ACCREDITATION CRITERIA FOR TESTING LABORATORIES AC89 February 2016 (Effective April 1, 2016) PREFACE The attached accreditation criteria has been issued to provide all interested parties with guidelines on implementing performance features of the applicable standards referenced herein. The criteria was developed and adopted following public hearings conducted by the International Accreditation Service, Inc. (IAS), Accreditation Committee and is effective on the date shown above. All accreditations issued or reissued on or after the effective date must comply with this criteria. If the criteria is an updated version from a previous edition, solid vertical lines (|) in the outer margin within the criteria indicate a technical change or addition from the previous edition. Deletion indicators (→) are provided in the outer margins where a paragraph or item has been deleted if the deletion resulted from a technical change. This criteria may be further revised as the need dictates. IAS may consider alternate criteria provided the proponent submits substantiating data demonstrating that the alternate criteria are at least equivalent to the attached criteria and otherwise meet applicable accreditation requirements. Copyright © 2016 1 IAS/TL/009 AC89 February 8, 2016 ACCREDITATION CRITERIA FOR TESTING LABORATORIES 1.0 INTRODUCTION demonstration of its competence to carry out specific conformity assessment tasks. 1.1 Scope: The purpose of this criteria is to set forth requirements for obtaining and maintaining International Accreditation Service, Inc. (IAS), testing laboratory accreditation and for the qualifying data that must be submitted relating to the scope of testing for which accreditation is sought. This criteria supplements the IAS Rules of Procedure for Laboratory Accreditation. 3.2 Accreditation Body (AB): that performs accreditation. 3.3 Assessment: Process undertaken by an accreditation body to assess the competence of a CAB, based on particular standard(s) and/or other normative documents and for a defined scope of accreditation. 1.2 References and Normative Documents: Publications listed below refer to current editions (unless otherwise stated), current editions of related construction codes published by the International Code Council or codes duly adopted by the relevant jurisdiction. 3.4 Calibration: Operation that, under specified conditions, in a first step, establishes a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications with associated measurement uncertainties and, in a second step, uses this information to establish a relation for obtaining a measurement result from an indication. 1.2.1 ISO/IEC (International Organization for Standardization/International Electrotechnical Commission) Standard 17025, General requirements for the competence of testing and calibration laboratories. 1.2.2 IAS Accreditation. Rules of Procedure for 3.5 Calibration and Measurement Capability (CMC): Calibration and measurement capabilities provided by the laboratory, available to customers under normal conditions, and as described in the laboratory’s scope of accreditation granted by a signatory to the ILAC Arrangement. Laboratory 1.2.3 ISO/IEC Standard 17011, Conformity assessment—General requirements for accreditation bodies accrediting conformity assessment bodies. 1.2.4 IAS Calibration and Accreditation Programs Definitions. Testing 3.6 Certified Reference Material (CRM): Reference material, accompanied by documentation issued by an authoritative body and providing one or more specified property values with associated uncertainties and traceability, using valid procedures. Laboratory 1.2.5 ILAC-P9, ILAC Policy for Participation in Proficiency Testing Activities. 3.7 Conformity Assessment Body (CAB): Body that performs conformity assessment services and that can be the object of accreditation. 1.2.6 Information on Proficiency Testing Providers for IAS Clients. 1.2.7 IAS Policy Guide on Calibration, Traceability, and Measurement Uncertainty for Testing Laboratories. NOTE: Whenever the word “CAB” is used in the text, it applies to both the “applicant and accredited CABs” unless otherwise specified. 1.2.8 Joint Committee for Guides in Metrology, International vocabulary of metrology – Basic and general concepts and associated terms (VIM). 3.8 Extending Accreditation: Process of enlarging the scope of accreditation. 1.2.9 IAS Policy on the Expansion of the Scope of Accreditation of Accredited Testing Laboratories and Inspection Agencies. 3.9 ILAC: Cooperation. 3.10 1.2.10 IAS Policy on Authorized Signatories. 1.2.11 IAS Laboratories. Policy on Proficiency Testing BASIC INFORMATION 3.13 Reference Material: Material, sufficiently homogeneous and stable with reference to specified properties, which has been established to be fit for its intended use in measurement or in examination of nominal properties. The following basic information is necessary: 2.1 Data showing compliance with the IAS Rules of Procedure for Laboratory Accreditation. 3.0 a with Section Laboratory: A body that calibrates and/or tests. 3.12 Proficiency Testing: A determination of the laboratory calibration or testing performance by means of interlaboratory comparisons. 1.2.13 IAS Policy on Accreditation Certificate Validity. 2.2 Data showing compliance Required Data, of this criteria. International Laboratory Accreditation 3.11 Metrological Traceability Chain: Sequence of measurement standards and calibrations that is used to relate a measurement result to a reference. for 1.2.12 IAS Policy on Testing at Off-site Locations by IAS-Accredited Laboratories. 2.0 Authoritative body 4, 3.14 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. DEFINITIONS 3.1 Accreditation: Third-party attestation related to conformity assessment body conveying formal 2 IAS/TL/009 AC89 February 8, 2016 3.15 Remote Surveillance Assessment: A remote assessment tool used to evaluate compliance as part of the IAS ongoing plan of surveillance. Remote surveillance assessments are limited in scope, typically covering a sampling of key requirements. Remote surveillance assessments rely on computer-assisted auditing techniques, including teleconferencing, interactive webbased communications or remote access to management system documentation and records. Remote surveillance assessments do not replace the requirement for initial assessments or periodic on-site reassessments of an accredited organization. by compliance with the requirement for evaluation of a nonaccredited calibration provider in accordance with the document referenced in Section 1.2.7 of this criteria. In all cases, bodies issuing accreditations to calibration laboratories must operate under ISO/IEC Standard 17011. 4.3 Laboratories performing in-house calibrations are required to maintain the reference standards and equipment necessary to ensure traceability. The reference standards/equipment must be calibrated by an accredited calibration laboratory or by NIST. In cases in which calibration services are not available from an accredited laboratory as defined above, laboratories must be able to demonstrate the steps they take to ensure the quality and traceability of their calibration services. Laboratories performing internal calibrations shall issue calibration certificates or reports that are in compliance with requirements detailed in Section 5.10 of ISO/IEC Standard 17025:2005. NOTES: In cases where a laboratory forms part of an organization that carries out other activities besides calibration and testing, the term “laboratory” refers only to those parts of that organization that are involved in the calibration and testing process. As used herein, the term “laboratory” refers to a body that carries out calibration or testing at or from a permanent location. 4.4 Internal Calibration: Testing laboratories that perform internal calibrations must meet all applicable requirements of the IAS Policy Guide on Calibration, Traceability and Measurement Uncertainty for Testing Laboratories for the calibrations that are performed internally. Additionally, the following information must be provided or made available to IAS: 3.16 Scope of Accreditation: Specific conformity assessment services for which accreditation is sought or has been granted. 3.17 Surveillance: Set of activities, except reassessment, to monitor the continued fulfillment by accredited CABs of requirements for accreditation. 4.4.1 A list of equipment that is calibrated internally and the equipment used as the reference standard(s). NOTE: Surveillance includes both surveillance on-site assessments and other surveillance activities, such as the following: 4.4.2 The specific procedures used for calibration of equipment. a) Enquiries from the accreditation body to the CAB on aspects concerning the accreditation; 4.4.3 The training records of personnel qualified to perform the internal calibration. b) Reviewing the declarations of the CAB with respect to what is covered by the accreditation; 4.4.4 A scope that lists the disciplines and parameters of the internal calibration, including the Calibration and Measurement Capability (CMC). c) Requests to the CAB to provide documents and records (e.g. audit reports, results of internal quality control for verifying the validity of CAB services, complaints records, management review records); 4.4.5 The calibration activity shall be audited as part of the laboratory’s internal audit. d) Monitoring the performance of the CAB (such as results of participating in proficiency testing). 4.4.6 The laboratory shall participate in proficiency testing, where available, for its calibration activity. The laboratory may also choose other options as indicated in Clause 5.9 of ISO/IEC Standard 17025:2005, Assuring the quality of test and calibration results. 3.18 Verification: Provision of objective evidence that a given item fulfills specified requirements. 3.19 Witnessing: Observation of the CAB carrying out conformity assessment services within its scope of accreditation. 4.0 4.5 Internal Audit: The testing laboratory shall, in accordance with a predetermined schedule and procedure, conduct internal audits annually of its activities to verify that its operations continue to comply with the requirements of the management system and ISO/IEC Standard 17025. (The internal audit program shall address all elements of the management system, including the testing and/or calibration activities. It is the responsibility of the quality manager to plan and organize audits as required by the schedule and requested by management.) Such audits shall be carried out by trained and qualified personnel who are, wherever resources permit, independent of the activity to be audited. REQUIRED DATA 4.1 The laboratory seeking accreditation must submit data showing compliance with ISO/IEC Standard 17025, General requirements for the competence of testing and calibration laboratories. 4.2 The following policy on measurement traceability and calibration is supplemental to the requirements noted in ISO/IEC Standard 17025: Accredited testing laboratories are required to ensure traceability of their measurements (whenever such traceability is achievable) by obtaining calibration services either directly from a national laboratory, such as the National Institute of Standards and Technology (NIST), or from a calibration laboratory accredited under ISO/IEC Standard 17025 or 4.6 Management Review: In accordance with a predetermined schedule and procedure, the laboratory's top management shall annually conduct a review of the laboratory's management system and testing and/or 3 IAS/TL/009 AC89 February 8, 2016 calibration activities to ensure their continuing suitability and effectiveness and to introduce necessary changes or improvements. The review shall take account of: • determine compliance with this criteria (AC89), and IAS policies, and to evaluate expertise and equipment in the area(s) of testing where accreditation is sought. 5.2 After the initial year of accreditation, laboratories are subject to a remote surveillance assessment as part of the ongoing plan of assessment. Upon request from IAS, laboratories shall provide the following information: the laboratory’s internal audit and management review reports/minutes; any complaints; actions resulting from any Concerns noted in the previous IAS assessment report; results of proficiency testing, if any; any major changes in key personnel, facilities, equipment or in the laboratory’s management system and actual test reports for test methods that are within the laboratory’s scope with IAS. Suitability of policies and procedures, • Reports from managerial and supervisory personnel, • Outcome of recent internal audits, • Corrective and preventive actions, • Assessments by external bodies, • Results of interlaboratory comparisons or proficiency tests, • Changes in the volume and type of the work, • Customer feedback, • Complaints, • Recommendations for improvement, 5.3 IAS will conduct an on-site reassessment of accredited laboratories at a minimum of once every two years, commencing from the date of the initial accreditation, for verification of continued compliance with IAS accreditation requirements. 6.0 • Other relevant factors, such as quality control activities, resources and staff training. 5.0 PROFICIENCY TESTING ACTIVITY Proficiency testing activity shall be completed in accordance with ILAC-P9. ASSESSMENTS 5.1 Prior to accreditation, laboratories are subject to an on-site assessment by IAS. This assessment is to (Previously issued: February 2015) September 2002, June 2003, May 2004, May 2005, August 2006, April 2008, May 2010 and 4 IAS/TL/009 AC89 February 8, 2016