ABSTRACT: In a world of ever changing safety technology and protection needs, choosing and understanding the standards and testing behind Personal Protective Equipment (PPE) can be an overwhelming task. This article is aimed to help you understand the different levels of compliance described by the newly released ANSI 125-2014 standard.
One of Ronald Reagan’s favorite sayings was “Trust, but verify”- this Russian Proverb really applies to your PPE. Years of hard work and experience have gone into creating the standards PPE is tested against; these documents were thoughtfully formed with the purpose of keeping you safe. You can trust the standards but it is up to you as an educated consumer to exercise care in verifying the testing and certification of the products you wear or intend to purchase.
Concerns about conformity assessment
In recent years, concerns have been raised about the lack of a consistent system of conformity assessment in the PPE industry. According to ANSI, conformity assessment is “the process used to show that a product, service or system meets specified requirements.” Many products on the market claim to meet standards and specifications. Some, however, either do not meet the requirements of the labeled standards, or use irrelevant standards or specifications to mislead the end user. Discussions of conformity assessment have brought awareness of different compliance options and what they entail.
What are the qualifications of test labs? Can I test in-house? Is third-party certification really necessary or even desirable? Why does testing and certification cost so much? ANSI/ISEA has just released a new standard, ISEA 125-2014 American National Standard for Conformity Assessment of Safety and Personal Protective Equipment. This new standard spells out three options and offers a standardized process to help suppliers demonstrate how they test and verify product performance. The use of this standard will help give end-users confidence in the PPE they depend on to perform as expected (International Safety Equipment Association 2014).
Three levels of conformity assessment
In May of 2013, the International Safety Equipment Association (ISEA) announced the development of a voluntary PPE conformity assessment standard to: establish criteria (for conformity assessment of safety and personal protective equipment sold with claims of compliance with product-performance standards) for testing data collection and maintenance, periodic verification, substantiation of processes to maintain manufacturing quality, and roles and responsibilities of suppliers, testing organizations, and certification organizations… (International Safety Equipment Association 2014). ANSI 125 is intended to help a supplier verify a product meets the requirements of a performance standard through initial and ongoing testing, process quality management, recordkeeping, surveillance, and declaration of conformity (International Safety Equipment Association 2014). The standard was created to bridge the consistency gap between conformity assessments in the U.S. This voluntary standard includes three levels of conformity assessment ranging from in-house testing and quality monitoring to full third-party certification.
While the three levels of conformity assessment outlined in ISEA 125-2014 state different testing and certification options, all options include:
- sufficient recordkeeping
- verification of ongoing compliance
- corrective action systems
- preventative action and product recall processes
- testing to a specific standard (International Safety Equipment Association 2014)
Declaration of self-conformity
Level 1 for conformity assessment in ISEA 125-2014 is intended for in-house or out-of-house testing with a declaration of conformity to the standard. For some test methods, it is acceptable to “self-certify”, meaning you can test your product according to a standard or specification and determine you are sufficiently meeting the standard or specification, then label the product to indicate the requirement has been met. Under Level 1, the supplier maintains a quality management system and issues a declaration of conformity, but no official accreditation requirements have been met. In this case, the manufacturer of the product can choose the test facility (either in or out-of-house). The supplier can determine test intervals; however, the standard does require testing every 5 years, at a minimum. In Level 1, the supplier has the final say in determining compliance. Documentation to determine this compliance is to be maintained and should be available upon the request of a customer. Level 1 is important for keeping small manufacturers’ and specialty products with low margins or low volumes in the market.
There are many benefits of having the option to “self-certify”, such as low cost and quick results. Some industry standards currently allowing self-certification include ASTM F1506 “Standard Performance Specification for Flame Resistant Textile Materials for Wearing Apparel for Use by Electrical Workers Exposed to Momentary Electric Arc and Related Thermal Hazards” and ANSI 107 American National Standard for High-Visibility Safety Apparel and Headwear. There are reasonable concerns over self-certifying, including accuracy, reliability, and consistency. While many manufacturers can be trusted and pride themselves on their quality products, there is concern over the lack of third-party involvement. There are products labeled to inappropriate standards or to standard specifications where full testing was not completed in accordance with specifications. At times, there are gaps in the standards leaving end users with questions. For example, ASTM F1506 is a performance specification for materials, and it may leave some to question how these materials will perform as a garment. Some manufacturers choose to go one step further and perform ASTM F2621 Standard Practice for Determining Response Characteristics and Design Integrity of Arc Rated Finished Products in an Electric Arc Exposure which is an additional standard used to determine arc resistance of a finished garment (American National Standards Institute 2014).
ISO Accreditation and Third Party ISO Accredited Testing
Something new in this standard is Level 2. ANSI 125 Level 2 is an option with an added layer for suppliers aiming to meet a standard specification. This is new to the market and will raise the level of safety PPE that has traditionally been self-certified. In Level 2, the supplier would still declare conformity of the standard themselves (self-certify). The primary difference between Level 1 and Level 2 is accreditation for the testing laboratory and certification for the supplier’s quality control system (ISO 9001). Under Level 2, the supplier would use a laboratory accredited to ISO/IEC 17025 for testing needs, better assuring the labs’ competence to perform the testing. An accredited laboratory has been formally recognized by an accreditation body (like A2LA or Standard’s Council of Canada) for technical competence to perform the tests on their scope as well as a review of the lab’s quality management system. This lab may be in-house or out-of-house, but must be accredited to the ISO 17025 standard for the test methods used. In addition to the testing laboratory having an ISO accreditation, the supplier would be registered to ISO 9001. There are benefits to Level 2; laboratory accreditation is a gauge of reliability and accuracy of test results. Further, if the 17025 lab is accredited by a signatory body to the International Laboratory Accreditation Cooperation’s Mutual Recognition Agreement ILAC MRA , the test results are more widely accepted globally, meaning you may enter your products into new economies without excessive retesting costs. If the ISO 17025 accredited lab is third party, this points to outside validation of the quality of the tested products. If an end-user specifies that purchased PPE comply with ANSI 125 Level 2 there is the added assurance that the quality of the lab and of the manufacturer meet some minimum standard.
In some cases, third-party certification is necessary to meet the requirements of a standard, the requirements of a customer, or both. This third-party certification is delivered by a laboratory or a certification body. Just like accredited laboratories, certification bodies are evaluated by third-party accreditation bodies. ANSI is an accreditation organization ensuring conformity assessment bodies meet the requirements of ISO 17065 Conformity Assessment-Requirements for bodies certifying products, processes, and services (UKAS, 2012).  This standard is used in accreditation of certification bodies like SEI (Safety Equipment Institute), a not-for-profit organization; Intertek and UL (Underwriter’s Laboratories), for-profit corporations; and the EU “notified bodies,” certifying products for a CE Mark in Europe. In an effort to cut costs and redundant testing similar to the ILAC MRA, ANSI offers a “Voluntary Agreement for the Mutual Acceptance of Test Data” which was aimed to encourage and increase the acceptance of test data by ANSI- accredited certification bodies. An example of a standard requiring third-party certification for compliance is NFPA 1971 Standard on Protective Ensembles for Structural Fire Fighting and Proximity Firefighting. Third-party certification is described as Level 3 in ISEA 125-2014.
Level 3 outlines a method of product conformity obtained by a third-party testing and certification body. This certification body may be private not-for-profit (i.e., Safety Equipment Institute or CSA) private for-profit (Underwriter’s Laboratories, Intertek), or government (i.e., NIOSH, or CGSB). The certification body would apply their certification mark upon completion of third-party, accredited testing to the applicable standard(s), or to the certification body’s testing requirements, including testing at the certification body’s required intervals. Some of the benefits of using a third-party testing and certification body include the convenience of having all of the testing and certification completed for you, and being able to label and advertise your product with the mark of the certification body. Many consider the third-party certification mark on the label as reliable proof your product has been rigorously evaluated and meets the standard requirements. It is more costly, but can offer a competitive advantage and legal comfort.
The development and release of ANSI 125 has shed some light on the hot topic of conformity assessment in the PPE industry. In addition to the release of ANSI 125-2014, the technical committee F23 of ASTM International is working on the creation of a conformity assessment standard intended for use by standard development committees.
Is one testing lab better than the other because it has an accreditation? Maybe, maybe not. Gaining accreditation is hard, admirable work proving to auditors you have extensive recordkeeping, quality procedures in place for just about any given situation, and you are striving to continually improve while meeting customers’ needs. However, there are plenty of laboratories without accreditation with the same values, striving to deliver accurate and reliable results. Do not be afraid to ask questions, and more importantly, ask for repeatability studies.
In the end, it is up to the consumer to educate themselves on their PPE, the standard requirements, and the testing they are comfortable with. Know which standards and specifications are relevant to your PPE, and make sure to not only check the labels of your clothing for a statement of compliance to these standards, but ask your suppliers and manufacturers for proof of the test results. Review the data to make sure it makes sense. In some cases, you may wish to verify testing with garment evaluations performed by a reliable test lab. Safety comes with education- be your own advocate and build relationships with your testing labs, certification bodies, and manufacturers; after all, they are all there to serve you, the end user.
American National Standard for Conformity Assessment of Safety and Personal Protective Equipment. ANSI/ISEA Standard 125-2014
American National Standards Institute. “Why Seek Accreditation?” Accessed February 20, 2014, https://www.ansica.org/wwwversion2/outside/Benefits.asp.
International Safety Equipment Association. “Conformity Assessment”. Last modified February 2014, http://www.safetyequipment.org/c/conformity.cfm.
International Safety Equipment Association. “ISEA Voluntary Consensus Standard for PPE Conformity Assessment.” Last modified February 2013, https://www.safetyequipment.org/userfiles/File/conformity/ISEA-standard-summary-feb2013.pdf.
Walter, L. (2013). “ISEA Develops a Voluntary PPE Conformity Assessment Standard” EHS Today, May 2, 2013, accessed February 20, 2014, http://ehstoday.com/ppe/isea-develops-voluntary-ppe-conformity-assessment-standard.
United Kingdom Accreditation Service. “ISO/IEC 17065: 2012 Transition Arrangements”. Accessed February 20, 2014, http://www.ukas.com/services/Technical_Bulletins/ISO_IEC_17065_2012_Transition_Arrangements.asp
 Certification bodies are currently in the process of transitioning accreditation from ISO Guide 65 General Requirements for bodies operating product certification systems to the improved more stringent version, ISO 17065:2012 Conformity Assessment-Requirements for bodies verifying products, processes and services. This transition must be completed by September 1, 2015 (United Kingdon Accreditation Service 2014)