Directives - Table of Contents|
| Record Type:||Instruction|
| Directive Number:||CPL 01-00-003|
| Old Directive Number:||CPL 1-0.3|
| Title:||NRTL Program Policies, Procedures, and Guidelines.|
| Information Date:||12/02/1999|
|DIRECTIVE NUMBER:CPL 1-0.3||EFFECTIVE DATE: December 2, 1999|
|SUBJECT: NRTL Program Policies, Procedures, and Guidelines|
|Purpose:||This instruction provides further detailing of OSHA Nationally Recognized Testing Laboratory (NRTL) Program Policies, Procedures, and Guidelines that interpret and clarify the regulations found in 29 CFR 1910.7, and in Appendix A to that section.|
|Scope:||All OSHA offices engaged in or supporting the oeprations of the OSHA NRTL Program.|
|References:||29 CFR 1910.7; Federal Register notices 53 FR 12102, 4/12/88 and 60 FR 12980, 3/9/95); and OSHA Instruction STP 2-1.147A.|
|Cancellations:||OSHA Instructions PUB 8-1.9 and CPL 2-2.49.|
|State Impact:||See Chapter 1, Paragraph V|
|Action Offices:||National, Regional, and Area Offices, OSHA Training Institute, and State plan states|
|Originating Office:||Office of Technical Programs and Coordination Activities|
|Contact:||Jennifer Silk, Director (202-693-2110)|
Office of Technical Programs and Coordination Activities
N3653, Frances Perkins Building
200 Constitution Ave. NW
Washington, DC 20210
By and Under the Authority of
Charles N. Jeffress
TABLE OF CONTENTS
TABLE OF CONTENTS
Chapter 1: Introduction
- Action Information
- Responsible Office
- Action Offices
- Information Offices
- Action Required
- Regional and State Impact
- Director of the Office of Technical Programs and Coordination Activities
- Director of the Directorate of Technical Support
- Office of the Solicitor
- Assistant Secretary
- Significant Changes
- Program Information
- Obtaining Information
- Application Guidelines
- Public and Confidential Information
- List of NRTLs and Specific References to NRTL Approval
Chapter 2: Overview
- Scope of Program
- Eligibility and Requirements For Recognition as an NRTL
- Scope of Recognition
- Test Standards
- Supplemental Programs
- Recognition Process
- Application Review
- On-site Review
- Evaluation and Approval
- Types of Applications and Other Actions
Chapter 3: Application Review
- Review Procedures
- Application Receipt
- Application Review and Discussion (Telephone Contact)
- Application Acceptance
- Determination of On-site Review
- Amendments and Withdrawal by Applicant
- Application Prioritization
- Applications Not Accepted or Not Approved
Chapter 4: On-site Review
- Pre-visit Activities
- On-site Activities
- Opening Conference
- Performance of Review Plan
- Closing Conference
- Post-Visit Activities
- Review Follow-up (Telephone Contact)
- Report on Findings and Written Response
- No Response (Applications)
- Inadequate or No Response (Audit)
Chapter 5: Evaluation and Approval
- Evaluation and Approval Procedures
- Preliminary Evaluation and Final Report
- Final Evaluation
- Recommendation and Preliminary Finding
- Comment Period and Final Decision
- Approval Criteria
Chapter 6: Post-Recognition
- NRTL Program Policies
- Schedule of Audits
- On-site Audits
- Office Audits
- Unscheduled or Special Audits
- Fees. (Reserved)
- Voluntary Terminations and Revocations
- Voluntary Termination
- Application Guidelines
- Evaluation Criteria
- NRTL Follow-up Inspections at Manufacturing Facilities
- Programs Allowed under March 9, 1995 FR Notice (60 FR 12980, 3/9/95)
- Independence of a Nationally Recognized Testing Laboratory.
- Quality Assurance and Internal Audits.
- Trained staff.
- Evaluation Policies and Procedures.
- Processing Procedures.
- Follow-up Inspection Program.
- Effective Reporting
- Allowable and Withdrawn Test Standards.
- Certification Mark(s) and Listing Program.
- Testing Procedures.
- Calibration Traceability.
- Definition of Foreign-based Testing Agency or Organization.
- Purpose. This Instruction provides further detailing of OSHA Nationally Recognized Testing Laboratory (NRTL) Program Policies, Procedures, and Guidelines that interpret and clarify the regulations found in 29 CFR 1910.7, and in Appendix A to this section.
- Scope. This Instruction applies to all national offices engaged in or supporting the operations of the OSHA NRTL Program.
- Cancellation. OSHA Instructions PUB 8-1.9, Nationally Recognized Testing Laboratory (NRTL) Accreditation Program (29 CFR 1910), September 11, 1991, and CPL 2-2.49, List of Nationally Recognized Testing Laboratories (NTRL's) per 29 CFR 1910.7, September 12, 1989, are canceled.
- References. The following documents should be consulted:
- Title 29 Code of Federal Regulations Section 1910.7
- 53 Federal Register 12102, 4/12/88; 60 Federal Register 12980, 3/9/95
- STP 2-1.147A - Safety Testing or Certification of Certain Workplace Equipment and Materials, August 7, 1989
- Action Information.
- Responsible Office. Office of Technical Programs and Coordination Activities (OTPCA).
- Action Offices. Directorate of Technical Support, Office of the Solicitor.
- Information Offices. National Office, Regional Offices, State plan States, OSHA Training Institute.
- Action Required. The responsible and the action offices will implement the policies, procedures, and guidelines contained in this Instruction.
- Regional and State Impact.
- Accept certifications of NRTLs recognized by OSHA for testing of equipment and materials where State safety requirements are the same as the Federal.
- Ensure that organizations receiving State recognition understand that it applies only within that State.
- Establish a program which is at least as effective as the OSHA NRTL Program.
- Director of the Office of Technical Programs and Coordination Activities. ("Director")
- Administers the NRTL Program.
- Establishes, ensures compliance with, and originates policies and procedures for the NRTL Program; modifies or clarifies this directive, as needed.
- Ensures the performance of all activities necessary for processing applications for NRTL recognition , including the preparation of Federal Register (FR) notices required for activities under the NRTL Program.
- Director of the Directorate of Technical Support.
- Oversees the administration of the OTPCA.
- Reviews and approves policies and procedures for the NRTL Program.
- Reviews and approves Program-related FR notices originated by OTPCA, following their approval by the Office of the Solicitor (SOL).
- Office of the Solicitor.
- Reviews and approves Program-related FR notices originated by OTPCA, for legal issues and requirements.
- Reviews and approves directives for the NRTL Program, including changes.
- Provides legal advice on other regulatory or legal issues regarding the NRTL Program.
- Assistant Secretary.
- Reviews and approves Program-related FR notices originated by OTPCA.
- Approves letters of recognition or other formal notifications for organizations recognized by OSHA as Nationally Recognized Testing Laboratories.
- Definitions. See Appendix B.
- Significant Changes. This Instruction updates the process for processing applications for recognition and the process for monitoring organizations after they are recognized by OSHA.
- Background. The Occupational Safety and Health Administration (OSHA) published a final rule on April 12, 1988 that modified those provisions in 29 CFR Part 1910 that require product safety "certification" (by whatever term used) to specify that these certifications be accomplished by a nationally recognized testing laboratory (NRTL). The final rule also established a new section, 29 CFR 1910.7 and Appendix A to this section, which are referred to as the "NRTL Program regulations" or "Program regulations" in this directive. As a result of this new section, an organization seeking to perform the "certification" required in Part 1910 must be "recognized" by OSHA and must apply to the OSHA NRTL Program for the recognition. The Program regulations include the requirements OSHA must follow in processing an application for recognition and the main criteria that OSHA must use to evaluate the qualifications of an organization for recognition.
- Program Information.
- Obtaining Information. Information about the NRTL Program may be obtained by selecting "Programs" on the OSHA home site on the world wide web (http://www.osha.gov), or by calling (202) 693-2110 or contacting:
- Application Guidelines. The Guidelines may be obtained from the above address and are available on the web site for the NRTL Program.
- Public and Confidential Information. Copies of the applications submitted by organizations are available to the public via the OSHA Docket Office. All information or documents submitted in an application becomes public information unless confidentiality can be justified by the applicant.
- List of NRTLs and Specific References to NRTL Approval. The list of organizations recognized as NRTLs can be obtained by contacting the NRTL Program. A listing of the specific references in OSHA's standards to NRTL approval can also be obtained. OSHA will make both lists available to the public in hard copy and on the web site for the NRTL Program.
This Instruction references each of these documents, which provide the primary basis for the policies, procedures, and guidelines of this Instruction.
Regional Administrators (RAs) and Area Directors will ensure that this Instruction is forwarded to appropriate administrative and compliance staff to review for changes pertinent to their areas of responsibility. RAs will also ensure that this Instruction is forwarded to each State Designee. As detailed in STP 2-1.147A, State Plan States are encouraged to adopt standards that rely on Nationally Recognized Testing Laboratories recognized by Federal OSHA, but State Plan States choosing to establish their own program for recognizing testing laboratories may do so as long as they:
Prior to publication of the rule, the provisions in 29 CFR Part 1910 either had explicitly required or had implied that product certifications be performed only by Underwriters Laboratories, Inc. (UL) and Factory Mutual Research Corporation (FMRC). Other testing organizations claimed these provisions caused them to suffer economic losses, and sought the changes effected by the adoption of the rule. To date, a number of organizations, including UL and FMRC, have been recognized by OSHA as NRTLs.
In 1991, OSHA issued Instruction PUB 8-1.9, which provided information on the "Nationally Recognized Testing Laboratory (NRTL) Accreditation Program (29 CFR 1910.7)." This Instruction included background on section 1910.7 and on the requirements and process of recognition, and listed general responsibilities of the Program and of Program staff. The Instruction however did not detail the policies or procedures to be used to process applications for recognition, or to monitor the organizations recognized by OSHA. In this current Instruction, the Program is simply referred to as the "NRTL Program."
On March 9, 1995, OSHA published a "Notice of interpretation" for the Program (60 FR 12980). This notice addressed "in particular those programs under which the NRTL controls and audits, but does not itself generate, the data relied upon for product certification." Nine "programs" were identified, along with the criteria that the NRTL must meet to permit its use. Eight of the programs are optional. See the 3/9/95 FR notice for details about these programs and Appendix C for additional information.
Occupational Safety and Health Administration
US Department of Labor
200 Constitution Avenue NW, Room N3653
Washington, DC 20210
- Purpose. This Chapter provides an overview of the NRTL Program.
- Scope of Program. The NRTL Program recognizes mainly private sector organizations that provide product safety testing and certification services to manufacturers. The testing and certification are done, for purposes of the Program, to U.S. consensus-based product safety test standards. These test standards are not developed or issued by OSHA, but are issued by U.S. standards organizations, such as the American National Standards Institute (ANSI). The range of products covered by the Program is limited to those items for which OSHA safety standards require "certification" by an NRTL (see Appendix A for a table of these types of products). The requirements mainly affect electrical products.
- Eligibility and Requirements For Recognition as an NRTL.
- Eligibility. Any testing organization based within or outside the United States may apply to the NRTL Program for recognition. They may be organized as for-profit or as nonprofit entities. However, approval to recognize a foreign-based organization is contingent on a determination by the US Trade Representative on "equal treatment" (as required in I.A.1 of Appendix A to 29 CFR 1910.7).
- Requirements. Recognition is granted to organizations that meet the requirements established by OSHA for an NRTL. The Program regulations list the requirements, which are summarized as follows:
- Capability (including proper testing equipment and facilities, trained staff, written test procedures, and quality assurance programs) to test and evaluate equipment for conformance with appropriate test standards
- Adequate controls for the identification of certified products, conducting follow-up inspections of actual production
- Complete independence from users (i.e., employers subject to the tested equipment requirements) and from any manufacturers or vendors of the certified products
- Effective procedures for producing its findings and for handling complaints and disputes
- Scope of Recognition. The NRTL's scope of recognition, which it must request, consists of the specific test standard(s), site(s) and program(s) for which it is recognized.
- Test Standards. The NRTL's recognition from OSHA is not for products, but for the appropriate test standards covering a type of product(s). OSHA uses the criteria found in paragraph IV of Appendix D in approving test standards.
- Sites. Recognition is site-specific and not necessarily granted to all testing facilities operated by an organization. However, an NRTL may accept test data generated by one of its sites that is not recognized, provided certain conditions are met (see policy on Sites in Appendix C). In addition, OSHA does not generally, but may, limit the recognition of a site to testing or certification of specific types of products, i.e., to specific test standards, or to specific types of programs (see next paragraph for more information).
- Supplemental Programs. The March 9, 1995 Federal Register (FR) notice (60 FR 12980) lists nine (9) programs and procedures (collectively, "programs"). An NRTL may use eight of these programs (referred to as supplemental programs) to control and audit, but not actually to generate, the data or support services relied upon for its testing and certification of products. The names of these nine programs are:
- The basic procedure (i.e, program)
- Acceptance of testing data from independent organizations, other than NRTLs
- Acceptance of product evaluations from independent organizations, other than NRTLs
- Acceptance of witnessed testing data
- Acceptance of testing data from non-independent organizations
- Acceptance of evaluation data from non-independent organizations (requiring NRTL review prior to marketing)
- Acceptance of continued certification following minor product modifications by the client
- Acceptance of product evaluations from organizations that function as part of the International Electrotechnical Commission Certification Body (IEC-CB) Scheme
- Acceptance of services other than testing or evaluation performed by subcontractors or agents
- Recognition Process.
- Application. Application Guidelines for recognition as an NRTL, and for expansion or renewal of recognition, are available to any interested organization. (see Chapter 1)
- Application Review. Program staff reviews the application for completeness and for adequacy. The applicant is given an opportunity to correct any deficiencies in its application. When the review is completed, OSHA will send a letter to the applicant to formally accept or reject the application. (see Chapter 3)
- On-site Review. Following acceptance of the application, one or more OSHA assessors performs the on-site review of the applicant's testing and administrative facilities. The review typically takes two or three days, but varies with the size of the applicant organization and its proposed scope of recognition. After the review, the assessor (or lead assessor, if more than one) sends a report of the findings to the applicant to obtain its written response to any corrective actions (i.e., deficiencies) noted. The applicant must respond by a mutually-agreed-upon or other appropriate deadline. (see Chapter 4)
- Evaluation and Approval. After the applicant submits its response, the assessor completes the On-Site Review Report describing the findings of the site visit and the preliminary evaluation of the application. This report and the application are the main basis for the final evaluation and for the notice of the preliminary finding, which OSHA publishes in the Federal Register for public comment. Through this notice, the Agency presents its finding on whether the applicant has or has not met the requirements for recognition. OSHA makes a final decision following resolution of any significant issues raised by timely comments. The Agency then submits the notice of final decision for publication in the Federal Register to officially approve or deny the recognition. (see Chapter 5)
- Notification. If the recognition is approved, the Assistant Secretary formally notifies the applicant of the decision and sets forth the terms of recognition. The recognition remains in effect for a five-year period. At the end of the initial five-year period, the NRTL must apply for renewal of recognition. If the recognition is denied, the Director notifies the applicant of the decision.
- Types of Applications and Other Actions. After its initial recognition, the NRTL may seek to expand the scope of its recognition for additional test standards, sites or programs. In addition, the NRTL must submit a request to renew its recognition prior to the end of its initial five-year recognition period. The process OSHA uses for expansion or renewal request is similar to the process for initial recognition. However, an on-site review may not be required per the guidelines in Chapter 3. As a result, the time to process these applications is often shortened. Two additional recognition-related actions are voluntary termination and revocation of recognition. See Chapter 6 for more details.
The NRTL's initial recognition will always include the first or basic program, which requires that all product testing and evaluation be performed in-house by the NRTL that will certify the product. In addition, program number nine (9) addresses the criteria for subcontracting services such as calibration, security, follow-up, and maintenance. As a practical matter, an applicant should request recognition for this program in its application since NRTLs commonly subcontract these types of services. See the 3/9/95 FR notice for details about these programs and Appendix C for additional information.
- Purpose. This chapter sets forth the procedures for reviewing applications from organizations seeking recognition, expansion, or renewal as an NRTL.
- Review Procedures.
- Application Receipt. Program staff establishes a Case File (for initial applications), sends an acknowledgment to the applicant, and sends a copy of the applicant's letter received with the application to appropriate staff. All materials that the applicant has justified as confidential will be maintained secure in the Case File only, and not in public files (see Chapter 1). In addition, for foreign applications, the Program staff:
- Sends a copy of the application letter to the US Trade Representative (USTR) if OSHA has not previously made a decision on reciprocity or equal treatment by the foreign country. USTR makes a determination of that country's compliance with the equal treatment provision in Appendix A to 29 CFR 1910.7. OSHA will consider USTR's determination in its decision to grant the recognition. No letter is sent if a determination is not needed or has already been made.
- Performs any additional procedures for foreign applications covered under any special agreements with a foreign country, to comply with provisions of the agreement.
- Application Review and Discussion (Telephone Contact). Program staff:
- Follows the procedures in Appendix D, and makes a determination regarding the completeness and adequacy of the application.
- Discusses the results of the review with the Director and then with the applicant, noting any deficiencies found or clarifications needed.
- Application Acceptance. If the application is determined to be complete and adequate, the Director sends a letter to the applicant to accept the application, noting that such acceptance is not a commitment on OSHA's part to recognize the applicant. If the application is incomplete or inadequate, the Director sends a letter to the applicant, detailing the deficiencies and the additional information needed and requesting a response by an appropriate deadline.
- If the response does not adequately resolve the deficiencies, the Director provides the applicant a final opportunity to respond within a given period. If the applicant responds adequately within this period, the Director sends an acceptance letter to the applicant.
- If the applicant does not respond adequately or fails to reply by any deadline(s) provided or an approved extension of these deadline(s), the Director sends a letter notifying the applicant that the application is not accepted and the Case File is closed.
- Determination of On-site Review. When the application is accepted, the assigned staff determines whether an on-site review is necessary. OSHA may choose not to perform an on-site review under any of the following circumstances:
- The application is for an expansion or a renewal of recognition, and OSHA determines adequate information is available from other valid sources (e.g., previous applications of the applicant) to permit a reasonable basis for evaluating the application;
- The application is for an initial recognition, and OSHA determines it contains sufficient and credible information to permit a reasonable basis for its evaluation; or
- The application is submitted pursuant to a valid agreement between an organization and OSHA or between an organization and the U.S., and OSHA participates in the agreement, that provides for the on-site review to be performed by others.
- Amendments and Withdrawal by Applicant.
- Timing. An applicant may amend its application at any time prior to the publication of the preliminary notice on the application. An amendment will be processed following the review procedures in Appendix D. However, significant changes may result in a delay in processing the application. An application may be withdrawn by an applicant, without prejudice, at any time prior to the final decision by the Assistant Secretary.
- Acknowledgment. The Director will acknowledge requests to amend or withdraw an application.
- Application Prioritization. The Director will normally commence the processing of applications on a first-come, first-served basis, and will continue processing to completion unless delayed for valid reasons. Processing is considered complete on the date the FR notice, announcing the final decision on the recognition, is submitted for publication. Each application will be assigned a priority number, generally determined by the date it is received. The assigned priorities may be changed for valid reasons, including delays in obtaining information necessary to application processing, issues unresolved by the applicant, and action or inaction by the applicant that causes delays in processing. Examples include the applicant submitting major amendments or its failure to meet deadlines for information requested by OSHA. The Director will maintain an appropriate record of the receipt dates of all applications, amendments, and application-related correspondence. The Director will use these records to establish and maintain the prioritization for pending applications, and will use this prioritization to establish a target completion date and a schedule of processing activities for each application.
- Applications Not Accepted or Not Approved. An applicant may reapply at any time after its application is not accepted or not approved (i.e., recognition is denied) by OSHA. However, the Director may consider the causes leading to the non-acceptance or denial in the evaluation of any future applications submitted by the applicant. Such evaluation will be made without prejudice if the applicant withdraws its application prior to the effective date of the rejection. The Director will retain one copy of the application, and other pertinent documents, in the Case File and, in cases involving denial, in public files. References in this Instruction to closing the Case File due to action or inaction by the applicant constitutes a non-acceptance of the application by OSHA. Note: this procedure also applies in those cases where an application is not approved by the Assistant Secretary (see paragraph II.D in Chapter 5 below).
If an application is frivolous or grossly incomplete or inadequate, the Director returns the application, notifying the applicant in writing that processing cannot proceed and explaining why this action is necessary, and takes no further action. The Director processes any future application from the applicant as a new application, following the review procedures in this Appendix C.
For expansion or renewal applications, the Program staff or the Director notifies the NRTL of the acceptance or deficiency.
If an on-site review is necessary, the assessor contacts the applicant to discuss and schedule the on-site review. The assessor sends the applicant the site specific agenda after the on-site review date(s) is finalized with the applicant and performs the review in accordance with procedures in Chapter 4 of this directive.
- Purpose. This Chapter sets forth the procedures for performing an on-site review of organizations seeking recognition, expansion, or renewal as an NRTL, and an audit of NRTLs. The on-site review includes the pre-visit and the post-visit activities.
- Pre-visit Activities. The assessor develops a site-specific review plan based on the scope of the recognition and the background of the applicant, the personnel capabilities required to conduct the review, the duration of the review, and associated travel requirements. In determining the scope of the on-site work, the assessor may consider third-party data submitted by the applicant or NRTL.
- On-site Activities. The assessor:
- Opening Conference. Conducts the opening conference with the applicant's staff, introducing team members, discussing the scope and objectives of the review, and responding to questions from the applicant's staff concerning the review methods. The site-specific agenda is modified as necessary based on the outcome of the opening conference.
- Performance of Review Plan. Performs the site-specific review plan following the procedures in Appendix E.
- Closing Conference. Conducts the closing conference with the applicant's staff, presenting a summation of the findings and a copy of the preliminary Report on Findings, if feasible, and responding to questions from the applicant's staff concerning the findings. (For an audit, the auditor also identifies any deficiencies that are a probable cause for revocation.) Where deficiencies are identified, upon request, the assessor may informally suggest possible corrective actions. Such suggestions should not be presented as exclusive solutions nor divulge confidential information of another applicant or NRTL.
- Post-Visit Activities.
- Review Follow-up (Telephone Contact). The assessor contacts the applicant to request any additional information, if some information is determined to be insufficient after a review of the findings, and to discuss an appropriate deadline for submitting its Written Response. The applicant's Written Response will include a schedule for completing any corrective actions, narrative explanation and supporting documentation to sufficiently address each area of deficiency identified, and any other comments on the report that the applicant determines to be appropriate.
- Report on Findings and Written Response. The assessor:
- Finalizes the Report on Findings, marks it "Confidential," officially submits it to the applicant with a cover letter requesting its Written Response by a mutually-agreed-upon or other appropriate deadline, and sends a copy to the Director and to each review team member. For an audit, the auditor includes a statement on revocation if any deficiencies are a probable cause of revocation.
- Begins to prepare the draft On-site Review Report following Appendix G.
- No Response (Applications). If the organization fails to submit its Written Response by the response deadline or an approved extension of this deadline, the application becomes inactive. The Director sends a final notification to the applicant requesting the information within 30 days of the date of the notice. If the applicant responds adequately within the 30 day period, the application is assigned a lower priority and becomes active. If the applicant does not respond adequately within the 30 days, the Director sends a letter notifying the applicant that the application is not accepted, and the Case File is closed.
- Inadequate or No Response (Audit). If the NRTL does not adequately respond or fails to submit its Written Response by the response deadline or an approved extension of this deadline, the auditor contacts the NRTL to discuss the adequacy of the response or the delay. The auditor also provides a final deadline for the response after consulting the Director. After the auditor's discussion with the NRTL, the Director notifies the NRTL in writing that OSHA is commencing the process to revoke the NRTL's recognition. In this notification, the Director will include the final deadline provided by the auditor or another deadline if more appropriate.
Note: when more than one assessor participates in a review, the term "lead assessor" replaces the term "assessor." Also, where appropriate in Chapters 4 & 5, "NRTL" and "auditor" replaces "applicant" and "assessor," respectively, when the review is an audit.
- Purpose. This Chapter sets forth the procedures for the evaluation and approval of applications of organizations seeking recognition, expansion, or renewal as an NRTL.
- Evaluation and Approval Procedures.
- Preliminary Evaluation and Final Report. The assessor:
- Reviews the Written Response of the applicant and contacts the applicant if necessary to resolve questions or obtain additional information.
- Completes the On-site Review Report following Appendix G, and forwards the final report to the Director,.
- Final Evaluation. Program staff:
- Reviews the On-site Review Report and any other documentation, and contacts the applicant if necessary to resolve questions or to obtain additional information.
- Makes the final evaluation on the application, and develops a recommendation on the preliminary finding regarding the application consistent with the approval criteria shown below. The Director may require additional reviews of the applicant's facility(ies), if necessary, before completing the final evaluation.
- Recommendation and Preliminary Finding. The Director recommends a positive or negative finding on the application consistent with the approval criteria shown below.
- For a negative finding, Program staff notifies the applicant, and the Director sends a letter to the applicant pursuant to Appendix A of 29 CFR 1910.7. Following the procedures described in "Revision of application" under I.B.3, the applicant may provide additional information. Program staff reviews this additional information, and the Director determines if the additional information justifies changing to a positive finding.
- Program staff prepares the FR notice for the preliminary finding, as required by 29 CFR 1910.7.
- The appropriate offices review and sign off on the FR notice. The Assistant Secretary then reviews and approves the notice. During this clearance process, Program staff modify the notice as needed.
- Program staff submits the notice for publication, sending a copy of the document and the final on-site review report to the applicant prior to publication. The Director sends a copy of the published notice to the applicant.
- Comment Period and Final Decision.
- Program staff reviews all timely comments, contacting the applicant or other parties as needed to resolve significant issues raised by these comments, and develops a recommendation regarding the recognition.
- The Director recommends approval or denial of the recognition, and Program staff prepare the final FR notice.
- The appropriate offices follow the clearance procedures under paragraph D of this Chapter, and for initial recognitions, the Assistant Secretary approves a letter or other document of recognition, which the Director also sends to the applicant. This letter or document sets forth the terms of recognition, which include the scope of recognition, specific conditions and limitations imposed by OSHA, general conditions required by Appendix A of the Program regulations, and references to applicable policies, directives, and requirements with which the NRTL must comply.
- If the Assistant Secretary does not approve the recognition, the Director sends an explanatory letter to the applicant and closes the Case File.
- Approval Criteria. An application for recognition, expansion, or renewal may be approved if OSHA determines that the following criteria are met:
- The application is both complete and adequate.
- The On-site Review Report or other written evaluation supports a recommendation for a positive finding, that is, the applicant appears to have met the requirements for recognition, expansion, or renewal.
- All significant issues raised during the comment period are resolved.
- Additional criteria for expansions and renewals:
- The NRTL has corrected all non-conformities from audits;
- The NRTL has not significantly or consistently violated its terms of recognition during the previous 24 months; and
- The NRTL has resolved all significant issues concerning its recognition raised, for example, in valid complaints or petitions, or which OSHA otherwise determines to be valid.
- Purpose. This Chapter sets forth policies and procedures for administering activities for continuing the recognition of NRTLs.
- NRTL Program Policies. Each NRTL will comply with policies issued by OSHA that revise or supplement the requirements or conditions of its recognition, including those in Appendix C.
- Schedule of Audits. Each year, the Director prepares a schedule of the on-site and office audits planned for the year. These audits will be performed to ascertain whether the NRTL continues to meet its terms of recognition.
- On-site Audits. OSHA will perform an on-site audit of each NRTL either annually or on another frequency as determined by the Director. The audit will generally be performed as prescribed by applicable portions of Chapters 4 and 5 of this Instruction.
- Office Audits. OSHA may perform an office audit of each NRTL not scheduled for an annual on-site audit. For this purpose, the Director may annually request each NRTL to respond to an appropriate questionnaire or other similar document for purposes of updating relevant information and to provide documentation or records to confirm conformance, in full or in part, to its terms of recognition.
- Unscheduled or Special Audits. OSHA may perform an unscheduled audit or advance the scheduled date of an audit, when the Director determines that the NRTL may have a serious violation of its terms of recognition. OSHA may also perform special audits, such as auditing manufacturer's or other testing facilities that the NRTL uses for purposes of testing and certifying its products.
- Fees. (Reserved)
- Complaints. Complaints received by OTPCA may be against a particular NRTL, the products it certifies, or against the NRTL Program. Program staff reviews the complaint, contacting the complainant or other parties as necessary, and reports to the Director. The Director makes the determination as to the validity of the complaint, and may refer the complaint to the Office of the Solicitor, if necessary.
- If the complaint is invalid, Program staff communicate the rationale to the complainant (if known), and takes no further action.
- If the complaint appears to be valid, the Program staff contacts the subject NRTL or other entity(ies), and takes appropriate steps to resolve the issues. When a Written Response from the NRTL is appropriate, the Director will follow the audit notification and deadline procedure in Chapter 4 of this Directive if the NRTL submits an inadequate or no response. The Director or Program staff then informs the complainant that the matter has been adequately resolved but does not reveal the resolution to the complainant, and does not divulge the name of the complainant or, if appropriate, the nature of the inquiry to the NRTL or to third parties.
- Program staff document the resolution, and the Director assures that required control measures are implemented.
- Voluntary Terminations and Revocations.
- Voluntary Termination. An NRTL may request a full or partial termination of its recognition by sending a letter with appropriate information to the Director (see II.D in Appendix A of the Program regulations). The request shall state the effective date of the termination. The Director confirms the request and submits a FR notice to terminate recognition by the effective date. Upon publication, the Director will send a copy of the notice to the NRTL.
- Revocation. Upon receipt of information that an NRTL may have committed one of the potential causes stated under II.E.1 in Appendix A of the Program regulations, the Director shall review relevant documentation and determine if the information appears to be valid.
- If invalid, the Director documents the decision and takes no further action. If valid, the Director, with the concurrence of the Office of the Solicitor and the Director of the Directorate of Technical Support, determines an appropriate course of action, which may include:
- No action to revoke recognition
- Complete revocation of recognition
- Partial revocation of recognition
- Submit a written request for the hearing allowed, or
- Submit the required response by the 60-day deadline and include appropriate documentation that demonstrate all deficiencies have been corrected. The Director will formally accept or reject the NRTL's response. Rejection means the NRTL failed to adequately correct the deficiencies.
TYPES OF PRODUCTS REQUIRING NRTL APPROVAL BY OSHA
The following categories of materials/equipment (products) are required to be approved by an NRTL, per provisions of the General Industry Standards (Part 1910 of Title 29, Code of Federal Regulations - 29 CFR Part 1910). Materials/equipment that are similar in type are grouped together.
|1. Electrical conductors or equipment (Subpart S of Part 1910).|
2. Automatic sprinkler systems.
3. Fixed extinguishing systems (dry chemical, water spray, foam, or gaseous agents).
4. Fixed extinguishing systems components and agents.
5. Portable fire extinguishers.
6. Automatic fire detection devices and equipment.
7. Employee alarm systems.
8. Self-closing fire doors. |
9. Fire (B) doors.
10. Windows (frames).
|11. Heat actuated (closing) devices (dip tanks).|
|12. Exit components.|
|13. Spray booth overspray filters.|
14. Flame arresters, check valves, hose (transfer stations), portable tanks and safety cans -
(flammable/combustible liquids). |
15. Pumps and self-closing faucets (for dispensing Class I liquids).
16. Flexible connectors (piping, valves, fittings) - (flammable liquids).
17. Service station dispensing units (automotive, marine). |
18. Mechanical or gravity ventilation systems (automotive service station dispensing area).
19. Automotive service station latch-open devices for dispensing units.
|20. New commercial and industrial LPG consuming appliances.
21. Flexible connectors (piping, valves, fittings) - LPG.|
22. Powered industrial truck LPG conversion equipment.
23. LPG storage and handling systems ( DOT containers, cylinders).
24. Automatic shut-off devices (portable LPG heaters including salamanders).
25. LPG container assemblies (non-DOT) for interchangeable installation above or under ground.
26. Fixed electrostatic apparatus and devices (coating operations). |
27. Electrostatic hand spray apparatus and devices.
28. Electrostatic fluidized beds and associated equipment.
29. Each appurtenance (e.g., pumps, compressors, safety relief devices, liquid-level gaging
devices, valves and pressure gages) in storage and handling of anhydrous ammonia.|
|30. Gasoline, LPG, diesel, or electrically powered industrial trucks used in hazardous atmospheres.|
31. Acetylene apparatus (torches, regulators or pressure-reducing valves, generators
[stationary and portable], manifolds). |
32. Acetylene generator compressors or booster systems.
33. Acetylene piping protective devices.
34. Manifolds (fuel gas or oxygen) - separately for each component part or as assembled units.
35. Scaffolding and power or manually operated units of single-point adjustable suspension scaffolds. |
36. Hoisting machine and supports (Stone setters' adjustable multiple-point suspension scaffold).
37. Hoisting machines (Two-point suspension scaffolds; Masons' adjustable multiple-point suspension scaffold.
The following are definitions applicable to the NRTL Program. See also definitions used in OSHA's safety standards, specifically 29 CFR 1910.399.
29 CFR 1910.7 - Section 1910.7 of Title 29, Code Of Federal Regulations (CFR) -- The regulatory authority that defines the requirements for a nationally recognized testing laboratory (NRTL), and the criteria and requirements to evaluate and recognize an NRTL.
ACCREDITATION -- A formal acknowledgment that a testing organization is competent to carry out a specific test or specific types of tests. (see definition of Recognition)
ACCREDITING BODY -- A government or non-government body that conducts and administers an accreditation system and grants accreditation. (see definition of NVLAP)
ANSI -- (American National Standards Institute) A standards issuing organization. More generally, the administrator and coordinator of the United States private sector voluntary standardization system.
APPROVED -- Acceptable to the Assistant Secretary. See the definition of "acceptable" in 29 CFR 1910.399. Products certified by an NRTL are acceptable to the Assistant Secretary, and therefore are approved for purposes of meeting the requirements in the specific paragraphs of 29 CFR Part 1910.
ASSESSMENT -- Common term used for the pre-recognition on-site reviews. The term applies to initial recognitions, and to expansion or renewal of recognitions.
ASSESSORS -- Personnel who are selected by the Director to perform the activities associated with assessments of applicants or NRTLs.
ASSISTANT SECRETARY -- The Assistant Secretary of Labor for Occupational Safety and Health, head of the Occupational Safety and Health Administration.
AUDIT -- Common term used for the post-recognition reviews of the NRTL.
AUDITORS -- Personnel who are selected by the Director to perform the activities associated with audits of NRTLs.
CASE FILE -- Consists of all relevant information, sensitive and non-sensitive, pertaining to an NRTL applicant. The Case File will include or incorporate the original application, amendments to the application, correspondence, the Federal Register (FR) notices that relates to the application, and other pertinent documentation.
CERTIFICATION -- The procedure by which written assurance is given that a supplier provides a product, process, or service which conforms to a standard or specification. Within the context of the NRTL Program, the NRTL provides such assurance showing that it has determined a product conforms to one or more specific consensus-based U.S. safety standard(s). The certification must be evidenced by the NRTL's certification mark on the product.
CERTIFICATION BODY -- Within the context of the NRTL Program, the part of the NRTL's organization that conducts the product certification, as opposed to testing laboratory, activities, i.e., listing and labeling and inspection of manufacturer's facilities.
CERTIFICATION MARK -- Protected mark, applied or issued under the rules of a certification, indicating that adequate confidence is provided that the relevant product, process, or service is in compliance with a specific standard or other normative document.
CERTIFY -- Tangible assurance by a recognized third party that a product is in conformity with the safety requirements in specified test standards. Within the context of the NRTL Program, the recognized third party is the NRTL and the term "certified", includes but is not limited to the following expressions and any combination of them found in any OSHA rule, regulation, or standard: "listed"; "accepted"; "approved"; "meet the requirements of"; "tested and approved"; "tested and listed"; "certified"; and "otherwise determined to be safe."
COMPLAINT -- As used in 29 CFR 1910.7(b), an expression of dissatisfaction received by an NRTL from one of its clients, a user of certified products or other interested party, generally regarding its services or a product it has certified. As used in Chapter 6 of this directive, an allegation that an NRTL is not in compliance with the requirements of its recognition, that a certified product does not meet the appropriate product standard and/or presents a hazard, or the NRTL Program or its staff is not providing adequate service.
CONFORMITY -- Fulfillment by a product, process or service of all requirements specified.
CONFORMITY ASSESSMENT -- A process that typically includes defining the applicable standard (specifications), developing confidence in the supplier's Quality System, having confidence in the data on which decisions are based, and confidence in the product (Product Certification).
DETAILED APPLICATION INFORMATION/EVALUATION CRITERIA -- The document primarily used to show the detailed criteria that OSHA will use in evaluating whether an applicant meets or an NRTL continues to meet the recognition requirements in 29 CFR 1910.7(b) and any applicable supplemental programs.
DETAILED PROCEDURE -- A step-by-step instruction for performing or accomplishing a specific activity. For purposes of the NRTL Program, an NRTL's detailed procedures for the activities it undertakes in its testing and certification operations, and for other activities, such as training and quality assurance, performed in support of the technical administration and related aspects of these operations.
DIRECTOR -- The Director of OSHA's Office of Technical Programs and Coordination Activities, named by the Directorate of Technical Support as responsible for the technical and administrative operation of the NRTL Program.
DOCKET FILE -- The official, non-confidential documentation contained within the case file and made available to the public.
EVALUATION -- A determination of the extent to which a product, process, or service fulfils specified requirements. Within the context of on-site reviews, or applications in general, a determination of the extent to which the policies, procedures, and operations of an organization or NRTL meets or continue to meet the terms of recognition.
FR NOTICE -- A notice published in the Federal Register.
IEC -- (International Electrotechnical Commission) An organization that develops international standards.
IEC-CB -- (International Electrotechnical Commission Certification Body ) A certification body scheme that requires participating members to accept test reports from other participating members, unless there are documented technical reasons why a test report is unacceptable.
INVOLUNTARY REVOCATION OF RECOGNITION -- Action taken when an NRTL is not satisfying all of the requirements or limitations in its letter of recognition, or has been in violation of one or more of the requirements stated in 29 CFR 1910.7.
ISO (International Organization for Standardization) -- Publishes generally accepted consensus guides and standards on conformity assessment, accreditation, etc.
LEAD ASSESSOR/AUDITOR -- Person assigned by the Director of OSHA's Office of Technical Programs and Coordination Activities (OTPCA) to direct the assessment/audit team if more than one assessor/auditor participates in an on-site review.
LETTER OF RECOGNITION -- A letter or document that sets forth the terms of recognition which include the scope of recognition, specific conditions and limitations imposed by OSHA, general conditions required by Appendix A of the Program regulations, and references to applicable policies, directives, or other requirements with which the NRTL must comply. The terms of recognition are also reflected in the FR notice for the recognition of an NRTL.
NVLAP -- (United States National Voluntary Laboratory Accreditation Program) Accredits test laboratories in specific disciplines.
NIST -- (United States National Institute of Standards and Technology) An agency of the U.S. Department of Commerce. It administers NVLAP.
NON-CONFORMANCE -- Failure of an applicant or NRTL to meet the requirements of 29 CFR 1910.7, NRTL Program policies, or their own internal requirements as documented in their policies and procedures.
NRTL -- (Nationally Recognized Testing Laboratory) The legal entity recognized by OSHA as meeting the requirements defined in 29 CFR 1910.7.
ON-SITE REVIEW -- The on-site investigation of an applicant's testing and administrative facilities for the purpose of determining its ability to comply or continue to comply with the requirements for recognition, as defined in 29 CFR 1910.7. The term is used in Appendix A of 29 CFR 1910.7. The pre-recognition review ("assessment") will focus upon development of findings for an evaluation of whether the applicant meets the requirements for recognition. This review is performed for an initial recognition, and may be performed for an expansion or renewal of recognition. The post-recognition review (audit) focuses upon the development of findings for an evaluation of whether the NRTL continues to operate in a manner consistent with it's terms of recognition.
ON-SITE REVIEW REPORT -- The report of the review issued by the assessor or auditor.
PROFICIENCY TESTING -- Determination of laboratory testing or calibration performance by means of inter-laboratory test comparisons.
RECOGNITION (AS AN NRTL) -- The acknowledgment by OSHA that an organization meets the requirements for an NRTL specified in 29 CFR 1910.7(b). In granting recognition, OSHA has determined that the organization has the capability, control programs, independence, and effective procedures to perform safety testing and certification of the types of products covered under the test standards included in its scope of recognition.
REPORT ON FINDINGS -- The report that summarizes the overall findings of an on-site review, and details the non-conformances that must be corrected by an applicant or NRTL to fulfill or continue to fulfill one or more of the requirements for recognition. For each non-conformance, the applicable requirement(s) is identified, and if necessary, a brief justification is provided.
STANDARD -- Document, established by consensus and approved by a recognized body, that provides, for common and repeat use, rules, guidelines, or characteristics for activities or their results, aimed at achievement of the optimum degree of order in a given context. Within the context of calibrations, an artifact, instrument, or other reference material that provides a basis for setting a parameter of a test instrument to a specific value.
STANDARD OPERATING PROCEDURES -- The detailed documents for a particular area or department of an organization, that identify the personnel positions responsible for and involved in performing specific tasks, and that provide the specific instructions, in sufficient detail, that personnel must follow to perform these specific tasks. For purposes of the NRTL Program, the SOPs should be consistent with an organization's policies in its quality manual or other guiding document.
SUPPLEMENTAL PROGRAMS -- The activities first described on pages 12983 through 12985 of the March 9, 1995 Federal Register notice (60 FR 12980) and grouped under sections 2 through 9. Each section is referred to as a "procedure" in the notice but sets forth criteria that will require the NRTL to have a set procedures to undertake the activities permitted in each section. These programs are optional as opposed to Program 1 under which the NRTL that will certify the product performs all product testing and evaluation activities "in-house."
TERMS OF RECOGNITION -- The scope of recognition, specific conditions and limitations imposed by OSHA, general conditions required by Appendix A of the Program regulations, and references to applicable policies, directives, and requirements with which the NRTL must comply.
TEST -- Technical operation that consists of the determination of one or more characteristics of a given product, process or service according to a specified procedure.
TEST METHOD -- Specified technical procedure for performing a test.
TEST REPORT -- Document that presents test results and other information relevant to a test.
TESTING LABORATORY -- Laboratory or portion of an organization that measures, examines, tests, calibrates, or otherwise determines the characteristics or performance of materials or products.
TEST PROCEDURE -- A sufficiently detailed instruction to follow in examining and testing a type of product, or in performing a specific type of test. For purposes of the NRTL Program, a test procedure must be consistent with and, where necessary, elaborate upon the product safety test standard(s) applicable to the products under test. A test standard may be used, partly or completely, as a test procedure if it contains sufficiently detailed instructions that will yield repeatable results. See Policy on Testing Procedures in Appendix C.
THIRD PARTY -- Person or body that is recognized to be independent of the parties involved, as concerns the issue(s) in question.
THIRD PARTY CERTIFICATION -- A form of certification in which the supplier's claim of conformity is validated by a technically and otherwise competent body other than one controlled by a producer or buyer. Within the context of the NRTL Program, the "third party" is the NRTL and the "supplier" is generally a product manufacturer.
VALID COMPLAINT -- A complaint that the Director has determined requires additional investigation to evaluate a course of action to take against the NRTL or product.
VOLUNTARY TERMINATION OF RECOGNITION -- Occurs when NRTL provides a written request for voluntary termination of all or part of its recognition as an NRTL, and OSHA takes appropriate action.
WRITTEN RESPONSE -- The detailed response of an applicant or an NRTL to the Report on Findings. The written response will include a schedule for completing any corrective actions, narrative explanation and supporting documentation to sufficiently address each area of deficiency identified, and any other comments on the report that the applicant determines to be appropriate.
NRTL PROGRAM POLICIES
- Application Guidelines. The Application Guidelines for the NRTL Program are incorporated by reference into this Instruction. These guidelines may be given to applicants wishing recognition, expansion, or renewal of recognition as an NRTL. The Director documents the current version of the guidelines in an OSHA internal memorandum and distributes it as needed to the appropriate offices. The Director makes the guidelines available in hard copy or diskette and on the web site for the NRTL Program. See contact information and web site address in Chapter 1.
- Evaluation Criteria. Appendix A to 29 CFR 1910.7 requires the following: "In the evaluation of the NRTLs, OSHA will use either consensus-based standards currently in use nationally, or other standards or criteria which may be considered appropriate." In compliance with this requirement, OSHA will use the specific criteria in the Detailed Application Information/Evaluation Criteria (DAI/EC) part of the Application Guidelines, to evaluate whether an applicant meets or an NRTL continues to meet the requirements for an NRTL in 29 CFR 1910.7. The general basis for these criteria is shown in Appendix F. OSHA may use other or alternative criteria that it deems necessary due to specific circumstances of an application, facility, organization, or other pertinent factors. In the event of a difference between an OSHA-specific criterion or policy, and any clauses of national or international standards or guides, the applicable OSHA-specific criterion or policy will control.
- NRTL Follow-up Inspections at Manufacturing Facilities. An NRTL must provide, to the extent needed for a particular product it has certified, inspection of "the run of production of such items at factories for product evaluation purposes to assure conformance with the test standards." As part of complying with this requirement, an NRTL must physically inspect each manufacturing facility of products it has certified to ensure that the manufacturer continues to produce these products as certified by the NRTL. The NRTL must inspect each such facility and each product it has certified at the minimum frequencies specified below. The NRTL must use qualified personnel or representatives to perform each inspection and, when appropriate, must perform unannounced inspections or give minimal notice. Inspections must involve an actual visit to the facility and not just a review of product plans, photographs, or similar items. Inspections at non-manufacturing facilities, if properly controlled, may supplement but cannot replace the minimum number of inspections for manufacturing facilities required in this policy. [For purposes of this policy, manufacturing facility is an establishment used for fabricating or assembling a product (model or item) covered under the NRTL's agreement for certification services. A facility that primarily distributes products, such as a "single point distribution" site, or that makes final, but minimal, assembly of products is not a manufacturing facility. Also, for purposes of this policy, the terms inspect and inspection refer to an audit of a manufacturing facility by the NRTL.]
- Frequency of Inspections. An NRTL must perform a greater frequency of inspections at facilities where greater safety concerns exist regarding the manufacture of products certified by the NRTL. At a minimum, such concerns exist under any of the following situations:
- The products are intended for use in hazardous locations;
- The NRTL has evidence or suspects that the manufacturer has not been producing a product in conformance with the product safety requirements or maintaining appropriate controls over its production process at a facility;
- The facility is in a region where mislabeling or counterfeit labeling occurs frequently and there is a question about the manufacturer's ability to control and mark products correctly;
- The NRTL has evidence or suspects that the manufacturer is not using or controlling the NRTL's certification mark(s) correctly; or
- The NRTL has evidence or suspects that safety concerns exists concerning the products.
- Policies and Procedures for Inspections. The NRTL must perform its inspections consistent with applicable NRTL Program policies and according to its follow-up inspection program. This program will include written procedures in sufficient detail that identify the specific activities the NRTL performs during inspections and how the NRTL addresses the various situations and options identified in this policy. The follow-up inspection program must be part of the official documentation of the NRTL, that is, part of its operating procedures or quality assurance program. The NRTL's inspection program must clearly and consistently justify the inspection frequency, and changes to this frequency, that the NRTL has adopted for a facility or for a particular type of product. The NRTL's procedures must address products having seasonal or non regular production cycles. In addition, the NRTL must address any concerns that can exist with production lines that are intermittent. The procedures must also adequately address reinstatement of inspections when the NRTL confirms that a facility, subject to regular inspections, does not have production or stock of certified products.
- Physical examination of the product being inspected against an inspection document that describes the product;
- Sample selection for subsequent countercheck testing, if appropriate;
- Verification of in-process and final testing that is required by the test standard or that is regularly conducted at the factory as a part of the manufacturer's quality management system;
- Confirming the use of approved components;
- Monitoring use and control of the NRTL's mark; and
- Calibration of equipment used in testing.
- Programs Allowed under March 9, 1995 FR Notice (60 FR 12980, 3/9/95)
- Content of programs. Nine programs are described in the March 9, 1995 FR notice. See list of names of programs in Chapter 2. With the exception of program #1, an applicant or NRTL must make a specific request to include a program within its scope of recognition. Each program provides alternatives for accomplishing portions of the product certifications. The term "program" encompasses all the policies and procedures that enable compliance with all the criteria listed for each program. A program is also referred to as a "procedure" in the March 9 notice. Recognition for a program is contingent on the applicant or NRTL adequately meeting all the criteria for a program. Each NRTL is automatically recognized for program #1, which is called the "Basic Procedure", when it is first recognized. Applicants should apply for program #9 which allows for the NRTL to subcontract for services other then testing and evaluation. Some of the subcontracted services that are covered under program #9 include calibration, follow-up inspections, equipment maintenance, and security.
- Use of Programs. With the exception of Program 1, to use any of the programs of the March 9 notice, the NRTL must meet the criteria for the particular program(s) and must:
- Be recognized to perform the tests and evaluations before it can accept such services from other organizations, except for unique or special testing needs.
- Use assessors having qualifications consistent with the competence requirements of the appropriate national standards and international guides to qualify organizations.
- Ensure that all aspects of certification work performed by others, including participants, locations of testing, witnessing, and evaluations, are identified in the NRTL and client records and reports.
- Correction of program descriptions. The term "program" replaces the term "procedure" when referring to the activities, numbered 1-9, described on pages 12982 through 12985 of the FR notice. In addition, the following corrections are made to the text for each of the following programs:
- Program 3 - Acceptance of Product Evaluations From Independent Organizations, Other Than NRTLs. In the following statement, the term "Procedure 1" is changed to "Program 2," to read as follows: "An NRTL may accept product evaluations prepared by an independent organization provided the following criteria, in addition to the requirements in Program 2, are complied with:"
- Program 5 - Acceptance of Testing Data From Non-Independent Organizations. In the following statement, the term "Procedure 1" is changed to "Program 2," to read as follows: "An NRTL may accept testing conducted by a non-independent organization provided the following criteria are complied with, in addition to the requirements in Program 2, with the exception for the need to document the independence of the organization:"
- Program 6 - Acceptance of Evaluation Data From Non-Independent Organizations (Requiring NRTL Review Prior to Marketing). In the following statement, the term "Procedures 1, 2, and 4" is changed to "Programs 2, 3, and 5," to read as follows: "Except for the requirement for independence, the specific program criteria in Programs 2, 3, and 5 shall apply to product evaluations by nonindependent organizations."
- Program 7 - Acceptance of Continued Certification After Minor Product Modifications by the Manufacturer. In the following statement, the term "Procedures 1, 2, 4, and 5" is changed to "Programs 2, 3, 5, and 6," to read as follows: "An NRTL may accept minor product modifications from a manufacturer without requiring recertification provided the following criteria, as well as the criteria in Programs 2, 3, 5, and 6(except for the requirements for independence), are complied with:"
- Independence of a Nationally Recognized Testing Laboratory. To comply with 29 CFR 1910.7(b)(3), an NRTL must be free from commercial, financial and other pressures that could compromise the results of its testing and certification processes. [For the purposes of this policy, an NRTL means an NRTL applicant or an existing NRTL.] The NRTL must be free of these pressures from employers that are major users of equipment or materials ("products") the NRTL may test and certify, if the employers are subject to the tested equipment requirements. [In general, the user in question is not the NRTL organization itself. Also, the "tested equipment requirements" are generally found in 29 CFR Part 1910.] In addition, the NRTL must also be free of these pressures from manufacturers or vendors ("suppliers") of these products. If the NRTL is not free of these pressures, it would not meet the requirements specified under 29 CFR 1910.7(b)(3), and would not obtain or could not retain its recognition unless it complies with the conditions that OSHA may impose. Such conditions shall be consistent with this policy. In general, the conditions may restrict the suppliers for whom the NRTL may test and certify products, or restrict the type of products the NRTL may test and certify.
- The NRTL is a supplier or major user of products that an NRTL must certify, or is organizationally affiliated with such a supplier or major user;
- The NRTL significantly finances, invests in, sells product design, similar services or products to a supplier or major user;
- The NRTL is owned in excess of two percent (2%) by a supplier or major user, or their major owners;
- The NRTL receives significant financing from a supplier or major user, or their major owners; or
- A person holding a substantial position with the NRTL has a significant financial interest in a supplier or major user, or is a director or key personnel of either.
- Quality Assurance and Internal Audits. An NRTL must have and must follow written quality assurance programs to meet the "capability" requirement of 29 CFR 1910.7. As part of meeting this requirement, the NRTL must fulfill all of the following:
- Have one or more quality manuals covering its testing and certification activities. Each manual should be consistent with ISO 10013, and should meet the applicable portions of the versions of Guide 25 and 65 referenced in Appendix F. ISO publications may be obtained from the American National Standards Institute (ANSI) or from the International Organization for Standardization (ISO).
- Perform internal audits of its testing and certification processes at least once per year. The NRTL's internal audits should be planned and performed in accordance with ISO 10011-1:1990(E), and any additional requirements contained in clause 4.17 of ISO 9000-2:1997(E). In addition, an NRTL's internal audit reporting must include, at a minimum:
- The name(s) of the auditor(s), the areas audited, the dates of the audit and the signature of the auditor(s);
- The discrepancies encountered, and corrective actions;
- Evidence of review by upper management;
- Tracking of discrepancies until they are resolved; and
- Time frames for completion of corrective actions, and verification of completion.
- Ensure the quality assurance plan provides controls and oversight of satellite laboratory facilities. This must include all the following:
- Audits conducted by the satellite facility personnel, routinely and documented;
- Headquarters review and audit of the quality assurance program and audits conducted by satellite personnel, on a regular basis; and
- Consistency of technical records and interpretations among all facilities.
- Trained staff. An NRTL must have "trained staff" as part of meeting the "capability" requirement of 29 CFR 1910.7. As part meeting this requirement, the NRTL must fulfill all of the following:
- Maintain up-to-date position descriptions (including qualifications and responsibilities of each position) for all staff.
- Ensure that staff members are qualified or trained to carry out specific tests, evaluations or calibrations.
- Ensure that staff training is kept up-to-date, and that staff keep up-to-date of current test standard issues.
- Have an employee safety program that identifies, evaluates, and prevents or controls laboratory hazards.
- Evaluation Policies and Procedures. An NRTL must have and must follow written policies and procedures for evaluating test data as part of meeting the "capability" requirement of 29 CFR 1910.7. As part meeting this requirement, the NRTL must fulfill all of the following:
- Have procedures on evaluation of test data that:
- Require the investigator to verify and use the latest edition of the test standard;
- Require the investigator to provide narratives of how a product complies with each section of the standard and reference a standard test procedure for sections that require tests be conducted;
- Address components that have been tested by a foreign test laboratory;
- Address components that are included but not listed; and
- Address special components that do not comply with a component standard by design.
- Have policies for evaluation of test data that:
- Identify the persons responsible for technical decisions, and ensure they qualified on the standard;
- Ensure decisions are readily available for the appropriate investigators;
- Ensure decisions and interpretations of the standards are noted in the evaluation procedures;
- Include steps for making a decision on which applicable section of a standard applies;
- Include steps for handling newly developed technologies when the standard does not apply; and
- Ensure product discrepancies are resolved without the lab redesigning the product or providing technical options, but only to explain the failures in regard to the standard.
- Processing Procedures. As part of meeting the "capability" requirement of 29 CFR 1910.7, an NRTL must have and must follow written standard processing procedures related to product testing, evaluation, certification, training, and other processes that are or will be used in operating as an NRTL. The NRTL must ensure it:
- Has procedures for processing a certification application that identify the steps for the application, administrative/technical processing of the investigation in chronological order, personnel responsible for each stage of the process, and records maintained at various steps of the process;
- Selects the product standard for certification, and has procedures that identify the steps and criteria for selection, personnel responsible for decision (who are experienced in the product area), manner of resolving disagreements concerning the applicability of a standard, and manner of handling products covered by two or more standards; and
- Has procedures for developing and maintaining processing procedures that identify personnel responsible for developing, reviewing and maintaining the procedures, the frequency for review, and personnel responsible for verifying that the procedures are being followed.
- Sites. An NRTL must have proper facilities to meet the "capability" requirements of 29 CFR 1910.7(b)(1). As part of meeting this requirement, the legal entity recognized by OSHA as the NRTL must wholly-own (directly or indirectly) or organizationally encompass the NRTL's laboratory and certification sites, and have administrative and operational control over these sites. If wholly-owned, the NRTL must provide evidence of 100% share ownership of the sites, and the certificates of incorporation or legal registration for the legal entities of these sites. The control or organizational tie must be evidenced by an organizational chart for the NRTL entity that clearly shows the laboratory site within the NRTL's organization. Also, the NRTL must clearly demonstrate control in its operating policies and procedures and quality assurance program documentation. The NRTL may use laboratory sites meeting these criteria but not formally recognized by OSHA, including any foreign-based sites, provided they are used only to conduct testing. An NRTL may use these non-recognized sites, referred to as "satellite facilities," only if OSHA has determined that the NRTL maintains proper controls over the use of these sites. OSHA must recognize any site before an NRTL may use it to:
- Authorize the use of the NRTL's mark for the product standards for which the NRTL has been recognized;
- Maintain primary product test and evaluation files;
- House the personnel in charge of any of the programs listed under the March 9, 1995, Federal Register (FR) notice; or
- House personnel whose expertise is used in the initial qualification of participants in any of the program options available under the March 9, 1995, FR notice.
- Records. An NRTL must maintain proper records of its activities related to testing and certification as an NRTL, as part of meeting the "capability" and "control procedures" requirements of 29 CFR 1910.7. In maintaining proper records, an NRTL must follow:
- Written policies and procedures for test standards distribution & control that:
- Specify the individual responsible for maintaining and distributing revised standards;
- Specify the methods to control the distribution of standards;
- Ensure availability of the current issues of the appropriate standards at all relevant locations;
- Specify the method to communicate modifications or amendments to all relevant locations, including clients and agents;
- Ensure deletion of superseded standards throughout the organization, and archiving; and
- Specify the effective date that laboratory clients must comply with the requirements of a modified standard.
- Written policies and procedures for testing and certification activities that:
- Specifies the individual responsible for maintaining records;
- Specifies retention period for each record, and persons authorized to access;
- Specifies how to correct administrative discrepancies with reports after they are issued, and how to correct or modify information on a completed record; and
- Documents how each certification procedure was applied, including test/inspection reports.
- Follow-up Inspection Program. An NRTL must provide "inspections" of manufacturing facilities, as required under 29 CFR 1910.7(b)(2). As part of meeting this requirement, an NRTL must meet the criteria in paragraph III of this Appendix, and must:
- Perform initial assessment of the manufacturing facility, manufacturer's quality control system, records and documents, and evaluations and tests required by the Standard, following written procedures.
- Perform follow-up inspections following written procedures that should:
- Identify who conducts the periodic follow-up inspections;
- Ensure agents used for follow-up inspections, if any, have the facilities and qualified staff for adequate surveillance; and
- Ensure results of the manufacturer's surveillance is routinely reported to the applicant and maintained in a file.
- Have and adhere to written contracts, agreements or procedures for the client-laboratory relationship that should include:
- Provision(s) for submitting products for inspection and testing;
- Provision(s) for permitting periodic inspections by the applicant;
- Provision(s) for permitting samples of product to be selected from production for independent testing;
- Covenants from the client to observe and comply with the applicable standards;
- Controls to prevent the client from releasing the products resulting from changes (in the product, process or quality management system) until the laboratory has notified the client;
- Provision(s) for unobstructed access to the manufacturing premises without prior notification;
- Provision that the product will be produced to the same specifications as the sample submitted for initial testing; and
- Controls to ensure that all quality management system and production records will be open and readily available for inspection by the laboratory.
- Effective Reporting - An NRTL must "maintain effective procedures" for producing credible "findings and reports," as required under 29 CFR 1910.7(b)(4). As part of meeting this requirement, an NRTL must have and must follow written procedures for:
- Preparing technical reports that:
- Identify person(s) responsible for preparation, technical content review, and approval;
- Clear and organized report format that facilitates data extraction;
- Sufficient information to permit repetition of tests;
- Identifies the appropriate test and evaluation procedures; and
- Identifies person(s) who authorize revisions or technical corrections.
- Report distribution that ensure that copies of tests report are limited for the sake of confidentiality, and that copies of test reports are sent to everyone who needs the information.
- Allowable and Withdrawn Test Standards.
- A test standard that meets the criteria for approval in Appendix D, and that is issued by the American National Standards Institute (ANSI), is an appropriate test standard as prescribed by 29 CFR 1910.7(c)(4). An NRTL that is approved for a particular test standard may use either the latest proprietary version of the test standard or the latest ANSI version of that standard, regardless of whether it is currently recognized for the proprietary or ANSI version.
- A test standard withdrawn by a standards organization is no longer an appropriate test standard. OSHA will de-recognize withdrawn test standards by issuing a correction notice in the Federal Register for all NRTLs recognized for the standards. An NRTL may request recognition for a comparable standard, and OSHA will note the substitution in the correction notice if it determines the standard is appropriate and comparable.
- Certification Mark(s) and Listing Program. An NRTL must implement "control procedures for identifying" products it has certified, as prescribed by 29 CFR 1910.7(b)(2). As part of meeting this requirement, an NRTL must have the following:
- A registered certification mark(s), as evidenced by a certificate of registration issued by the U.S. Patent and Trademark Office (USPTO) or by a national or international body under a registration system that requires ownership of the mark(s) and that is equivalent to the USPTO system of registration. An applicant for initial recognition must submit, at the time of application, evidence of such registration or, if not registered, evidence of application for registration of its mark(s) with the USPTO and, within a reasonable time after applying for recognition, evidence of registration with the USPTO. In addition, the NRTL must:
- Use only this certification mark(s) for its NRTL activities, and
- Ensure this certification mark(s) is applied to each unit, or if not feasible, to the smallest package of the products it has certified; and
- A listing and labeling program that includes:
- Procedures and resources to properly control its certification mark;
- Procedures and resources to monitor advertisements, catalogues and brochures for incorrect references or misleading use of its certification, and to take appropriate corrective actions; and
- Procedures and resources to take corrective action when its mark is misused.
- Testing Procedures. An NRTL must have and must follow adequate "written testing procedures" in order to meet the capability requirement of 29 CFR 1910.7. To meet this requirement, the NRTL must have all the following:
- Written test procedures for any test standard for which it seeks recognition and that contain:
- Title, effective date, specific test equipment, minimum accuracy requirements;
- Hazard warnings/caution statements for operators, normal and any unusual ambient conditions (including tolerances) for tests;
- Test operator instruction on equipment operation and the handling and preparation of test samples if applicable, including multiple sample marking;
- Test data to be obtained and recorded, the minimum resolution of measurements; and
- Objective acceptance criteria for results, testing techniques (unless obvious), sufficiently detailed instructions that assure reasonable repeatability of tests.
- Test data sheets that require recording of :
- Test procedure and standard used, product or component tested, test equipment used in the test;
- Date of the test, test report number, and signature of the person performing the test; and
- Ambient test conditions and test results.
- Written procedures for developing and maintaining testing methods and procedures that:
- Identify person(s) responsible for developing, reviewing and maintaining the procedures;
- Specify frequency of review by management;
- Ensure consistency with recognized standards, and deviations that still assure the product conforms with the standard; and
- Ensure modifications are reviewed by personnel who are familiar with the standard.
- Calibration Traceability. An NRTL must have an adequate "calibration program" in order to meet the capability requirement of 29 CFR 1910.7. As part of meeting this requirement, an NRTL must have and must follow written procedures that address calibrations and reference standards or materials, and that ensure their traceability to the appropriate standards maintained by the U.S. National Institute of Standards and Technology (NIST), or if in a foreign country, to equivalent standards or materials maintained by a nationally or internationally recognized body.
- Definition of Foreign-based Testing Agency or Organization. Appendix A to 29 CFR 1910.7 requires that OSHA consider certain policies of the foreign government in determining the eligibility of a foreign-based testing agency or organization [collectively, organization] that applies for recognition as an NRTL. For the purpose of this requirement, an organization is foreign-based if (1) the legal entity in which it conducts business is incorporated or otherwise legally registered in a country other than the United States (including its territories) ("US"), or (2) it is headquartered or has its main office or place of business outside the US, even though the legal entity in which it conducts business may be incorporated or otherwise legally registered in the US.
An applicant meeting the pertinent detailed criteria of the DAI/EC meets the corresponding recognition requirement in 29 CFR 1910.7(b) or has the capability to use the corresponding supplemental program. An applicant not fully meeting the detailed criteria for one or more evaluation categories in the DAI/EC must submit sufficient information and detail to clearly demonstrate how it otherwise meets the corresponding requirement(s).
The NRTL must perform these inspections to the extent needed to provide assurance that the product is manufactured as certified. In situations involving the above safety concerns, the NRTL must perform no fewer than four (4) inspections per year at these facilities.
An NRTL may perform the inspections less frequently at any facilities where the above safety concerns or similar situations do not exist. However, the manufacturer in such situations must consistently demonstrate ongoing quality management and control programs, and effectiveness in meeting the product safety requirements. In such cases, the NRTL must perform no fewer than two (2) inspections per year at these facilities.
While its certification remains in effect, an NRTL must inspect each certified product to the extent needed for that particular product but not less frequently than once every two years. In performing this inspection, the NRTL may use the inspection of a product at a manufacturing facility to meet the inspection requirements for similar products manufactured at this specific facility. For purposes of this policy, similar products are products grouped in a category based on the same or equivalent product manufacturing characteristics or technical requirements.
The NRTL will determine the specific activities to undertake in performing each inspection and will document these activities. However, follow-up inspections activities (but not necessarily every inspection) will at least include or address the following:
In performing an inspection at a manufacturing facility, an NRTL may perform multiple activities. Such activities include auditing more than one product, performing a quality audit to ISO 9000 or other standard, qualification audits for programs that OSHA has recognized (see March 9, 1995 Federal Register notice), or any combination of activities with similar purposes. For example, the NRTL may include a quality audit of a manufacturing site as part of an inspection it performs for this site. For such inspections, the NRTL must use inspectors qualified in performing all activities undertaken. ISO or similar audits or activities may not replace the inspections required by this policy.
In determining the areas to review during an on-site visit (i.e., records, quality control, calibrations), an NRTL can take into consideration inspections performed by others that are not subcontractors or agents of the NRTL. However, use of such inspection data generated by others does not relieve the NRTL from its responsibilities for performing the required inspections. An NRTL that has received recognition for Program 9 may use others acting as subcontractors or agents of the NRTL to perform follow-up inspections, unless such recognition limits this use.
These pressures are presumed to exist if there is a substantial relationship between the NRTL and a supplier or major user of products that must be certified which could compromise the objectivity and impartiality in determining the results of its testing and certification processes. [Substantial, for the purposes of this policy, means of such a nature and extent as to exert undue influence on the testing and certification processes.] This presumption may be rebutted by the NRTL provided it can present clear and convincing information to the contrary.
Such a relationship includes, but is not limited to, the following:
The NRTL must have policies and procedures in place to ensure that none of the relationships described above or similar relationships exists with respect to suppliers or major users of products. In addition, the NRTL must submit a statement to OSHA certifying that it complies and will continue to comply with this policy on independence, and it will fully comply with any conditions imposed by OSHA.
APPLICATION REVIEW PROCEDURES AND CHECKLIST
- Review for Completeness.
- Completion of the Application Review Checklist.
- Review each section of the application, and place a check mark in the appropriate column and line item of the Application Review Checklist if the appropriate document is found. Note any questions pertaining to the section under review in the Checklist.
- Determine that information is provided for each relevant item of the General Application Information, Applicable Test Standard, and Detailed Application Information/Evaluation Criteria parts of the Application Guidelines, and that information is appropriate to the particular item. If not, note this on the specific line item of the Checklist.
- Lists any additional items needed, and sign and date the Checklist.
- Determination on Completeness. An application is considered complete if it contains all necessary documents, and sufficient information for all relevant items in the Guidelines.
- Review for Adequacy.
- Review of Details.
- Compare the information included in the General Application Information, Applicable Test Standard, and Detailed Application Information/Evaluation Criteria parts, or its equivalent, to the relevant detailed evaluation criteria or NRTL Program policies. Determine whether the information reasonably demonstrates how each pertinent criterion or policy will be met, and note this on a copy of application documents or on a blank copy of the applicable part of guidelines, if the guidelines format was not used by the applicant. Prepare a summary of the criteria that are not met.
- Determine which test standards requested by the applicant can be approved utilizing the procedures in III below.
- Determination on Adequacy. An application is considered adequate if the information submitted sufficiently demonstrates that the requirements for recognition can be met, and where relevant, if at least one test standard requested can be approved.
- Review of Test Standards.
- Review the listing of test standards submitted for recognition and ascertain that each test standard is listed in the Current Listing of Standards Approved Under the NRTL Program. Approve a standard for recognition if it is already included in this listing, unless unresolved issues exist with respect to that standard.
- For standards not issued by an acceptable organization (ANSI, ASTM, UL, or FMRC), inform the applicant by phone that it must submit the information showing the standard meets the criteria in paragraph IV below, and follow-up in writing.
- For standards issued by an acceptable organization, but not previously approved, ascertain that the standards are listed in a current index of published standards. Verify the current designation and status (active, withdrawn, etc.) of each standard requested.
- Standards not listed may not be approved.
- For each listed standard, review its scope and technical requirements, utilizing the available standards program or standard provided by the applicant, and determine that the standard is appropriate.
- If the standard is appropriate, determine that the product(s) within the scope of the test standard must be certified by an NRTL, by checking the specific reference(s) in 29 CFR Part 1910.
- Document rationale for approving or denying each standard. Inform the applicant by phone of standards that cannot be approved, and follow-up in writing.
- Test Standard Approval Criteria. A test standard may be approved for recognition if the following criteria are met (A test standard should be consistent with applicable requirements of ISO Guide 7, "Requirements for standards suitable for product certification".):
- Its scope pertains primarily to equipment or materials (products) covered under the NRTL Program, and its requirements are consistent with applicable OSHA Safety Standards.
- It must be "a document that specifies the safety requirements" for a specific type of product. In general, this means:
- Safety requirements are features, parts, capabilities, usage limitations, or installation requirements which if they did not exist would create a potential hazard in using the equipment. Standards issued by acceptable organizations are generally, but not necessarily, appropriate.
- The NRTL must determine through some testing or examination that the specific product conforms to the requirements of the standard.
- The standard does not need to contain the testing methods that will be used to judge the products for which recognition is requested (see I.b of Appendix A to 29 CFR 1910.7). If the methods are not in the standard, they must be separately documented, and referenced accordingly.
- The standard may not focus primarily on usage, installation, or maintenance requirements.
- It must be recognized in the United States (i.e., developed by a U.S. based standards organization) as a safety standard providing an adequate level of safety.
- It must be developed by a standards organization under a method providing for input by a broad spectrum of those experienced in the safety field involved. The methods of obtaining consensus must be consistent with the appropriate Procedures for the Development and Coordination of American National Standards used by the American National Standards Institute.
- It must be maintained current with revisions of applicable codes and installation standards. The standards (or alternative test standards) organization must have appropriate policies and procedures for maintaining its standards as current.
ON-SITE REVIEW PLAN PROCEDURES
- Overall Procedures.
- Before and During the On-site Visit.
- For a site visit required for a recognition, expansion or renewal, perform the procedures shown below that are necessary for the review of the applicant or NRTL. Verify the policies, procedures, or other information provided for each category (e.g., testing equipment) of the Guidelines, and determine whether the applicant or NRTL follows its policies, procedures, and practices, and meets the applicable criteria or policies, or clearly demonstrates it meets the applicable requirements for recognition. (References to "Guidelines" means the Detailed Application Information/Evaluation Criteria part of the current NRTL Program Application Guidelines.) Perform the procedures to review the supplemental programs only if requested in the application or necessary to the review. Where feasible, perform procedures before the actual visit.
- For an audit, perform selected procedures to verify whether the NRTL continues to operate in a manner consistent with the conditions of its recognition, and follows its policies, procedures, and practices. Determine what changes the NRTL has made to its operations since the last on-site visit. Perform the procedures to review the supplemental programs only if pertinent to determine continued conformance.
- Discuss findings that suggest non-conformance with the appropriate management official at the time of the finding, unless disclosure can be compromising.
- Record the information gathered in the appropriate section of the Guidelines, or on equivalent worksheets, referencing relevant laboratory documents. Include the name and title of any person interviewed.
- Review situations encountered during the visit that are not specifically addressed in this Appendix following procedures similar to those of a related area. Note alternative or other procedures in the review report.
- Following the On-site Visit.
- For an initial recognition, expansion, or renewal, using the findings of the review, determine the degree to which the applicant or NRTL meets the applicable requirements for recognition. For an audit, determine whether the findings reasonably demonstrate that the NRTL continues to meet the requirements for recognition in the areas reviewed, and continues to follow its policies, procedures, and practices.
- For a specific program evaluation, observe and evaluate a sample number of parties with whom the applicant laboratory has entered into an agreement to perform any part of the testing/certification process.
- Obtain additional information, as necessary.
- Procedures for Review of Capability.
- Testing Facilities.
- Tour overall or necessary parts of laboratory facility with laboratory staff, as needed. Where feasible, prepare a list of equipment observed and for each item record the: inventory item number, calibration date on the calibration stickers, location within the laboratory, and the laboratory identification number. Note items with overdue or no calibration.
- Document in-progress testing and interview the person performing the testing, if feasible. Include the following information:
- Test procedure numbers and the name of the personnel conducting the test.
- Manner of recording test data
- General observations such as whether the test procedures are being properly followed, and whether test equipment is identified on the data sheets.
- The type and name of testing or certification program involved, and whether the testing pertains to the proposed or current scope of recognition.
- Randomly select testing requirements in the product standards to verify that test equipment are available in the lab to perform tests required by the standards to be used for the NRTL Program.
- Randomly select testing equipment from an inventory listing, including equipment required for testing to the standards submitted for recognition, and:
- Review the calibration, repair, and maintenance records for the equipment for accuracy, and for adherence to procedures.
- Compare any laboratory equipment instructions to the manufacturer's user manuals for consistency.
- Interview laboratory staff qualified to use the equipment to ascertain their knowledge on its proper use.
- Review applicable policies or procedures listed in the corresponding category of the Guidelines to determine their adequacy.
- Review experience and training for employees that will perform work under the NRTL Program. Review training program documentation and verify the employee has received training in accordance with applicable procedures. Evaluate whether applicable procedures are being followed.
- Interview staff that will oversee operations under the NRTL Program, and evaluate their knowledge of their area(s) of responsibility.
- Randomly select relevant testing procedures or methods, and determine the consistency of these procedures with the requirements of the applicable test standard(s).
- Select a sample of the testing and evaluation procedures to be used under the NRTL Program and determine whether each procedure meets the criteria in the Guidelines.
- Select a sample of calibration reports and testing instruments to determine adequacy of applicable policies or procedures on calibration intervals (including check whether calibration intervals are exceeded), primary standards, and calibration of new, leased, rented, and repaired equipment.
- Review the reports for measurement equipment to verify they are traceable to primary standards or reference materials maintained by the National Institute for Standards and Technology, or if in a foreign country, to equivalent standards or materials maintained by a nationally or internationally recognized body.
- Review the Quality Assurance Manual and quality documents to ensure they are appropriate for the scope and size of the organization.
- Select a sample of minutes of meetings or reports dealing with the quality assurance program, including the internal audit program. Determine whether the programs meet applicable NRTL Program policies and internal procedures, and are effective in achieving the stated goals. Determine the effectiveness of the programs by reviewing a sufficient number of the items identified in internal audits.
- Verify whether any closed corrective actions mentioned were implemented as intended, and reasons for failure in implementation. Obtain a listing of open corrective actions and determine current status. Verify adherence to applicable internal procedures.
- Interview quality manager, internal audit staff, and other key staff to evaluate their knowledge of the quality process and procedures.
- Review satellite facilities to assure that all the applicable criteria in the Guidelines are addressed, except where the headquarters facility provides coverage of those areas. Assure that the headquarters facility monitors the satellite facility to ensure compliance with the headquarters policies and procedures. Review the headquarters facility's documents applicable to the satellite facility, and compare to the comparable records located at the satellite facility for consistency of the information in these records.
- Randomly select product test standards used for testing or certification. Also include standards submitted for recognition, if not selected.
- Verify that the latest revision or the latest ANSI version is on hand, and will be used for testing and certification under the NRTL Program.
- Evaluate the procedures for updating, selecting, and use of standards.
- Listing and Labeling.
- Follow-up and Field Inspections.
- Determine that there are resources to survey the client's products and process.
- Randomly select product certification reports for products to be certified for the NRTL Program, if available, and for products still active with the applicant. Evaluate whether the procedures for processing, evaluation, inspection, and other applicable activities are being followed, and with respect to products under the NRTL Program, whether procedures follow applicable sections of the Guidelines.
- Review the file documentation to evaluate the initial and continuing conformance of the product with the standard.
Verify controls are in place to assure accuracy of information in the listing book by selecting a sample of listing files and comparing the information in the file to a current copy of the listing book or records.
- Ownership. Verify the NRTL's procedures to monitor owners having more than 2% ownership.
- Major services provided and clients. Verify the names of major clients of the NRTL and the products/services sold to those clients using random sampling.
- Review policies on conflict of interests for adequacy.
- Interview key personnel regarding the NRTL's statement on independence, and evaluate compliance with OSHA's policy on independence.
- Reports. Randomly select test reports from files pertaining to products to be certified under the NRTL Program, or from other files pertaining to certification or testing. Review the reports and applicable records for adherence to product handling and test reporting procedures. Review that proper testing methods were used and were followed.
- Complaints. Review the complaint handling procedure to determine whether it meets the criteria in the corresponding category of the Guidelines.
- Review of Program 2 through 8 under the March 9, 1995 FR Notice (when applicable).
- Review the procedures and associated documentation pertaining to each of the programs requested and verify that the pertinent criteria set forth in the notice will be or continues to be met. For audits, review only the program of interest.
- Select test and evaluation reports produced under these programs, if available, and verify that the information is from qualified organizations, contains sufficient information to repeat the test or evaluation, and meets the applicable criteria in the March 9, 1995 FR notice.
- Review of Subcontracted Work (Program 9 under the March 9, 1995 FR notice).
- Review the procedures and associated documentation pertaining to this program to verify each item listed for the program.
- Review contracts for subcontracted work, and reports or other documentation submitted by contractors to determine adherence to internal procedures and practices.
- Verify that there is a qualification program for subcontracted work; review requirements of this program and determine that the procedures are being followed.
GENERAL BASIS FOR EVALUATION CRITERIA
The evaluation criteria shown in the Detailed Application Information/Evaluation Criteria (DAI/EC) part of the Application Guidelines are generally based on OSHA-specific policies or on specific clauses of international guides (or national standards). The policies and clauses most pertinent to each evaluation category (e.g., Testing facilities) are shown in this Appendix. Only the clauses from each international guide (or national standard) listed below are applicable. Later or earlier versions of these guides (or standards) are not applicable. The clauses of the guides are not necessarily adopted as criteria in whole, but are modified in many cases to suit OSHA's requirements. In this appendix, reference to a "policy" means the applicable policy in Appendix C of the NRTL Program Directive. Some policies are reflected only in the criteria shown in the DAI/EC; they are not shown in any part of this directive. In the event of a difference between an OSHA-specific criterion or policy and any clauses of national or international standards or guides, the applicable OSHA-specific criterion or policy will control.
Current Version of International Guides Used for Evaluation Criteria:
ISO/IEC Guide 25 : 1990 (E)
ISO/IEC Guide 28 : 1982 (E)
ISO/IEC Guide 65 : 1996 (E)
ISO publications may be obtained from the American National Standards Institute (ANSI) or from the International Organization for Standardization (ISO). The specific guides cited above are available for inspection at the OSHA Docket Office.
- Testing facilities: Guide 25, Clause 7.
- Testing equipment: Guide 25, Clause 8.
- Testing, evaluation, and processing procedures: Policy on Test Procedures; Policy on Evaluation Policies and Procedures; Guide 65, clause 10; Guide 25, Clause 10 and Clause 11.
- Calibration program: Policy on Calibration Traceability; Guide 25, Clauses 9, 10.1, and 10.2.
- Quality assurance program: Policy on Quality Assurance and Internal Audits; Guide 25, Clauses 5; Guide 65, Clauses 4.5, 4.7, & 7.
- Records: Policy on Records; policy on Allowable and Withdrawn Test Standards; Guide 65, Clauses 4.8.2, 4.9, 6, and 11.
- Personnel: Policy on Trained Staff; Guide 65, Clause 5; Guide 25, Clause 6.
- CONTROL PROGRAMS.
- Controls for identifying the equipment or materials to be listed or labeled: Policy on Certification Mark(s) and Listing Program; Guide 65, Clauses 12 and 14.
- Controls for follow-up inspections and evaluation of products: Policy on Follow-up Inspection Program; Guide 28; Guide 65, Clauses 4.3, 4.6, 6, 8, 9, 10, and 13.
- Controls for field inspections to monitor and to assure the proper use of identifying mark or label on products: same general criteria as in B above; Policy on Certification Mark(s) and Listing Program.
- REPORT AND COMPLAINT PROCEDURES.
- Effective procedures for producing findings or reports: Policy on Effective Reporting; Guide 65, Clauses 4.8 and 11; Guide 25, Clause 13.
- Effective procedures for handling complaints and disputes under a fair and reasonable system: Guide 65, Clause 7; Guide 25, Clause 16.
- SUPPLEMENTAL PROGRAMS
- See Appendix C, paragraph IV.B, "Use of Programs."
- Programs 2 through 9: see March 9, 1995 FR Notice for specific criteria of each program. See Appendix C for corrections to this FR notice.
- ADDITIONAL CRITERIA.
- Policy of NRTL Follow-up Inspections at Manufacturing Facilities.
- Policy on Sites.
- Policy on the Definition of Foreign-based Testing Agency or Organization.
Policy on the Independence of a Nationally Recognized Testing Laboratory (NRTL) and Guide 65 clause 5.2.
All other applicable policies of Appendix C of the NRTL Program Directive not specifically mentioned above, including:
FORMAT AND CONTENT FOR REVIEW REPORTS
The On-Site Review Report will be prepared in a format acceptable to the Director, and will be signed and dated by the assessor/auditor or lead assessor/auditor, as appropriate. The Review Report sent to the Director will also include, as separate enclosures:
1. The Report on Findings (if revised since officially submitted to the applicant or NRTL);
2. The Written Response(s);
3. The Detailed Information or other detailed findings; and
4. Other relevant supporting documents or information.
The On-Site Review Report will contain the following:
1. The recommendation, including any limitations or conditions, in a cover memo to the Director.
2. The purpose, dates, assessors/auditors, and location name(s)/address(es) for the review.
3. Background or other information, if relevant to the evaluation.
4. The supporting statement - an evaluation explaining in sufficient detail how the applicant or NRTL meets or continues to meet the applicable requirements in 29 CFR 1910.7(b), the criteria of any applicable programs (i.e., from the March 9, 1995 notice), and other or alternative criteria. The supporting statement must address the applicable categories of the Detailed Application Information/Evaluation Criteria (DAI/EC) part of the Application Guidelines.
Allowable and Withdrawn Test Standards
Application Review Checklist
Code of Federal Regulations
General Industry Standards
Letter or other document of recognition
On-site Review Report
OSHA Docket Office
Report on Findings
Terms of recognition
U.S. Patent and Trademark Office
US Trade Representative
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