Standards establish requirements. A supplier needs to be able to communicate to the purchaser and user that its product, process or service conforms to a standard.
This is the purpose of conformity assessment:
- Conformity assessment is the name given to the processes that are used to demonstrate that a product, service or management system or body meets specified requirements. When applied to product, it involves testing to an established performance standard, as well as inspection, quality management, surveillance, accreditation and declaration of conformity.
PPE conformity assessment in the U.S. is a mix of manufacturer’s self-declaration, government approval and third-party certification. OSHA requires that respirators be NIOSH approved, but does not require any level of conformity assessment for other PPE.
Self-declaration is the most common approach. Manufacturers test their products, or have them tested, and declare that they meet the standard by marking or labeling the product as required by the standard, providing information in packaging, literature and advertising, and in some cases producing a written declaration of conformity.
Government certification programs include NIOSH testing and approval of respirators and breathing apparatus. These standards are imbedded in regulation, and have the force of law.
Where self-declaration will not satisfy market demand or regulatory requirements, manufacturers rely on third-party certification. In this case, an independent organization conducts ongoing testing of a product, to see if it meets the performance requirements of a recognized standard. It may also require an assessment of the company’s quality systems to ensure that the manufacturer’s internal production controls are designed and operated so that every product that comes off the line will meet the standard’s requirements. When these conditions are met, the third party grants the manufacturer the use of its certification mark. In the safety equipment marketplace, familiar certification marks include the SEI mark of the Safety Equipment Institute, the CSA mark in Canada, and marks of independent labs such as UL and Intertek. In Europe, the CE mark is used on PPE to indicate conformity with European requirements.
While this mix of conformity assessment systems has worked well over the years, it becomes a challenge in a global marketplace, where substandard look-alike PPE may bear the markings required by a standard, but fail even the most basic test. Responsible manufacturers have to compete with suppliers of these low-cost variants, and workers may be put at risk.
For this reason, ISEA developed a voluntary standard for PPE conformity assessment, which was approved as an American National Standard in February 2014, and revised in 2021. ANSI/ISEA 125-2021 establishes requirements for initial and ongoing product testing, quality assurance, recordkeeping, market surveillance, corrective action and declaration of conformity. Using this standard, suppliers of PPE have a way to document the process by which they test and evaluate products, and communicate that process to customers, without necessarily turning the process over to a third-party certification organization.
ANSI/ISEA 125-2021 presents three alternative levels of conformity assessment, which differ in the type and rigor of testing and quality assurance, from self-testing to full-blown third-party certification.
- For Level 1, the supplier tests the product in-house or at a third-party lab.
- For Level 2, the product is tested in a facility that is accredited to international standard ISO 17025, and manufactured under an ISO 9001-registered quality system. Both Level 1 and Level 2 require issuance of a supplier’s declaration of conformity.
- Level 3 of the standard is third-party certification, where the entire process from testing to surveillance is under the direction of an accredited certification body, whose mark is applied to conforming products.
The standard does not match a conformity assessment method with a specific product, hazard or performance standard, leaving that decision to the supplier, purchaser or regulatory agency.