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The American Association for Laboratory Accreditation. October 22, P – A2LA . A2LA requirements pertaining to measurement . relation between the quantity values with measurement uncertainties provided by measurement. Explanations for the ISO/IEC Requirements Can I issue an accredited calibration certificate that lists an uncertainty that is smaller than the Calibration. ISO/IEC – Conformity Assessment – General requirements for accreditation bodies accrediting conformity assessment bodies, the.
The writers of this international standard acknowledged the intricate web of relationships between businesses including their employees and contractors and other people and organizations, and realized that to require pure independence would create significant barriers to the certification of products and to their final market destinations. There are some independence-like restrictions placed on certain personnel within the CB in Section Four of the standard, but these are generally set forth in such a manner as to clearly ensure that the final certification decisions are made by persons without a material interest in the product receiving its desired certification.
Business relationships between the CB and other interested parties are permitted so long as the CB can account for any potential risks to its impartiality, and can address those risks in an appropriate manner.
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This section is relatively short and straightforward, but the publication of this standard incorporated something that was not present in previous iterations, that is, the mechanism for impartiality. Evaluation is discussed in more detail in section seven of the standard, but typically involves process es such as testing, inspecting, auditing, or otherwise gathering information on the characteristics of the product being certified in order to later compare that information against the scheme requirements.
If a CB chooses to use an external resource subcontractor for its testing or other evaluation tasks, the standard further defines the requirements that the CB must meet in order to justify use of that external resource. Ultimately, the CB is responsible for the evaluation results it chooses to use in its decision-making process, but the standard has laid out steps that must be followed in all cases.
Section Seven—the Certification Process Section Seven of the standard covers the requirements the CB must follow while performing the various steps in the certification process. This section also includes the required information on documents given to the client to signify that their product, process, or service has been certified. Furthermore, Section Seven of the standard discusses the situations when surveillance activities are necessary.
Many of the requirements are similar to those found in ISO However, for most products this role can also be filled by accredited third-party private-sector laboratories and certifying organizations.
ISO Scope of A2LA Accreditation - METTLER TOLEDO
Issues such as fees for product testing are more easily handled and updated in private-sector organizations. NPPTL devotes a significant portion of its resources to do rigorous testing and the associated conformity assessment efforts for respirators. As noted above, challenges in this process include updating the manufacturer fee schedules because the schedules are part of federal regulations.
International standards for accreditation are detailed in ISO standards, e.
ISO 17025: Scope of A2LA Accreditation
In addition to laboratory accreditation, which is done by federal, state, local, and private-sector programs, there are also organizations that accredit the accrediting bodies and ensure a further level of adherence to quality testing and certification processes. NFPA standards require that the certifying organizations and the accrediting bodies be accredited to meet ISO standards, but do not specify which organization is used to conduct the accreditations.
Several laboratory accreditation programs are operated by federal agencies Breitenberg, Under this voluntary program, each NRTL-accredited laboratory must be reviewed at least once every 5 years.
- ISO/IEC 17025
This program accredits laboratories to conduct one or more of a wide range of testing or calibration protocols. Accreditation programs under NVLAP include those for chemical calibration, information technology security testing, personal body armor, energy-efficient light products, thermal insulation materials, and a wide variety of commercial products NIST, Each laboratory must renew its accreditation annually.
In addition to federal programs, there are a number of private-sector for-profit and not-for-profit laboratory accreditation programs. Committee Comments The committee identified a number of organizations that accredit laboratories and certifying organizations to test and certify non-respirator PPT. What data are used to attest to the conformity? These questions have many varied answers. Certain products pose little risk to the end user, and in those cases the consumer and the marketplace sort out the high-quality products from those of low quality.
For some products it is easy for the consumer to determine if the product works consistently over time, but for other products the only way to know if a product will be effective is to test it.
Consumers need verification that tests have been conducted, and that the product has met the expected criteria. The attestation or declaration of conformity can be done by the manufacturer first partyby the purchaser second partyor by an independent third party. First-Party Declaration of Conformity For many products sold in the United States, the manufacturer declares that the product conforms to relevant requirements and meets the industry standards.
For example, manufacturers of hearing protective devices attest to the noise reduction level. Second-Party Declaration of Conformity Purchasers become involved in conformity assessment, particularly when they serve as a link between the manufacturer and the general public or end-user consumer.
Wholesalers or retailers may verify that a product meets standards before putting the merchandise on store shelves. Second-party declarations may also be made by manufacturers who verify and attest that the component parts from other manufacturers meet the requisite standards and can thus enter the assembly process. Third-Party Declaration of Conformity Although the term certification is often used interchangeably and colloquially to encompass all forms of conformity assessment, the term has a much more specific definition that requires independent third-party involvement.
Certification encompasses both a verification of testing data and follow-up product and manufacturing audits. Third-party attestation of conformity provides the verification by an organization that is not the seller or buyer and thus offers a more independent appraisal. Third-party declaration is based in some cases on testing or inspection data from the manufacturer, and in other cases on data generated by a third-party testing laboratory.
The NIOSH respirator certification process conducted by NPPTL follows a different model in which the testing is done by the government laboratory charged with verifying that the products meet the requisite standards. In both processes there are post-marketing testing and evaluation components, including product audits and manufacturing site audits. Requirements and timelines for recertification vary.
Committee Comments The committee believes each conformity declaration approach has value. Each serves a purpose, depending on the type of product and the nature of the marketplace. Given that most PPT products are designed specifically to prevent worker illness, injury, or death, third-party certification declaration of conformity would be the preferred approach.
Independent verification and attestation that the product meets the requisite standards gives increased assurance to the worker of product effectiveness. Currently, many approaches to conformity assessment for non-respirator PPT require only first-party declaration of conformity.
For example, OSHA regulations for protective helmets used in the workplace require that the products meet a specific standard, but third-party certification is not required. Voluntary third-party certification is available from several private-sector testing and certifying organizations. For example, SEI and UL offer certification programs for protective helmets and fall protection harnesses. Manufacturers can have their products certified and thus meet employer and worker demands for certified fall prevention equipment.
Further efforts are needed to explore whether third-party certification should be federally mandated for some non-respirator PPT products or what incentives could be put in place to encourage third-party testing and certification.
Purchasers need to know what products have been deemed to meet the relevant standards and what products have not.
Communicating conformity assessment generally takes the form of either a certification mark or the inclusion of the product on a list of certified or approved products. Additionally, certificates of conformity are used to indicate that all essential characteristics of the product have been assessed and have met certain standards.
The owner of the certification mark is responsible for the certification, including determining the requirements for certification. Certification marks are often, but not always, registered marks with the U. Many private-sector organizations have a specific logo or mark; for example, the Woolmark issued by Australian Wool Innovation Limited attests to wool quality and performance criteria AWI, According to the U.
Patent and Trademark Office, three types of certification marks are used: The certification mark does not need specific wording—in fact, a design can be used. The accompanying proof of conformity, however, should indicate: In addition, the supplier, type or model number, and all important safety and maintenance instructions should be included.
Government agencies can issue certification marks; for example, the Federal Communications Commission uses a mark for computers and other electronics FCC, These agencies also use online lists of certified products as another way to communicate which products have met testing criteria.
Public listing is required as part of meeting the ISO requirements to receive accreditation as a certifying entity. A major challenge in conformity assessment is enforcing the certification mark and identifying and policing fraudulent use.
In those cases, NIOSH has contacted the manufacturers of mislabeled products and requested that the product be relabeled or recalled.
Manufacturers of certified products are often vigilant in identifying non-certified products offered by their competitors. Committee Comments Communication about certified products is a valuable role for government agencies to fulfill because the agencies can provide websites or other tools that offer lists of certified products from multiple certifying organizations.
No comprehensive list is currently available of non-respirator PPT products that meet the required standards or other regulations. A similar effort with a central database website for other types of PPT would be a valuable resource. An information source would be especially important for small and large employers that may not be affiliated with a consolidated purchasing arrangement, for self-employed individuals, and for low-wage temporary workers so they can make informed decisions about quality PPT.
Manufacturers also have responsibilities to provide product use instructions that can be readily understood. Worker, union, and employer demand for certified products is one of the positive driving forces for fire protection PPT. Local fire departments often stipulate that contracts be awarded for PPT products that meet NFPA standards as evidenced by third-party testing and certification.
Similarly, financial incentives can include stipulations in federal contracts that only certified products can be purchased using federal grant funds see Chapter 4.
Sincemore than 13, jurisdictions have participated in the Bulletproof Vest Partnership Program, which provides matching funds to law enforcement agencies if they purchase body armor from the NIJ Compliant Product List NIJ, Some government agencies have the jurisdiction to issue regulatory requirements, issue stop use alerts, or impose penalties for the use of noncompliant products.
Coast Guard-approved personal flotation devices, and can issue citations and penalties for noncompliance.
If deemed appropriate for other types of PPT particularly PPT used in medium-and high-risk work environmentsOSHA and the Mine Safety and Health Administration could establish regulations requiring third-party declaration of conformity certification.
Pre- and post-marketing testing and evaluation efforts include the manufacturing and product audits conducted on the products and manufacturing sites Gillerman, Product assessments may include testing of products selected at random from retailers or from the production line. In addition, health surveillance efforts are needed to assess the impact on the health and safety of the worker.
Occupational health surveillance is defined as the systematic collection and analysis of occupational injuries, illnesses, hazards, and exposures NIOSH, e.Webinar 3/29/2018: ISO/IEC 17025:2017 & 17025:2005 - A Glimpse At The Differences
The FDA, for example, has several communication avenues for the reporting and communication of adverse events and conducts manufacturing and import inspections.
The NIOSH respirator certification program involves both site and product audits in addition to several specific follow-up programs see Chapter 3.
New initiatives for body armor are requiring further efforts in post-market testing and evaluation. To conduct surveillance and post-marketing follow-up, CPSC has several data collection systems in place that allow consumers to report problems with unsafe products directly through an online reporting system CPSC, b and that collect data on emergency room visits in which consumer products are involved through the National Electronic Injury Surveillance System CPSC, c.
With an annual average of 23, deaths and more than Data are needed so that problems with PPT performance or use can be identified and resolved. For example, in a health hazard evaluation was conducted to evaluate potential hazards associated with repackaging of reflective glass beads; safety glasses were recommended to prevent eye injury NIOSH, More information on the extent and nature of PPT use in the workplace would inform improvements in both PPT products and their use.
Workplace injury and illness reporting systems may be another potential source of information. Additionally, the Bureau of Labor Statistics conducts an annual Survey of Occupational Injuries and Illnesses that requests information from a stratified sample of employers on injuries and illnesses listed on the OSHA log.
This survey could be another source for PPT information if that data were required. Additionally, as mentioned above, serving as an information clearinghouse to provide a reliable source of information on PPT selection, use, care, and maintenance is a critically important role.
In part this may be research that is not of high interest to individual manufacturers, or the market niche may be so narrow for some types of PPT that federal agencies are best suited as funders. In addition to strengthening the conformity assessment process, these types of research are vital to protecting worker safety and health and are needed for reducing liability risk for purchasers and manufacturers.
NPPTL has been active in research on test methods in a number of areas, including chemical permeation through protective clothing materials.
A partnership involving NPPTL, NIST, and North Carolina State University conducted interlaboratory testing and validation of the stored-energy test method; stored-energy testing is needed to avoid skin burns when wearing firefighter turnout gear.
As discussed in Chapter 4research is needed on testing methods and standards criteria for protective ensembles and the interface among multiple types of PPT e.