TR 78-02 - Sanas

DEPARTMENT OF HEALTHTR 78-02DEPARTMENT OF HEALTH (DOH) AND SANASTECHNICAL REQUIREMENTS FOR THE APPLICATION OFSANS/ISO/IEC 17020: 2012 FOR TESTING OFDIAGNOSTIC X-RAY IMAGING SYSTEMSBY INSPECTION BODIESApproved By:Chief Executive Officer: Ron JosiasSenior Manager: Mpho PhaloaneReviewed by: Lead Assessor: Eben SmitDate of Approval: 2012-07-26Date of Implementation: 2012-07-26©SANAS Page 1 of 15

TR 78-02CONTENTS0. Introduction ................................................................................................................. 31. Scope ......................................................................................................................... 32 Normative References ................................................................................................ 43. Terms and Definitions ................................................................................................. 44. General Requirements ................................................................................................ 45. Structural Requirements ............................................................................................. 56. Resources .................................................................................................................. 77. Process Requirements................................................................................................ 98. Management System Requirements ......................................................................... 119. List of Approved Inspection Authorities ..................................................................... 13APPENDIX 1: Schedule of Accreditation ...................................................................... 14ADDENDUM 1: Amendment Record .................................................................................. 15©SANAS Page 2 of 15

TR 78-020. IntroductionGeneral requirements for Inspection Bodies specialising in testing of Diagnostic X-ray ImagingSystems in South Africa is laid down in the Department of Health (DoH) Licence conditions forDiagnostic X-ray Imaging Systems and the international standard SANS/ISO/IEC 17020. Theserequirements are quite comprehensive and detailed but explanations provided in this documentmay be helpful to ensure consistent application of the Standard(s) and Regulation.The structure of this document reflects that of the standard SANS/ISO/IEC 17020 including titlesof clauses and their numbering. To facilitate future reference to the explanations the paragraphsof this document are consecutively numbered within each commented sub-clause.The interpretative guidance notes are intended neither to add to nor subtract from therequirements of SANS/ISO/IEC 17020. They are intended to clarify the requirements to assistInspection Bodies for Electrical Inspections in practically implementing the standardSANS/ISO/IEC 17020 and to minimise differences of interpretation. This document should beread in conjunction with the standard SANS/ISO/IEC 17020.The term "shall" is used throughout this document to indicate those provisions, which, reflectingthe requirements of SANS/ISO/IEC17020, are mandatory. The term "should" is used to indicatethose provisions, which, although they constitute guidance for the application of the requirements,is expected to be adopted by an Inspection Body. Any variation from the guidance by anInspection Body shall be an exception. Such variations will only be permitted on a case-by-casebasis after the Inspection Body has demonstrated to the SANAS that the exception meets therequirements of the relevant clause of SANS/ISO/IEC 17020 and the intent of this Guidance insome equivalent way.Note: The term for Diagnostic X-ray Imaging Systems Inspection Body and Inspection Body isconsidered synonymous throughout this document.In case of dispute concerning application of this document, Department of Health and SANAS willadjudicate on unresolved matters.It is intended that after a certain period of use, the content of this document will be revised.CopyrightThe copyright of this text is jointly held by SANAS and the Department of Health (DoH). The textmay not be copied for resale.1. Scope1a Testing performed by Inspection Bodies may fall in two (2) categories namely functionaland analytical. Functional testing is within the scope of SANS/ISO/IEC 17020. Analytical testing, forexample air or metallurgical analysis, is a Laboratory activity and therefore does not fall within thescope of SANS/ISO/IEC 17020. Approved Inspection Authorities wishing to undertake suchLaboratory type analytical testing as part of an Inspection Body will need to do so in accordance withthe relevant requirements in SANS/ISO/IEC 17025: 2005.1b If accredited Inspection Bodies decisions are reliant upon analytical test results or theresults of any sub-contracted specialist service, these tests or services shall, where possible, becarried out by appropriately accredited, as part of the ILAC Multilateral Arrangement, organisationsand the results must be in the form of an endorsed certificate or report.©SANAS Page 3 of 15

TR 78-022 Normative ReferencesThe following referenced documents are indispensable for the application of this document. For datedreferences, only the edition cited applies. For undated references, the latest edition of the referenceddocument (including any amendments) applies.2.1 ISO/IEC 17000, Conformity assessment — Vocabulary and general principles2.2 Hazardous Substances Act. Act No: 15 of 1973 as Amended3. Terms and Definitions3.1 Inspection3.1a Throughout these interpretative notes the word “product” should be understood to includethe words “product design”, “service”, “process” and “plant” as specified in clause 2.1.of thestandard.3.1b In recognition of the wide range of industries represented by Inspection Bodies’ alternativeterminology could be used for what is inspected.3.1c For professional judgement to be exercised the staff member responsible for theInspections, referred to in Clause 6.1, shall personally perform the Inspections or effectivelysupervise the Inspection Body.3.2 Inspection BodiesAn Inspection Body is a legal entity approved by the Regulator that is accredited by SANAS inrespect of the competence of its personnel, equipment, procedures and environment, in accordancewith the requirements of SANS/ISO/IEC 17020 and any additional requirements that might bedetermined by the Regulator from time to time.3.2a An Inspection Body may consist of one (1) person provided the requirements of all relevantclauses of SANS/ISO/IEC 17020 are fulfilled. An Inspection Body can be an organisation, or part ofan organisation.4. General Requirements4.1 Impartiality and independence4.1.2a Explicit guidance shall be documented for instances where staff experience undue pressurefrom any source, internal or external to the organisation, which could influence the results ofassessments. Such pressures could include threats, inducements, unreasonable time pressures, bonusschemes, productivity incentives, etc. Records of any unreasonable pressure experienced by a QA X-Ray Technical Signatory and the Inspection Body’s response to it should be retained. See 17020clause 6.1.12 a well4.1.3a The inspection body shall document risks to its impartiality on an on-going basis. Thestandard, ISO 31000 - Risk management - Principles and guidelines and related documents may be auseful document to assist with the approach to the identification of risks.4.1.6a The categorisation of Inspection Bodies as Type A, B or C is essentially a measure of theirindependence. Demonstrable independence of an Inspection Bodies may strengthen the confidence ofthe Inspection Bodies’ customers in the body’s ability to carry out inspection work with impartiality andobjectivity.©SANAS Page 4 of 15

TR 78-024.2. Confidentiality4.2.1a The Inspection Body shall have a policy, documented in its management system, concerningthe observance of the confidentiality requirements of the customer, by the inspection body (see clause 7of SANS/ISO/IEC 17020) and by any sub-contractors engaged by it (see clause 6.1.13 ofSANS/ISO/IEC 17020), taking into account any relevant legal requirements.4.2.2a For mandatory inspections the procedures should set out who, besides the customer, isentitled to have access to the results.5. Structural Requirements5.1. Administrative Requirements5.1.1a The Inspection Body should be a registered juristic person (corporate body). Companyname, address, names of directors, contact numbers and registration number shall be made available.No “Sole Proprietor”.5.1.1b Approval, which is subject to additional conditions, is granted by the Department of Health(DoH). While accreditation is a prerequisite for approval, the possession of such accreditation does notimply an assurance that approval will be granted. The DoH may set additional conditions beforeapproval is granted.5.1.1c Upon obtaining accreditation and subsequently approval, a certificate that contains the name,location of the Inspection Bodies, the name of the responsible person (however named) and approvedsignatories, and the type (scope) shall be issued. The certificate of approval issued by the DoH, andcertificate of accreditation from SANAS shall be prominently displayed at all times.5.1.2a An organisational diagram is the most common means of illustrating the position of theInspection Body in relation to a larger organisation. Diagrams showing relationships with relatedcompanies or organisations and relationships between departments within the same organisation areuseful support for claims of independence5.1.3a SANAS presents the scope of activity for which accreditation of Inspection Body is granted ina formal statement, called the Accreditation Schedule that accompanies the Accreditation Certificate.The Accreditation Schedule is produced by the SANAS in consultation with the assessor(s) involved inthe assessment of the Inspection Body. It is based on information provided by the Inspection Body inconnection with the application for accreditation and the demonstrated and verified competence of theInspection Body. See Annex 1 for guidance.5.1.3b The Scope of Accreditation shall be defined in the schedule in sufficiently precise terms thatpotential customers may establish accurately and unambiguously the general field of inspection, thetype and range of inspection and, where applicable, the regulations, standards or specificationscontaining the requirements against which the inspection will be performed.5.1.3c Contracts or work orders for inspection should ensure that there is a clear and demonstrableunderstanding between the Inspection Body and its customer of the scope of the services to beundertaken by the Inspection Body. In many inspection areas (e.g. in-service inspection based onnational regulations) individual contracts are not signed with customers. In these cases, the work ordermust be contained in some underlying documentation, e.g. regulations issued by regulatory authorities.5.1.4a The Inspection Body is expected to be able to show what factors have been taken intoaccount when determining the necessary level of insurance or reserves. One of the factors that shouldbe taken in to account is the risks associated with the performance of inspection activities.©SANAS Page 5 of 15

TR 78-025.1.4b It is not the role of accreditation bodies to approve the level of insurance cover or reservesheld by their customers. The types of liability covered by insurance, for example, may includeemployers’ liability, public liability and professional indemnity.Note: Inspection Bodies should pay particular attention to insurance cover when undertakinginspection work in another country, where legal requirements may differ from those in the body’s homecountry.5.1.5a The conditions referred to here is contractual conditions not physical conditions of InspectionBody sites. Items, which are commonly included in these conditions, include: access to documented inspection history responsibility for safe site access availability of key personnel preparation of items for inspection response to adverse weather conditions level of reporting terms of payment etc.5.2. Organisation and Management5.2.1a The size, structure and composition of an Inspection Body which taken together should besuitable for the competent performance of the tasks with which the Inspection Body is concerned.5.2.1b A one person ‘organisation’ may be accredited provided all relevant clauses of SANS/ISO/IEC17020 are effectively implemented.5.2.3a The Inspection Body should maintain an up-to-date organisational chart clearly showing thefunctions and lines of authority for staff within the Inspection Body and the relationship, if any, betweenthe Inspection Body’s function and other activities of the organisation. The position of the TechnicalManager and Quality Manager (however named) shall be clearly shown in the chart.5.2.3b For each position in the organisation that could have an effect on the quality of assessments,or records of inspections, details of responsibility should be included in the management systemdocumentation. This may include clerical staff.5.2.3c The degree of complexity of documentation and the extent to which staff members can holdseveral functions will depend upon the size of the organisation.5.2.5a Different persons may take up the role of technical manager for different activities. Wheremore than one person acts as the technical manager, the specific responsibilities of each person mustbe defined and documented.5.2.5b The Technical Manager of the Inspection Body shall:a) Be responsible for ensuring compliance with all requirements of the relevant standards andregulations;b) Be knowledgeable about the hazards, procedures and equipment associated with theinspections;c) Be familiar with the general requirements as appropriate to the accreditation granted of standardsand regulations;d) Not be impaired by the execution or responsibilities of duties extraneous to the operation of theInspection Body; and,5.2.6a The purpose of nominating a deputy is to satisfy the need for competent management in theabsence of the manager.5.2.6b In a small organisation, where the absence of a key person causes the cessation of work, therequirement for deputies may be waived.5.2.7a Positions, which could affect the quality of inspection services, including managerial andinspectors as well as clerical staff shall be described.©SANAS Page 6 of 15

TR 78-026. Resources6.1 Personnel6.1.1a The Inspection Body shall define and document the competence requirements for allpersonnel (see also clauses 6.1.4 and 6.1.5 of SANS/ISO/IEC 17020). SANAS shall assess theappropriateness of the competence requirements, education, training, technical knowledge, skills andexperience for the scope of inspections to be accredited.Note: Achievement of qualifications and completion of training and experience is not a guarantee ofpractical competence in inspection or the development of sound professional judgement.6.1.5a SANAS shall assess the documented procedures and mechanism for selecting, training,formally authorizing, and monitoring inspectors and other personnel involved in inspection activities.See clause 6.1.10 as well.6.1.5b The purpose of these records is to demonstrate that the Inspection Body managementconsiders each member of staff to be competent to perform specific inspection tasks and, whererelevant, to use specific equipment.6.1.8a The Inspection Body should be able to demonstrate that it is organised in such a way that thework of the staff performing inspections is supervised by personnel who are familiar with the objectivesof the inspections, the inspection methods and procedures being used and the inspection results. Theextent, nature and level of supervision exercised should take in to account the qualifications,experience, training and technical knowledge of the Inspection Body staff and the inspections beingundertaken.6.1.8b Identification of training needs for each person shall take place at least once per year. Thisreview shall result in documented plans for further training or a statement that no further training isrequired for the individual at present. Training records should normally be signed by the individual andthe reviewer. (If training needs assessment records are not signed, they must include the identity of thereviewer.) A statement that no further training is needed shall be interpreted as an endorsement, by theorganisation, of the person’s competence in all aspects of their role at the date of the review.6.1.8c Where records indicate that a member of staff has not maintained current involvement in aparticular skill area, the Inspection Body must have documented procedures for managing theprogressive reduction of current knowledge, which inevitably results. Procedures must also be in placefor providing refresher training where required.6.1.9a Monitoring of performance of inspections should include On-site witnessing of inspections.On-site witnessing of inspections should be carried out by technically competent personnel, who aresufficiently independent to carry out the witnessing of inspections objectively6.1.9b Monitoring of performance of inspectors may include, but not be limited to, the regular reviewof inspection reports to ensure that they are in accordance with relevant legislation, procedures and asnecessary, contractual obligations agreed with the customer. (See also clause 7.1.5)6.1.10a The Inspection Body’s programme for witnessing inspectors should be designed so that arepresentative sample of inspectors is witnessed. As a minimum, every inspector should be witnessedat least once during the normal accreditation cycle (4-years) performing each field of inspection forwhich they are authorised by the inspection body. Records of observed inspections shall be kept.6.1.12a The purpose of this clause is to reduce the potential for Inspection Body results to becompromised by financial pressures.©SANAS Page 7 of 15

TR 78-02Table 1. – Qualifications RequirementsThe table below sets out minimum qualifications and experience requirements that are deemed such to ensurecompetence to the required functions of an Inspection Body.TITLEEDUCATIONALQUALIFICATIONSPRACTICALEXPERIENCETRAININGTechnical Manager(however named)Matric plus 3 years in arelated field4-Years’ experience intesting of Diagnostic X-rayImaging Systems perscope of accreditationSpecific courses / training inthe field of accreditation froman SAQA accredited institutionTechnical Signatory(Inspector)(however named)Matric plus 3 years in arelated field.Note: In the event thata person does not fullycomp2-Years’ experience intesting of Diagnostic X-rayImaging Systems perscope of accreditationSpecific courses / training inthe field of accreditation froman SAQA accredited institutionQuality Manager(However named)Specific courses /training in the field ofInspection Bodymanagement systemsexperience in the field ofInspection Bodymanagement systemsSpecific courses / training inthe field of Inspection Bodymanagement systemsNote 1: All registrations prior to publication of this document will remain valid until such time an equivalence ofqualification structure is in place to certify equivalence of the qualification required above.Note 2 In the event that a person does not fully comply with the education and qualification criteria theInspection Body may apply for special permission to take prior learning experience and knowledge intoconsideration6.2. Facilities and Equipment6.2.1a If an Inspection Body does not have suitable and adequate facilities and equipment to servicetheir scope of accreditation it may be grounds for withholding accreditation.6.2.1b The management systems should include procedures to ensure the safety of personnel and,where appropriate, protection of the surrounding environment6.2.2a Use of facilities and equipment by unauthorised persons shall not be permitted. If any item isfound to have left the Inspection Body’s direct control, measures must be taken to confirm its continuingsuitability before its return to use for accredited work. Typical measures would include visual inspection,functional checks and/or re-calibration/ validation.6.2.4a It is the responsibility of the Inspection Body to define the equipment that may have asignificant influence on the results of inspections. SANAS shall assess the appropriateness of theequipment defined.6.2.4b Unique identification of items of equipment is important even when the organisation has onlyone example of a particular item. This enables tracking when items are replaced for whatever reason.6.2.6a Equipment identified under the criteria in clause 6.2.4, as clarified in 6.2.4a, must be traceablycalibrated to national or international standards where possible. For guidance on measurementtraceability, refer to SANAS TR 25 document.6.2.6b Where the calibrations are performed in-house, traceability to national standards shall beassured by using reference standards of measurement for which the Inspection Body holds a currentcalibration certificate or equivalent from a competent body. The certificate or equivalent shall detail anuncertainty of measurement that is appropriate for the equipment that is to be calibrated from thereference standard. For further information on uncertainty of measurement, see ISO/IEC Guide 98.www.iso.org6.2.7a Measurement traceability can be provided only by a National Metrology Institute (NMi) or acalibration Laboratory appropriately accredited to SANS/ISO/IEC 17025 as part of the ILAC MRA.Calibration certificates from these sources will include statements of uncertainty.©SANAS Page 8 of 15

TR 78-02Equivalent calibration Laboratories from other countries may also be used, provided that they haveestablished an acceptable traceability of measurement chain. Such traceability of measurement isprovided by national metrology institutes participating in internationally recognised inter-institutecomparisons and by laboratories accredited by bodies that are signatories to the ILAC multilateralagreement on calibration.6.2.7b Measurements, which do not have a direct effect on inspection decisions, do not need to betraceably calibrated. Equipment used for these indicative measurements must be maintained in aserviceable condition. Measures to confirm serviceability may include visual examination for wear ordamage and in-house “calibration” by comparison against a traceably calibrated reference instrument orartefact.NOTE: “Calibrations” performed in this way are not traceable according to the internationally accepteddefinition and cannot be used as references for further calibration. Instruments “calibrated” in this wayshall not normally be used for measurements critical to Inspection Bodies’ decisions.6.2.9aRecords of in-service checks shall be maintained.6.2.13a In-house developed software such as spread-sheets shall be validated by processing a knowndata-set and performing equivalent manual calculations on the same data-set. Records of validationsshall be maintained. The data set used for validation shall be run from time to time to confirmcontinuing validity of the software. Validation checks shall be recorded.6.2.13b If software validation checks identify anomalies corrective action shall be taken.6.2.13c All software, including proprietary products, shall be controlled in a way similar to hard-copydocuments. Records of version numbers and dates when these came into and went out of service shallbe maintained.6.2.13d Where electronic records are the primary storage medium appropriate methods such asregular backup and offsite safekeeping of backups should be implemented. Frequency of backups shallbe set to reduce the risk of loss to an acceptable level.6.2.14a Records of the examination of the effect of defects on previous inspections, and whennecessary, appropriate corrective action taken, shall be recorded.6.3 Sub-contracting6.3.2a The Inspection Body’s communication to inform the customer of its intention to sub-contractany part of the inspection should be maintained. This may form part of the contract review process andrecords.7. Process Requirements7.1 Inspection method and procedure7.1.1a The Inspection Body’s communication to inform the customer if the inspection methodproposed by the customer is considered to be inappropriate should be maintained. This may form partof the contract review or works order control process and records.7.1.5a Where appropriate (see note) each contract or request should be reviewed by the InspectionBody to ensure that:1. the Inspection Body has the capability to meet the customer’s requirements, and2. the customer’s requirements are adequately defined, documented and understood, and3. contract conditions are agreed, and4. special equipment needs are identified, and5. personnel training needs are identified, and©SANAS Page 9 of 15

TR 78-026. statutory requirements are identified, and7. special safety requirements are identified, and8. the extent of sub-contracting arrangements required are identified, and9. documentation needs are identified, and10. the final contract or request accepted by the Inspection Body agrees with the originalversion that was reviewed as in (1), (2) and (3) above.Records of contract review shall be retained.Note: For routine or repeat work requests, review may be limited to considerations of time andhuman resources and an acceptable record in such cases would be a signed acceptance of the contractby an appropriately authorised person.7.1.5b In situations where verbal agreements are acceptable, the Inspection Body should keep arecord of all requests and instructions received verbally, dates and the identity of the customer’srepresentative7.1.7a Worksheets, notebooks, raw data etc. used to record observations during inspections shall beretained for reference for a defined period.7.2 Handling inspection items and sample7.2.1a The Inspection Body shall have a system for identifying inspection and/or test items. Theidentification shall be retained throughout the life of the item for inspection. The system shall bedesigned and operated to ensure that items cannot be confused physically or when referred to inrecords or other documents. The system shall accommodate, if appropriate, a sub-division of groups ofitems and the transfer of items within and from the Inspection Body.7.2.4a The Inspection Body shall have procedures and appropriate facilities for avoidingdeterioration, loss or damage to the inspection or test item during storage, handling and preparation.Handling instructions provided with the item shall be followed. When items have to be stored orconditioned under specified environmental conditions, these conditions shall be maintained, monitoredand recorded.7.2.4b Where inspection or test item or a portion of an item is to be held secure, the Inspection Bodyshall have arrangements for storage and security that protect the condition and integrity of the secureditems or portions concerned.7.3 Inspection Records7.3.1a The Inspection Body shall retain records of original observations, derived data and sufficientinformation to establish an audit trail, calibration records, staff records and a copy of each inspectionreport or inspection certificate issued, for a minimum period of five (05) years.7.3.2a The records shall include the identity of personnel responsible for the sampling, performanceof each inspection and/or test and checking of results.7.4 Assessment Reports and Assessment Certificates7.4.1a The terms “report” and “certificate” are used synonymously in this clause. However, in thisguidance document it is assumed that “reports” are detailed descriptions of the inspection and its resultswhereas “certificates” are generally short formal statements of conformity with requirements issued, forexample, in connection with mandatory inspection.7.4.1b The fact that the customer does not require a detailed report does not remove the requirementfor detailed inspection records to be kept.©SANAS Page 10 of 15

TR 78-027.4.2a The content of an inspection report or inspection certificate may vary depending on the type ofinspection and legal requirements. Where inspection is for legal purposes national authorities mayplace special requirements on the reporting of inspection results. The elements listed in clause 7.4.2 a)to g) are considered mandatory for compliance with ISO/IEC 17020.7.5 Complains and AppealsNo interpretation required, as per the requirements of ISO/IEC 170207.6 Complains and Appeals processNo interpretation required, as per the requirements of ISO/IEC 170208. Management System Requirements8.1 Options8.1.1 General8.1.1a It is the responsibility of the Inspection Body to select, define and maintain a managementsystem based on Option A or Option B. SANAS shall assess the appropriateness of the managementsystem defined.8.1.2 Option A8.1.2a The management system established and maintained by the Inspection Body shall address allthe requirements of this International Standard, SANS/ISO/IEC 17020, as listed in clause 8.1.2.8.1.3 Option B8.1.3a The management system established and maintained by the Inspection Body shall address allthe requirements of ISO 9001 and this International Standard, SANS/ISO/IEC 17020, as listed in clause88.2 Management system documentation (Option A)8.2.1a Policy statements are intended to demonstrate senior management commitment to the qualitysystem. Objectives shall include measurable targets, which are reviewed at least annually. Policiesand objectives shall be reviewed at management review, see clause 8.5. Training records shall showthat all staff is familiar with the quality system.8.2.2a Top management commitment may be indicated in the management system documentationsuch as policies, statements etc.8.2.3a The position of the quality manager (however named) shall be clearly shown in theorganisational chart referred to in clause 5. The quality manager shall be free from any influences thatmay affect the quality of their work.©SANAS Page 11 of 15

TR 78-028.2.3b In cases where an Inspection Body has a number of offices at different locations,responsibility for the practical maintenance of the quality system in each office should be assigned to anamed, local, individual.8.2.4a For easy reference, it is recommended that the Inspection Body’s documentation indicatewhere in the management system the requirements of SANS/ISO/IEC 17020 are addressed, e.g., across reference table may be included in the management system8.3 Control of documents (Option A)8.3.1a The document control system must be proceduralised; a statement that documents will becontrolled is not sufficient. See clause 8.3.28.4 Control of records (Option A)8.4.1a All records shall be safely stored for a specific period (5-year minimum), held secure and inconfidence to the customer, unless otherwise required by law.8.4.1b All records shall be legible and shall be stored and retained in such a way that they are readilyretrievable in facilities that provide a suitable environment to prevent damage or deterioration and toprevent loss.8.4.1c The Inspection Body shall have procedures to protect and back-up records storedelectronically and to prevent unauthorized access to or amendment of these records8.5 Management review (Option A)8.5.1 General8.5.1.1a Management reviews should take account of any relevant information, such as reportsfrom supervisory and managerial staff, the outcome of recent internal quality audits and externalassessments, complaints from customers, changes needed in the management system, the adequacyof current resource resources, future plans, estimates for new work, and additional human resources, aswell as the need for training of both new and existing staff. The frequency of management reviewsshould be determined by the Inspection Body, taking account of the results from internal audits andprevious reviews and reports from SANAS.8.5.1.1b The outcome of a management review should include the setting of objectives for thecoming period, proposed improvements to the quality system or a positive statement that noimprovements are required.8.5.1.2a If an Inspection Body opt for the rolling review it should be accumulative for the year andnot a month-to-month review.8.6 Internal audit (Option A)8.6.1a Inspection Bodies with more than one operational site clause all aspects of the managementsystem and all the sites shall have a full internal audit during an accreditation cycle.8.6.2a The internal audit programme shall address all elements of the management system,including the inspection and/or testing activities.8.6.5b Audits shall be carried out by trained and qualified personnel who are, wherever resourcespermit, independent of the activity to be audited©SANAS Page 12 of 15

TR 78-028.7 Corrective action (Option A)No interpretation required, as per the requirements of SANS/ISO/IEC 170208.8 Preventive action (Option A)8.8.1a Preventive action is a pro-active process to identify opportunities for improvement rather thana reaction to the identification of problems or complaints.9. List of Approved Inspection AuthoritiesA list of approved inspection bodies will be maintained by the Regulator of the Department of Health.Copies of this list will reflect the name and address, contact details, services approved, initial date ofapproval and the approval number of each Inspection Body.SANS/ISO/IEC 17020: 2012Hazardous Substances Act No 15 of 1973Diagnostic QC (latest revision)SANAS R & TR-documentshttp://www.iso.org & https://www.sabs.co.za/https://sites.google.com/site/radiationcontroldoh/https://sites.google.com/site/radiationcontroldoh/www.sanas.co.za©SANAS Page 13 of 15

TR 78-02APPENDIX 1: Schedule of AccreditationS C H E D U L E O F A C C R E D I T A T I O NInspection Body Accreditation Number: LIFT 0001TYPE APermanent Address:ACME QA X-Ray Inspection (Pty) Ltd104 Piet Pompies strPompiesvilleVerverlatevlakte0001Tel : (012) 123-4567Fax : (012) 123-4568Email : pete@pppp.co.zaPostal Address:Private Bucket at the farm gatePompiesville9081Issue No:Date of issue:Expiry date:Inspection Body Sites:Gauteng SitePompiesville PlantVerverlatevlakteWestern Cape SitePompiesville PlantVerverlatevlakte00July 2010July 2014Nominated Representative:Pete PlumberTechnical Manager:Pete PlumberQuality Manager:Pete PlumberTechnical Signatories:Pete PlumberField of Inspection Service Rendered Codes and RegulationsRegulatory:The supply of services as an InspectionBody for the inspection and test ofdiagnostic X-Ray Imaging systems asdefined in the Department of Health’sLicense conditions for Diagnostic X-RayImaging SystemsHazardous Substances Act.Act No: 15 of 1973 as AmendedFunctional test and verification of thefollowing:3. X-Ray Tubes and Generators –Conventional film systems; (tests 1,4-8, 33-35, 75-89, 115-118.1);4. Computerised Radiography Reader(tests 18-19, 23, 29-35, 90-101,119-122);5. Direct Digital Radiography System,(tests 1, 4-8, 24-25, 27, 29-35, 75-84,102-114,119-122);6.1 Fixed Fluoroscopy Equipment(tests 1, 38-42, 75, 79-84, 123-139.1);6.2 Mobile Fluoroscopy Equipment(tests 1, 39, 79-84, 123-131, 137-139.1);7 Computed Tomography (tests 46-49, 75, 119-122, 140-146);8 Screen film Mammography (tests51, 53, 75, 116-117, 118.1, 147-163);9 Digital Mammography (tests 57-58,60-65, 68, 75, 119-122, 164-214).10 Dental10.1 Dental X-ray equipment10.2 Digital Dental X-ray equipment10.3 Cone Beam CTInspection methods and procedures asper Inspection Body’s field of activityInspection methods??Original date of accreditation: July 2010 Page 1 of 2ISSUED BY THE SOUTH AFRICAN NATIONAL ACCREDITATION SYSTEMProgramme Manager©SANAS Page 14 of 15

TR 78-02ADDENDUM 1: Amendment RecordProposedBy:DoHSectionAll3.24.1.2a5.1.1b5.1.3bTable 16.2.1b9ChangeInclude “SANS” to ISO-documentsRemove “Electrical”Change “Inspector” to “Technical Signatory” to reflect Table 1Add section “which is subject to additional conditions” DoH requirementsDelete 2 nd and 3 rd paragraphs, DoH agreement for Type C Inspection BodiesAdd “Note 2:”to allow for prior learning situationsDelete paragraph, considered not applicable to QA X-RayUpdate links to DoH websiteFM All Alignment to 17020: 2012FM 8.6b, Table 1 Changed “Inspector” to “Technical Signatory (Inspector)FM Schedule ofAccreditationFM Schedule ofAccreditationCurrent Specific Services replaced:Safety of premisesEntrance surface exposureX-Ray Tubes and Generators – Conventional.Computerised Radiography ReaderDirect Digital Radiography SystemFluoroscopy Equipment - mobile and fixedComputed TomographyScreen film MammographyDigital MammographyRemoved Certificate of Accreditation©SANAS Page 15 of 15