ANSI-ASQ National Accreditation Board APPLICATION FOR REFERENCE MATERIAL PRODUCER (RMP) 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.) Organization 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): Corporation, Proprietorship, LLC Other Technical: Initial Accreditation Renewal of Accreditation RMPs with Testing Labs: Does the organization perform in-house calibrations? Yes No If the organization performs in-house calibrations, list devices or attach list: Has the organization ever been accredited as an RMP? Yes No Note: If previously or currently accredited as an RMP, 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: Indicate areas for which you are seeking accreditation: Chemical Indicate areas of specialty: Biological and Clinical Properties Indicate areas of specialty: Physical Properties Indicate areas of specialty: ACLASS Form 17 RMP Application Page 1 of 5 January 31, 2014 Engineering Properties Indicate areas of specialty: Other Properties (please explain): Indicate areas of specialty: Please provide any additional information related to the RMP capabilities for which you are seeking accreditation: Documentation to Be Supplied by the Customer A. Completed application form (include all relevant locations to be covered by the accreditation) B. Quality Manual C. Standard operating procedures and work instructions D. Organizational structure, specifically noting the persons responsible for assigning the property values of all reference materials or certified reference materials related to the application for accreditation E. List of all relevant collaborators, if applicable. F. Completed draft scope of accreditation for reference material producers, following the template provided in the application for RMP accreditation. G. List of all equipment used for reference material production (the reference material services that you wish to have accredited) and note the equipment calibrated in-house and the equipment calibrated externally by a commercial calibration laboratory. If the equipment is calibrated externally please provide all relevant available information on the organization. H. Example certificate of analysis for each RMP area for which accreditation is sought 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 RMP 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 17 Date: RMP Application Page 2 of 5 January 31, 2014 Draft Scope of Accreditation for Reference Material Producer Please input your proposed scope of accreditation using the following as an example. Category and Subcategory of Reference Material Certified Reference Material (CRM) Chemical ILAC Class or Type of Reference Materials RM Produced (include range where Category applicable Biological and Clinical Reference Material (RM) Engineering ACLASS Form 17 A7.1 A1.1 B2.3 Methods or Techniques Used in RMP Laboratory (if appropriate) Binary gas mixtures Steel rods with specified metal content Enzymes for laboratory analysis RMP Application Page 3 of 5 GC-MS ICP Leco analyzer January 31, 2014 Appendix A Responsibilities and Obligations of the Customer By signing the application, the customer hereby requests ACLASS to perform RMP 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 RMP 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 RMP 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 RMP 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 17 RMP Application Page 4 of 5 January 31, 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 RMP 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’ then 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 17 RMP Application Page 5 of 5 January 31, 2014