1、A N S I / I S E A 125-2014 American National Standard for Conformity Assessment of Safety and Personal Protective Equipment ANSI/ISEA 125-2014 American National Standard for Conformity Assessment of Safety and Personal Protective Equipment Secretariat International Safety Equipment Association Appro
2、ved February 5, 2014 American National Standards Institute, Inc. American National Standard Approval of an American National Standard requires verification by ANSI that the requirements for due process, consensus and other criteria for approval have been met by the standards developer. Consensus is
3、established when, in the judgment of the ANSI Board of Standards Review, substantial agreement has been reached by directly and materially affected interests. Substantial agreement means much more than a simple majority, but not necessarily unanimity. Consensus requires that all views and objections
4、 be considered and that a concerted effort be made toward their resolution. The use of American National Standards is completely voluntary; their existence does not in any respect preclude anyone, whether he/she has approved the standards or not, from manufacturing, marketing, purchasing or using pr
5、oducts, processes or procedures not conforming to the standards. The American National Standards Institute does not develop standards and will in no circumstance give an interpretation of any American National Standard. Moreover, no person shall have the right or authority to issue an interpretation
6、 of an American National Standard in the name of the American National Standards Institute. Requests for interpretation should be addressed to the secretariat or sponsor whose name appears on the title page of this standard. CAUTION NOTICE: This American National Standard may be revised or withdrawn
7、 at any time. The procedures of the American National Standards Institute require that action be taken to reaffirm, revise, or withdraw this standard no later than five years from the date of publication. Purchasers of American National Standards may receive current information on all standards by c
8、alling or writing the American National Standards Institute. Published by International Safety Equipment Association 1901 North Moore Street, Arlington, Virginia 22209 Copyright 2014 by ISEA All rights reserved. No part of this publication may be reproduced in any form, in an electronic retrieval sy
9、stem or otherwise, without the prior written permission of the publisher. Printed in the United States of America Foreword (This Foreword is not part of American National Standard ANSI/ISEA 125-2014) Conformity assessment is defined as the demonstration that specified requirements relating to a prod
10、uct, process, system, person or body are fulfilled. For safety and personal protective equipment (PPE), the specified requirements are found in product standards, along with test methods, sampling procedures, and labeling and marking requirements. Conformity assessment includes testing, evaluation o
11、f test data to determine conformity, declaration of conformity, and accreditation of laboratories, certification bodies and quality management systems. In the United States, there are multiple approaches to PPE conformity assessment. Respiratory protection PPE is subject to federal regulations requi
12、ring government testing and certification. Some product standards include specific conformity assessment requirements, including in some cases independent third-party certification. Most PPE is tested and evaluated by the supplier to requirements of voluntary product standards, and the supplier atte
13、sts to the products conformance to the standard by marking or labeling. Federal regulations require that employers provide PPE that meets minimum performance requirements, but in most cases do not specify any type of conformity assessment. ANSI/ISEA 125-2014 is designed to provide a standardized con
14、formity assessment system that can be used by suppliers, specifiers, users and regulators. As a stand-alone document it can be applied as a uniform reference across a range of product categories. It is intended as a resource that can be referenced by end user purchasers of products, who may include
15、compliance to this standard as a requirement of a purchase contract with a supplier; by regulatory authorities having jurisdiction over workplace safety and health, or by product standard development committees to define their conformity assessment requirements for a particular product performance s
16、tandard. As part of their benchmark research, the developers of the standard studied conformity assessment models in use around the world. These models include comprehensive national requirements for standards, testing and certification; the multinational European system based on product performance
17、 requirements established in legislation, and the decentralized system in the US. ANSI/ISEA 125-2014 provides three levels of conformity assessment. For each level, there are requirements for initial and ongoing testing, quality management, corrective and preventive action, recordkeeping and declara
18、tion of conformity. Where standards are specified for these processes, accreditation requirements are included. The standard provides the option to select a method of conformity assessment that provides a suitable level of assurance of conformity for any product or application. It is beyond the scop
19、e of this standard to prescribe the appropriate level of conformity assessment for any product category, hazard or work environment. This is a decision that is made by the end use purchaser who references standards, by a regulatory agency with authority over the use of PPE, or by the product standar
20、ds committee whose members are closest to the product category and the products application. Guidance for selecting the appropriate level is included in an appendix. Suggestions for the improvement of this standard are welcome. They should be sent to the ISEA, 1901 N. Moore Street, Suite 808, Arling
21、ton, VA 22209; e-mail standardssafetyequipment.org. This standard was developed and drafted by the ISEA Standards Policy and Planning Committee (SPPC), whose members are knowledgeable and experienced in the development and implementation of PPE product standards and conformity assessment in the Unit
22、ed States and around the world. Members of the drafting committee included representatives of 3M Company, Capital Safety, Encon Safety Products, ERB Industries, Gateway Safety, Honeywell Safety Products, ICS Laboratories, Kimberly-Clark Professional, Lakeland Industries, MSA and OccuNomix Internatio
23、nal. This standard was processed and approved using consensus procedures prescribed by the American National Standards Institute. The following organizations were contacted prior to the approval of this standard. Inclusion in this list does not necessarily imply that the organization concurred with
24、the submittal of the proposed standard to ANSI. AFL-CIO ALANRO Consultants American Society of Safety Engineers Atlas Industrial Contractors Bashlin Industries Center to Protect Workers Rights Mr. Bret Clausen, CIH, CSP DuPont Personal Protection ERB Industries Environmental Industry Associations Ga
25、teway Safety International Safety Equipment Association International Personnel Protection Inc. INSPEC International JSJ and Associates Mr. Michael Kertis Mine Safety Appliances Company National Institute for Occupational Safety and Health National Institute of Standards and Technology National Inst
26、itutes of Health National Safety and Training Institute National Safety and Transportation Institute OccuNomix International, LLC Raytheon Intelligence, Information and Services Reliance Industries, LLC Restoration Services Inc. Safety Equipment Institute The SEA Group Underwriters Laboratories US D
27、epartment of Labor OSHA US Food and Drug Administration J. P. Zeigler, LLC Contents SECTION PAGE 1. Scope 1 2. Normative References 1 3. Definitions . 1 4. Application 2 5. Compliance . 2 6. Requirements for Level 1 3 6.1 Quality Management System . 3 6.2 Conformance Testing 3 6.3 Corrective and Pre
28、ventive Action . 3 6.4 Recordkeeping 3 6.5 Suppliers Declaration of Conformity . 3 7. Requirements for Level 2 4 7.1 Quality Management System . 4 7.2 Conformance Testing 4 7.3 Corrective and Preventive Action 4 7.4 Recordkeeping 4 7.5 Suppliers Declaration of Conformity 4 8. Requirements for Level
29、3 5 8.1 Quality Management System . 5 8.2 Conformance Testing 5 8.3 Corrective and Preventive Action . 5 8.4 Recordkeeping 5 8.5 Declaration of Conformity . 5 8.6 Requirements for Third-Party Certification Organization 5 9. Marking . 6 Appendices Appendix A. Required Elements of Conformity Assessmen
30、t Systems . A-1 Appendix B. Guidance on Application of Conformity Assessment Methods . A-2 Appendix C: Example of Suppliers Declaration of Conformity . A-4 ANSI/ISEA 125-2014 Page 1 American National Standard for Conformity Assessment of Safety and Personal Protective Equipment 1. Scope 1.1 This sta
31、ndard establishes criteria for conformity assessment of safety and personal protective equipment which is sold with claims of compliance with product performance standards. Specific provisions are described for: qualification performance testing data collection and maintenance, periodic verification
32、, substantiation of processes to maintain manufacturing quality, roles and responsibilities of suppliers, testing organizations, and certification organizations who participate in the process. A summary of the provisions of the standard is presented in table form in appendix A. 1.2 This standard doe
33、s not attempt to assign a level of conformity assessment to any product, hazard, or work environment. Guidance in making a determination of an appropriate conformity assessment level is found in appendix B. 1.3 This standard does not address fines, penalties, or government enforcement of activity co
34、vered in criminal code such as fraud and counterfeiting, or other material consequences resulting from failure to maintain conformance. 2. Normative References ISO 9001:2008, Quality management systems Requirements, ISO/IEC 17011:2004, Conformity assessment General requirements for accreditation bod
35、ies accrediting conformity assessment bodies ISO/IEC 17021:2011, Conformity assessment requirements for bodies providing audit and certification of management systems ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories ISO/IEC17065:2012, Conformity ass
36、essment Requirements for bodies certifying products, processes and service 3. Definitions 3.1 accreditation. Procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks. The body or person deemed competent through this process is a
37、ccredited. 3.2 attestation. Issue of a statement, based on a decision following review, that fulfillment of specified requirements has been demonstrated. 3.3 certification. A system whereby a certification organization (3.4) determines that a supplier (3.14) has demonstrated the ability to produce a
38、 product that complies with the requirements of a specified product performance standard (3.12), authorizes the supplier to use a label on products that comply with the requirements of a specified standard, and establishes and conducts a surveillance program to provide confidence in the continued co
39、nformity of certified products with the requirements of a specified standard. 3.4 certification organization. An independent third-party (3.9) organization that determines product conformance (3.6) with the requirements of a specified standard with a labeling/listing/surveillance program. 3.5 compli
40、ance. A judgment based on evidence that a supplier meets the requirements of a standard or regulation. 3.6 conformance. A judgment based on evidence that a product or service meets the requirements of a specified standard. 3.7 conformity assessment. Demonstration that specified requirements ANSI/ISE
41、A 125-2014 Page 2 relating to a product, process, system, person or body are fulfilled. 3.8 cosmetic variation. A change in the appearance of the product. 3.9 independent third party. An entity unaffiliated with another through common or shared ownership, governance, management or operating control,
42、 and having no ability to materially guide or influence the decisions or actions of the other party. 3.10 quality management system. A set of interrelated or interacting elements that organizations use to direct and control how quality policies are implemented and quality objectives are achieved. 3.
43、11 personal protective equipment. Equipment worn or used to minimize or mitigate the effects of exposure to hazards encountered by people doing work, designed and manufactured in conformance to requirements in product performance standards (3.12). 3.12 product performance standard. A document, that
44、provides rules, guidelines or characteristics for a product or process for common and repeated use. A product performance standard may be established by consensus and approved by a recognized body, or established by a government entity. 3.13 safety alert. A notice regarding a safety issue with a pro
45、duct, providing guidance for user actions to address the issue. 3.14 supplier. The business entity that claims conformance (3.6) of a products performance with a standard (3.12), sells it as conforming, and issues a suppliers declaration of conformity (3.15). This may be the manufacturer, distributo
46、r, importer or assembler. 3.15 suppliers declaration of conformity. Signed documentation provided by a supplier (3.14) that indicates the suppliers attestation (3.2) that a product conforms to the requirements of an applicable product performance standard (3.12) for which claims are made. 4. Applica
47、tion 4.1 This standard may be applied to a broad range of safety and personal protective equipment. 4.2 Purchasers, specifiers and users of safety and personal protective equipment may include conformity assessment to performance standards, conducted in compliance with this standard, as a requiremen
48、t of a purchase contract with a supplier. 4.3 Product standard development committees may make reference to this standard to define their conformity assessment requirements for a particular product performance standard. 4.4 Regulators and authorities having jurisdiction over the selection and use of
49、 safety and personal protective equipment may use this standard as a basis for specifying an appropriate method of conformity assessment for a particular product or system. 5. Compliance 5.1 A supplier shall use a conformity assessment system that complies with this standard to demonstrate that a product conforms to the requirements of a product performance standard to which the supplier is claiming conformance. 5.2 A product for which Level 1 conformity is claimed shall meet all the requirements of the product performance standard to which the supp
