Title Requirements for the accreditation of calibration laboratories

Transcription

1 Title Requirements for the accreditation of calibration laboratories Reference RT-25 Revision 05 Date NOTE: The present document represents the English version of document under reference at the specified revision. In case of conflict, the Italian version will prevail. To identify the revised parts reference must be made to version in Italian language only. Preparation Approval Authorization Application date The Department Director The Directive Council The General Director TECHNICAL REGULATION RT-25 rev.05 pag. 1/25

2 CONTENTS 1. INTRODUCTION SCOPE AND APPLICATION FIELD DEFINITIONS AND REFERENCES DEFINITIONS REFERENCES MANAGEMENT REQUIREMENTS ORGANIZATION MANAGEMENT SYSTEM DOCUMENT CONTROL REVIEW OF REQUESTS, TENDERS AND CONTRACTS SUBCONTRACTING OF CALIBRATIONS PURCHASING SERVICES AND CALIBRATIONS SERVICE TO THE CUSTOMER COMPLAINTS CONTROL OF NON-CONFORMING CALIBRATION WORK IMPROVEMENT CORRECTIVE ACTIONS PREVENTIVE ACTIONS CONTROL OF RECORDS INTERNAL AUDITS MANAGEMENT REVIEWS TECHNICAL REQUIREMENTS GENERAL PERSONNEL ACCOMODATION AND ENVIRONMENTAL CONDITIONS CALIBRATION METHODS AND METHOD VALIDATION EQUIPMENT MEASUREMENT TRACEABILITY SAMPLING HANDLING OF CALIBRATION ITEMS ASSURING THE QUALITY OF CALIBRATION RESULTS TECHNICAL REGULATION RT-25 rev.05 pag. 2/25

3 5.10. REPORTING THE RESULTS ACCREDIA REQUIREMENTS CONTAINED IN OTHER ACCREDIA DOCUMENTS PROVISIONS RELATING TO THE APPLICATION OF THE METHODOLOGICAL TRACEABILITY REQUIREMENT OF MEASUREMENT RESULTS FOR CALIBRATION LABORATORIES PROVISIONS RELATING TO INTERNAL CALIBRATION TECHNICAL REGULATION RT-25 rev.05 pag. 3/25

4 1. INTRODUCTION 1.1. The present Technical Regulation sets out the general criteria for the accreditation of Calibration Laboratories by ACCREDIA (the Italian Accreditation Body) Department of Calibration Laboratories (DT) The application of the criteria of provisions reported here has the target to favour the creation and the maintenance of the trust of customers in the calibration activities of the accredited Laboratories, and in the impartiality and integrity of technical and business operations related to them. ACCREDIA accreditation is granted to Laboratories that meet the requirements of standard UNI CEI EN ISO/IEC "General Requirements for the competence of Testing and Calibration Laboratories" (hereinafter "the Standard"), EA and ILAC requirements and those of this Regulation and of other ACCREDIA prescriptive documents applicable to Calibration Laboratories This document refers to the requirements of standard UNI CEI EN ISO/IEC The paragraph numbering for Chapters 4 and 5 is the same as that in the standard. In these chapters, and in Chapter 6, the specifications and provisions introduced by ACCREDIA to be implemented with the standard requirements, are outlined The accreditation attests the technical competence of the Laboratory to carry out the calibrations indicated in the scope of accreditation, and the implementation of a quality management system aligned with the principles of UNI EN ISO 9001 standard for activities falling within the scope of accreditation. Calibration Laboratories (LATs) accredited by ACCREDIA operate as Calibration Centres within the National Calibration System defined by Law 273/91 and are deemed competent to carry out calibrations to support the activities of Test Laboratories and accredited Certification and Inspection Bodies. 2. SCOPE AND APPLICATION FIELD 2.1. This regulation specifies the management and technical competence for Calibration Laboratories on the basis of: physical quantities that are the scope of accreditation; different measurement fields; working premises; the updating of EA and ILAC provisions This document applies to all laboratories that perform a calibration service. Both organizationally and commercially independent laboratories and those from a larger organization (such as manufacturing companies, public or private organizations, research centres, etc.) are taken into account The specifications given in this document are applicable to any metrological sector; specific requirements defined by binding norms or international standards (EA, ILAC, ISO, EN, etc.) are listed in the ACCREDIA Calibration Laboratory LS-09 Document "Standards and Reference Documents for Accreditation of Calibration Laboratories" in the existing revision, downloadable from the website TECHNICAL REGULATION RT-25 rev.05 pag. 4/25

5 2.4. In order to obtain and maintain accreditation, the Laboratory must demonstrate compliance with all the requirements of the standard, with the exception of those that are not applicable with a reason, for all calibration activities defined in the scope of the Quality Manual; for calibrations under accreditation the technical expertise will also be verified (staff training, validation of methods, measurement traceability, etc..). Note: It is also taken into account that all the organizational activities of the laboratory fall within the requirements of cap. 4, while the calibration processes fall in chap Accreditation obtained by the Laboratory based on the requirements of this document does not include activities related to the formulation of subjective judgments or professional opinions, even if based on the objective results of accredited calibrations The Laboratory is required to comply with the provisions of the ACCREDIA RG-09 document regarding the use of the Accreditation Mark. 3. DEFINITIONS AND REFERENCES 3.1. DEFINITIONS This document utilises the definitions contained in reference standards UNI EN ISO 9000, UNI CEI EN ISO/IEC 17000, UNI EN ISO/IEC 17011, UNI CEI EN ISO/IEC 17025, UNI CEI EN 45020, UNI CEI EN 4546, UNI CEI International Vocabulary of Metrology (VIM3), in the regulations in force on the subject, in the General Accreditation Regulations and other applicable Technical Regulations/Documents. Some definitions follow: Reference measurement standard (reference standard): measurement standard designated for the calibration of other measurement standards for quantities of a given kind in a given organization or at a given location (UNI CEI VIM3-5.6). NOTE: usually indicated as a first line standard Working measurement standard (working standard): measurement standard that is used routinely to calibrate or verify measuring instruments or measuring systems (UNI CEI VIM3-5.7). NOTE: usually indicated as a second line standard Travelling measurement standard (travelling standard): measurement standard, sometimes of special construction, intended for transport between different locations (UNI CEI VIM3-5.8). NOTE: usually used for on-site calibrations Transfer measurement device (transfer device): device used as an intermediary to compare measurement standards (UNI CEI VIM3-5.9) Reference Material (RM): material, sufficiently homogeneous and stable with respect to one or more specified properties, which has been established to be fit for its intended use in a measurement process. TECHNICAL REGULATION RT-25 rev.05 pag. 5/25

6 NOTE 1: Reference Material is a generic term. NOTE 2: Properties can be quantitative or qualitative, e.g. identity of substances or species. NOTE 3: Uses may include the calibration of a measurement system, assessment of a measurement procedure, assigning values to other materials, and quality control. NOTE 4: ISO/IEC Guide 99:2007 (UNI CEI 70099:2008, 5.13) has an analogous definition, but restricts the term measurement to apply to quantitative values. However, Note 3 of the definition in ISO/IEC Guide 99:2007 specifically includes qualitative properties, called nominal properties Certified Reference Material (CRM): reference material characterized by a metrologically valid procedure for one or more specified properties, accompanied by a reference material certificate that provides the value of the specified property, its associated uncertainty, and a statement of metrological traceability. NOTE 1: The concept of value includes a nominal property or a qualitative attribute such as identity or sequence. Uncertainties for such attributes may be expressed as probabilities or levels of confidence. NOTE 2: Metrologically valid procedures for the production and certification of reference materials are given in, among others, ISO Guide 35. NOTE 3: ISO Guide 31 gives guidance on the contents of reference material certificates. NOTE 4: ISO/IEC Guide 99:2007 has a similar definition (UNI CEI 70099:2008, 5.14) Calibration and Measurement Capability (CMC): in the context of CIPM MRA and ILAC Mutual Acknowledgement Agreement, and in compliance with the CIPM-ILAC Common Statement, the following definition is agreed upon (ILAC-P14-3.2): A CMC is a calibration and measurement capability available to customers under normal conditions: as described in the laboratory s scope of accreditation granted by a signatory to the ILAC Arrangement; as published in the BIPM key comparison database of the CIPM MRA Agreement. NOTE: for ACCREDIA the scope of accreditation is described in the annex of the Accreditation Certificate Requirement, provisions: regulation that defines the needs to meet, and it is expressed by the modal shall. The requirements of regulatory document must be respected to comply with the document itself Guide, guideline: document that contains guidelines on how to meet the requirements of a regulatory document. It does not in itself contain mandatory requirements, but a Laboratory deciding not to follow the indications of a guideline indicated by ACCREDIA assumes the burden of proof that it satisfies the requirements in an equivalent manner Management procedure: a document describing the modalities and conditions for implementing the elements of the quality system and describing the relations between the functions related to a given activity and its responsibilities. TECHNICAL REGULATION RT-25 rev.05 pag. 6/25

7 Technical procedure: document describing the method, modalities, conditions and responsibilities necessary to carry out a technical activity (such as calibration, metrology confirmation, maintenance, use, etc.) Head of Laboratory: the person that has the responsibility and the authority defined to carry out all the management and technical operations regarding the functions for what the laboratory is accredited, and the management of resources, material and human, made available by the Director for laboratory activities Head of Quality Management System: the person who has the responsibility and the authority defined to ensure that the Quality Management System is implemented, followed and continually improved Substitute of the Head of Laboratory: the person supporting the Head and who can exceptionally replace him in carrying out the ordinary activities Metrological sector: identifies, for a specific quantity, metrology chains, measurement fields and parameters, types of equipment that have common calibration procedures and methods Internal Calibration: calibration performed to establish the metrological traceability of own activities in relation to the scope of accreditation and that does not fall within the scope of LAT accreditation (and as such cannot be offered as an accredited calibration service); is carried out by personnel and instrumentation under the direct and exclusive control of the LAT or the organization to which LAT belongs, by applying techniques positively evaluated by ACCREDIA DT REFERENCES The regulatory references to be considered for the application of this Regulation are reported in the ACCREDIA Department of Calibration Laboratories Document LS-09 Standards and reference documentation for the accreditation of Calibration Laboratories, in the revision in force. This Regulation also makes reference to applicable ACCREDIA documents/provisions. 4. MANAGEMENT REQUIREMENTS 4.1. ORGANIZATION NOTE: If the Laboratory acts as a Reference Laboratory, this must also apply the provisions of standard UNI EN ISO "Laboratory Medicine - Requirements for Laboratories Performing Reference Measures" The standard requirement applies, including Note 2. TECHNICAL REGULATION RT-25 rev.05 pag. 7/25

8 NOTE: It is recommended that the Quality Management System have: i) an overall organizational chart of the organization to which the Laboratory is part, stating the position of the Laboratory itself and ii) a nominal organizational chart of Laboratory personnel, with the identification of any figures that, while operating both within the organization and within the Laboratory, have different roles in the two areas a) The standard requirement applies, with the provision that the organizational chart of the Laboratory shall include at least the following functions: Head (see point h) below); Head substitute (see point j) below); Head of Quality Management System (see following point i). NOTE: ACCREDIA can evaluate evidence of the application of the requirement by examining organization charts, job descriptions, assignment letters, and any contracts. It is recommended that evidence be made of the awareness of all personnel of the relevance and importance of its operations related to accredited activities. b) NOTE: ACCREDIA can evaluate evidence of application of the requirement by examining contractual clauses, job descriptions or assignment letters. c) NOTE: It is recommended to identify i) the personnel authorized to access the premises of the laboratory, ii) the personnel authorized to access the Customer's data (whether in paper or electronic format), and iii) expected modalities to check such accesses. d) NOTE: For completeness, please refer to Note of Requirement e) NOTE: It is recommended that evidence is provided that the laboratory personnel know the limits and extensions of their activities, for example by signing for acceptance of job descriptions and assignments. f) NOTE: It is recommended to identify i) adequate staff supervision (with particular attention to training and qualification), ii) the staff responsible for carrying out such activities, and iii) the procedures for assessing the effectiveness of supervisory activities. The standard requirement applies, identifying the function of "technical direction" in the figure of the Head of Laboratory (as defined in point a). NOTE: The Manager's involvement in the management review is recommended as evidence of liability and the authority required by the standard. TECHNICAL REGULATION RT-25 rev.05 pag. 8/25

9 g) The standard requirement applies, identifying the function of "Quality Manager" in the figure of the Head of the Quality Management System of the Laboratory (as defined in point 1). If this role is covered by external staff (for example, an external consultant), the exact definition of the role that this task entails and the timing of the assignment must be formalized in the contract. h) NOTE: Depending on the size and the scope of accreditation, the Laboratory may identify Substitutes of the Head, distinct by physical quantity. It is recommended that the assignments for the Substitute function be formalized and contain the exact indication of the delegated powers, particularly as regards the signature of the issued Calibration Certificates. i) NOTE: It is recommended to identify ways of assessing the effectiveness of communications, appropriate to the size and type of the Laboratory (for example, notification of reading in the case of communications) MANAGEMENT SYSTEM NOTE: As far as the provision of system documentation to staff is concerned, if the Laboratory uses corporate information systems to support the management system, it is recommended that the relevant access modes (such as permissions, limitations, access control) be identified NOTE: If the Laboratory is part of an organization, the Quality Policy can refer to similar higher level documents, but it should still contain specific declarations of compliance with the requirements of the standard (and those deriving from EA and ILAC prescriptive documents, as indicated in this Regulation) aimed at obtaining and maintaining accreditation NOTE: If the Quality Manual also deals with activities other than those relating to the Laboratory's scope of accreditation, it is recommended that the latter be clearly identified and meet the requirements of the standard and of this Regulation as a whole. For this purpose it is also recommended that the quality manual follows the numbering of the chapters of the standard (also reproduced in this document) or contains a suitable correlation matrix TECHNICAL REGULATION RT-25 rev.05 pag. 9/25

10 NOTE: Any changes to the management system should be previously recorded in the Management Review DOCUMENT CONTROL General NOTE: When applying the standard requirement, the Laboratory's attention is drawn to the need to identify ways of adapting technical procedures to regulatory sectorial developments Document approval and issue Following their issuance in compliance with the standard, the quality manual and all technical and management procedures should be sent to the ACCREDIA Technical Officer. Before becoming operative and then being able to be implemented by the Laboratory, the technical procedures must be evaluated positively by ACCREDIA. The Quality Manual and the related management procedures may, however, be implemented by the Laboratory even in the absence of a specific positive evaluation, which has elapsed fifteen days after their transmission to the Technical Officer. Transmission to the Technical Officer of this documentation must take place: at the time of application for accreditation, extension and renewal; when there are changes The standard requirement applies, with the additional requirement that the first page of each document contains the date of positive evaluation by ACCREDIA Document changes The standard requirement applies with the additional requirement that the documentation be revised highlighting the modified parts TECHNICAL REGULATION RT-25 rev.05 pag. 10/25

11 4.4. REVIEW OF REQUESTS, TENDERS AND CONTRACTS The standard requirement applies, by identifying in the Head and/or the Head Substitute the role only to which the review of technical aspects is to be entrusted NOTE: In cases where the exchange of information takes place by , it is sufficient to keep the archive of contacts with customers. Tacitly renewed calibration cases may be excluded from a documented review, or on a periodic basis determined by agreement with Customer SUBCONTRACTING OF CALIBRATIONS ACCREDIA does not plan that accredited calibrations or parts thereof may be continuously subcontracted. In the case of calibration applications that cannot be performed by the Laboratory, they may be entrusted to another accredited Laboratory, subject to the Customer's agreement. NOTE: If the calibration is entrusted to another Laboratory, the relevant calibration certificate must be issued by this second Laboratory and report the Customer as holder (see IO-09-DT). NOTE: operations performed by personnel outside the Laboratory that are however tied to a specific contract, which operates under the control of the Laboratory Head and uses equipment, instruments and standards owned by the Laboratory, are not considered as subcontracting PURCHASING SERVICES AND CALIBRATIONS NOTE: If the Laboratory is part of an organization, it is possible to refer to general procedures at the top level, but the requirements of the standard (especially for technical aspects) aimed at obtaining and maintaining accreditation should be met SERVICE TO THE CUSTOMER NOTE: It is recommended that the Laboratory provide its Customers with adequate support for the interpretation of the results of the calibration activities and foresee the actions to be implemented if it is impossible to perform the required calibrations. TECHNICAL REGULATION RT-25 rev.05 pag. 11/25

12 NOTE: It is recommended that the Laboratory continuously reviews the effectiveness of its Customer Satisfaction Measurement Tools, evaluating other ways in the event of a poor return of such information COMPLAINTS 4.9. CONTROL OF NON-CONFORMING CALIBRATION WORK IMPROVEMENT NOTE: When applying the standard requirement, the Laboratory should not neglect the technical adjustments, for example: staff updating programmes; improving calibration methods and increasing their efficiency to better meet customer demand and requirements; updating the equipment and keeping them at the best possible level CORRECTIVE ACTIONS General In case any non-conforming activities are identified that could affect the performing of the accredited calibration, the Laboratory shall, in addition to what provided for by its quality management system in compliance with the requirements of the standard, inform ACCREDIA in good time and, if necessary, proceed on the request for self-suspension according to the provisions of the RG-13 Regulation Cause analysis Selection and implementation of corrective actions TECHNICAL REGULATION RT-25 rev.05 pag. 12/25

13 Monitoring of corrective actions Additional audits PREVENTIVE ACTIONS CONTROL OF RECORDS General Technical records The standard requirement applies, with the requirement to set a minimum period of time for the retention of all documentation relating to accredited calibration to ten years, subject to different legal provisions, in which case the latter shall prevail INTERNAL AUDITS The standard requirement applies with the requirement that the internal audit planning should include the assessment of the effectiveness of the corrective actions relating to the findings of previous audits, both of a first and third party. Second and third party audits cannot replace technical and system internal audits. NOTE: In the event that the Head of Laboratory has also the function of Quality Manager and the organization to which the Laboratory belongs does not have trained and qualified personnel to carry out internal audits, the Quality system of the Laboratory envisages an internal audit of the management system part carried out by an external auditor during the year with proven experience both in calibration and audit planning and conduct in compliance with standard UNI CEI EN ISO/IEC It is also recommended that the annual plan includes technical checks such as calibration comparisons, of the same object, performed by different operators and, if possible, by the same operator at different times TECHNICAL REGULATION RT-25 rev.05 pag. 13/25

14 MANAGEMENT REVIEWS The standard requirement applies, with the additional obligation for the Quality Management System Manager to submit to the Management Review (with adequate advance ahead of the scheduled meeting) a "Quality Status Report" including input elements indicated in the standard. NOTE: Depending on the size of the Laboratory and the possible organization of which it is part of, it may be possible to review at different levels, for example: one at a local level where the issues of the Laboratory are discussed and a more general one, corporate, to which the results of local reviews come as input TECHNICAL REQUIREMENTS 5.1. GENERAL PERSONNEL Following the training and qualification actions, the proposal by the Management of the appointment of the Laboratory Head and its Substitute should be evaluated positively by ACCREDIA on the basis of evidence on the candidate's skills and abilities. NOTE: For the appointment of the Substitute please refer to the NOTE under j) of NOTE: For the purposes of evaluating the effectiveness of training activities, the Laboratory may use questionnaires, interviews, quizzes, open questions, measurement comparisons between operators The standard requirement applies, specifying that the Laboratory must clearly define the role, commitment, responsibilities and limits in relation to the activities performed by all staff on contract The standard requirement applies, also extended to any Technical Operators who perform the calibrations The standard requirement applies, identifying the functions in the Laboratory Head and Substitute (or Substitutes) that must be authorized by the Management to sign the Calibration Certificates. Authorizations must be dated, signed by the Management and countersigned by the staff concerned. NOTE: Authorizations can be registered with the job descriptions or may be explained in the job descriptions themselves. TECHNICAL REGULATION RT-25 rev.05 pag. 14/25

15 5.3. ACCOMODATION AND ENVIRONMENTAL CONDITIONS NOTE: It is recommended to establish acceptance limits and related verification modalities for the environment conditions where calibration is performed (both in the Laboratory and for external calibrations) Any record of the environmental conditions of the premises where the Laboratory performs the accreditation calibration must be kept for at least ten years. NOTE: If the recordings of the environmental conditions indicate that the limits defined by the Laboratory have been exceeded, it is recommended that this situation be treated as Non-Conformity according to the Laboratory Management System NOTE: If maintenance activities are entrusted to external personnel (e.g. cleaning the premises), it is recommended that the Laboratory prepares appropriate and timely operating instructions for external personnel, including any operational limitations for specific areas of the Laboratory or for specific instrumentation CALIBRATION METHODS AND METHOD VALIDATION General The technical procedures (and their subsequent revisions) regarding calibration methods (with relative uncertainty estimate), internal calibration, management of standards /reference materials, should be evaluated positively by ACCREDIA before their use. NOTE: metrological confirmation procedures and intermediate checks are configured as technical procedures Selection of methods The Laboratory must exclusively apply methods that have been evaluated positively by ACCREDIA. NOTE: Requests for calibrations performed by methods other than those evaluated positively by ACCREDIA or outside accredited metrology sectors, even if requested by the Customer, cannot be accepted for issuing ACCREDIA accreditation certificates. NOTE: For non-standardized, flexible-purpose calibration methods, the requirements of Regulation RT-26 shall apply. TECHNICAL REGULATION RT-25 rev.05 pag. 15/25

16 Laboratory-developed methods The Laboratory must exclusively apply methods that have been evaluated positively by ACCREDIA Non-standard methods The Laboratory must exclusively apply methods that have been evaluated positively by ACCREDIA. NOTE: For non-standardized flexible-purpose methods refer to the RT-26 Regulation Validation of methods The Laboratory, for accredited calibrations, must always comply with its Accreditation Table. If it fails to meet the Customer s request, it must give written notice Estimation of uncertainty of measurement The uncertainty estimation reported in the various accredited calibration procedures must be in compliance with document EA-4/02 (translated into Italian in DT-05-DT) and reference standards. In technical procedures, the uncertainty estimation must be summed up in one or more tables (also known as the uncertainty budget), also showing the CMCs reported for the purpose of accreditation. The estimation of uncertainty must be subject to periodic review and changes in its components. NOTE: The calibration of the reference standard is one of the possible variations leading to a reassessment of uncertainty estimation The standard requirement applies, properly documenting any uncertainties identified by the Laboratory as negligible Control of data EQUIPMENT Equipment management procedures must be positively evaluated by ACCREDIA before they are used. The use of standards used for accredited activities for other purposes should in no way undermine their metrological characteristics and their reliability. TECHNICAL REGULATION RT-25 rev.05 pag. 16/25

17 The Laboratory must prepare a metrological confirmation program (including calibration and intermediate checks) of the reference, working and travelling standards, including those that are subject to internal calibration. In the case of travelling standards, checks on the effect of the transport must also be provided. The programme must indicate, for each standard, the periodicity of metrological confirmations (including calibration and intermediate checks) and the relative limits of acceptability by documenting the choices made. This programme, and its subsequent documented reviews, must be evaluated positively by ACCREDIA before its implementation. NOTE: It is recommended that you enter the metrological confirmation programme, including the above requirements, in the equipment management procedures. NOTE: It is recommended that you meet the requirements of UNI EN ISO standard For each equipment used (including standards), the Laboratory must prepare a document or a series of documents that, in addition to the elements listed in the standard, also include the following information: date of receipt and date of commissioning; responsible for calibration, intermediate checks and metrological confirmation; reference to the related equipment management procedure; chronological annotation of: - the date of execution of the calibrations carried out; - date of next calibration; - identification of the calibration certificate; - date of metrological confirmation implementation and intermediate checks; - suitability of the instrument/standard after each intervention The Laboratory shall keep records of the corrections applied for the same period of the Certificate's retention TECHNICAL REGULATION RT-25 rev.05 pag. 17/25

18 5.6. MEASUREMENT TRACEABILITY General Specific requirements Calibration Laboratories must apply metrological traceability as defined in standard UNI CEI 70099: 2008 (VIM: 2007). In particular, reference standards shall be calibrated up by the competent bodies referred to in paragraph 7. In the case of internal calibration, the provisions of paragraph 8 shall apply. NOTE: The Department implements ILAC-P10 "ILAC Policy on the Traceability of Measurement Results" requirements and accordingly evaluates how Calibration Laboratories guarantee metrological traceability to SI units of measurement using equipment, tools and standards calibrated by the competent bodies, as described in paragraph Testing This point of the rule does not apply to Calibration Laboratories Reference standards and reference materials Reference standards Laboratories, on the basis of ILAC-P10 "ILAC Policy on the Traceability of Measurement Results" requirements, must obtain metrological traceability through calibrations of their reference standards performed by Italian or foreign institutions meeting the requirements of paragraph Reference materials Laboratories, on the basis of the ILAC-P10 "ILAC Policy on the Traceability of Measurement Results" requirements, must obtain metrological traceability through reference materials certified or manufactured by competent producers, meeting the requirements of paragraph Intermediate checks The periodicity of the intermediate checks must be documented and evaluated positively by ACCREDIA Transport and storage TECHNICAL REGULATION RT-25 rev.05 pag. 18/25

19 NOTE: Where special arrangements are made by manufacturers, it is recommended that the Laboratory adequately trains the assigned staff SAMPLING Any deviation from the sampling procedure must be recorded and reported as a note on the Certificate, whether this is required by the Customer or whether it is necessary for different reasons HANDLING OF CALIBRATION ITEMS The Laboratory must provide adequate and well-defined areas for the conservation of objects to be calibrated before and after calibration and warehousing, pending further information from Customer The Laboratory must describe how it identifies the standards and instruments to be calibrated and how it distinguishes them from their own. The identification procedure may be anonymous or may become so by specific customer request The Laboratory has to identify areas of the permanent laboratory in which to safely store and manipulate instruments and standards during their stay. These areas must be well recognizable and possibly accompanied by appropriate indications (calibration waiting area, expected customer information area, expected shipping area). If in the laboratory there are instruments and standards for non accredited activities, the Laboratory must ensure appropriate procedures to avoid confusion with those for accredited calibrations ASSURING THE QUALITY OF CALIBRATION RESULTS The laboratory must prepare procedures for statistical analysis of data collected from metrological confirmation, for example, control cards or more simply calibration and verification charts with respect to its predetermined limits. Data derived from the activities described in this paragraph must be reviewed by the Laboratory and the subsequent actions must be handled in compliance with the procedures of its Quality Management System (Non-Conformity, Corrective Actions/Preventive Actions, Management Reviews and Improvements Plans). TECHNICAL REGULATION RT-25 rev.05 pag. 19/25

20 5.10. REPORTING THE RESULTS General Calibration Certificates must be issued using letterhead paper with the ACCREDIA symbol, according to a template provided by IO-09-DT Instruction, on which unrecognized calibration results cannot be reported or measurement points that are not included in the table of accreditation/in CMC published for the purpose of accreditation. NOTE: It is recommended that the Laboratory keeps copies of the original Calibration Certificates, in paper format (as reproduction) or in electronic format, provided that they guarantee total correspondence to the original. NOTE: It is recommended that the Laboratory use a format other than the Certificate (reference IO- 09-DT) for calibration reports issued outside the accreditation, not to make the customer think erroneously that it is an accredited performance. It is also recommended that the number of reports outside accreditation follow criteria other than those applied for Calibration Certificates Test reports and calibration certificates The Calibration Certificate must also include: the statement that the results relate only and exclusively to the calibration object; reference to the metrology chain that ensures the traceability to the calibration performed and calibration procedure applied; the statement that the results reported are valid at the time and in the conditions in which the calibration has been carried out. Any declaration of conformity shall be reported in compliance with paragraph 4 of document IO-09- DT. Any explanatory notes that are useful to the results are to be provided to the customer on a document other than the calibration certificate, which must not bear the ACCREDIA symbol. The data in the Certificate must also comply with the writing rules described in the DT-04-DT and IO-09-DT documents Test reports This point of the rule does not apply to Calibration Laboratories Calibration Certificates Certificates must describe the environmental conditions where they are fundamental for calibration. The measurement uncertainty must be expressed according to the related regulations (see also document EA-4/02 and DT-05-DT) The standard requirement and paragraph 4 of document IO-09-DT applies TECHNICAL REGULATION RT-25 rev.05 pag. 20/25

21 ACCREDIA labels may be used directly on the instrument/standard following calibration, provided that such calibration is included in the purpose of accreditation. The ACCREDIA mark must not be used/pasted on the instrument/standard independently of the label identifying it. Such label shall bear at least the following fields: The corporate name and LAT accreditation number; Instrument/standard identification; Calibration date; The unique reference to the Certificate associated with the instrument/standard. The use of the ACCREDIA mark must comply with the requirements of the RG-09 Regulation. These requirements are necessary to ensure that the calibration is carried out by an accredited organization in compliance with UNI CEI EN ISO/IEC standards. The presence of the ACCREDIA label on an instrument/standard does not imply that this instrument/standard is approved by ACCREDIA Opinions and interpretations The standard requirement and paragraph 5 of document IO-09-DT applies Testing and calibration results obtained from subcontractors ACCREDIA DT does not accept accredited calibrations in subcontracting Electronic transmission of results The standard requirement and the provisions of document IO DT apply. If the Customer requests a copy of the Certificate already issued, the Laboratory must issue a copy in compliance with the original Format of certificates The calibration certificate model must always be related to the revision of the current technical procedure to which it refers. If the Laboratory considers the certificate model as a data entry form for its quality management system, this should be kept up-todate according to the documentation management procedure Amendments to test reports and calibration certificates ACCREDIA does not envisage that any calibration certificates already issued may be modified. Whenever, for any reason, a correction is required for a Calibration Certificate, provision should be made for: withdrawal of the certificate that has anomalies; TECHNICAL REGULATION RT-25 rev.05 pag. 21/25

22 issuing a new certificate with a new number and the words "replaces certificate no.... "on the front page; filing the retrieved certificate with the words "replaced by the certificate number ACCREDIA REQUIREMENTS CONTAINED IN OTHER ACCREDIA DOCUMENTS The following table shows the ACCREDIA documents and the topic the Laboratory must ensure compliance. In cases where the document contains some or the entire topic related to the Standard, the related paragraph is inserted. Document IO-09-DT: Operating instruction on compiling a calibration certificate for ACCREDIA DT accredited calibration centres DT-04-DT: Provisions on the Principal Writing Rules DT-05-DT: Introduction to the criteria for measuring uncertainty in the calibration RG-09: Regulation for the use of the ACCREDIA mark IO DT: Prescription for sending the calibration certificate RT-26: Requirements for accreditation with flexible scope RT-36: Interlaboratory Evaluation Tests (PT) and Interlaboratory Comparisons (ILC) for the Calibration Laboratory Department Topic Requirements concerning the form and content of calibration certificates; compliance with these requirements will help to ensure the uniformity of all calibration certificates, with a view to their recognition, in particular, among the signatories of the EA and ILAC multilateral agreements. Requirements regarding how to write procedures and calibration certificates. Requirements regarding the calculation of the uncertainty to be used in the technical procedures. Requirements concerning the permitted use of the ACCREDIA mark. Requirements concerning the transmission of calibration certificates issued under accreditation. Accreditation with flexible scope for calibration and testing laboratories. Quality assurance of test and calibration results. Paragraph ISO/IEC TECHNICAL REGULATION RT-25 rev.05 pag. 22/25

23 7. PROVISIONS RELATING TO THE APPLICATION OF THE METHODOLOGICAL TRACEABILITY REQUIREMENT OF MEASUREMENT RESULTS FOR CALIBRATION LABORATORIES The Calibration Laboratories, in order to ensure the metrological traceability to the SI System of units of measurement, in compliance with the requirements of ILAC P10, must use equipment, instruments and measurement standards calibrated by competent bodies that meet the following characteristics: 1 - National Metrology Institutes (NMIs) and Designated Institutes (DIs) whose services (CMCs) are eligible and covered by the International Mutual Recognition Agreement (CIPM MRA) and included in the BIPM KCDB database. The presence of the note and/or the CIPM MRA logo on Calibration Certificates demonstrates the coverage of CMCs; if the note and/or logo are not present, being their entry discretionary, the Laboratory must verify the coverage of CMCs by consulting the BIPM website at: Accredited calibration laboratories whose services are eligible and whose accreditation is issued by Accreditation Bodies (EA) signatories to the EA-MLA or ILAC-MRA Agreement for the purpose of calibration within the frame and within the limits set by the CMCs published by the AB. The use of Calibration Certificates issued under these two possibilities is considered to be of equal validity, without prejudice to the different value of the calibration uncertainties that must be adapted to the needs of the Laboratory. There may be situations where metrological traceability cannot be obtained from either of the above cases. The alternatives listed below are acceptable only if supported by evidence as described in Section 6. 3a - NMIs whose services are eligible but not covered by the CIPM-MRA agreement. 3b - Calibration laboratories whose services are eligible but not covered by ILAC agreements or regional agreements recognized by ILAC. Case 3a should not be chosen on the basis of purely economic or logistical reasons but should be considered as the last resource if cases 1 and 2 were unavailable. Case 3b should only be chosen if type 1, 2 and 3a suppliers are unavailable. In this case also the assessment of the supplier by the Laboratory must be done through audit of the second part with the presence of an assessment team of ACCREDIA, with a Technical Officer involved. The supplier's evaluation by the Laboratory is in turn evaluated by ACCREDIA. 4 - Section of standard UNI CEI EN ISO/IEC 17025: 2005 indicates how to operate when calibrations cannot be strictly performed with reference to SI units. It is the Laboratory's responsibility in these cases to provide evidence that meets the standard requirements. Such evidence, such as the evaluation of the supplier by the Laboratory, is being evaluated by ACCREDIA. 5 - In some cases metrological traceability must be obtained through certified reference materials (CRMs). In this case, materials produced by bodies that meet the characteristics of the previous points or by accredited reference materials producers must be used. The standard UNI CEI EN ISO/IEC provides that, in addition to these, materials produced by manufacturers "competent" on these TECHNICAL REGULATION RT-25 rev.05 pag. 23/25

24 products can be used, as defined in standard ISO 17034, ISO Guide 35, other rules on the subject, prescriptive documents ILAC, EA and ACCREDIA. 6 - Laboratories using calibration services offered in compliance with cases 3a and 3b use services that have not been subject to peer evaluation or accreditation. The Laboratory must therefore ensure that adequate evidence is available on the supplier's competence and in particular on the traceability and measurement uncertainty of the calibrations that are to be supplied. ACCREDIA will assess both such evidence and the ability of the Laboratory to evaluate them itself. Appropriate evidence of the technical competence of the supplier calibration laboratory and metrological traceability could include, but not necessarily be limited to: Records of the results of the interlaboratory, key and supplementary comparisons in the CIPM MRA environment or regionally organized (e.g. EURAMET); Records of the results of the interlaboratory comparisons carried out with other NMIs and/or DIs; Recordings on validation of the calibration method (scientific publications, technical reports, etc.); Procedures for estimating uncertainty and copies of Metrological Capacities; Documentation on the traceability of measurement results; Documentation on the quality guarantee of the calibration results; Evidence of the competence of the personnel responsible for the calibration; Documentation on laboratory premises and environmental conditions where the calibrations were carried out; Recording of internal Audits; Registration of Second Party Audits. Certification of a company's management system does not constitute a certification of competence of the company laboratories. The evidence of metrology traceability accepted by ACCREDIA is limited to specific procedures and for the evaluated quantities and does not imply any competence assessment for other measures or other services offered by the organization (in cases 3a and 3b). 8. PROVISIONS RELATING TO INTERNAL CALIBRATION The technical aspects regarding the execution of internal calibration must comply with UNI CEI EN ISO/IEC standard. In particular, the internal calibrations must be carried out: by a competent staff of the LAT or of the organization to which LAT belongs, properly trained and qualified; with instruments or standards under the direct and exclusive control of the LAT or organization to which LAT belongs, calibrated to ensure dissemination of metrology traceability; in an environment suitable for the calibration type; applying technical procedures managed by the LAT in compliance with the requirements specified in of RT-25 and evaluated positively by ACCREDIA DT. TECHNICAL REGULATION RT-25 rev.05 pag. 24/25

25 The internal calibrations results must: be accompanied by measurement uncertainty; be recorded in a calibration report conforming to section 5.10 of standard UNI CEI EN ISO/IEC TECHNICAL REGULATION RT-25 rev.05 pag. 25/25