ANSI-ASQ National Accreditation Board APPLICATION FOR ISO/IEC 17025 ACCREDITATION Please complete this application electronically. Organization Name: (As to be officially listed on certificate and scope of accreditation. Separate application required for each accreditation location.) Accreditation Location: (As to be officially listed on certificate and scope of accreditation.) Mailing Address: (If different from Accreditation Location.) Website Address: Authorized Representative Name: Contact to be listed on Scope of Accreditation (if different from above): Telephone: Facsimile: Email: Note: Please supply an email address that is checked daily. ACLASS uses email to communicate when reports have been uploaded, invoicing, and changes to requirements. Accounting Contact: Telephone: Email: Note: Even if this contact is the same as above, please complete to ensure ACLASS has the appropriate individual for invoicing. Legal Status: Government Body Corporation – Not for Profit Staff Size: Managerial: Application for (check one): Application for Scope of: Corporation, Proprietorship, LLC Other Technical: Initial Accreditation Calibration Testing Renewal of Accreditation Scope Expansion Calibration and Testing Does the organization perform customer of field (i.e., on-site) calibrations or tests? Does the organization maintain multiple laboratory sites? Yes Yes No No Note: If yes, please contact ACLASS directly for guidance and requirements for multi-site organizations. Testing Labs Only: Does the organization perform in-house calibrations? Yes No If the organization performs in-house calibrations, list the devices or attach a list: Calibration Labs Only: Does the organization perform in-house calibrations to disseminate traceability to other in-house standards? Yes No If yes, will any of these standards be done only in house (i.e., not listed on the scope of accreditation? Yes No If yes, please complete ACLASS-FQS form 71, Off-Scope Calibration Tracking (available at www.aclasscorp.com) and submit with this application. Does the organization intend to meet requirements of ANSI/NCSL Z540-1? ACLASS Form 4 ISO/IEC 17025 Application Page 1 of 10 Yes No March 14, 2014 Does the organization intend to meet requirements of ANSI/NCSL Z540.3? Has the organization ever been accredited to ISO/IEC 17025? Yes Yes No No Note: If previously or currently accredited to ISO/IEC 17025, please attach copies of certificate, scope and previous reports issued by organization’s accreditation body. The process cannot begin until these reports are received. If yes, has the organization’s accreditation been suspended in the past 12 months? Yes No List recent proficiency testing (PT) activities or provide plan for PT: Attach Draft Scope of Accreditation: Guidance for preparation of the draft Scope for ISO/IEC 17025 Accreditation is provided as Appendix B of this application. Your draft scope of accreditation must be completed and submitted for ACLASS to better serve you. Please be advised that failure to submit a draft scope of accreditation prior to the assessment may result in your assessment being delayed. Authorization My organization has submitted payment for the non-refundable application fee. We understand that ACLASS will invoice us for other accreditation activities when they are performed, and that all invoices are due net 30 days. We understand that ACLASS will use its best efforts to schedule accreditation services on dates agreeable to us and that when we agree to specific dates ACLASS will confirm the dates in writing. We understand that if we cancel confirmed dates within 30 days prior to the first confirmed date, ACLASS will charge us 50% of the daily fee for each cancelled date. We further understand that there may be additional charges for review of corrective action and/or a follow-up visit for any nonconformance. We certify that we have read and agree to comply with the applicable requirements and ACLASS Document 3, including use of the accreditation symbol. We certify that we have read and agree to the Responsibilities and Obligations of the Customer in Appendix A of this application. We agree to cooperate fully and supply to ACLASS all information and documentation needed before, during, and after the accreditation process. We further agree to allow the release of PT/ILC reports directly to ACLASS from providers of such services, as applicable. We attest that our organization is a legally identifiable entity and maintains the appropriate resources to supply services under ISO/IEC 17025 requirements. I am authorized by my organization to apply to ACLASS for accreditation. I am further authorized to agree that my organization will pay ACLASS for any charges billed, net 30 days, for services leading to accreditation rendered at the request of my organization. Authorized Representative Signature ACLASS Form 4 Date: ISO/IEC 17025 Application Page 2 of 10 March 14, 2014 ACLASS Preparation of Draft Scope of Accreditation Calibration Laboratories Only The following information must accompany the Application for Accreditation to assist in preparation of the Scope of Accreditation (please use the attached scope template table below or obtain the relevant scope template from the ACLASS website and fill in the relevant information): 1. Listing of types of measurement and test equipment (M&TE) calibrated by the applicant laboratory. 2. Range identification for each calibration line item, grouped by a Calibration and Measurement Capability (CMC) distinct from other ranges. 3. Identification of methods used to perform the calibrations defined. These may be laboratory-specific, but whenever possible they should be based on internationally accepted calibration procedures. 4. Uncertainty (CMC) budgets, determinations, and procedure for preparing them. 5. Identification of the relevant reference standards and accessories used in the calibration procedure for each line item. 6. Identify with an asterisk or other notation those calibrations and measurement parameters that are performed off the accredited laboratory premises (on-site calibrations). The assessor(s) will observe a sampling of on-site calibrations during the assessment. 7. Check all of the following that are applicable to your laboratory: In-house calibration only Commercial calibration On-site (field) calibration Mobile calibration Calibration and Measurement Capability: ACLASS requires the CMCs be expressed as an expanded uncertainty which is obtained by the following formula: U = kuc(y) where U = expanded uncertainty k = coverage factor uc(y) = combined standard uncertainty of measurement process for y In line with current international practice and National Institute of Standards and Technology (NIST) policy, the coverage factor of k = 2 (level of confidence of approximately 95 percent) will satisfy the majority of situations encountered in calibration work. Values of k other than 2 should only be used for specific applications dictated by established and documented practices. Some guidance documents for determination of uncertainty are: ANSI/NCSL Z540-2-1997, American National Standard for Expressing Uncertainty-U.S. Guide to the Expression of Uncertainty in Measurement - http://www.ncsli.org/ NIST Technical Note 1297, 1994 Edition, Guidelines for Evaluating and Expressing the Uncertainty of NIST Measurement Results, Taylor & Kuyatt - https://srmors.nist.gov/referencelinks/references/TN1297.pdf NISTIR 6919 – Recommended Guide for Determining and Reporting Uncertainties for Balances and Scales - http://www.aclasscorp.com/documents/industry-guidance-documents.aspx ACLASS requires scopes of accreditation to meet NIST SP 811, Guide for the Use of the International System of Units (SI), where available. This NIST 811 Guide has been prepared by the National Institute of Standards and Technology (NIST) to assist those who may have need of such assistance, in the use of the SI in their work, including the reporting of results of measurements. NIST SP 811 can be accessed on the ACLASS website at http://www.aclasscorp.com/documents/industry-guidance-documents.aspx The table will be used to develop the draft Scope of Accreditation for your laboratory. A list of suggested measurement areas/parameters follows the table. All measurement capabilities/uncertainties will be reviewed and validated by the technical assessors prior to and during the assessment visit. ACLASS Form 4 ISO/IEC 17025 Application Page 3 of 10 March 14, 2014 Draft Scope of Accreditation - Calibration Please complete the following table by typing and submitting electronically in Microsoft Word to allow for future modifications. For examples of accredited laboratory scopes, visit www.aclasscorp.com and click on “Search Accredited Organizations.” Parameter/ Equipment ACLASS Form 4 Range Calibration and Measurement Capability [Expressed as Uncertainty(+)] ISO/IEC 17025 Application Page 4 of 10 Reference Standard or Equipment Method(s) March 14, 2014 Calibration/Measurement Areas and Parameters Instructions: The following are examples of parameters within each calibration area. Check the calibration parameters for which your laboratory is seeking accreditation. If you do not see your parameter, check “other” and specify in the space provided. This document is used in conjunction with the draft scope of accreditation above. Dimensional Angularity Gage blocks Hand tools (mics, calipers) Step gages Measuring wires Laser frequency/wavelength UMM/bench micrometers Roundness Surface texture Optical reference planes OD cylindrical diameter ID cylindrical diameter CMMs Threaded product Height gages Surface plates Radius gages Indicators, LVDT Microscopes Video/optical measuring machines Other-specify: Mechanical Air speed Flow rate (air or liquid) Hydrometers Mass Volume Force Density Ultrasonic reference block Ultrasonic transducer Vibration Torque Pressure/vacuum Hardness testers Acoustics Scales and balances Pipettes Other-specify: Thermodynamic Humidity Thermometry Other-specify: IR thermometry Thermocouples/pyrometer indicators Electromagnetic - DC/Low Frequency DC voltage AC voltage DC current AC current Resistance Capacitance Inductance Voltage/current converters (to 1 Mhz) Current transformers High voltage resistors LF power/energy magnetic mixed dividers phase meters power-frequency DMMs pulse waveform Resistance dividers Oscilloscopes Voltage transformers Calibrators RTD/thermocouples Other-specify: Electromagnetic - RF/Microwave RF power Attenuation Phase Amplitude modulation Harmonics Electromagnetic field strength HF capacitance Reflection Transmission SWR Other-specify: Time and Frequency Frequency/time (source/measure) Other-specify: Time dissemination Ionizing Radiation Dosimetry Radioactive sources Other-specify: Chemical Quantities PH Conductivity Refractometry Viscosity Optical Radiation Laser power energy Photometric UV radiometric-standard detectors Other-specify: ACLASS Form 4 Frequency modulation Distortion HF inductance Q-standards Timers and stopwatches Other-specify: Radiometric Spectrophotometric Wavelength UV radiometric-standard source Attenuation ISO/IEC 17025 Application Page 5 of 10 March 14, 2014 Preparation of Draft Scope of Accreditation Testing Laboratories Only The following information must accompany the Application for Accreditation to assist in preparation of the Scope of Accreditation. Using the format on the following page, provide the following information: 1. Reference to the general field of testing covered under the scope (e.g., Biological, Chemical, Medical, Mechanical testing). 2. Identification of the group of products, materials, or items tested, including any relevant matrices. 3. Identification of the specific tests or types of tests performed. 4. Identification of the specification, standard (method), or technique used. These may be laboratory-specific but, whenever possible, they should be based on internationally accepted test procedures. 5. Other information as applicable such as detection limit, range, type of equipment used, etc. The key equipment or technology designation is always included here. Limits and ranges are typically not included unless the applicant lab desires to market particularly sensitive capabilities. 6. ACLASS requires scopes of accreditation to meet NIST SP 811 Guide for the Use of the International System of Units (SI), where available. NIST 811 Guide was prepared by the National Institute of Standards and Technology for those who need assistance in the use of the SI in their work, including the reporting of results of measurements. NIST SP 811 can be accessed at www.aclasscorp.com/documents/industry-guidancedocuments.aspx. The table following will be used to develop the draft Scope of Accreditation for your laboratory. A list of suggested test areas follows the table. Please check all that apply to your laboratory. ACLASS Form 4 ISO/IEC 17025 Application Page 6 of 10 March 14, 2014 Draft Scope of Accreditation - Testing Please complete the following table by typing and submitting electronically in Microsoft Word to allow for future modifications. For examples of accredited laboratory scopes, visit www.aclasscorp.com and click on “Search Accredited Organizations.” Field of Test Items, Materials, Specific Tests or or Products Properties Tested Measured Specification, Standard Method, or Technique Used Key Equipment or Technology* *As applicable ACLASS Form 4 ISO/IEC 17025 Application Page 7 of 10 March 14, 2014 Testing Areas and Parameters Instructions: The following are examples of parameters within each testing area. Check those testing parameters for which your laboratory is seeking accreditation. If you do not see your parameter, check “other” and specify in the space provided. This document is used in conjunction with the draft scope of accreditation above. Accoustics and vibration Biological/microbiological Pharmaceutical/nutraceutical Biotechnology/biochemical Chemical Animal drug testing Fasteners Metals Inorganics/organics Other-specify: Paint Fertilizers Solvents Coal Construction materials Dimensional inspection/measurement Electrical Environmental Air Environmental lead Bioassay Underground storage Other-specify: Asbestos Water Radon Solid/hazardous wastes Mechanical Fasteners and metals Plastics Windows and doors Other-specify: Paint Rubber Paper Non-destructive Optical/photometric/radiometric: Ionizing radiation Thermal Other-specify: Multi-disciplinary Information technology Forensic Health/hygiene ACLASS Form 4 Medical/veterinary Occupational Food/beverage ISO/IEC 17025 Application Page 8 of 10 March 14, 2014 Appendix A Responsibilities and Obligations of the Customer By signing the application, the customer hereby requests ACLASS to perform ISO/IEC 17025 accreditation activities pursuant to the application submitted to ACLASS by the customer (“Accreditation Activities”). ACLASS shall perform the Accreditation Activities in accordance with ACLASS’s current Accreditation System. ACLASS shall make available to the customer at the customer’s request the documents comprising ACLASS’s ISO/IEC 17025 Accreditation System. ACLASS shall determine in its sole discretion whether the customer meets ACLASS requirements for accreditation to the applicable requirements as set forth in ACLASS’s ISO/IEC 17025 Accreditation System (“Accreditation Criteria”). In the event ACLASS determines that the customer meets the Accreditation Criteria, ACLASS shall deliver to the customer ACLASS’s Certificate and Scope of Accreditation, which shall include a copy of the accreditation symbol. The Certificate and Scope of Accreditation shall be deemed evidence of the customer’s status as accredited pursuant to ACLASS’s Accreditation Criteria. ACLASS shall have the right to carry out surveillance and reassessment pursuant to ACLASS’s ISO/IEC 17025 Accreditation System to verify the customer’s continuous compliance to the Accreditation Criteria. The customer shall conform to the following: a. Maintain impartiality and integrity for all services provided under their scope of accreditation. b. Commit to meeting the requirements of ACLASS’s Accreditation Criteria including adapting to changes in the requirements for accreditation. c. Take such actions as necessary to allow ACLASS to perform the Accreditation Activities, including providing for the examination of documentation and the assessment of all areas, records, and personnel for the purposes of assessment, surveillance, reassessment, resolution of complaints, and access to relevant documents that provide insight into the level of independence and impartiality from any related body. d. Record and address complaints, report complaints to ACLASS, and otherwise continuously comply with all relevant provisions of the Accreditation Criteria and claim accreditation only in respect of requirements and scope for which the customer has been granted accreditation (ACLASS certificate and scope of accreditation do not cover subcontracted calibrations). e. Notify ACLASS within 30 days of changes to customer’s laboratory management system or changes significantly affecting customer (such as a change of ownership, change of location, change in key personnel including top management, main policies, resources, or change in equipment or if analysis of a complaint or other information indicates that customer no longer complies with the Accreditation Criteria) (“Change”). f. Allow ACLASS to conduct surveillance and/or reassessment of the customer in the event of a Change. g. Not expose assessors or others representing ACLASS to unsafe working conditions or environments, and provide all assessors and others appropriate protective equipment. h. Arrange witnessing of services performed at the request of ACLASS, including allowing third parties selected by ACLASS to witness ACLASS’ assessments. i. Not use its accreditation in a manner that may bring ACLASS into disrepute. j. Pay ACLASS for the Accreditation Activities as set in ACLASS’ procedures. The ACLASS logo is a registered trademark solely owned by ACLASS. As long as the customer maintains its status as accredited by ACLASS pursuant to ACLASS’s Accreditation Criteria, the customer shall have the non-exclusive and non-transferable right to use the Certificate and Scope of Accreditation and the accreditation symbol (except as provided for in the paragraph directly below) in the customer’s advertising, and marketing materials and campaigns, certificates, and reports. In no event shall the customer use the Certificate and Scope of Accreditation and the accreditation symbol (or a confusingly similar certificate and scope of accreditation or symbol) in a misleading or unauthorized manner, including but not limited to representing that the Certificate and Scope of Accreditation and the accreditation symbol exemplifies a product, service, or performance conformity certification; using the ACLASS Form 4 ISO/IEC 17025 Application Page 9 of 10 March 14, 2014 Certificate and Scope of Accreditation or the accreditation symbol in connection with requirements or activities not approved by ACLASS; or otherwise acting to bring ACLASS or the accreditation symbol in disrepute. If ACLASS expresses any concern with respect to the use of the Certificate and Scope of Accreditation or the accreditation symbol as being inconsistent with or impermissible under this Application or ACLASS’s ISO/IEC 17025 Accreditation System, (“Improper Use”), ACLASS may ask the customer to cease and desist the Improper Use, and it shall be deemed to be a condition to the customer’s continued accreditation that such Improper Use be immediately discontinued. In addition, in the event of such Improper Use or in the event ACLASS determines that the customer is not complying with any obligation of the customer under this Agreement or the Accreditation System, ACLASS shall have the right upon written notice to the customer to (a) suspend its Accreditation Activities until the customer complies with its obligation, (b) determine that the customer is no longer entitled to identify itself as accredited by ACLASS and to require the customer (temporarily or permanently) to cease using in any manner the Certificate and Scope of Accreditation (and to return such Certificate and Scope of Accreditation), the accreditation symbol and/or accreditation mark, (c) refuse to issue a Certificate and Scope of Accreditation to the customer, (d) require corrective action, (e) publish the customer’s transgression, or (f) take other legal action. In the event ACLASS takes any of the foregoing actions, ACLASS shall not be required to reimburse any amount to the customer. ACLASS and its assessor shall perform the Accreditation Activities in a workmanlike manner consistent with ACLASS’s current Accreditation System. The warranty set forth in this section is the sole and exclusive warranty of ACLASS under this application and the services contemplated to be provided herein and no other express or implied warranties exist, including but not limited to any warranty of merchantability and any warranty of fitness for a particular purpose. The customer acknowledges that ACLASS does not warrant and has no liability or responsibility for (and such liability and responsibility belongs solely to customer) the laboratory and safety of any product or service produced, manufactured, delivered, sold or otherwise distributed by customer. ACLASS and the customer are independent parties and nothing set forth in this Application creates a joint venture, partnership or other concerted activity. If, in ACLASS’s sole discretion, an assignment and/or activity by the customer effects a Change to the customer’s management system under this Application and/or changes made by ACLASS to the Accreditation Criteria, the customer shall cooperate and take the actions necessary to allow the assignment to occur based on a reassessment and/or surveillance visit or such other activity as ACLASS reasonably deems necessary. These Responsibilities and Obligations of the Customer shall be governed by, and construed and enforced in accordance with, the laws of the State of Wisconsin. Any dispute under this Application shall be resolved pursuant to the appeals procedure adopted by ACLASS from time to time. In the event the customer makes any claim that a dispute is not subject to the appeals process or has not been adjudicated pursuant to the rules provided therein, the customer shall not have the right to bring any action with respect thereto before a court of law or equity, but shall only have the right to seek a determination from one arbitrator pursuant to the rules of the American Arbitration Association as to whether such dispute was subject to the appeals process or was adjudicated pursuant to the rules provided therein. Such arbitration shall be conducted in the State of Wisconsin, and each party shall bear its own expense for such arbitration. ACLASS Form 4 ISO/IEC 17025 Application Page 10 of 10 March 14, 2014