Certification of PPE in North America & Europe

Personal Protective Equipment (PPE) is clothing or accessories worn to minimize the risks associated with mechanical, electrical, fire, thermal, chemical, biological, water, impact, fall and other hazards.

Unlike other products that are designed to be safe, such as radios, lamps and toasters, the wearing of PPE is a conscious decision made by the person who dons or holds the equipment because he or she realizes that there is a potential risk associated with the activity or work in which he or she is engaged.

 We could probably devote an entire article to the psychology of PPE wear, but for the time being, we will focus on the following: 

  • The history and origins ofcertification
  • The need for PPE certification
  • The certification request and process
  • The product certification process
  • The European Conformity Assessment Program
  • The CE marking
  • The PPE Directive
  • The future of PPE certification.

THE HISTORY AND ORIGINS OF CERTIFICATION

To tell the story of certification is really to recount the history of Underwriters Laboratories (UL).  This organization provides the knowledge and expertise to help customers navigate growing complexities across the supply chain, from compliance and regulatory issues to trade challenges and market access.

Conducting business in more than 100 countries with its 152 laboratories and 11,000 employees, UL outreaches to almost one billion consumers each year, and has written close to 1500 standards for safety. The familiar UL mark appeared on 23 billion products in 2013. 

To find the sources of certification in the United States, we go back to 1894, when an engineer by the name of William Henry Merrill opened the Electrical Bureau of the National Board of Fire Underwriters (UL), and conducted his first test on a noncombustible insulation. At about the same time, in 1896, the National Fire Protection Association was also founded, which is now responsible for much of the PPE certified in the United States and Canada. By 1899, UL had issued morethan 1000 test reports. And in 1905 the first certified products were made available: a fire extinguisher and a set of multi-colored Christmas tree lights.

But reporting test results is just one part of the certification process. Having published testing and performance requirements, usually referred to as testing standards, and having a means to verify that products continue to comply with the test report are also critical in the certification process. 

An effective certification system can be described as having the following three elements: 

  • The publication of nationally recognized requirements 
  • The testing and evaluation by competent testing and certification organizations, typically accredited to internationally recognized ISO standards for testing, certification, and follow-up 
  • A system to check that the product is manufactured in accordance with the standard and the requirements of the certification organization.

 THE CERTIFICATION REQUEST AND PROCESS

UL is referred to as a third-party, independent certification organization. The term “independent” means that the organization has no shareholders or other entities that might influence its decisions as to which products receive or do not receive certification.

The “second party” is the authority having jurisdiction. This can be a local, state, or federal agency with the power to enforce compliance, an insurance company with the ability to require its clients to comply, or a retail outlet that states that it will only accept products that are certified.

The “first party” is the manufacturer of the product that needs to be certified. The manufacturer learns about the need for certification and then works with a “third-party” certification organization to have the product tested and certified to the applicable requirements. It then has the product checked at the manufacturing location for continued compliance. 

THE PRODUCT CERTIFICATION PROCESS 

There are many activities associated with certification of products, and confusion sometimes arises about what they are and how they differ from one another. Among the more common areas of confusion is the difference between testing and certifying a product— in other words, the difference between a test report and a product certification.

An International Standard1 makes a clear distinction between the concepts of “testing” and “certification”. The colloquial meaning of “product certification” is a third-party demonstration that a product fulfills specified requirements. Only the organization that controls the manufacturing of the product can implement this type of control.

Product certification is expected to provide assurance that specified requirements are fulfilled for those individuals and organizations that regulate, distribute, sell or use the product. The demand for assurance arises from the consequences for acceptance interests of non-compliance with the specified requirements. Individuals and organizations expect product certification to provide assurance for all individual items of the same product covered by the certification. In order for product certification to provide assurance on an ongoing basis, it must commonly imply the following: 

  • The certification process is controlled by a third party whose interests are neither those of the manufacturer nor those of the acceptance interests 
  • The contract between the certification body and the manufacturer creates obligations for the manufacturer to fulfill requirements for all individual items of the same product covered by the certification.
  • The information and results of the initial evaluation of the product against the specified requirements undergo a separate review for suitability, adequacy and effectiveness by individuals not involved in the evaluation process.
  • The certification body makes a formal decision that an effective demonstration of fulfillment of specified requirements has been completed.
  • The certification body is responsible for the decision and must defend it (and its ongoing validity) as needed in the market and in legal proceedings. 
  • The certification body performs surveillance activities to assure the ongoing validity of the demonstration of fulfillment of specified requirements (e.g., periodic product retesting, audits of manufacturing processes or management systems, inspection of manufacturing locations, etc.).

All these characteristics are included in product certification so that acceptance interests can be assured that the specific requirements for the product are covered by the certification.

However, none of the above characteristics is necessarily a part of product testing, and most are not usually tested. Testing involves applying a test methodology in a controlled manner to a sample and measuring or observing the results. A test report identifies the organization performing the testing and provides information on the methodology and results.

Testing is frequently a part of product certification, but testing alone provides a different level of assurance that specified requirements are fulfilled. Testing is intended to provide information only about the samples tested. When assurance demands are higher and product certification is demanded, testing is generally not sufficient.

There is a similar relationship between inspection and product certification, and between auditing and product certification. Both inspection and auditing can be a part of product certification. As stand-alone activities they lack a number of product certification’s characteristics and address different levels of assurance needs.

THE EUROPEAN CONFORMIT Y ASSESSMENT PROGRAM

In many ways, the European Conformity Assessment Program is very similar to the certification system in the United States and Canada: it is intended to allow users to access products that have been tested and/or certified to minimum standards of safety, where applicable.

The mechanisms in place to achieve this aim are based on prevention of new barriers to trade, mutual recognition and technical harmonization. Therefore, the commercial launch of a product can only take place when it complies with the provisions of all applicable technical harmonization legislation, and when conformity assessment has been carried out in accordance with that legislation. The manufacturer has an obligation to ensure that a product intended to be placed on the EU market is designed and manufactured, and its conformity assessed, to the essential requirements of the applicable legislation.

Conformity assessment includes activities such as testing, inspection and certification, all aimed at determining that a product fulfills the relevant requirements of the applicable technical harmonization legislation.

To comply, the manufacturer or the authorized representative established within the EU must draw up an EC declaration of conformity (DoC) as part of the conformity assessment procedure. The EC DoC should contain all relevant information to identify the legislation it is issued under, along with the manufacturer; the authorized representative; the notified body, if applicable; the product; and, where appropriate, a reference to harmonized standards or other normative documents.

THE CE MARKING

By affixing the CE marking to a product, a manufacturer declares, on its sole responsibility, that the product meets all the legal requirements for the CE marking, which means that the product can be sold throughout the European Economic Area (the 28 member states of the EU and European Free Trade Association (EFTA ) countries, Iceland, Norway, Liechtenstein). This also applies to products made in other countries that are sold in the EU.2

THE PPE DIRECTIVE

The PPE Directive covers products as simple as gardening gloves and as complex as hazardous material garments. Not all of these products require the same level of conformity assessment or surveillance. As such, the PPE Directive defines three categories of products:

  • Simple design (Category I). Gardening gloves, thimbles, seasonal clothing, etc. This category typically relies on what is referred to as self-certification to the applicable requirements. 
  • PPE that is neither simple nor complex, sometimes known as intermediate (Category II). Personal flotation devices fall under this category. This category requires that a notified body issue the CE mark certificate, but surveillance is not required. 
  • Complex design (Category III). Garments, gloves, helmets, footwear and fall protection for use by first responders, etc. This category typically requires some sort of factory surveillance.

THE FUTURE OF PPE CERTIFICATION

Fortunately, the need for certified PPE continues to be strong as more and more nationally adopted standards are published, and regulators recognize the need for PPE certification to the minimally acceptable requirements provided in the standards.

Certification is an important part of the PPE market. It provides a means by which users can be assured that the products they are donning or holding to protect themselves have met the minimally acceptable levels of safety as written in nationally recognized consensus standards.

New technologies will require that the organizations writing standards, the manufacturers and the certification organizations continue to work together to ensure that new products are made available, but only in a manner that advances the protection of the PPE wearer.

1. SO/IEC 17000:2004 – Conformity Assessment – Vocabulary and general principles.

2. http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/index_en.ht