Inter American Accreditation Cooperation IAAC APPLICATION FOR THE ASSESSMENT AND ACCREDITATION OF PROFICIENCY TESTING PROVIDERS

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1 IAAC APPLICATION FOR THE ASSESSMENT AND ACCREDITATION OF PROFICIENCY TESTING PROVIDERS CLASSIFICATION This document is classified as an IAAC Mandatory Document AUTHORIZATION Issue Nº: 01 Prepared by: Laboratories Subcommittee Date: March 2013 Revision Nº: 00 Approved by: General Assembly Issue Date: August 23, 2013 Application Date: Immediate Document number: IAAC MD 038/13 Inquiries: IAAC Secretariat Telephone: +52 (55) AVAILABILITY Copies of this document in English are available from the IAAC Secretariat and at the IAAC website. COPYRIGHT IAAC holds the copyright of this document and it may not be copied for resale. Original: English Date of Issue: August 23, 2013 IAAC MD 038/13 Pages 1 of 7

2 TABLE OF CONTENTS 1. PURPOSE INTRODUCTION TERMINOLOGY APPLICATION FOR THE ASSESSMENT AND ACCREDITATION OF PROFICIENCY TESTING PROVIDERS...4 Date of Issue: August 23, 2013 IAAC MD 038/13 Pages 2 of 7

3 1- PURPOSE Inter American Accreditation Cooperation The application in this document has been developed to ensure a consistent approach to the assessment and accreditation of Proficiency Testing Providers (PTPs) 2- INTRODUCTION Participation in proficiency testing programs is one of the key activities undertaken by laboratories that comply with ISO/IEC and ISO Proficiency testing programs should be viewed, and promoted as a component of a laboratory s quality assurance and continuous improvement tool. ISO/IEC clearly recognizes that PTs are valuable and requires accreditation bodies to take account of laboratories participation and performance in proficiency testing. Over the years there has been a need and market demand for the competence of Proficiency Testing) providers (PTP) to be recognized through accreditation so that laboratories can have confidence in the programs that PTPs produce. ISO /IEC 17043: 2010 Conformity assessment General requirements for proficiency testing contains criteria that can be used to assess the competence of Proficiency Testing Providers (PTPs). PT provision has been recognized as a conformity assessment activity in ISO/IEC Since 2004 ILAC General Assembly has worked to include accredited PT providers in the ILAC MRA. The following are the ILAC General Assembly resolutions related to the accreditation of PTPs. ILAC Resolution GA approved in September 2005 Taking into account the current wide use of ILAC G13, and the need for a future Standard to be a suitable common base for accreditation of PT providers in all sectors by ILAC Members, the General Assembly endorses ILAC requesting an urgent revision of ISO/IEC Guide 43 Part 1 & 2 by ISO/CASCO and its conversion into a Standard. ILAC Resolution GA approved in September 2005 While awaiting the availability of a replacement Standard for ISO/IEC Guide 43, and noting the global use of many PT programs, the General Assembly recognizes the need for its Members to use harmonized requirements for the accreditation of PT Providers and endorses the use of ILAC G13 and ISO/IEC Guide 43 as the base criteria for such accreditations. ILAC Resolution GA approved in November 2006 Noting Resolution GA 9.13 for harmonized criteria for accreditation of PT Providers, the General Assembly resolves that accreditation of proficiency testing providers will be considered for inclusion under the ILAC Arrangement, when appropriate procedures for this activity are developed and agreed by ILAC. ILAC Resolution GA approved in October 2007 The ILAC General Assembly, taking into account the PTCG analysis of compliance with steps a) to e) of ILAC-S6, agrees to proceed with an expansion of the scope of the ILAC MRA to include accredited PT scheme providers. Date of Issue: August 23, 2013 IAAC MD 038/13 Pages 3 of 7

4 ILAC Resolution GA approved in October 2008 Following ILAC Resolution GA (to include accredited PT Providers in the ILAC MRA), the General Assembly notes that the analysis of ISO/IEC and the IAF/ILAC A-Series has been carried out by the PTCG and confirms these documents are applicable to the implementation of an extension of the ILAC MRA. However, they need to be supported by an ILAC Policy interpreting the circumstances where PT can be provided by Accreditation Bodies or where providers can be accredited. The General Assembly notes that the PTCG has prepared such a draft Policy, entitled Use of ISO/IEC 17011, with Appropriate Interpretation, as Applied to the Accreditation of Proficiency Testing Providers and agrees that this draft policy be distributed for comment and ballot by ILAC Members ILAC Resolution GA approved in October 2009 Referencing ILAC GA Resolutions GA 9.12 and 9.13, and recognizing that ILAC has played a significant role in the creation of a draft International Standard for Proficiency Testing, the General Assembly endorses the use of ISO/IEC 17043, when published, for the accreditation of Proficiency Testing Providers. Effective two years after publication of ISO/IEC 17043, the General Assembly withdraws its endorsement of the use of ILAC G13 and ISO/IEC Guide 43 as referenced in GA Resolution 9.13 and approves the withdrawal of ILAC G13. ILAC Resolution GA & Attachment - approved in October 2010 The General Assembly confirms the results of the electronic ballots, as listed in the attachment to this document, undertaken by ILAC since the 13The General Assembly in 2009:.ILAC-P13:10/2010 Application of ISO/IEC for the Accreditation of Proficiency Testing Providers IAAC Resolution GA/2011/16 (only the relevant parts are copied below): The General Assembly agrees to extend the IAAC MLA to include the following scopes: Proficiency Testing Providers, according to ISO/IEC The General Assembly requests the MLA Committee to qualify evaluators and to update the MLA documents as necessary in order to implement these new scopes This document contains the application for accreditation body signatories, or applicants for signatory status, to the IAAC MLA for accreditation of proficiency testing providers. The explanation about the concept of application and the meaning of shall and should in the application can be found in the Introduction to document IAF/ILAC A5. 3- TERMINOLOGY For the purpose of this document, the terms and definitions given in ISO /IEC 17043: 2010 apply. 4- APPLICATION FOR THE ASSESSMENT AND ACCREDITATION OF PROFICIENCY TESTING PROVIDERS M ISO/IEC 17043:2010 shall be the general requirements for accreditation of PTPs. Date of Issue: August 23, 2013 IAAC MD 038/13 Pages 4 of 7

5 ISO/IEC makes normative reference in clause 4.1 Note, to ISO/IEC or ISO 15189, to be used to demonstrate the competence of PTP s laboratory or the laboratory subcontracted to perform test or measurements related to the PT schemes, as well as to ISO Guide 34, to be used to demonstrate the competence of producers of reference materials that provide proficiency test items. ISO/IEC also states in its Annex B that the statistical methods used to analyse the results need to be appropriate for each situation, and so are too varied to be specified in ISO/IEC ISO describes preferred specific methods for each of the situations discussed below, but also states that other methods may be used as long as they are statistically valid and are fully described to participants. M The AB shall obtain information from the PTP that demonstrates how the PTP is organised and how it meets the relevant requirements of ISO/IEC The information should include but not be limited to the following: (i) Proficiency Testing Schemes that are organised by the PTP (ii) The technical approach used to determine the assigned value and its uncertainty. (iii) The technical standards that are used for the organisation of PTs. (iv) If the PTP uses a subcontractor, information about the subcontractors: Name and address of the subcontractor, The scope of activities performed by the subcontractor, including, the type of testing, calibration and measurement activities done by the subcontractor, Information about how the PTP assesses the competence of each subcontractor. M The assessment team appointment by the AB shall include adequately trained assessors who have relevant knowledge of the determination of the assigned value, calculation of performance statistics, evaluation of performance, and preliminary determination of proficiency test item homogeneity and stability carried out by the PTP and an ability to cover the technical competency elements of an assessment based on ISO/IEC as well as the applicable requirements from ISO/IEC or ISO 15189, ISO and, if applicable, the revised International Harmonized Protocol for Proficiency Testing. M The procedures for sampling of the scope shall ensure that the assessment team reviews a representative sample of PT schemes during the assessment process to ensure proper evaluation of the competence of the CAB M Key activities, which the PTP cannot subcontract, include: policy formulation, process and/or procedure development, contract review, planning of proficiency testing schemes evaluation of performance. authorization of issuing of proficiency testing reports M It should be noted that a PTP may operate in different modes for different PT schemes. This shall be taken into account in the assessment approach that is adopted by the AB. M If the PTP or the specified subcontractor is accredited to ISO/IEC or ISO by an IAAC and/or ILAC MRA signatory for the testing/calibration/measurement activities it undertakes in the operation of proficiency testing schemes, this accreditation Date of Issue: August 23, 2013 IAAC MD 038/13 Pages 5 of 7

6 can be considered satisfactory to meet the ISO/IEC or ISO requirements for testing or calibration competency, as required by the PTP accreditation criteria. M If the PTP is not accredited to ISO/IEC or ISO by an IAAC and/or ILAC MRA signatory for the testing/calibration/measurement activities it undertakes in the operation of PT schemes, but performs the testing/calibration/ measurement determinations activities, the AB s assessment of the PTP shall include an assessment of the PTP s testing/calibration/ measurement determinations activities against the relevant parts of ISO/IEC or ISO These assessments on the testing or calibration activities are carried out on their suitability in supporting the proficiency testing schemes but the scope of accreditation issued by the AB for the PT provider shall not imply accreditation to ISO/IEC 17025, or ISO for those test and/or calibration activities. M Where the PTP uses a subcontractor to perform the testing/calibration/ measurement activities that does not hold ISO/IEC or ISO accreditation by an IAAC or ILAC MRA signatory for these activities, the AB shall assess how the PTP determines the competence of the subcontractor and their compliance with the relevant parts of ISO/IEC or ISO The AB may determine that an on-site assessment of the subcontractor is necessary to directly assess its technical competence and compliance to the relevant parts of ISO/IEC or ISO M The certificate of accreditation shall state that the PTP meets the requirements of ISO / IEC M An AB shall provide a scope of accreditation that describes the specific types of Schemes that the PTP is competent to produce. The scope of accreditation shall state the following: Type of proficiency testing item The measurand(s) or characteristic(s) that are to be identified measured or tested." Techniques for determination of the assigned value and its uncertainty (See ISO/IEC 17043, Annex B, clause B.2.1. for common techniques used.) Note: For quantitative schemes it may be necessary to specify the range of the measurand. M Proficiency testing can be used to monitor the on-going competence of the testing and calibration processes. When the PTP performs testing/calibration or measurement that significantly affects the validity and uncertainty of the assigned value of a measurand or characteristic in a particular PT scheme, the PTP shall participate in the proficiency testing programs as required in ILAC P9 for the tests/calibrations and measurements it performs. Note: Special consideration should be given in cases where the only option for a proficiency testing programme is one offered by a competing PTP. In these instances, the PTP would not be expected to enroll in a competitor s proficiency testing programme but could meet the requirements of ILAC P9 by other means, for example, use of reference materials, replicates tests or calibrations using the same of different methods. When an accredited laboratory acts as a subcontractor, it shall also participate in proficiency testing programs, as required to meet ILAC P9 for the tests and calibrations it performs. A non ILAC-accredited subcontractor shall similarly demonstrate competence Date of Issue: August 23, 2013 IAAC MD 038/13 Pages 6 of 7

7 through proficiency testing or other equivalent means. In situations where relevant PT is not available, the AB shall consider if the proficiency test items prepared are adequate to demonstrate competence, considering the data analysis and evaluation of proficiency testing scheme results. M The AB shall require that it is informed by the accredited PTP without any delay if the arrangements between the PTP and any of its subcontractors change during the accreditation period. The conditions shall stipulate that the PTP provide written details of provisions that are in place to assure continued technical competency and measures demonstrating that accreditation is being effectively maintained. M A PTP shall comply with the requirements for measurement traceability established in ILAC P10 for laboratories, when either its laboratory or its subcontracted laboratory is responsible for providing measurements based on which the PTP will determine the assigned value. M Where the PTP determines the assigned value solely based on the values assigned to reference materials or on value provided by one laboratory only, the requirements for measurement traceability established in ILAC P10 apply. Date of Issue: August 23, 2013 IAAC MD 038/13 Pages 7 of 7