ISO/IEC ACCREDITATION REQUIREMENTS FOR CALIBRATION LABORATORIES

Transcription

1 ISO/IEC ACCREDITATION REQUIREMENTS FOR CALIBRATION LABORATORIES AUTHORITY: VICE PRESIDENT EFFECTIVE DATE: 2015/01/01 DOCUMENT NUMBER: MA 2002

2 TABLE OF CONTENTS Foreword Application Proficiency Testing/Inter-laboratory Comparisons Traceability and Measurement Uncertainty Calibration laboratory Certificates Calibration Laboratory Scope of Accreditation Laboratories With Multiple Locations Page 2 of 18

3 FOREWORD This manual and MA 2001, ANAB Accreditation Manual for Laboratory-related Programs, define all mandatory requirements for ISO/IEC accreditation of calibration laboratories. This manual is based on the current version of ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories. For more information, contact the ANSI-ASQ National Accreditation Board, 500 Montgomery Street, Suite 625, Alexandria, Virginia, 22314, USA, telephone , facsimile , All references to ISO, ILAC, and ANAB documents and other controlled materials are to the current versions. Most ANAB documents are accessible free of charge at ILAC documents are accessible free of charge at Page 3 of 18

4 1. APPLICATION 1.1. The application should be submitted in electronic format when possible and include the following: Locations to be covered by the accreditation Proposed scope of accreditation Quality manual and associated operating procedures, however named Uncertainty budgets Proficiency testing/inter-laboratory comparison activity Calibrations that will not be on the scope of accreditation but are done internally to disseminate traceability 1.2. ANAB accreditation activities shall be confined to the draft scope of accreditation agreed on during the opening meeting of the initial accreditation assessment Separate applications are required for each location to be accredited. Physical locations in close proximity can be considered one location (to be determined by ANAB). See also ANAB Guidance for Classification and Assessment of Multi-Site Laboratories ANAB reviews the application to determine if additional information is required. After final review, ANAB acknowledges receipt of the application and ensures that all laboratory expectations can be met, including the laboratory s desired scheduling. 2. PROFICIENCY TESTING/INTER-LABORATORY COMPARISONS 2.1. Laboratories are required to participate in proficiency testing/inter-laboratory comparisons (PT/ILC) except when this is not reasonable or possible PT/ILC Requirements ANAB requires any laboratory applying for accreditation to show evidence of participation in relevant proficiency testing (if available). Relevant PT is defined as a test in an area of the proposed scope of accreditation. Participation is defined as completing the test. Results shall be reported to ANAB within six months of initial accreditation Where required, laboratories accredited by ANAB are expected to select PT providers that can demonstrate their programs are accredited and comply with the requirements of the current version of ISO/IEC Acceptable PT providers are accredited to ISO/IEC by ANAB or another accreditation body that is a signatory of the ILAC, APLAC, or IAAC MRA for calibration or testing When appropriate accredited PT providers are not available, laboratories should use programs that operate in accordance with ISO/IEC ANAB reserves the right to require mandatory 1 In the absence of an ILAC MRA for accreditation of PT providers, accreditation bodies such as ANAB that are signatories of the ILAC MRA for calibration and testing offer accreditation for PT providers. Page 4 of 18

5 participation of any accredited laboratory in any future program mandated or administered by APLAC, ILAC, or IAAC When a selected proficiency test provider is not accredited, the laboratory shall seek ANAB concurrence (via FM 2040) that the organization conducting the PT/ILC is competent in accordance with the current version of ISO/IEC For additional guidance, see ANAB Guidance on Proficiency Testing/Inter-Laboratory Comparisons (available on ANAB s website) Any laboratory that is unable to locate or requires assistance in selecting a suitable PT provider should contact ANAB for assistance Definitions Inter-laboratory comparisons (ILC): Organization, performance, and evaluation of calibration or test results for the same or similar item by two or more laboratories in accordance with predetermined conditions ILC are used to: Determine a laboratory s performance in conducting specific tests or calibrations. Monitor an accredited laboratory s ongoing performance (by the laboratory s accreditation body). Identify possible problems and initiate any required remedial action related to issues such as individual staff performance or calibration of standards. Provide customers with confidence in the laboratory s measurements. Determine a method s performance characteristics, effectiveness, or comparability of a new method with established methods Proficiency testing (PT): Evaluation of calibration or test results against pre-established criteria by means of inter-laboratory comparisons. The difference between PT and ILC is one of formality: PT is typically organized by a commercial organization A laboratory s participation in PT enables the laboratory to assess and demonstrate the reliability of the resultant measurement data by comparison with results from other participating laboratories. Ideally in PT programs, laboratories receive in their reports independent feedback on potential biases in their measurement systems PT is most often used to assess a laboratory s capability to perform competent tests or measurements. The data resulting from a proficiency test may be used by the accreditation body, a laboratory customer, or the laboratory itself, and thus can supplement the laboratory s internal quality program. Customers of calibration laboratories want confidence that the calibrations they receive are reliable and accurate Major discipline: For ANAB purposes, calibration is defined as a major discipline and identified as such on the scope of accreditation Major sub-discipline: Parameters falling within the major discipline of calibration. Some examples of calibration major sub-areas include dimensional, electromagnetic-dc/low frequency, mechanical, and thermodynamic. Page 5 of 18

6 2.4. Continuing Accreditation PT/ILC Requirements ANAB-accredited laboratories shall submit the results of PT to ANAB via EQM. Assessors shall verify during surveillance and reassessment that up-to-date information is in EQM and shall ask that a completed PT/ILC Four-year Plan (FM 2015), be attached in each assessment If PT is not available for a particular measurement discipline or parameter through existing PT programs, internal performance-based data demonstrating laboratory competence and measurement performance in comparison with another laboratory entity can be substituted for achieving and/or maintaining accreditation. When comparisons with another laboratory are not feasible, the laboratory shall use other methods to assess the quality of its output to meet the requirements of the standard. Laboratories must ensure that normal PT/ILC takes place when a feasible laboratory comparison becomes available. FM 2040 is used to report alternate quality measures to ANAB for approval The typical requirement for PT/ILC is that each accredited location, including any satellite sites, participates in a minimum of one test for each major sub-discipline on the scope of accreditation (or applicable sub-discipline of the scope for satellite sites) at least every four years. In addition, the typical minimum participation required is one per calendar year per location. ANAB may revise this requirement for a specific laboratory based on the scope of accreditation or demonstrated stability and competence. Laboratories are strongly encouraged to participate more frequently as individual circumstances may dictate For additional guidance, refer to ANAB Guidance on Proficiency Testing/Inter-Laboratory Comparisons Reporting PT/ILC Results A calibration laboratory s PT results usually are reported as an E n value and based on the following equation: En = ( Lab Re f ) (U 95Lab) 2 + (U 95Re f ) 2 Lab and Ref are the laboratory and reference measurement values for the measurement in question and U 95 Lab and U 95 Ref represent the expanded uncertainties expressed at the 95% confidence level for the laboratory and reference laboratory, respectively. E n values greater than 1 or less than -1 (or a z-score greater than 3) are considered unsatisfactory in that they indicate an uncertainty issue or that the laboratory s measurement result deviates significantly from the reference measurement result If the above equation is not applicable to the measurement in question for whatever reason, the PT provider s interpretation and calculations may be used, in addition to other applicable calculations of performance found in ISO/IEC A laboratory that receives unsatisfactory results during a proficiency test is required to promptly provide to ANAB evidence of action taken to correct the problem. If a thorough investigation fails to identify a cause of the unsatisfactory result, or if a follow-up test results in Page 6 of 18

7 another outlier, the laboratory is required to provide ANAB all details of its investigation for further review and determination of the subsequent course of action, which may include suspension, reduction in scope of accreditation, or withdrawal of accreditation Non-accredited PT/ILC Programs Laboratories that have access to commercial PT/ILC may organize their own interlaboratory comparisons or proficiency tests. They must provide ANAB with the reason for not using a PT provider accredited to ISO/IEC17043 and must submit a plan to ANAB on FM ANAB will verify the plan against the requirements of ISO/IEC and the plan must be approved by ANAB prior to beginning the first test. The plan must be documented and include the following: Designated coordinator with name and contact information Objective, nature, and purpose of the plan Procedure for selection of PT/ILC participants or criteria to be met before participation is allowed Anticipated number of participants Description of the manner in which PT items are to be obtained, processed, checked, and distributed, taking into account in its design the major sources of analytical errors involved in the area of PT offered Designation of the reference laboratory Description of the information to be supplied to participants (pre-notification) and the schedule for the various phases of the plan Information on methods or procedures participants may need to use to perform the tests or measurements (commonly their routine procedures) Basis of performance evaluation techniques, where appropriate Description of the extent to which test results and the conclusions based on the outcome of the plan are to be made Origin and traceability of any reference values Traceability of the key reference standards of each participant lab, as warranted Plan to include CMC and MU for each participant in the reports Additional details such as assuring artifact stability, as warranted The PT reports resulting from the related PT programs must include: Name and contact details of the provider Date of participation and date of report Number of pages and clear identification of the end of the report Report number and clear identification of the plan Clear description of the PT items used Laboratory participation codes and test results Statistical data and summary, including assigned values and range of acceptable results Procedures used to establish any assigned value or reference values Details of traceability and uncertainty, as warranted, of the reference values Assigned value and summary statistics for test methods used by each participant Page 7 of 18

8 Comments on participants performance by the technical advisors, as warranted Procedures used to statistically analyze the data ANAB Accreditation Managers are responsible for review and approval of the internal PT plan. ANAB notifies the laboratory of approval or disapproval, and approved plans are attached in EQM for verification during assessments Unless specifically indicated otherwise in the approved FM 2040, approval of the plan authorizes the laboratory to conduct future PT/ILC as long as the plan remains valid. ANAB verifies compliance with the plan during assessments. Additional assessment time may be required, in which case ANAB shall invoice the laboratory for review based on current assessment-day rates If PT is not available for a particular measurement discipline or parameter through existing PT programs, internal performance-based data demonstrating laboratory competence and measurement performance in comparison with another laboratory entity can be substituted for achieving and/or maintaining accreditation. When comparisons with another laboratory are not feasible, the laboratory shall use other methods to assess the quality of its output to meet the requirements of the standard. The laboratory should ensure that normal PT/ILC takes place when a feasible laboratory comparison becomes available. FM 2040 is used to report alternate quality measures to ANAB for approval. 3. TRACEABILITY AND MEASUREMENT UNCERTAINTY 3.1. Definitions Metrological traceability: Property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty. [JCGM 200:2012] Measurand: Quantity intended to be measured. [JCGM 200:2012(E/F)] Measurement uncertainty (MU): Non-negative parameter characterizing the dispersion of the quantity values being attributed to a measurand, based on the information used. [JCGM 200:2012(E/F)] Calibration and measurement capability (CMC): Calibration and measurement capability available to customers under normal conditions (a) as published in the BIPM key comparison database (KCDB) of the CIPM MRA or (b) as described in the laboratory s scope of accreditation granted by a signatory to the ILAC Arrangement. [CIPM MRA-D-04, Version 2 (2011), Calibration and Measurement Capabilities in the context of the CIPM.] 3.2. Traceability Traceability is a process whereby the indication of a measuring instrument (or a material measure) can be compared with a national standard for the measurand in question in one or more stages Traceability is characterized by a number of essential elements: Page 8 of 18

9 There must be an unbroken chain of comparisons going back to a standard acceptable to the parties, usually a national or international standard, and ending with laboratory working reference standards used in a metrology laboratory. MU for each step in the traceability chain must be calculated according to defined methods and must be stated so an overall uncertainty for the whole chain can be calculated. Each step in the chain must be performed according to documented and generally acknowledged procedures. The results must be equally documented (calibration certificate or test report). Laboratories performing one or more steps in the chain must supply evidence of their technical competence. Accreditation by an ILAC signatory accreditation body is considered evidence of technical competence within the scope of accreditation Use of Non-accredited Laboratories for Traceability Laboratories could receive calibration certificates from non-accredited laboratories (including OEMs) when there is no other source or economical means to have a standard calibrated. In this case, the laboratory should encourage the provider to achieve accreditation to ISO/IEC The provider may be considered acceptable for traceability if the laboratory submits acceptable information to ANAB for review (see below) The provider must meet a number of essential elements for traceability. At a minimum, the laboratory seeking permission to use the non-accredited provider must provide to ANAB: An unbroken chain of comparisons going back to a standard acceptable to the parties, usually a national or international standard. Proof that measurement uncertainty throughout the traceability chain has been calculated according to accepted methods and stated so an overall uncertainty for the whole chain can be calculated. Proof that each step in the chain has been performed according to documented and generally acknowledged procedures, including documenting results (before and after data). Evidence of technical competence of the non-accredited providers. Proof that traceability is to SI units. Evidence that calibrations have been repeated at appropriate intervals ANAB shall invoice the laboratory for review based on current assessment-day rates For additional guidance, see ANAB Guidance on Metrological Traceability and the current version of ILAC P10, ILAC Policy on Traceability of Measurement Results Nonconformities for Traceability ANAB shall issue a nonconformity (NC) against clause 5.6 of ISO/IEC if evidence exists that instruments have been calibrated using a provider not compliant with the traceability requirements of ILAC P10 and this document. An NC also shall be issued against the same element if evidence exists that instruments have been calibrated by a laboratory accredited by an accreditation body that is not a signatory of an ILAC or ILAC-approved regional cooperation MRA or by a laboratory that has not provided an accredited certificate Page 9 of 18

10 of calibration or is not accredited specifically for the parameter calibrated. The severity of the NC depends on the effect on the resultant calibrations done with that device and other considerations. 4. CALIBRATION LABORATORY CERTIFICATES 4.1. To demonstrate measurement traceability, calibration certificates shall indicate traceability to national or international standards of measurement and provide the result of the measurement and the associated uncertainty of measurement, as applicable Calibration certificates shall contain a statement of traceability that affirms the calibration was performed using a standard traceable to an appropriate national, international, intrinsic, or mutual-consent standard. Calibration certificates that refer only to a NIST test number as evidence of traceability are not considered a sufficient demonstration of measurement traceability. NIST test numbers do not in and of themselves provide a statement of uncertainty associated with the link in the chain farthest from NIST (the last facility providing the measurement value) Many laboratories use documents found in the Government-Industry Data Exchange Program (GIDEP) database (accessed online or through discs) as direct source documents for calibration procedures. These include military documents such as NAVAIR and 33K and industry calibration procedures. In these cases, the laboratory shall maintain a record of validation that the procedure meets customer requirements and identify the procedure by: Incorporating the procedure used into the laboratory s document control system, assigning its own number that is referenced on the calibration certificate, or Refer to the GIDEP procedure number with revision date To be considered satisfactory for traceability purposes, calibration certificates shall include the accreditation symbol of ANAB or another accreditation body recognized by ILAC, APLAC, and/or IAAC or otherwise refer to such accredited status. Non-accredited certificates or test reports, even if issued by accredited laboratories, will result in a finding during the assessment. If unable to find a source for an accredited calibration or test, the laboratory shall follow the procedure outlined below Measurement Uncertainty MU and the calculation thereof is one of a number of essential elements contributing to the concept of traceability The MU for each step in the traceability chain must be calculated according to defined methods and must be stated so that an overall uncertainty for the whole chain may be calculated Defined methods for calculation of MUs can be found in the current versions of: ISO Guide 98-3, Extension to any number of output quantities (formerly Guide to the Expression of uncertainty in Measurement) NIST Technical Note 1297, Guidelines for Evaluating and Expressing the Uncertainty of NIST Measurement Results ANSI/NCSL Z , U.S. Guide to Expression of Uncertainty in Measurement Page 10 of 18

11 EA-4/02, Expressions of the Uncertainty of Measurement in Calibration M H Ramsey and S L R Ellison (eds.), Eurachem/EUROLAB/ CITAC/Nordtest/AMC Guide: Measurement uncertainty arising from sampling: a guide to methods and approaches Eurachem (2007). EURACHEM/CITAC Guide CG-4, Quantifying Uncertainty in Analytical Measurement Second Edition, Editors S L R Ellison (LGC, UK) M Rosslein (EMPA, Switzerland) A Williams (UK) Eurachem/CITAC Guide Use of uncertainty in compliance assessment Uncertainties on Calibration Certificates ANAB-accredited calibration laboratories shall report MU on accredited calibration certificates with one allowable exception. When issuing a customer-requested statement of compliance with a specification (as evidenced in contract review records), the laboratory may omit MU on the certificate but shall take it into consideration in making the compliance determination. In all cases, the laboratory is required to maintain a record of MU for each accredited calibration ISO/IEC requires calibration laboratories to report on the calibration certificate the measurement results with MU and/or a statement of compliance with a customer-identified specification ANAB-accredited calibration laboratories shall report the measured quantity value and the uncertainty of measurement unless it has been established during contract review that only a statement of compliance with a specification is required by the customer When the customer requests only a statement of compliance as evidenced in contract review documentation, the measured quantity value (data) and the MU may be omitted on the calibration certificate. The following shall apply: The customer shall be notified during contract review that the calibration certificate is not intended to be used in support of the further dissemination of metrological traceability (i.e., to perform an accredited calibration on another device) because the MU, an integral part of metrological traceability, will not be included in the certificate. The laboratory shall determine the MU and take it into account when issuing the statement of compliance (see ISO/IEC 17025:2005, clause ) At specific customer request, a statement of compliance issued without considering uncertainty in determining compliance to specification shall contain the results and the MU. The customer assumes partial risk of determining compliance (rather than the entire risk being assumed by the calibration laboratory). The certificate shall also include the following statement: The statement of compliance in this certificate was issued without taking the uncertainty of measurement into consideration. The customer shall assess the results and uncertainty when determining if the results meet their needs It is essential for the laboratory to maintain contract review documentation with proof that the laboratory s customer was notified of its shared responsibility. Page 11 of 18

12 In all cases, the laboratory is required to maintain a record of MU for each accredited calibration. The laboratory shall be able to provide MU for any accredited calibration immediately upon request by an assessor or the laboratory s customer The following rules apply: Tabular presentation of the measurement result may be used, and the relative expanded uncertainty U / y may also be provided if appropriate. The coverage factor and the coverage probability shall be stated on the calibration certificate. To this an explanatory note shall be added, which may have the following content: The reported expanded uncertainty of measurement is stated as the standard uncertainty of measurement multiplied by the coverage factor k such that the coverage probability corresponds to approximately 95%. Uncertainty statements not specifying (at a minimum) the coverage factor/confidence level will be considered incomplete and inadequate for purposes of demonstrating measurement traceability. The numerical value of the expanded uncertainty shall be given to, at most, two significant figures. The numerical value of the measurement result shall in the final statement be rounded to the least significant figure in the value of the expanded uncertainty assigned to the measurement result. For the process of rounding, the usual rules for rounding of numbers shall be used, subject to the guidance on rounding provided in section 7 of the GUM. For further details on rounding, see the current version of ISO Where applicable, the uncertainty shall cover the same contributions to uncertainty that were included in evaluation of the CMC uncertainty component, except that uncertainty components evaluated for the best existing device shall be replaced with those of the customer s device. Random contributions that cannot be known by the laboratory, such as transport uncertainties, should normally be excluded in the uncertainty statement. If, however, a laboratory anticipates that such contributions will have significant impact on the uncertainties attributed by the laboratory, the customer should be notified according to the general clauses regarding tenders and reviews of contracts in ISO/IEC Calibration and measurement capability (CMC) is available to customers under normal conditions: (a) as published in the BIPM key comparison database (KCDB) of the CIPM MRA or (b) as described in the laboratory s scope of accreditation granted by a signatory to the ILAC Arrangement. Where the term NMI is used it is intended to include Designated Institutes (DIs) within the framework of the CIPM MRA. [Calibration and Measurement Capabilities in the context of the CIPM MRA (CIPM MRA-D-04, Version 2] As the definition of CMC implies, ANAB-accredited calibration laboratories shall not report a smaller MU than the CMC uncertainty for which the laboratory is accredited. Laboratories should take this restriction into consideration when deciding how many ranges to include on the scope of accreditation for a given parameter (and, accordingly, how many CMC budgets must be maintained). Page 12 of 18

13 In some instances, a calibration certificate may contain the statement in tolerance, along with a statement that the measurement uncertainty does not exceed a certain fraction of the tolerance. These fractions are often called test accuracy ratios (TARs) or test uncertainty ratios (TURs). Uncertainty statements phrased in terms of TARs or TURs are not acceptable for demonstrating measurement traceability or as an alternative to calculated MU. 5. CALIBRATION LABORATORY SCOPE OF ACCREDITATION 5.1. Scope of Accreditation A laboratory s scope of accreditation is a document specifically stating the disciplines or parameters that have been verified by ANAB ANAB requires scopes of accreditation to meet the current version of NIST SP 811, Guide for the Use of the International System of Units (available on ANAB s website). This guide was prepared to assist in the use of the SI, including reporting of results of measurements For calibration laboratories, the scope defines the type and ranges of the accredited measurand, key equipment, methods, and reference standards used and the CMC expressed as an uncertainty for each measurand and range For calibration scopes of accreditation, the following major sub-areas apply: Electromagnetic DC/Low Frequency Electromagnetic RF/Microwave Optical/Fiber-Optical Radiation Time and Frequency Thermodynamic Mechanical Dimensional Chemical Quantities Ionizing Radiation 5.2. Parameters listed on the scope of accreditation for Electromagnetic (DC/Low Frequency and RF/Microwave), Optical Radiation, Thermodynamic, and Time and Frequency, the parameter normally are identified by the type of measurement done (for instance, DC Voltage Measure or Frequency Source) For parameters listed under Dimensional and Mechanical, the type of instrument calibrated is normally listed under Parameter (for instance, Calipers or Analytical Balances) Ionizing Radiation and Chemical Quantities may be seen in either format Chemical Quantities using specific solutions shall be listed on the scope of accreditation at those specific solution points only (i.e., not as a range of values). Solutions used must meet the traceability requirements outlined in this document The scope of accreditation of an ANAB-accredited calibration laboratory shall include the CMC expressed in terms of: Page 13 of 18

14 Measurand or reference material Calibration/measurement method/procedure and/or type of instrument/material to be calibrated or measured Measurement range and additional parameters where applicable, e.g., frequency of applied voltage Uncertainty of measurement 5.7. There shall be no ambiguity on the expression of the CMC on the scope of accreditation and, consequently, on the smallest uncertainty of measurement that can be expected to be achieved by a laboratory during a calibration or a measurement. Particular care should be taken when the measurand covers a range of values. This generally is achieved by employing one or more of the following methods for expression of the uncertainty: A single value, which is valid throughout the measurement range A range, in which case the calibration laboratory should have proper assumption for the interpolation to find the uncertainty at intermediate values An explicit function of the measurand or a parameter A matrix where the values of the uncertainty depend on the values of the measurand and additional parameters A graphical form, providing there is sufficient resolution on each axis to obtain at least two significant figures for the uncertainty 5.8. The following rules apply: Open intervals (e.g., U < x ) are not allowed in the specification of uncertainties. The uncertainty covered by the CMC shall be expressed as the expanded uncertainty having a specific coverage probability of approximately 95%. This probability shall also be identified in a statement in the certificate. The unit of the uncertainty shall always be the same as that of the measurand or in a term relative to the measurand (e.g., percent). CMC uncertainties shall include any contributions from a best existing device available for the specific category of calibrations. Best existing device is defined as the best device commercially available and may reasonably be expected to be available to a laboratory customer. CMC budgets shall include at a minimum the measurement uncertainty of the standards, the specification of the standards, repeatability, and contributions from a best available unit under test. If any of these contributors are determined to be insignificant, justification for the decision shall be documented. There should be no significant contribution to the CMC uncertainty component attributable to physical effects that can be ascribed to imperfections of even the best existing device under calibration or measurement In some calibrations a best existing device does not exist and/or contributions to the uncertainty attributed to the device significantly affect the uncertainty. If such contributions can be separated from other contributions, they may be excluded from the CMC statement. In such a case, the scope of accreditation shall clearly indicate that the contributions to the uncertainty from the device are not included. These cases are rare and the laboratory is expected to provide evidence during the assessment. Page 14 of 18

15 5.10. Calibration laboratories shall demonstrate the ability to provide calibrations to their customers in compliance with the above rules so that measurement uncertainties equal those covered by the CMC CMC shall be supported by evidence of calculations (uncertainty budgets) and represented as expanded uncertainties using a coverage factor of k=2 to approximately the 95% confidence level. Laboratories shall update CMC budgets as needed and shall provide the revised budgets to ANAB during assessments In-house accredited calibrations used by applicant and accredited laboratories to disseminate traceability but not listed on the proposed scope of accreditation are subject to witnessing during initial assessments and reassessments. These capabilities will be added to a separate document and maintained in ANAB records for information when assigning assessors. Additional competency codes will be added in EQM as necessary. 6. LABORATORIES WITH MULTIPLE LOCATIONS 6.1. ISO/IEC applies to laboratories that perform calibrations in the main laboratory and at other locations. For the purposes of this document, the term on-site refers to tests or calibrations performed at the laboratory or a third-party location Definitions Multi-site laboratory: Laboratory whose activities are carried out at more than one location. The organization may have satellite sites under the oversight of the main laboratory, conduct on-site calibrations and/or tests, or have more than one address for the main laboratory. A multi-site laboratory is presumed to maintain a single accreditation that covers the main laboratory and all satellite and on-site operations Multi-laboratory corporation: Organization with more than one main laboratory whose corporate site may conduct some key activities (see definition below) that are also carried out at each main laboratory. The corporate site may provide guidance and oversight and maintain quality documents but the individual laboratories operate on a day-to-day basis as autonomous organizations. Each laboratory applies for accreditation separately and is assessed and accredited as a separate entity, including a scope of accreditation specific to each laboratory. The individual laboratories may themselves be multi-site laboratories as defined above Main laboratory: Organization that performs key activities including calibrations and operates on a day-to-day basis as an autonomous organization. The main laboratory may oversee operations that include one or more satellite locations or on-site calibrations and/or tests Laboratory with satellite sites: Organization that consists of a main site and satellite site or sites that perform calibrations and/or tests at a remote permanent or semi-permanent location. The main site provides oversight of the satellite site activities Satellite site: Permanent or semi-permanent remote site that operates as a subsidiary to the main laboratory. Calibrations and/or tests (and possibly other key activities) are conducted at the satellite site. Customer equipment or test samples are usually received at the satellite site and not normally processed through the main laboratory. The main laboratory provides oversight of all Page 15 of 18

16 satellite site key activities. Satellite site scope parameters are normally identical to or a sub-set of the main laboratory s scope parameters. In cases where a different or additional parameter is done at the remote site, ANAB determines on a case-by-case basis whether the site qualifies as a satellite site or requires its own accreditation Multi-location main laboratory: Organization with more than one address. Calibrations and/or tests done at each address are distinct and one address must be designated as the main laboratory for identification on the ANAB certificate and scope of accreditation. The alternate address is considered another room of and is assessed as part of the main laboratory On-site calibration or testing: Calibrations or tests completed by the staff of the main or satellite laboratory at a customer or customer-designated location on a temporary basis. Mobile laboratories are included in this category Key activities: Calibration activities, calibration certificate generation, policy formulation, process and procedure development, and, as appropriate, contract review, planning conformity assessments (internal audits), reviews, approvals, and decisions on the results of conformity assessments Multi-site Laboratory Accreditation Application The application for accreditation must identify the addresses of the laboratory and any satellite sites where accredited calibrations are performed. On-site capability also must be identified. If the laboratory is part of a multi-laboratory corporation as defined above, the applicant must identify the corporate site, which must apply for accreditation at the same time or already be accredited by ANAB During initial assessment, ANAB visits the main site or head office and all other premises covered by the scope of accreditation and from which one or more key activities are performed Multi-laboratory Corporations Multi-laboratory corporations are assessed and accredited individually. If the quality management system is written and maintained by the corporate site, assessors emphasize the laboratory s compliance to the corporate quality system, but deficiencies in the corporate quality system may be identified during the assessment Individual laboratories also may be multi-site laboratories (i.e., have satellite sites, on-site capabilities, and/or multiple addresses) as defined in this document Multi-site Laboratories Laboratories with Satellite Sites Laboratory sites are considered satellite sites if they meet the following requirements: The main laboratory provides oversight of all satellite site key activities. The laboratory and the sites form one legal entity. Page 16 of 18

17 The accreditation is for the entire organization and only one certificate and scope of accreditation is issued. One management system covers the entire organization. Adequate procedures exist to protect the integrity of the reference standards and equipment used for each calibration or test All satellite sites are visited, at a minimum, before being added to the scope of accreditation and every four years thereafter during reassessment. ANAB schedules additional visits to satellite sites based on assessment history or other reasons. Training records of all technicians from the corporate and satellite sites shall be made available on request. ANAB determines procedures to be witnessed and checklist elements to be assessed during a site visit to add a satellite site During each reassessment of the main laboratory, ANAB assessors shall ensure that the main laboratory has addressed the following for each satellite site: Internal audit Management review Adherence to ANAB requirements for satellite sites in the assessment checklist PT/ILC or its alternative. Typically, accredited satellite sites are required to participate in PT/ILC each year and cover all major sub-areas of the scope that apply to the satellite site over a rolling four-year period. ANAB may approve variations based on the specific scope of accreditation Multi-location Main Laboratories If a main laboratory operates out of more than one location, it may be classified as a multi-location main laboratory instead of being considered a main laboratory with satellite sites. If the calibration capabilities at the main laboratory and the other site are distinct, the site may be considered as part of (another room of) the main laboratory (as opposed to a satellite site, which does the same or a subset of the main laboratory s scope). In this case, the laboratory is assessed as one entity and should be considered as such during the laboratory s internal audits, management reviews, and PT/ILC activities. ANAB makes the final determination of classification On-Site Calibrations On-site activities introduce critical variables to the operational environment. This includes factors outlined in ISO/IEC 17025, such as environmental effects on tests and calibrations, site security, and transportation issues ANAB assessors witness calibration on site before adding the on-site to the scope and at least every four years thereafter during reassessment. Extra costs may be incurred if the location of on-site calibration or testing adds additional time to the assessment. The laboratory also may be invoiced for additional travel expenses. Simulation of tests or calibrations shall be minimized and must be approved by the Accreditation Manager. On-site witnessing is required only for laboratories that perform accredited calibrations on site. Page 17 of 18

18 Additional requirements for on-site calibration or tests are included in the ISO/IEC checklist (CL 2001, available on ANAB s website) Scope of Accreditation for Multi-site Calibrations The scope of accreditation shall indicate which parameters are available at satellite sites and on site if less than the full scope of accreditation. Locations of satellite sites or additional addresses (in the case of multi-location laboratories) will be identified in footnotes Scopes of accreditation that include on-site capability shall state in the footnotes: Because on-site conditions typically are more variable than those in the laboratory, larger measurement uncertainties are expected in the field than what is reported on the accredited scope Use of Personnel for Multi-Laboratory Corporations Multi-laboratory corporations frequently exchange personnel for technical activities. Accredited laboratories need to ensure that all technical personnel, including those assigned temporarily from another site of the corporation, are appropriately trained and approved for their accredited work. Evidence of training and approval is required in the laboratory where the work takes place. Page 18 of 18