OA08 ACCREDITED BODIES' REPORTING. Table of contents

Transcription

1 ACCREDITED BODIES' REPORTING Table of contents 1 PURPOSE AND SCOPE GENERAL LABORATORY'S REPORTING Test reports Calibration certificates INSPECTION BODY'S REPORTING Ways and forms of inspection body's reporting The contents of inspection body's reporting Presenting the inspection body's findings CERTIFICATION BODY'S REPORTING Contents of formal certification documents REPORTING BY EMAS VERIFIERS AND GHG EMISSIONS REPORTS VERIFIERS CONTROL OF THE DOCUMENT CHANGES WITH REGARD TO PREVIOUS REVISION TRANSITORY PROVISIONS... 7 Release Page 1 of 7

2 1 PURPOSE AND SCOPE The products of an accredited body shall be: a report containing the results of the accredited activity or a certificate. In this way it shall communicate to its client and through him to other interested parties (users), the data obtained by calibration, testing, certification or inspection. In order to ensure accurate, clear and unambiguous reporting of the results, to avoid wrong understanding or misleading as to the contents, scope and results of the work performed by an accredited body, all the standards containing requirements for accreditation of conformity assessment bodies also contain requirements on reporting In addition to those on reporting of accredited bodies, requirements also apply to making reference to accreditation which, when complied with, ensure clear distinction between the results of accredited and non-accredited activities. This document is intended to explain the above-mentioned requirements, to ensure distinction between different types of conformity assessment bodies when reporting of an accredited activity, and to delimit an accredited activity from other activities performed by the organisation. 2 GENERAL An accredited body shall report the results of its work in a document referring exclusively to the type of activity for which it holds accreditation, i.e., a laboratory in a test report or calibration certificate; an inspection body in an inspection report; a certification body in a corresponding certification document and a verifier in an environmental statement or a verification report. The contents of these documents should be limited to the information and other elements required by the relevant standard containing requirements for accreditation (see S03). The results of other activities, e.g. other types of conformity assessment, consulting, design & development, shall not be included in the same document. When the above-listed activities rely on a result of the accredited activity, the connection can be established by making reference to a (separate and independent) report in which the results of the accredited activity are given. Examples 1 An accredited testing or calibration laboratory shall not report the results of the accredited activity in an inspection report, even if it has carried out the tests or calibrations within the scope of an inspection procedure. It can, however, issue a test report or a calibration certificate referring to accreditation, to which it then makes reference in the inspection report. t. 2 Likewise, an accredited inspection body shall not make reference to its accreditation in a test or calibration report, even if such tests or calibrations are performed within the scope of inspection procedures for which it holds accreditation. 3 In a report of their accredited activity, accredited bodies shall not include any advice, guidance or instructions to the client, except those needed for the interpretation of the result. The product of the accredited body (report, certificate, statement) shall always refer to a specific conformity assessment activity carried out on a specific object of conformity assessment. Therefore only the data and descriptions directly related to this work shall be indicated. Any references to other documents shall be made in relation with individual elements of the report, for which they have been Release Page 2 of 7

3 used, and when not all the provisions or contents of the document have been complied with in carrying out the activity by reference to the relevant individual contents. Providing lists of documents (e.g. Bibliography at the end of a report) without explaining which parts thereof have been used to which purpose, is inappropriate. An accredited body shall make its clients and other users aware of the fact that only the results in relation to which it makes reference to accreditation in the prescribed way (S05) shall be considered as the accredited activity. To ensure transparency and to avoid the users' misunderstanding, the results of the accredited activity and those of other activities shall be reported in separate documents. Exceptions are some reports presenting the results of several parallel and in principle not interdependent, accredited and non-accredited activities of the same type (of testing or calibration), when justified for practical reasons or for the sake of transparency (e.g. a test report or calibration certificate providing several test/calibration results for the same object). In such case a clear distinction between the "accredited" and "non-accredited" results shall be assured to all the users, as provided by the rules on making reference to accreditation (S05). It should be taken into account that, besides the client, other users are often interested in the results of the accredited body. Therefore simplifications of the contents of the reports are only possible when all potential users not just the client are familiar with them and agree to them (in practice this is possible especially in orders of internal nature). Accredited bodies are obliged to avoid misunderstanding or intentional or unintentional misleading, both when reporting the results and other data and when making reference to accreditation. Example An accredited body who has obtained permission (e.g. authorisation by a state authority) to perform under accreditation an activity, which has been ordered by a client, should in principle not make arrangements with the client as to omit reference to the accreditation in reporting. Should the accredited body do so for any reason whatsoever, it shall keep records on having informed the client of the circumstances and consequences (e.g. that it might not be possible to use such report in further procedure). In addition to the contents provided by the standards and other documents containing requirements for accreditation, the reports shall also contain the requirements of special standards and other normative documents, which define the conditions of work in the accredited field. However, the purpose of some standards or other normative documents could be wider than to regulate the accredited activity. In such a case the accredited body shall, when reporting, only take into consideration the provisions and include in its report the contents which refer to the accredited activity. Examples 1 When the description of a test method is just one of the clauses of a standard containing the requirements for a single product, the testing laboratory shall take into account when reporting of the accredited activity those requirements of the standard only that refer to testing. 2 A regulation describing a test or inspection method covers a wider field and thus contains a number of other provisions, which do not refer to the accredited activity. It is sometimes difficult to Release Page 3 of 7

4 distinguish between these requirements. For example, it may contain requirements for reporting, which include the data necessary to understand the test result (special data on the condition of the test object or on testing conditions), and which need to be taken into account in the report on the accredited activity as well, but besides these, other requirements may be stated (e.g. defining actions in the case of deviations), which, however, should not be included in this report. Making statements of compliance of a work done with the requirements of regulations from a certain field in reports/certificates on accredited activity is only appropriate when these regulations or parts thereof define the scope of accreditation, otherwise it is misleading. Making reference to authorisations, appointments and the like, when the activity and the related tasks of the authorised body do not fully agree with the type and scope of the accredited activity, is similarly misleading. The standards containing requirements for accreditation also require unambiguous indication of all possible deviations from the defined requirements, procedures and arrangements (e.g. special circumstances, modifications of implementation procedure, the condition of test object on receipt). When the deviations are such that not all the requirements for accreditation or the requirements of the accredited procedures can be taken into consideration, the accredited body shall not make reference to accreditation in relation with those results. 3 LABORATORY'S REPORTING A laboratory shall report the results of testing or calibration in a test report or calibration certificate, respectively. Reports can also be called otherwise, if such is the established practice in the laboratory's field of activity. It is important, however, that the title is not misleading as to the content of the report (e.g. established name of some other type of conformity assessment or some other activity). The results of tests/calibrations for which the laboratory does not hold accreditation, or in obtaining of which it has not met all the requirements for accreditation, shall each be marked by the laboratory in a prescribed manner (using #) in its report/certificate making reference to accreditation. The laboratory shall also indicate by an appropriate note the results of tests/calibrations carried out by a subcontractor. When those are the results of tests or calibrations for which the reporting laboratory is accredited and which have been carried out by a competent subcontractor (e.g. as its accredited activity), such results shall be considered as accredited activity of the reporting laboratory. When those are the results of tests or calibrations for which the reporting laboratory is not accredited, such results cannot be considered as its accredited activity and shall be marked accordingly (using #) in its report/certificate making reference to accreditation. When an accredited activity of a subcontractor is involved, reference to accreditation shall be made in the subcontractor's report. In the report, the results shall be clearly separated from other information provided; the source of each piece of such information shall be stated (e.g. bibliography, client, other report). 3.1 Test reports Any opinions or interpretations included in the report shall be clearly marked as such. When stating opinions or interpretations in test reports, these shall be limited to explanations necessary for understanding and using the results, and interferences in other activities (other types of conformity Release Page 4 of 7

5 assessment, consulting, administrative decisions, etc.) shall be avoided. A laboratory which includes opinions or interpretations in its reports shall have procedures in place that define the scope and limitations to their contents. Opinions and interpretations shall not be considered as accredited activity, and this shall be properly marked in the report, in accordance with S05. Assessment of compliance with a requirement or specification (under sub-clause of SIST EN ISO/IEC17025) shall mean simple comparison of the test results with a uniformly defined requirement or specification (the requirement or specification being defined so that the result of the comparison is defined in a uniform way and does not depend on the knowledge of other data and conditions or professional judgement).. About providing compliance with a specification in its reports the laboratory shall make arrangements with the client when receiving the order/reviewing the contract, and the client shall decide which requirements/specifications should be used for comparison as well as any special decision rules in relation to taking into account the measurement uncertainty of the test result. When the requirements are not unanimously defined and allow different interpretations, the laboratory may report its assessment only in the form of an opinion. In relation with the assessment of compliance, the report shall include the source/s from which individual requirements/specifications are taken. When "non-accredited" results have been used in assessing the compliance, the assessment shall be designated as non-accredited activity, too. Assessment of compliance with a requirement or specification, or an opinion on conformity, shall not be included in a test report, when this interferes with the activities of inspection or certification (e.g. assessment of conformity with general requirements). 3.2 Calibration certificates Calibration certificates making reference to accreditation shall not include opinions or interpretations. Indication of the standard used or an appropriate statement of assured traceability to the SI, shall provide evidence that the measurements are traceable (sub-clause c of SIST EN ISO/IEC 17025). The calibration laboratory shall pay particular attention to make this statement clear and not misleading. 4 INSPECTION BODY'S REPORTING Inspection bodies may report using an inspection report and/or an inspection certificate. Different marks affixed to the inspected objects (e.g. verification labels) can alone not replace the issuance of a report and/or certificate. 4.1 Ways and forms of inspection body's reporting An inspection body can decide between two ways of reporting, i.e. an inspection report or an inspection certificate (or a report and certificate at the same time). When reporting through an inspection certificate only, the inspection body shall have at its disposal data for drawing up an inspection report, so that the two documents are traceable to each other. An inspection report includes detailed indications of the results and findings of the inspection, while an inspection certificate does not provide the results of the inspection, but it shall include assessment of conformity, when appropriate, or else any other final finding of the inspection. Release Page 5 of 7

6 The prescribed form of reporting (e.g. in assessing conformity with prescribed requirements) can be used in reporting on the accredited activity when it enables compliance with accreditation requirements. 4.2 The contents of inspection body's reporting An inspection body performing its activity in an area where regulations lay down additional obligations related to activities which are not accredited (e.g. verification of a measuring instrument), shall not include in its inspection report/certificate making reference to accreditation the results and findings deriving from these additional obligations. The report/certificate shall not include statements such as "Issued on the basis of authorisation ", and the like. 4.3 Presenting the inspection body's findings The inspection body shall clearly and unambiguously decide regarding the conformity of the object of inspection with the requirements, except in cases when the inspection procedure (inspection scheme) does not include conformity assessment (e.g., a scheme which defines determining the amount of cargo on board based on the ship's draft, but does not provide for defining the conformity of the amount determined). When the inspection body conducts the inspection fully and without restrictions in accordance with the relevant regulation, the finding of conformity may relate to the complete regulation. When there is a restriction defined in the scope of accreditation in terms of articles or clauses which the inspection should pursue, the inspection body shall specify its finding according to the restrictions. Even if the inspection body holds public authorisation, and the authorisation refers to the complete regulation in question, which, however, includes requirements that are not covered by the scope of accreditation, the statement of conformity shall include the restrictions. 5 CERTIFICATION BODY'S REPORTING Certification bodies shall issue to their clients formal certification documents. Usually, certification bodies issue certificates of conformity/competence, but they can also communicate their decision in a different way, e.g. by a letter. 5.1 Contents of formal certification documents Whether it is a certificate or a letter, the obligatory elements to be stated in formal certification documents are defined by the standards for the competence of certification bodies, and by other documents defining the certification schemes, as well as guidance documents for certification bodies. When a certification body is designated/notified to perform related activities to those comprised in the scope of accreditation, it shall make sure that its clients or the users of the certificates know the difference between a certificate issued by the certification body as a designated body/authorised organisation and a certificate issued by it as an accredited certification body. The difference shall be clearly visible on the certificate, under the indication of certification scheme. When the designation /authorisation refers to an activity that is wider than its accredited activity, the certification body shall, Release Page 6 of 7

7 in documents with direct or indirect reference to the designation/authorisation, not make reference to accreditation but rather issue an additional certificate or other formal certification document as a formal proof of implementation of the accredited activity. 6 REPORTING BY EMAS VERIFIERS AND GHG EMISSIONS REPORTS VERIFIERS An EMAS verifier shall issue to the client an Environmental Statement on verification and validation activities (Regulation (EC) No 1221/2009, Annex VII), an obligatory part of which shall be the EMAS registration number (number of accredited body), which is considered to be appropriate reference to accreditation in this field. According to the requirements of S05, an EMAS verifier may also refer to accreditation by affixing the accreditation mark on the Statement. A GHG emissions reports verifier shall issue to the operator or aircraft operator for each report on emissions or ton kilometres verified, a verification report based on the information collected during verification. In such reports the verifier shall refer to accreditation in accordance with S05. 7 CONTROL OF THE DOCUMENT A valid document shall be located in i4 (SA Information System). A clean copy shall be published on the SA website, and shall be available on printed format at the SA Head Office. Printouts and copies of the document shall have informative nature and shall not be considered as controlled copies. The validity of these documents should be checked in i4 or on the SA website. 8 CHANGES WITH REGARD TO PREVIOUS REVISION The changes related to reporting of inspection bodies as provided by the new version of SIST EN ISO/IEC 17020:2012 have been complied with. Rules on reporting by EMAS verifiers and GHG emissions reports verifiers have been added. With regard to the experience in using the guidance so far, some interpretations have been completed, while only editorial corrections have been made to some parts of the text. 9 TRANSITORY PROVISIONS Previous edition of this document remains in use in relation with inspection body assessments carried out against the standard SIST EN ISO/IEC 17020:2004, but only until 1 March 2015, when the transitional period for the enforcement of SIST EN ISO/IEC 17020:2012 expires. Release Page 7 of 7