication internally for accreditation purposes. Individuals may store a copy of this publication for private non-commercial use or copy a reasonable portion of this publication in accordance with the fair dealing provisions 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 this publication. 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 distribute this content in any way or any form or by any means without express written authority from NATA.

Inspection Application Document – Supplementary requirements for accreditation

December 2011 Page 3 of 31

Contents SECTION 1 Introduction 3 SECTION 2 Accreditation procedures 5 SECTION 3 Supplementary requirements for accreditation 11 Annex 3.1 Application of ISO/IEC 17020 to modelling 21 SECTION 4 Calibration guidance for Inspection Bodies 24 SECTION 5 Categories of inspection 28 SECTION 6 References 30

Section 1

Introduction

Scope The general requirements for the competence of inspection bodies are described in ISO/IEC 17020:1998. This document was issued as a joint Australian / New Zealand Standard, AS/NZS ISO/IEC 17020:2000 General criteria for the operation of various types of bodies performing inspection. While the body of the two standards is identical, the 1998 ISO/IEC document includes an Introduction and cross-reference material not included in the 2000 Australian/New Zealand document. Unless dates are identified, reference to ISO/IEC 17020 indicates the AS/NZS version. These requirements apply to all types of inspection and may require interpretation for specific applications or inspection techniques. This Application Document provides an explanation of the application of ISO/IEC 17020 for facilities and includes a description of the NATA accreditation procedures applied in this field. Facilities must comply with this document, all relevant clauses of ISO/IEC 17020, the NATA Rules and relevant statutory requirements. Additional information relating to specific areas of inspection, or changes or additions to accreditation requirements, or policies may be issued from time to time in the form of Technical or Policy Circulars. These shall supersede any previous requirements where indicated. The application document must therefore be read in conjunction with all of these references and are included in the NATA Accreditation Requirements (NAR). The NATA Accreditation Requirements (NAR) are made up of a number of documents, most of which are available for download as a zipped file from the 'Accreditation Publications' section of the NATA website, www.nata.com.au. The documents comprising the NAR are: 1. The relevant standard (e.g. ISO/IEC 17020) for which accreditation is held or sought. This is not

supplied by NATA and must be obtained by the facility. The following table provides information about where to obtain the applicable standards or documents.

Standard/document Field/Program Organisation Website

AS ISO/IEC 17025 Laboratory Accreditation

Supplier of Australian standards

AS/NZS ISO/IEC 17020

Inspection Supplier of Australian standards

ISO 15189 Medical Testing Supplier of Australian standards

RANZCR Standards Medical Imaging RANZCR www.ranzcr.edu.au

ILAC Guide 13 Proficiency Testing ILAC www.ilac.org



Scheme Providers

ISO Guide 34 Reference Material Producers

Supplier of ISO standards

OECD Principles of Good Laboratory Practice

GLP Recognition OECD Environment Directorate Environmental Health and Safety Division

www.oecd.org/env/glp

2. Relevant application document i.e. this document, for the program/field in which accreditation is held or sought (available from the NATA website).

3. NATA Rules (available from the NATA website).

4. Current Policy/Technical Circulars (where relevant) (available from the NATA website). 5. Some fields/programs have additional documents that also form part of the accreditation

requirements which are referenced in the relevant application document (FAD).

Technical Notes are also available to assist facilities in relation to particular technical matters. They are intended to provide guidance and therefore do not contain requirements for accreditation. Copies may be obtained from NATA offices or from our website. A copy of the NATA Accreditation Requirements must be readily available to staff working in a NATA accredited or applicant facility. Other informative documents are also available from the NATA website, such as: 1. About NATA and Accreditation

2. Information Papers 3. Proficiency Testing information

Applicability Inspection accreditation is formal third-party recognition of the competence of an inspection body. Because the organisation, its systems, facilities, equipment and inspectors contribute to credible inspection reports, all these matters are considered during the accreditation process. The accreditation criteria are applicable to all facilities, irrespective of size, range of inspection activities or number of personnel. It should, however, be noted that it is not possible to set rigid requirements for all aspects of a facility’s operation. Some flexibility is necessary so that each facility’s unique situation can be considered. The acceptability (or otherwise) of certain practices can therefore only be determined by assessment. Information on the assessment process is contained in Section 2. Application documents are also available for NATA’s other programs including accreditation for various fields of testing, medical testing, medical imaging, proficiency testing scheme providers, reference materials producers and research & development. Additionally, an interpretation document is available for GLP recognition against the OECD principles.

Administration NATA’s accreditation activities are administered, under the Board’s direction, by the relevant field/program Accreditation Advisory Committee. The current NATA Rules outline the functions of the Board and the Accreditation Advisory Committees.

Terminology and presentation The clause numbers in Section 3 of this document follow those of ISO/IEC 17020 but since not all clauses require interpretation the numbering may not be continuous. The term ‘facility’ is used in this document to refer to bodies providing inspection services and/or testing services. This is in keeping with NATA practice in referring to any accredited organisation, or one seeking accreditation, as a facility. The words ‘shall’ and ‘must’ are used interchangeably throughout this document to describe mandatory criteria for inspection accreditation. The word ‘should’ is used where guidance is provided but does not



preclude other acceptable practices. Where a smaller size font has been used i.e. a ‘Note’, this indicates a matter of an advisory or informative nature. Any references to the NATA Rules, Fee Schedule, Technical Policies, etc. imply the current version of such documents. Where the words ‘policy’ and ‘procedure’ are used in ISO/IEC 17020 it is possible that one document may meet the requirements of the standard. This will be determined at assessment.

Legislation It is the responsibility of each facility to ensure that it complies with all relevant legislation. Legislative requirements may take precedence over, or provide additional criteria to those detailed in this document. It is also strongly recommended that facilities hold copies of relevant legislation.

Safety, environment and heritage NATA does not define mandatory measures to protect safety, the environment or heritage values, but does draw attention to any unsuitable work practices that are observed in the course of an assessment. When clauses covering safety, environmental or heritage protection are written into standard inspection codes, methods or specifications covered by the scope of accreditation these must be observed by the facility and are subject to assessment.

Section 2

Accreditation procedures The following information is provided to assist facilities who seek or hold accreditation or wish to extend the scope of their accreditation. General information is also provided with regard to NATA’s policies and procedures. It should be noted that there are some differences between the fields/programs with regard to the order in which these steps are followed. Hence, this section may vary from other Application Documents which reflects relevant but different emphases in the various activities NATA accreditation covers, or limitations that have been placed on the NATA process by outside influences, such as regulatory or industry-specific requirements. Where an organisation may require accreditation in a number of different fields or programs, every attempt is made to harmonise and coordinate accreditation activities. Corporate accreditation is available in defined circumstances to assist this process. A Policy Circular is available explaining this process and can be obtained from our offices or the NATA website. There may also be a need to vary the steps detailed below in the case of applications from overseas facilities. Once again, every attempt is made to ensure the accreditation process is carried out in the most efficient and effective way for all parties concerned. Where applications or accreditations are required that include testing/non-testing/calibration NATA accreditation activities (such as the Reference Material Producers Accreditation Program, Proficiency Testing Scheme Providers Accreditation, or GLP Recognition) every effort is also made to appropriately coordinate activities.

The role of the authorised representative The authorised representative is the person nominated by the facility to be its representative in all matters relating to the application or accreditation and is the recognised official contact with NATA. Nomination is made in the appropriate place on the application form or when changes are required thereafter, on the ‘Nomination of New Authorised Representative’ form available for this purpose. The rights and legal obligations of the authorised representative are detailed in the NATA Rules. At a practical level, the authorised representative is normally a senior staff member who is in a position to make decisions regarding the facility’s accreditation and to effectively communicate with facility staff. The authorised representative may also choose to direct NATA to other facility personnel with whom relevant issues may be discussed. The authorised representative is required to notify NATA within 14 days if:



• the name or ownership of the facility changes; • there are changes in duties or departures of key staff; or • significant changes occur to the functions or accommodation of the facility.

Facility contact person Recognising that the authorised representative is not necessarily the most appropriate person to answer day to day and technical queries regarding an accredited facility’s activities, NATA provides facilities the opportunity to nominate a person to deal with technical and other enquiries. This person can, however, also be the authorised representative.

Fees for services The various parts of the accreditation process where charges are levied are indicated in this document. Specific information on charges can be obtained from our current Fee Schedule (available from the NATA website) or by contacting a NATA office.

Preliminary steps The facility is encouraged to hold discussions with relevant NATA technical staff prior to lodging a formal application for accreditation. When seeking accreditation, facility staff should also familiarise themselves with the NATA Accreditation Requirements (NAR). The NAR can be obtained from the NATA website.

Advisory visits An advisory visit to the facility can be undertaken by a NATA technical staff officer (lead assessor) to further discuss the assessment process and to explain the significant requirements that relate to accreditation. Such a visit includes an informal review of the facility which can help determine its state of readiness for accreditation. It should, however, be remembered that the NATA lead assessor, whilst an experienced scientist, is not a technical assessor. Accordingly, the formal assessment (refer below) is the process whereby compliance with the accreditation requirements is determined. Following the visit, a written report is provided which summarises the key points of discussion. An advisory visit is usually conducted prior to an application for accreditation being submitted, however, the most appropriate timing for such a visit will be a matter for negotiation between the facility and the NATA lead assessor. While an advisory visit is not mandatory it is strongly recommended that facilities avail themselves of this service prior to applying for accreditation. There are of course cases in which facilities have good knowledge of NATA through existing contacts or accreditations. In such cases, the merits of a pre-assessment visit should still be discussed with relevant NATA technical staff. Prior to an advisory visit, the facility will be asked to provide relevant documentation for review. The NATA lead assessor will advise exactly what information is required. This activity is known as 'document review' and is described below. A fee is levied for an advisory visit in accordance with NATA’s Fee Schedule.

Document review Depending on the state of readiness of the facility for accreditation, it will be asked (either prior to an advisory visit or after an advisory visit, but before the formal on-site assessment), to submit a copy of its proposed scope of accreditation, current management system documentation, inspection procedures and information on staff so that a document review can be undertaken. A document review is most often conducted by the NATA lead assessor who will be involved in the assessment of the facility. The document review provides a comparison of the facility’s documentation and procedures with the accreditation requirements as detailed in the NAR. The NATA lead assessor also makes note of particular references within the facility’s documented system that require review at the assessment or areas that appear to require further explanation or investigation. Written feedback will be provided on the findings of



the document review. Depending on the extent of the action required the facility may be asked to provide further information prior to the assessment or this information will be sought at the assessment. A fee is levied for the document review in accordance with NATA’s Fee Schedule.

Application for accreditation Applications for accreditation may be made by any legally identifiable organisation and must be made on the prescribed application form. This form will be provided at an appropriate time with regard to the intended time of application. The application must be accompanied by the current application fee in accordance with NATA’s Fee Schedule.

Assessment Compliance of an applicant with the accreditation requirements is determined primarily by an on-site assessment. The objective of an assessment is to establish whether the facility can competently perform the activities for which accreditation is being sought. The NATA assessment team is required to investigate the operation of the facility against the criteria detailed in the NATA Accreditation Requirements. The assessment team reports its findings to both the facility seeking accreditation and the relevant Accreditation Advisory Committee (AAC). The assessment team is comprised of at least one NATA lead assessor and one or more specialist volunteer technical assessors. Review of the management system is essentially conducted by the NATA lead assessor. The size of the assessment team is dependent upon the areas that must be covered in the course of the assessment. Technical assessors are chosen according to their specialist knowledge and are matched as closely to the activities of the facility as is possible. Consideration is given to possible concerns about conflicts of interest in selecting assessors. Assessments will generally take at least one working day and may extend over a number of days depending on the range of activities to be covered. Facility staff will be called upon to discuss, with the technical assessors, technical issues relating to inspection activities that are in progress or are carried out by the facility. Occasionally, such discussions may be hypothetical. NATA may also request prior to the assessment, or in the course of the assessment, that particular inspection activities be demonstrated. Facilities undergoing an assessment should expect all areas for which accreditation is sought to be covered in some way. Where consultants are associated with a facility, NATA reserves the right to contact these persons to establish their level of involvement if they are not present at the assessment. An exit interview or meeting is held at the conclusion of the assessment at which the assessment findings are presented by the NATA lead assessor. It is the prerogative of the facility to decide which of their staff should attend this meeting. Generally, the authorised representative would be expected to attend as well as relevant senior staff. The purpose of the exit meeting is to allow frank and open discussion about the findings of the assessment. Facilities are strongly encouraged to clarify issues they consider may have been misunderstood by the assessment team and to seek clarification about assessment findings where this may be necessary. Where the assessment team and facility do not agree on a finding or the emphasis placed on an issue, this will be noted by the NATA lead assessor and considered during the report review process (refer below). Further information may also be requested by NATA and included in the final report where this information was not available during the assessment. An interim written report is usually left on the day. This report is subsequently reviewed by NATA senior staff and where relevant, the AAC, prior to the issue of the final report to the facility. This review ensures that the assessment team findings are appropriate and in accordance with the accreditation requirements, that evidence gathered at the assessment support the findings and that there is consistent interpretation and appropriate application of the accreditation requirements. Occasionally, a specific issue raised in the report may also be referred for review to other technical experts (not members of the AAC) where further advice is sought. In such cases, the identity of the facility concerned is kept confidential. Where necessary, the final report will detail the action required by the facility to allow accreditation to be recommended. In these cases, the facility will be asked to provide NATA with the necessary evidence that action has been taken, as claimed.



Occasionally, the AAC may recommend that a further visit by a NATA lead assessor or that another assessment be conducted. There are a number of reasons for this, including concerns about the competence of the facility, the inability to assess certain aspects of the facility during the scheduled visit because of lack of availability of key staff, or to review the effective implementation of the corrective action taken as a result of the assessment. The same procedures for assessment will be followed but may concentrate on only the area(s) found to be deficient. Fees are levied for the conduct of assessments in accordance with NATA’s Fee Schedule.

Granting accreditation NATA’s Chief Executive grants accreditation following a recommendation by the relevant AAC. This recommendation is made when the facility has met all the requirements for accreditation. The authorised representative is formally advised of the granting of the accreditation and issued with a certificate and the scope of accreditation.

Scope of accreditation Accreditation in Inspection is described by categories and sub-categories. The collection of categories covered in a facility’s accreditation, is known as its ‘scope of accreditation’. These categories and sub-categories are fixed descriptors, free text being used to qualify or amplify the scope as necessary. Where the scope of accreditation of a facility cannot be adequately described by existing descriptors, the AAC may from time to time establish new categories and/or sub-categories. A copy of the classes of test available in the Inspection accreditation program is provided in Section 5 of this document. Categories are, however, revised from time to time so for the most current version please contact a NATA office or visit our website. Applications for accreditation may be made for one or more categories, or for one or more subcategories within a category. The scopes of accreditation of all NATA accredited facilities are available on the NATA website.

After accreditation NATA accredited facilities must continue to comply with all accreditation requirements detailed in the NATA Accreditation Requirements. In order to ensure continued compliance with these requirements, scheduled visits to facilities are arranged. Generally the assessment cycle is three years which includes a surveillance visit at 18 months followed by a reassessment at 36 months. Shorter intervals to a facility may also be specified by the relevant Accreditation Advisory Committee. Such intervals will be determined on the significance of issues identified during a visit to a facility and/or any doubt over a facility’s continuing compliance with the accreditation requirements. Reassessments follow the same general process as the initial assessment. The scope of review covers all of the facility’s technical activities, however only selected elements of the management system against the accreditation requirements detailed in the NAR. A document review is generally not conducted prior to a scheduled reassessment. Extensions to the scope of accreditation requested as part of a scheduled reassessment will only be accommodated where such requests do not compromise the purpose of the reassessment (see Variations to scope of accreditation). Fees will be charged where additional resources and time are required to accommodate the request as part of a scheduled reassessment. NATA technical staff will provide further information. Surveillance visits are conducted by a NATA assessment team and involves review of the management system in full (including a document review) and selected technical elements against the accreditation requirements detailed in the NAR. Extensions to the scope of accreditation will normally not be considered at such visits. Facilities must respond to reassessment and surveillance visit findings by the nominated response date, otherwise the status of their accreditation will be reviewed. The annual membership fees payable by accredited facilities generally cover the costs of reassessments and surveillance visits.



Requests for variations to the scope of accreditation outside routine reassessments may also be considered (see Variations to scope of accreditation). Unscheduled visits may be conducted to investigate a complaint or following the receipt of information that casts doubt over the facility’s continuing compliance with the accreditation requirements. At such visits, specific activities may be targeted for review rather than the entire facility operation.

Variations to the accreditation Accredited facilities may request variations to their scope of accreditation at any time once accredited. NATA technical staff will provide direction on the information required, the process that will be followed and the charges that will be levied. Extensions to the scope of a facility’s accreditation may be accommodated at the same time as a scheduled routine reassessment but only where review of the additional activity(ies) will not compromise the purpose of the reassessment (which is to review the existing scope of accreditation to determine ongoing compliance with the accreditation requirements). Adequate notice by the facility must also be provided in order for the variation to be considered. Variations to the scope of accreditation must be supported by relevant documentation in advance of the assessment (e.g. proposed scope, inspection procedures, sample worksheet and report). Fees will be charged for extensions to the scope of accreditation conducted during a routine reassessment where additional effort is necessary (e.g. additional time and/or technical assessors are required).

NATA Approval of Facility Staff NATA no longer identifies or approves facility staff to sign endorsed documents. NATA may identify individual persons as required, if needed by a regulator. This decision effectively shifts the responsibility for “approved staff” from NATA to the facility management. However, individuals who issue reports are still expected to assume responsibility for the technical validity and accuracy of all information contained in the reports.

Reports and use of the NATA endorsement Accredited facilities are encouraged to apply the NATA endorsement to reports on those activities covered by their accreditation. In addition, the NATA endorsement may need to be applied due to customer request, legislation, regulation or contract requirements or in the case of calibration certificates being supplied to an accredited facility. Additional details relating to the appropriate forms of endorsement and the reproduction of endorsed reports are provided in the relevant schedule of the NATA Rules. The endorsement may not be applied to reports on activities outside the facility’s scope of accreditation. Such documents must not include the NATA emblem, reference to the accreditation or any other reference to NATA. Also refer to NATA’s Rules and Policy Circular 18 for further details of the circumstances under which the endorsement must not be applied. Where unendorsed reports are issued on work covered by the scope of accreditation, all aspects of the inspection activities, including the reports, must meet the accreditation requirements outlined in this document. The terms ‘report’ and ‘certificate’ are often used interchangeably. It is generally accepted that an inspection report is a detailed description of the inspection conducted and its results. Inspection certificates are shorter statements that may be issued, sometimes with statutory or legal authority. A facility may issue either, provided that the minimum reporting requirements are met and that relevant laws and regulations are observed. In some industries the term ‘certificate’ is associated with compliance under a product certification scheme. In these industries the terms ‘inspection report’ or ‘inspection statement’ are preferred to avoid misunderstanding.

Proficiency testing Each applicant or accredited facility is required to participate in appropriate proficiency testing or equivalent activities, where relevant.



Technical Circular 11, available from the NATA website, outlines the policy for proficiency testing in Inspection. NATA’s Proficiency Testing Policy (Policy Circular 2) is also available from the NATA website.

Non-compliance with accreditation requirements In accordance with the NATA Rules, non-compliance with the accreditation requirements may lead to the accreditation status of a facility being suspended or cancelled. In these circumstances the facility is not able to issue endorsed reports or claim to be accredited for those services affected by the change in status. The NATA Rules define the reasons, processes and the appeals mechanisms that will be followed.

Provision of information on scope of accreditation Details of a facility’s scope of accreditation are posted on the NATA website once accreditation has been granted and are also made available to enquirers.

Complaints and feedback NATA encourages and welcomes feedback from facilities. Such feedback, for example, may relate to the apparent inconsistent application of the requirements for accreditation, compliments regarding NATA staff, etc. NATA maintains a complaints procedure for the investigation of concerns which may be raised against applicant or accredited facilities, or any aspects regarding the services or activities which NATA offers or the conduct of its staff. Provision is available on the NATA website for submitting complaints on-line. All such feedback should be referred to the Field or Program Manager.

Confidentiality All information provided by a facility in connection with an enquiry or an application for accreditation, and all information obtained in connection with an assessment, is treated as confidential by NATA staff, technical assessors, Committee and Board members. All such personnel are made aware of this requirement and have signed confidentiality agreements.

Privacy NATA respects and upholds the rights of individuals to privacy protection under the National Privacy Principles contained in the Privacy Amendment (Private Sector) Act 2000. A copy of NATA’s Privacy Policy can be obtained from the NATA website (www.nata.com.au) or by contacting one of the NATA offices. This policy describes how NATA manages the personal information we hold. The following is a summary of the personal information collected from individuals in applicant and accredited facilities and the disclosure of that information.

Authorised representative The personal information collected will include name; position; business address, business telephone, mobile phone and fax numbers; e-mail address. Credit card details may also be held for those purchasing NATA services. This information may be used to: • administer and manage your accreditation; • seek feedback from you on ways to improve NATA’s services; • provide you information on NATA’s activities and services. The information may also be made available to enquirers requiring the services of NATA accredited facilities. Personal information may be disclosed to organisations outside NATA. Such organisations may include: • government and regulatory authorities and other organisations, as required or authorised by law

and/or with which NATA has a Memorandum of Understanding or similar formal agreement; • accreditation bodies with which NATA has a Mutual Recognition Agreement (MRA); • professional advisers including accountants, auditors and lawyers;



• credit providers; • outsourced service providers managing NATA services.

Facility contact Recognising that the authorised representative is not necessarily the most appropriate person to answer day to day and technical queries regarding an accredited facility’s activities, NATA provides facilities with the opportunity to nominate a person to deal with technical and other enquiries. (This person can, however, also be the authorised representative.) The personal information collected will include name; position; business address, business telephone, mobile phone and fax numbers; e-mail address. This information may be given to enquirers and is included in the on-line Directory.

Facility personnel The personal information collected on personnel of the applicant or accredited facility may include name, position, professional, technical or other relevant qualifications, membership of professional associations, employment history. This information is used for the conduct of the assessment, reporting on the assessment and the process of granting/continuing accreditation. It may be disclosed to NATA staff members, assessors, assessment observers and NATA committee members, all of whom have signed confidentiality agreements. It may also be disclosed to agencies to which NATA has a legal obligation or with which NATA has a formal agreement.

Disclosure of personal information by applicant and accredite d facilities at assessments In order for NATA to determine compliance with some accreditation criteria, it will be necessary to sight personal information at assessments. Examples might include personal information held in training records, complaints records, lists of approved suppliers etc. It is the responsibility of the facility to ensure that, in accordance with The Commonwealth Privacy Act 1988 National Privacy Principle 1.3(d)], it has appropriate arrangements in place to advise individuals that personal information collected may be disclosed to NATA.

Section 3

Supplementary requirements for accreditation

Interpretation of ISO/IEC 17020 This section provides interpretation of the application of ISO/IEC 17020, together with the supplementary requirements applicant and accredited facilities must comply with. The clause numbers in this section follow those of ISO/IEC 17020 but since not all clauses require interpretation the numbering may not be consecutive. In writing this document, reference has been made to IAF/ILAC A4 Guidance on the Application of ISO/IEC 17020 and APLAC TC 006 Guidance notes on ISO/IEC 17020. These documents are commended to people seeking guidance and general interpretation of ISO/IEC 17020.

1 Scope 1.3 The criteria detail general principles of good inspection practice. Some clauses may not be relevant to particular industry groups or to small (e.g. one-person) operations.

2 Definitions 2.1 Inspection There are many types of inspection activities that can be conducted. These include activities such as design verification, fabrication inspection, product inspection, installation inspection, commissioning inspection, in-service inspection, expediting, witnessing, consignment verification, quantity surveying, modelling and classification inspection. Inspection of processes includes personnel, facilities, technology and methodology. Interested parties are referred to the guidance documents identified in the opening paragraphs to this section. Professional judgement is understood to entail decision making that is supported by a body of rigorous and objective analysis.



Identification of what is inspected and where in the process professional judgement is exercised, enables inspection activities to be discriminated from other activities, such as product approval schemes or personnel licensing systems.

3 Administrative requirements 3.3 It is acknowledged that often individual contracts are not signed with clients; and that workscopes may be established through reference to other documents such as regulations. 3.4 The facility must have current insurance policies and should be able to show the factors taken into consideration when determining the necessary level of insurance. If it is applicable, the insurance should be shown to cover sub-contracting activities. Typical factors considered in determining the level of insurance might include risk, client demand and regulation. Inspection bodies should seek professional advice on insurance matters. The types of liability covered by insurance may include employer’s liability, public liability and professional indemnity. 3.5 In this clause, conditions refers to contractual matters. A facility must establish its normal terms and conditions of contract. Type C Inspection bodies should include a clear statement of the activities that prevent it from being classified as a Type A inspection body. This statement should be sufficiently explicit to enable potential clients to make informed decisions on the adequacy of the level of independence offered. 3.6 Evidence of annual returns provided to the Australian Taxation Office and/or Annual Reports provided to shareholders may be used to demonstrate compliance with the requirement to have independently audited accounts.

4 Independence, impartiality and integrity 4.1 Guidance should be provided to staff for situations where undue pressure is applied (see Clause 8.5). Records of situations where undue pressure has been applied to inspectors should be kept. 4.2 Categorisation of inspection bodies as Type A, B or C is essentially a measure of their independence. The traditional measures of independence being first-, second- and third-party organisations do not equate directly with these categories. Assignment of Type will be made as part of the assessment process. The assigned Type can, however, be amended if the nature of a business changes, provided the inspection body can demonstrate that it meets the criteria of a different inspection body Type. An organisation must meet all the requirements listed in the normative annexes to be assigned to a particular type of inspection body. 4.2.1 Type A Inspection Body A Type A inspection body shall demonstrate that it is not linked to a party directly involved in design, manufacture, ownership, use or maintenance of the items inspected, or similar competitive items by: • Common ownership (except where the owners have no ability to influence the outcome of an inspection); • Common ownership appointees on boards (or equivalent) of the organisations (except where these have

functions that have no influence on the outcome of an inspection; • Directly reporting to the same or higher level of management; • Contractual arrangements, informal understandings or other means that may have an ability to influence

the outcome of an inspection. 4.2.2 Type B Inspection Body A Type B inspection body may form part of a user organisation or a supplier organisation. 4.2.3 Type C Inspection Body Type C inspection bodies are distinct from Type B inspection bodies because they are not required to be a separate but identifiable part of the parent organisation. They may also offer their inspection services on the open market.



5 Confidentiality A policy regarding the confidentiality requirements of clients should be documented. Sub-contractors should be bound by this policy as part of the contractual arrangement between the inspection body and its sub-contractors.

6 Organisation and management 6.2 The degree of complexity of documentation and the extent to which staff members can hold several functions will depend upon the size of the organisation. 6.3 Where an inspection body has one technical manager per division the specific responsibilities of each position must be defined and documented. 6.4 Competent personnel are essential for supervision to be effective when it is required. The extent, nature and level of supervision exercised should take into account the qualifications, competence, training and technical knowledge of the inspection body staff and the inspections being undertaken. Effective supervision can be claimed only where the inspection body is able to verify that inspection decisions are reliable. This may include direct supervision in the field, witnessing of field activities and regular review of records and reports. NATA Technical Circular 11 identifies some systematic means of assuring the quality of inspection activities, and includes a variety of techniques that are also used in proficiency testing activities. 6.5 A deputy does not have to be permanently employed. In organisations where an absence causes the cessation of work, deputies are not required to be defined. 6.6 Position descriptions must be documented for managers, clerical staff and inspectors.

7 Quality system Further guidance on the aims, elements and implementation of quality systems is provided in ISO 9004: 2000 Quality management systems - Guidelines for performance improvement. In conducting assessments, NATA cannot accept a facility’s ISO 9000 certification as the sole statement of compliance with the management requirements of ISO/IEC 17020. ISO 9001: 2008 is an outcome based standard and has fewer requirements for documented procedures and records. It is also necessary to consider how the system is applied at a technical level. Therefore, the management system requirements of ISO/IEC 17020 will still be assessed in these situations. NATA Policy Circular 15 further describes NATA’s current practices regarding the acceptance of certification to ISO 9001 when conducting NATA assessments. 7.3 Policy and/or procedures addressing all clauses (where relevant) shall be included in the management system documentation. Organisations are free to choose their own format and style of collating and presenting policy, procedure and information in documents. Annex D of ISO/IEC 17020 is an indicative guide to the content of the management system elements of an organisation. This information may be collated in a form other than as a single document called ‘Quality Manual’. Quality documentation must include or reference the scope of accreditation and the policy on the use of the NATA endorsement. 7.4 The position of Quality Manager (however named) should be clearly defined on the organisation chart. 7.5 In cases where an inspection body has a number of offices in different locations, responsibility for the practical maintenance of the quality system may be assigned to a named individual in each office. 7.6 For staff operating out in the field away from the office environment, extra care should be taken to ensure that they are kept up-to-date with documentation changes. In particular, field notebook computers must be up-dated regularly and included in the internal audit program for content review.



7.7 As a general principle, an internal audit schedule should be structured to ensure that all policies and procedures of the documented management system are examined at least once per year including the performance of inspections. A predetermined schedule can assist in ensuring that all procedures are covered during an annual cycle. The internal audit procedure should be flexible enough to include unscheduled internal audits as well as planned audits and identify the conditions under which an unscheduled audit is appropriate. 7.9 Management reviews should take account of all relevant information including changes in the business environment, organisational changes, the results of internal audits and external assessments, complaints, operational reports and training needs analyses. Management review should be conducted at least once per year. Audit results and other business changes may provide information that necessitates more frequent reviews being conducted.

8 Personnel 8.1 Permanent personnel include staff contracted into an organisation to work within its system. Sub-contracting accredited inspection activities out to another organisation should normally be practised only in exceptional circumstances (see clause 14.1). 8.2 The competence of inspectors is critical to the validity of inspection findings. Competence is understood to encompass both theoretical knowledge and practical ability. Depending upon the industry group, competence may demand familiarity with relevant regulations, technologies, processes, standards, codes, materials, failure modes and industry practice. Staff competence Where relevant, inspection body staff must have:

• relevant qualifications and/or be assessed as competent within the National Training Framework; • completed relevant in-house training; • familiarity with the principles of the inspections they perform or supervise including relevant practical

experience; • familiarity with inspection equipment, including its performance, use and calibration; • knowledge of the standards or specifications used; • knowledge of the organisation’s management system; • ability to record inspection findings and write clear and appropriate reports and/or certificates; • an understanding of the legal significance of approving and issuing reports; • knowledge of ISO/IEC 17020, NATA Rules, this document, and relevant NATA Technical and Policy

Circulars; and • they must participate in continuing professional development.

Inspection bodies may engage inspectors and other staff under casual or part-time contracts. Casual or part-time staff shall meet the above criteria and have their role and authority clearly defined. Issues of independence, conflict of interest and confidentiality must be addressed. The contract or agreement should further indicate that the facility is responsible for work performed by the consultant including acceptance of the indemnity responsibilities detailed in NATA Rules. Management of Inspector and staff competence The management of an inspection body may appoint and authorise staff in support of the inspection activities. Such appointments shall be in accordance with a documented policy and procedure. This system must cover all inspection staff having an effect upon inspection outcomes, including inspectors, clerical, ancillary and service personnel as appropriate. Appointment and authorisation may cover all, or be limited to specifically identified, technical elements or process steps associated with the inspection. Where administrative personnel are authorised to issue documents the inspection body shall be able to demonstrate that reports are subjected to an appropriate level of technical review prior to issue. The following matters are required to be addressed: 1. The inspection body must identify the minimum levels of qualification and experience necessary for

people to perform relevant tasks. 2. A system to manage the development and appointment of staff must be developed and associated

procedures must be documented. It may be possible for a graded system to be developed, allowing for personnel development, enabling recognition of experience while limiting the risks associated with using less experienced staff.



3. The inspection body must develop and implement competency assessment criteria for staff outlining their responsibilities, and the expectations of the inspection body regarding the conduct of work including field activities and interpretation of codes.

4. Where relevant, staff must participate in professional development (for example, through attendance at exhibitions, industry meetings and ongoing training).

5. Records of qualification, professional development, experience and participation in in-house training must be kept for each staff member.

6. A record of the appointment dates and extent of each approval must be retained. At cessation of engagement (for example upon staff leaving the organisation) a record of the withdrawal including the date of withdrawal must be kept.

7. A system to assure confidence in inspections conducted by different inspectors must be developed. NATA Technical Policy 11 offers possible models for implementation. The use of this system must continue at appropriate intervals throughout the employment of the inspector. Records of outcomes and any associated corrective actions must be retained.

Loss of staff If a facility does not have staff with relevant competencies for one or more technical elements of its scope of accreditation, the inspection body is unable to perform inspection work involving this technical element. NATA must be advised of the situation and the accreditation will be suspended (in part or in full) pending the organization gaining the necessary resources to competently deliver the relevant services.

Corporate accreditations Inspection staff appointed by facilities with corporate accreditation may fulfil their appointed role across different sites, providing they are familiar with each site’s operations, and have access to relevant records e.g. training, calibration, quality control.

Records Facilities should hold a current listing of staff authorised to issue reports, including as appropriate the range of activities for which they are approved. 8.3 Trainee inspectors, contract staff and other staff may assist with inspection work while under effective supervision. Their duties should be commensurate with their knowledge and experience. There should also be adequate direction via provision of detailed procedures, checklists and/or work instructions. Training records must at all times be able to confirm the competency level of an individual for a given task. 8.4 Copies of relevant health records (for example, records of eyesight or hearing tests) and specialist licences must be maintained as part of the individual’s qualification list. If appropriate, systems should exist to prompt when checks or re-certifications fall due. 8.5 The inspection body should consider issues such as work ethics, impartiality, customer relations, presentation, safety, environmental and heritage protection, response to undue pressure (see Clause 4.1 para 2) etc. Guidance can be provided in the form of a code of conduct. Records of training covering these issues should be maintained. 8.6 In many inspection bodies there is often a direct connection between the number of inspections performed and the income of the organisation (and hence its staff). In such cases it is recommended that records be kept of the time taken for each inspection.

9 Facilities and equipment 9.1 In this clause “facilities” refers to materiel necessary for the conduct of an inspection. This can include items necessary for access, safety, recording or interpretation of findings as well as items directly used in the inspection task. With many kinds of inspection, measurement or testing is of an indicative nature only. Equipment used by an inspector may therefore only need to provide screening, check or indicative levels of accuracy. Responsibility for determining the suitability and calibration status of any equipment used in inspection remains solely with the inspection body and cannot be delegated. However, the inspection body need not be the owner of the facilities and equipment that it uses. Equipment may be borrowed, rented, hired, leased or otherwise procured. In such circumstances, the inspection body should review and retain appropriate



records demonstrating that the equipment meets the relevant requirements of this Standard as if the facility owned it. 9.2 Where required, documented instructions covering the control and use of equipment by authorised operators should be in place. 9.4 Even where the equipment is not owned by the inspection body, records must be able to clearly identify what piece of equipment was used in the process and its suitability for use, if relevant. Where verification of suitability for use cannot be achieved, this fact shall be prominently stated in the inspection report and the client shall be informed of it. 9.6 Where, as part of an inspection activity, an inspector is required to conduct measurements with a clearly defined accuracy, equipment used must meet the requirements of ILAC P10. Further guidance upon calibration requirements is provided in section 4. When establishing an equipment calibration program, reference may be made to equipment calibration frequency intervals provided in section 4 of this document. Other NATA documents may provide further guidance. NATA Policy Circular 11 requires that, in line with ILAC P10 and the guidance of HB 86.1 Clause 5.5.4, all test and measuring equipment having a direct effect on the accuracy and significance of inspection results must be calibrated. Calibrations must demonstrate traceability to the Australian national standards of measurement or their international equivalent. Inspection bodies are guided to the information of HB 86.1 when addressing matters of equipment selection, care, calibration and checking. 9.7 Where test and measurement results have a significant influence on the inspection results, the inspection body must have a mechanism that alerts staff when calibrations and subsidiary in-house checks are due. The nature of the calibration or check required should also be indicated. In-house calibrations should be conducted using calibrated reference standards of measurement. External suppliers of calibration services for both reference standards of measurement and working equipment may provide calibration certificates with uncertainty of measurement detail as required by ISO/IEC 17025, or complying with national requirements for equipment used in trade measurement. 9.8 Calibration services accredited by NATA or an MRA partner to ISO/IEC 17025 will be regarded as competent for the purpose of meeting this sub-clause. Equivalent systems for legal metrology may also be used provided there is an equivalent established traceability of measurements system in place. NATA Policy Circular 11 provides further guidance. 9.9 The frequency of in-service checks should be established by the inspection body. Guidance on check intervals for many items of equipment is provided in section 4. Where no check interval is offered, the inspection body should establish its own schedule of equipment checks, reviewing these at suitable intervals to ensure that the check interval is appropriate. 9.10 Providers of reference materials should operate to ISO Guide 34 General requirements for the competence of reference material producers and, where possible, hold accreditation for the production of reference materials. 9.13 Validation of purpose-written or user-generated computer software (for example, spreadsheets with formulas or macros) must be conducted before the software is implemented for general use. Records of this validation and subsequent checks on its integrity must be retained. Checks on software updates should be carried out before the up-dates are implemented. At all times, the organisation must be able to identify which version of software was or is in use and be able to confirm the current status of software used by staff in portable electronic equipment. Interested parties may refer to the validation and verification requirements outlined in Annex 3.1 clauses 9 and 10. Computers, software and electronic automated equipment should be treated as another item of equipment in the equipment register and calibration/validation system and scheduled for service, review and/or update as required. Electronic data security should be considered routinely as part of the record integrity system. 9.15 Information recorded should, where appropriate, include: a) the name of the equipment and its identification;

b) manufacturer’s name;

c) manufacturer’s equipment identification such as serial number;



d) date received and placed in service;

e) condition when received;

f) maintenance instructions; g) history of maintenance and calibration;

h) calibration records;

i) current location or who the equipment has been assigned to; j) calibration procedures used.

All equipment checks and calibrations must record the following information: • Name of equipment; • Identification of equipment (for example, a serial number, etc); • Location of equipment if relevant; • Specification (including year) where appropriate; • Indication of the acceptance criteria used on the records; • Identification of personnel carrying out the work; • Identification of reference equipment used (for example, vernier callipers 36101, reference thermometer

A227, etc); • Procedure used or reference to documented procedure; • Date the check was performed; • Results obtained; • Statement of acceptability or otherwise of the check; • Any follow-up action required to correct deficiencies. Where performance checks on critical equipment are conducted by an external provider, these checks must be undertaken by a laboratory who is accredited to perform that check, and can provide a NATA endorsed report for that check. Organisations performing equipment checks in-house must document the procedures used. Alternatively, they may use proforma worksheets provided it is clear as to the procedure to be performed. However, where operator technique is critical, additional written procedures are required.

10 Inspection methods and procedures 10.1 The requirements against which the inspection is performed are normally specified in regulations, standards or specifications. Specifications may include those developed by customers or in-house. When inspection methods and procedures are not defined by publicly available documents, the inspection body itself is expected to define and document the methods and procedures for inspection. If the inspection body uses information provided by external sources as part of an inspection then it should identify the source of the information and the measures taken to verify the integrity of such information. 10.2 Inspection bodies often perform sampling as part of their services. Such samples may be retained for reference purposes or tested. In some cases appropriate sampling activities demand the development of job-specific sampling plans and/or the use of professional judgement. Sampling may also be performed as part of a wider inspection activity. Accreditation for these activities is possible under NATA’s Inspection Accreditation Program. Interested organisations are invited to contact NATA to discuss accreditation of these sampling activities. Where acceptance/rejection criteria are nominated in contracts or specification documents, the criteria should be included, as appropriate, in the worksheets and/or checklists used by the inspection body. Facilities are reminded of the risks associated with extending results from a sample to a wider population of items. While it is the practice in some industries to base an evaluation upon limited sample sizes, facilities are reminded of the existence of Australian standards for sampling. Where assumptions of homogeneity have been made, these must be brought to the attention of the client. 10.3 A standard method is one that has been published

• by a reputable technical organisation, • by co-operation of several inspection bodies, or • in relevant scientific text or journals.



Clear in-house instructions on inspection procedure and technique may be required to support inspections conducted against defined product specifications. The effectiveness of these procedures should be validated and the validation documented. In many instances it may be more appropriate for accreditation to be held for a technically valid, in-house inspection procedure referencing all applicable specifications against which items are to be evaluated rather than for the scope of accreditation to detail individual specifications. This will vary from industry to industry and should be discussed with your NATA lead assessor. 10.5 Inspection records must clearly cover the contract review process including any subsequent amendments to the work order requested by the client. Documented client approval should be obtained for any changes to the work order issued. Verbally established agreements, requests and changes to the scope of works are considered a form of contract and must be documented, included in contract review processes and confirmed in writing with the client. For routine or repeat work, contract review may be limited to consideration of resource availability. 10.6 All primary records must be made as soon as is practicable. Whatever the recording system used, it should be designed to minimise the need for data and information transfer. 10.7 The policy and system for checking calculations and data transfers must be documented. Corrections to original inspection records shall be initialled and dated by the amending officer. 10.8 The safety of inspection personnel should be considered at all times when conducting inspections, as should protection of the surrounding environment. Safety issues of concern noted by an inspector should be recorded and reported to the site management and the client or those responsible for rectification of the situation. NATA does not define mandatory safety measures but does draw attention to any unsafe work practices that are observed in the course of an assessment. When clauses covering safety are written into standard inspection codes, methods or specifications covered by the scope of accreditation these must be observed by the inspection body. Inspection bodies visiting clients and other organisations must also observe site specific safety requirements.

11 Handling Inspection samples and items 11.1 The system in place must ensure the unique identification of each inspection task or job as well as the individual items within the task or job to enable the appropriate linking of all records. Where appropriate, items under inspection should carry permanent identification labels. 11.2 Inspection records should detail the decisions made by the client regarding the issue. 11.3 Inspection records must clearly detail the client direction regarding inspection item preparation (where appropriate). 11.4 Appropriate precautions include protection of items from corrosion, stress application or contamination that would invalidate inspection/test results or otherwise reduce the serviceability of the item. Relevant client instructions covering the retention, bonded storage, return or disposal, etc of inspection items should be observed.

12 Records 12.1 The records system must provide a traceable pathway covering all activities from the contract review process, through receipt of client/work instructions to the issuing of inspection reports. 12.2 As ISO/IEC 17020 is not prescriptive with respect to what constitutes inspection records, the following must, where appropriate and/or relevant, be considered as inspection records: a) contract review negotiations;

b) client/work instructions (preferably written, with all oral instructions from the client to be recorded);

c) all original notes and calculations taken by the inspector and/or other staff during an inspection; d) original copies or negatives of photographs (including electronic retention of original digital photographic

data);

e) the identity of the staff undertaking part(s) or the whole of the inspection; f) computer data files and/or software programs;



g) reports on sampling, tests and measurements including copies of reports on sub-contracted inspection, sampling and/or testing work conducted;

h) a copy of the inspection report and a record of its distribution; i) records of all discussions with clients during or after the inspection relevant to the preparation of the

inspection report.

j) date and time of inspection. Electronic records involve capture, digitisation, storage and output. Systems to manage electronic records must consider the ability of each step to accurately reproduce the information of interest. Record modification Electronic records (both images and sound) are liable to alteration, clarification or enhancement. While such processing offers a number of benefits to the inspection body, it must be used with care. As ISO/IEC 17020 is not prescriptive with respect to post-capture processing upon digital records, the following must be considered where relevant: a) An original record must be maintained and ultimately archived.

b) The original record must not be subjected to processes that cause permanent alteration. Where processing and/or analysis is required a working copy is needed.

c) The purpose and requirements of the end product drive the selection of enhancement. Therefore, the final use of the record should determine the choice of enhancement.

d) All instances of electronic enhancement of records shall be recorded.

e) Details of the processes used in enhancement must be recorded. This should include all the steps performed in the enhancement operation and the level to which these enhancements were applied. The level of detail required is such as to enable another operator to validate the original enhancement process if required.

12.3 All records must be retained by the facility for a minimum of three years from the date of issue of the inspection report. Statutory and contractual obligations may specify longer record retention periods. The inspection body should also be aware of any client requirements regarding records storage. The inspection body must ensure the confidentiality of all client information obtained in the course of its inspection activities, including the protection of proprietary rights (see clause 5).

13 Inspection reports and Inspection certificates The fact that a client does not require a detailed report does not remove the requirement for detailed inspection records to be kept. 13.2 Inspection reports – content Inspection reports must include as a minimum: a) * a title, e.g. Inspection Report;

b) * identification of the issuing facility by:

• the name in which the accreditation is held , • the accreditation number, • the street address. As required, other unique organisation identification may be used;

c) unique identification of the report on each page;

d) indication of the total number of pages, each page being numbered for multi-page reports; e) * client identification;

f) * identification of the work ordered by the client;

g) * date(s) the inspection was conducted; h) location the inspection was conducted (where appropriate);

i) * inspection procedure or method used or a statement of the work performed, including mention of deviations, additions or exclusions from agreed methods and procedures;

j) * reference to the use of sub-contractors (where appropriate) including identification of the sub-contracted inspection and/or testing results;

k) * identification of the item(s) or material inspected and, where applicable, identification of specific components inspected and/or subjected to more rigorous inspection (for example, NDT);



l) where applicable, details of sampling including methods used and where, when, how and by whom sampling was performed;

m) environmental conditions during the inspection (where appropriate); n) * inspection results including reference to specifications, defects or other non-compliances identified;

o) * a declaration of conformity;

p) statement that the inspection results relate exclusively to the work ordered or to items or the batch inspected;

q) * clear information on what has been omitted if the inspection was not carried out in full as detailed in the original contract/work order;

r) caveats and assumptions made by the facility, and the basis for these (where applicable);

s) reference to sub-contractor’s attached reports (where appropriate - see Note below);

t) clear identification of inspection and test data from non-accredited sources that has been utilised in the inspection (where appropriate);

u) * the name and signature (or electronic equivalent) indicating the authorised issuance/issuer of the documents;

v) date of issue of the report;

w) the correct NATA endorsement (see NATA Rules,) including conditions under which the report may be reproduced;

x) any other information required by the client.

Note : The following information should be included from a sub-contractor’s original report: • name and accreditation number of the accredited sub-contracting facility; • site identification of the report issuing accredited facility; • document identification. A copy of the complete report from the sub-contractor must also be forwarded to the client. Opinions Reporting professional judgement including inspectors notes and calculations based upon published formulae applied to reporting the current status of an inspected item is considered normal inspection reporting practice. Statements unsupported by a body of rigorous and objective analysis are considered expressions of opinion and must be conveyed to clients through a separate document. Use of client’s forms Regulatory authorities or clients may place additional reporting requirements on the reporting of inspection results and these must be addressed. Where client report forms are used, the issuing NATA-accredited facility must be clearly identified on the report. Where such forms do not require the information of items a) to v) above, the facility must retain information sufficient to provide that information if requested. A note to the effect that the client specified the use of these forms must be retained. Inspection certificates As a shorter compliance statement, inspection certificates should include all elements marked above with an asterisk (*). In such circumstances, the facility must maintain separate documentation covering the remaining reporting elements. Progress reports Progress reports issued over an extended period in relation to fabrication, installation, commissioning and/or any other time-dependant inspection activities must each comply with the reporting requirements detailed above. The final inspection report/certificate must reference all progress reports issued. Reports may be handwritten and presented at the inspection site, or typed, checked and formally presented. Site reports and associated work covered by the scope of accreditation must meet all the requirements for accreditation. 13.3 Where electronic means are used to approve an inspection report, the authorised issuance/issuer must be uniquely identified and access to the electronic storage medium strictly controlled.



Report authorisation procedures must be fully documented. It may assist if lists of authorised personnel and their signature are kept on file. Such lists should include the commencement and conclusion dates for such authority. 13.4 Procedures must be documented covering the withdrawal and re-issue of inspection reports when it is required.

14 Subcontracting 14.1 This clause is intended to relate to work that is sub-contracted out by the accredited inspection body. It does not cover staff contracted in to an accredited inspection body to undertake the inspection work within its system. Sub-contracting inspection work out should only be practised in exceptional circumstances, for example: • there is a small part of a big contract not covered by the accreditation; • the inspection body is temporarily unable to carry out work that it normally undertakes or there is an

unforseen or abnormal workload; • specialised activities which are beyond the resources and/or the capability of the inspection body are

required such as testing needed to determine conformity with specifications. The responsibility for determination of conformity remains with the contracting accredited inspection body. It is not the intention of inspection accreditation that it is available to contracting organisations that do not hold the relevant expertise on their staff and do not carry out the inspections themselves. 14.2 The sub-contracting body should hold the relevant inspection (ISO/IEC 17020) or laboratory (ISO/IEC 17025) accreditation for the work it will be conducting on behalf of the inspection body. The contracting inspection body must ensure that: a) written notice is given to the client of the arrangements and that the client’s approval is obtained in

writing; b) all relevant information is provided to the sub-contractor;

c) where possible, endorsed reports are obtained from the sub-contractor for the work conducted. 14.3 Confirmation of current NATA accreditation scope and status will be considered satisfactory investigation of a sub-contractor’s competence. Inspection bodies are reminded however that their service needs may go beyond technical competence and these additional service needs should be considered in identifying suitable providers of sub-contracted services.

15 Complaints 15.1 The procedures should cover the authentication, investigation and resolution processes. 15.2 An appeals resolution system is not required unless the inspection is carried out under legally delegated authority, e.g. when exercising responsibility as a Designated Authority. 15.3 Records must include the authentication, investigation and resolution of complaints.

16 Cooperation Keeping up-to-date with developments in the relevant industry is expected of all facilities. The means by which this may be accomplished include, but are not limited to, attendance at relevant seminars and conferences, professional membership, in-house training sessions, up grading of qualifications, etc.

Annex 3.1

Application of ISO/IEC 17020 to modelling Modelling is the construction of mathematical or physical analogues to objects, systems or environments with a view to the determination of otherwise hard-to-obtain properties. Modelling data may be used to characterise systems of interest, to resolve management problems associated with the object, system or environment, or to predict behaviour under variant conditions.



The modelling process involves the selection of suitable media, then the selection, validation and combination of parameters, to establish a predicted performance. Modelling has application in many fields, including engineering design, design verification, construction and in-service asset management. Parameters that may be addressed in modelling can include load, deflection, fluid flow, signal dissemination, fire propagation, remaining asset life, weather patterns etc. This annex provides additional amplification of those requirements of ISO/IEC 17020 relevant to the accreditation of modelling activities. Where a clause is not included please refer to the general comments of Section 3.

Process background It is assumed that the process flow in modelling an activity may be detailed as in the following table.

Step Process Notes

1 Identification of problem

2 Selection of appropriate modelling technique

A range of physical and mathematical techniques offer solutions

3 Collection of input data Data may be sourced from clients, measurement or other public data

4 Construction of the model May be through physical construction, programming or setting parameters in an existing program

5 Application of data to model Data entry task

6 Determination of outcome Operation of the key algorithms and input data

7 Iterations of modelling Time/step-based development, or noting slight variations from parametric changes

8 Output data analysis As appropriate to task

9 Report generation To include limitations and details of relevant parameters

8 Personnel Where models are developed or adapted for specific jobs, the inspection body shall have staff conversant with the techniques or software used.

9 Facilities and equipment Note: Equipment for the construction of a model may range from workshop machinery to computers. Models may vary from purpose-built structures to electronic configurations and software. In many instances standard modelling tools are modified to suit case-specific applications. 9.6 Where physical analogues of input parameters are required in the model (e.g. masses in some structural models), the equipment shall be appropriately calibrated and the scaled effects of the uncertainty of the analogue upon the outcomes of the model shall be determined. 9.11 Where the analogous performance of the model is determined by environmental considerations (e.g. temperature of a material analogue) the inspection body shall have procedures in place to ensure the continued suitability of the material in question. Computers Where computers are used (in data capture, storage or manipulation) the inspection body shall be able to demonstrate the adequacy of the complete system. Where software is open to modification by the inspection body (at all levels from the algorithm used, the input parameters selected and the match of data to inputs i.e. the extended dataset) the inspection body shall record the extended dataset applied to the model, and shall be able to demonstrate the validity of the inputs used.



10 Inspection methods and procedures Choice of model The inspection body shall provide guidance to staff upon the selection of models appropriate to the job. Worst-case models are to be applied unless reasonable justification is available for not doing so. The inspection body shall perform validation of the model chosen. Validation is understood here to entail the steps necessary to establish that the assumptions and governing equations of the model are relevant to the problem as outlined by the client. Considerations relevant here may include geometry, the size, separation and discretisation of both grid and steps, boundary conditions, spatial, temporal, static/dynamic conditions and other limitations relevant to the problem. The inspection body shall perform verification of the model chosen. Verification is understood here to entail the steps necessary to determine the correctness of the solutions generated by the model, including both algorithm validation and code validation. The inspection body shall also establish systems to control the software in use to ensure that the most appropriate version of software is used in the modelling process. In cases where extensive development of software is necessary, this will include systems for documenting and control of updates and, where necessary, training of staff in new functions. Selection of parameters In many models, appropriate parameters will not be available. Examples where this may arise include job specific parameters (such as crushability and impact resistance) or where parameters are not consistently defined between designer, specifier and manufacturer (e.g. ‘Yield strength’ can have at least 4 different definitions). Frequently solutions to this matter involve the substitution of alternative parameters or the use of approximations. Where such substitution or approximation is applied to a model the justification of the substitution or approximations shall be recorded by the inspection body. Relevance of data The inspection body shall identify all data sources, and any data validation performed, that are used in the model. There shall be an evaluation of the possibility and consequences of parameter variation under conditions of interest. Note : Product datasheets typically report single-point values under standard or stable conditions. Such data may not be suited to application in modelling dynamic conditions. Inspection bodies should establish property profiles considering the potential variation in environmental conditions in the model. Where data sources are based upon statistical data the inspection bodies shall detail the assumptions pertaining to the distribution and homogeneity of samples contributing to the data. In some models the properties of interest may be influenced by transient or ephemeral sources adjacent to the field of interest. Where possible the effect of uncontrolled influences from adjacent sites are to be accommodated in the model and reported. This may be by estimation, approximation, direct measurement or other means. The means of identifying the magnitude of such influences is to be identified and reported. Output constraints The inspection body must consider issues of rounding of output data and issues related to non-linear responses / interpolation between grid points. Where such issues have the potential to be significant they must be reported. Iterations The reasons for the application of iterations and the application of changes to the extended dataset shall be recorded. Confirmatory testing Where possible, modelling statements should be corroborated by confirmatory testing – relating data generated back to:

• Standard test results; • Full-scale test results; • Previous experience; • Accepted benchmarks; • Other quantitative means.

Records of such confirmatory testing shall be kept.



12 Records Records must be sufficient to allow replication of the model by an equivalent organisation. Records of validation, verification and confirmatory testing shall be kept.

13 Inspection reports and inspection certificates Inspection reports and inspection certificates must include the following data:

• General problem description; • Model objectives; • Model selected; • Software used; • Data set up and sources; • Model set-up including geometry, discretisation, boundary conditions and model features; • Results; • Sensitivity of results to parametric variation, including measurement uncertainty; • Limitations of the model applied; • Discussion of results.

Section 4

Calibration guidance for Inspection Bodies ISO/IEC 17020 provides little guidance upon the calibration of equipment used by inspectors. In summary the requirements state that equipment is to be: suitable, maintained and (where appropriate) calibrated to ensure traceability to national or international standards of measurement. In the standard the detailed interpretation of the appropriateness of calibration and the extent to which traceability is to be established are left to the discretion of the inspection body. For the purposes of accreditation, the guidance of HB 86.1 - The selection, care, calibration and checking of measuring instruments in industry is acknowledged. Clearly the contribution of equipment variation to the overall result and the expected accuracy of measurement as set out by codes and contract will influence these decisions. In setting out the guidance below, it has been noted that for inspection bodies:

• Many measurements are indicative rather than critical to the inspection process; • A range of measurements and measurement accuracy (measurement uncertainty) will be required,

and the required uncertainties will be determined by client, standard or circumstance; • Frequently the quantities involved are outside the calibration ranges relevant to laboratories (e.g.

kilometre baselines).

Implications for inspectors The implication of uncertainty of measurement for the inspector is to reinforce the basis of good measurement practice, notably the selection of appropriate techniques and suitable measuring equipment to achieve an adequate level of confidence in the validity of measurements taken. The inspector may encounter a range of situations, as follows: a) In many situations measuring equipment will be indicative, and neither accept/reject criteria nor

compliance data will be derived from the measurement. Under these conditions calibration and measurement performance are probably not relevant.

b) In most inspections it is sufficient that measuring equipment be demonstrated to comply with a recognised standard. Typically this approach will use a maximum permissible error (MPE) or a limit of performance (LoP) philosophy. Uncertainties of measurement arising from calibration are normally much less than instrument errors and may be reasonably ignored.

c) In some inspections where a higher level of measurement is required the inspector will apply the corrections provided in the calibration certificate. Under these circumstances the ‘corrected value’ will have a corresponding uncertainty. Inspectors are reminded that uncertainties reported in calibration certificates relate to the calibration system operating under laboratory conditions. Uncertainty in outputs from measuring devices in uncontrolled environments as are encountered in the field or workshop may be much greater.

d) In some instances the performance of the measuring instrument will be significantly better than that demanded by the application. Under these circumstances an evaluation of the risks associated with variation in measurement may suggest that a relaxation of the acceptance requirements for instrument performance will not deleteriously affect the quality or acceptability of measurements. Such a relaxation is acceptable where documentary records of the evaluation are retained.



Metrological traceability NATA’s policy for metrological traceability requires that the results of all tests, measurements and calibrations, together with the assigned values of reference materials, that have a significant effect on the reported result and associated uncertainty of measurement, to be traceable, where possible to national or international standards. To ensure this policy is maintained, all facilities must:

Have relevant equipment calibrated by one (or more, if relevant) of the organisations included below:

a) a NATA accredited calibration facility and the results reported on a NATA endorsed document;

b) a calibration facility accredited by one of NATA’s mutual recognition arrangement (MRA) partners, when the MRA recognition covers calibration and the results are reported on an endorsed document;1

c) Australia’s National Measurement Institute (NMI) or a national metrology institute that is a signatory to the Comité International des Poids et Mesures (CIPM) MRA.2

Notes: 1. For details of NATA’s current MRA partners, refer to NATA’s website: www.nata.com.au.

2. The calibration must actually be done by the NMI. Unendorsed reports from organisations claiming traceability to a NMI or those bearing only an ISO 9000 series certification logo are not acceptable.

Note: National Measurement Act

The National Measurement regulations contain schedules listing the maximum permissible variations and maximum permissible uncertainties that are required for various reference standards and measuring instruments.

Identification of critical parameters A facility must demonstrate how it has determined which parameters are critical (and non critical) to the overall quality of results. As an example, critical parameters may be analytical or quantitative data, or measurements which have a significant contribution to the final result and associated measurement uncertainty.

Definitions

‘Metrological Traceability ’ is the property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations , each contributing to the measurement uncertainty (ISO/IEC Guide 99 (2007) – 2.41). Applying this definition, the measurement uncertainty must be determined for each link of the traceability chain back to a realised standard. The last step of the link must also be included e.g. equipment calibrated in-house through use of a reference item or reference material. To demonstrate evidence of measurement traceability, each link of the traceability chain, including its measurement uncertainty, must be reviewed. NATA’s policy for measurement traceability is detailed in Policy Circular 11. ‘Calibration ’ is an operation that, under specified conditions, in a first step, establishes a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications with associated measurement uncertainties and, in a second step, uses this information to establish a relation for obtaining a measurement result from an indication (ISO/IEC Guide 99 (2007) – 2.39). As detailed in Policy Circular 11, calibrations are normally carried out by an external calibration authority and an endorsed test report is obtained for this work. For calibrations performed in-house, a facility must demonstrate the capability to do so according to the criteria set out in NATA Policy Circular 12. Note: Some items of equipment such as sound level meters are designed to have a level adjustment before each use by applying a known source to the input of the instrument. Although sometimes called a ‘calibration’ or ‘internal calibration’ by the manufacturer, it is a single point level adjustment and is not to be confused with a full calibration which provides measurement traceability across the instruments full measurement range.



‘Check’ is a measurement of at least one point in a range of a measuring instrument or system or material against a known value to confirm that it has not deviated significantly from its original calibrated value. It is also an examination of the condition of an artefact i.e. the reference of known value, to determine that it has not been adversely affected by constant use. Checks are usually carried out in-house by the facility staff. If, however, the checks are carried out by an external authority then an endorsed report must be obtained. By performing a check on an instrument, a facility is able to determine if the instrument has changed since its last calibration. By performing regular checks, the interval between periodic calibrations may be extended. Alternatively, in some applications, where an instrument is used for indicative results and it has been determined that measurement traceability is not required, a check of the instrument’s measurement functionality may be deemed acceptable. Calibration and checking intervals

Facilities are responsible for establishing their own equipment assurance program. This is to ensure that all equipment used satisfies the need to produce consistent and reliable and where appropriate, traceable results. When establishing an equipment assurance program, consideration should be given to the following: • history of stability; • frequency of use; • accuracy required; • requirement for traceability of measurement; • ability of staff to perform in-house checks; • successful participation in proficiency testing programs. • Client and stakeholder specifications for equipment validation • variation to the frequency of checks and calibrations in cases of damage and/or non-use. NATA encourages facilities to develop equipment assurance programs. These programs move the emphasis from a high reliance on demonstration of equipment conformance at the time of calibration to: • having a greater contribution from more frequent checks against reference items or materials; • cross-checking against similar systems; • the checking of particular critical features. Equipment calibration and check programs should cover: • commissioning of new equipment (including initial calibration and checks after installation); • operational checking (checking during use with reference items or materials*); • periodic checking (interim but more extensive checking, possibly including partial calibration); • scheduled maintenance by in-house or specialist contractors; • complete recalibration. Note: * If no appropriate reference items or materials are available, then the facility shall demonstrate that the alternatives used have sufficient traceability, stability, homogeneity and accuracy such that the method and subsequent results can be deemed fit for purpose. Full details of the documents referenced may be found in Section 6.

Hired or borrowed equipment There are no additional calibration or check requirements for equipment that has been hired or borrowed either from within or externally from an organisation. A facility must be able to provide documentary evidence that the equipment has been appropriately calibrated and/or checked. Organisations must document if any additional checks are required (due to transportation, rough handling, temperature variations, etc.) in order to validate the calibrations that normally apply.



Storage of equipment including reference equipment All equipment must be stored in an environment that does not affect its calibration or check status. If the item has been subject to severe use or extreme environment, then the effect on the invalidation of the calibration or check must be considered. Extra care must be taken when using reference equipment to ensure that it is not damaged in any way when in use.

Calibration details The following table provides details of recommended calibration intervals for equipment under conditions of ideal use. Environmental conditions, operation and operator may all influence the quality of any particular measurement. For any given application the suitability of measurement techniques and systems must be considered, taking into account factors that will influence the result.

Calibration guidance for common measuring equipment Item of equipment Calibration

interval (years)

Checking interval (months)

Procedures and references

Length measurement

Callipers (vernier) 2 AS 1984

Dial Gauges 2 AS 2103

Feeler Gauges 2 AS 1665

Gauge blocks, jigs, go/no-go gauges

–used as reference standards

4 then 8 years

–used as working equipment 2 then 4 years

Micrometers 5 AS 2102

12 Check zero and one point against gauge block. Inspect anvils.

Steel rules Initial BS 4372

Tape measures Initial AS 1290.4, BS 4035

24 to 60 Check at maximum length, depending on use and accuracy required.

Force Measurement (electronic indicators)

2 AS 2193

Pressure equipment

Test gauges used for calibration of industrial gauges

1 AS 1349

Industrial gauges not subject to shock loading

1 AS 1349

Industrial gauges subject to shock loading

6 months AS 1349

Pressure transducers 1 AS 1349

Other Quantities

Digital equipment, including electrical meters and digital thermometers

1 As per manufacturer’s instructions



Notes 1. SAA/SNZ HB 86.2:1998 The selection, care, calibration and checking of measuring instruments in

industry: Simple length and angle measuring instruments

Section 5

Categories of Inspection The following is a listing of the categories and subcategories available in the Inspection program. When detailing a scope of accreditation, the following principles will be applied in all instances. The appropriate category and sub-category will be selected for the inspection activity. Free text further defining and/or limiting the technical capability of the organisation that NATA has assessed will be added. Groups of three lines of text will normally be used as follows:

• ‘type’ of inspection conducted (e.g. design verification / survey / modelling / in-service inspection etc) • all applicable codes, methods, specifications or procedures will be listed • free text words covering any competency limitations not already defined within the above

parameters. A typical example of this is as follows: 02. Industrial equipment and machinery .01 Pressure equipment

In-service inspection Code(s): AS/NZS 3788 Unfired pressure equipment only

Categories 01. Agriculture and agricultural products .01 Livestock .02 Meat products .03 Milk and milk products .04 Crops .05 Grain products .06 Wool .07 Seed production .99 Other 02. Industrial equipment and machinery .01 Pressure equipment .01 Design verification .02 Fabrication inspection .03 In-service inspection .04 Witnessing .02 Lifting and lifted equipment

.01 Lifting devices .02 Lifted equipment .03 Rigging .04 Rigging components .05 Cranes .06 Crane components .07 Elevators and lifts .08 Conveyors .09 Forklifts .10 Fall arrest systems .11 Anchorages and holding points .12 Goods lifts .13 Motorised and static ladders (naval)

.03 Mobile equipment .04 Industrial machinery .05 Explosion-protected equipment .06 Coatings and corrosion .07 Construction equipment



.08 Fabricated assemblies and structures .09 Electric generators, motors and related equipment .10 Power transmission equipment .11 Fixed plant .12 Pipelines .13 Pressurised machines .14 Storage tanks .15 Temperature controlled equipment .16 Functional safety .17 Diesel engine systems .99 Other 03. Manufactured goods .01 Fabricated metal components and products .02 Moulded polymers and composites .03 Electrical and electronic products

.01 Electromagnetic compatibility .02 Electrical safety .03 Risk assessment .04 Software

.04 Food and beverages .05 Textiles and textile products .06 Refractories and ceramics .07 Timber products .08 Gaming systems .09 Medical devices .99 Other 04. Natural resources and refined products .01 Ores and minerals .02 Ore concentrates and metals .03 Coal and coke .04 Gas, petroleum and petrochemical products .05 Timber .99 Other 06. Building construction and maintenance .01 Commercial buildings .02 Residential buildings .03 Roads and associated works .04 Temperature control and associated plant .05 Coatings and corrosion .07 Building products .08 Earthworks .09 Underground conduits .10 Steel fabricated structures and assemblies .11 Concrete structures .12 Telecommunications cabling .13 Utilities metering .14 Fire protection equipment .15 Playground equipment .16 Signage .17 Barriers .99 Other 07. Transport .01 Aviation .02 Road .03 Rail .04 Marine surveying and seaworthiness .05 Cargo verification .06 Transport infrastructure .99 Other



08. Accommodation 09. Environment .01 Landform .02 Soil and geotechnical .03 Vegetation .04 Hydrology .05 Biota .06 Atmosphere .07 Contaminated sites .08 Odour .09 Noise and vibration .10 Built environment .11 Electromagnetic fields 10. Inspection of processes .01 Welding .02 Coatings .03 Packaging .04 Labelling .05 Cleanliness .06 Contamination .07 Product identification .08 Product traceability .09 Process readiness .10 Expediting .11 Witnessing .12 Process surveillance 90. European regulatory requirements .01 Machinery Directive .02 Simple Pressure Vessels Directive .03 Electromagnetic Compatibility Directive .04 Low Voltage Equipment Directive .05 Telecommunications Terminal Equipment Directive

Section 6

References This section lists publications referenced in this document. The year of publication is not included as it is expected that only current versions of the references shall be used. APLAC Documents APLAC TC 006 Guidance Notes on ISO/IEC 17020 Australian Standards AS 1290.4 Linear measuring instruments used in construction - Retractable steel pocket rules AS 1349 Bourdon tube pressure and vacuum gauges AS 1665 Feeler gauges (metric units) AS 1984 Vernier callipers (metric series) (ISO 3599) AS 2102 Micrometer callipers for external measurement (ISO 3611:1978) AS 2103 Dial gauges and dial test indicators (metric series) AS 2193 Methods for calibrating and grading of force measuring systems of testing machines AS/ISO Standards AS ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories AS/NZS Standards AS/NZS ISO/IEC 17020 General criteria for the operation of various types of bodies performing

inspection SAA/SNZ HB 86 The selection, care, calibration and checking of measuring instruments in industry .1 General principles



Other national Standards BS 4372 Specification for engineers' steel measuring rules ILAC Documents ILAC P10 ILAC Policy on Traceability of Measurement Results ILAC/IAF A4 Guidance on the Application of ISO/IEC 17020 ISO Documents ISO 9004 Quality management systems - Guidelines for performance improvement ISO Guide 34 General requirements for the competence of reference materials producers NATA Documents NATA Policy Circular 11 Policy on Metrological Traceability NATA Policy Circular 12 NATA Requirements for the performance of calibrations in-house NATA Policy Circular 15 Recognition of ISO 9001 certification at NATA assessments NATA Policy Circular 18 Use of the NATA Emblem, NATA Endorsement and references to accreditation NATA Policy Circular 2 Proficiency Testing Policy Guidance documents covering the implementation of specific accreditation requirements are available from the ILAC (www.ilac.org) and APLAC (www. aplac.org) websites.