Tag Archives: accrediting body

Accreditation

Why Accredited Services Increase Business Opportunities And Contribute To The Harmonization Of Regulations

By Natalia Larrimer, Jacqueline Southee, Ph.D.
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Accreditation

Accreditation is an internationally accepted independent oversight process for maintaining operational standards and ensuring confidence. It is accepted by many governments and private industries, including at various levels of the global food supply.

Recognized within the food industry and endorsed by the Global Food Safety Initiative (GFSI), the process of accredited certification has become essential for business.

In the United States, the Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA), in its rule on accredited third-party certification, incorporates the accreditation process for oversight over third-party certification bodies certifying foreign food facilities manufacturing for import into the United States.

With accredited services increasingly becoming an integral part of business operations, many wonder how the processes of accreditation and certification work.

Accreditation is the process of ensuring that an organization has the necessary technical competence to perform a specific task, and has met and continues to meet a specific set of operational requirements. An accreditation body (AB) uses internationally established techniques and procedures to assess conformity assessment bodies (CABs) against recognized standards to ensure their impartiality, competence, and ability to produce consistently reliable, technically sound and impartial results.

Accreditation provides formal recognition that an organization is competent to carry out specific tasks, and provides an independent assessment of conformity assessment bodies (CABs)1 against recognized standards to ensure their impartiality and competence. Accreditation provides assurance to a CAB’s customers and industry that the CAB continuously operates according to internationally accepted criteria applicable to CAB’s scope of accreditation.

Although there is flexibility for an AB to design its accreditation process within the constraints of ISO/IEC 17011, Conformity assessment – General requirements for accreditation bodies accrediting conformity assessment bodies, the standard to which all internationally recognized ABs must conform, some aspects are mandatory.

As part of the application process, the applicant for accreditation submits information about the desired scope of accreditation and its documented quality management system. The AB conducts a document review to verify that the applicant has documented all management system requirements specified in the relevant criteria and any other applicable requirements. Additional requirements could include, for example, those mandated by a specific regulatory authority or industry. During the assessment, through witnessing of the CAB conducting a conformity assessment activity, interviews of personnel, and review of records and other objective evidence, the AB’s assessment team verifies the CAB’s technical competence and implementation of the quality management system.

The applicant is required to provide corrective action for all identified deficiencies. Only after all identified issues have been addressed can the accreditation decision process begin. To ensure that the accreditation decision is impartial, members of the assessment team do not take part in the decision. The designated decision maker, which may be a group or an individual, is responsible for reviewing the assessment team’s recommendation and ensuring that all accreditation requirements have been met by the applicant and are properly documented before granting accreditation.

A certificate and scope of accreditation are issued only after a favorable accreditation decision.

Once accredited, the CAB is regularly re-assessed to ensure continued conformance to the accreditation requirements, and to confirm that the required standard of operation is being maintained.

To ensure transparency, the AB is required to make publicly available information on the status and scope of accreditation for each accredited CAB. Any changes occurring after initial accreditation, such as suspension for all or part of the scope of accreditation, are published on the AB’s website.

It is important to note while ABs provide oversight over CABs, internationally recognized ABs are themselves subject to regular oversight from organizations orchestrating the harmonization and recognition of the accreditation process internationally.

The International Laboratory Accreditation Cooperation (ILAC) and the International Accreditation Forum (IAF) provide this international oversight. ABs that are signatories of the ILAC and/or IAF mutual recognition agreements (MLAs or MRAs) must conform with the requirements of ISO/IEC 17011 as applicable program-specific requirements, and are admitted to the agreements for a specific capability, for example, as an accreditor for testing labs or for management systems certification bodies. Technical competence of the AB and conformance to the requirements is verified through rigorous on site evaluation by other member of the IAF or ILAC community.

Without international oversight, there would be no evidence or confirmation that an AB operates in accordance with international requirements when providing oversight of accredited CABs. This oversight provides assurance that the AB understands the CAB’s process and can attest to the CAB’s competence.

The IAF, MLA and ILAC agreements are internationally recognized forms of approval; signatories have demonstrated their compliance with specified standards and requirements. Accreditation by a signatory of the ILAC MRA and/or IAF MLA provides assurance that decisions are based on reliable results, thus minimizing risk.

This is of particular importance in the constantly evolving global food-supply network. Many specifiers, such as regulatory authorities, have acknowledged the importance of credible accreditation programs.

A number of government agencies in the United States and around the world, including the U.S. Consumer Product Safety Commission (CPSC), U.S. Environmental Protection Agency (EPA) and the Canadian Food Inspection Agency (CFIA), have mandated accreditation by an internationally recognized accrediting body for their programs.

Accreditation within the MLA/MRA process helps regulators meet their legislative responsibilities by providing assurance that testing, inspection and evaluation results are issued by organizations whose technical competence and compliance with specified criteria has been verified by an independent third party. It provides assurance to stakeholders, such as the regulatory authorities, that the accredited CAB operates in accordance with recognized and accepted criteria.

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Best Practices for ISO 17025 Accreditation: Preparing for a Food Laboratory Audit (Part I)

By Joy Dell’Aringa
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An increasing number of food testing laboratories are seeking accreditation to the ISO/IEC 17025:2005 standard. This growth is chiefly due to regulatory implications, customer requirements, and trade organization recommendations and is seen across laboratory segments: third-party contract laboratories, private in-house laboratories, and government laboratories. ISO 17025 is the most common standard in the food testing industry and sets the guideline for “Laboratories Performing Microbiological and Chemical Analysis of Food and Pharmaceuticals”. Accreditation is known generally as a third-party attestation related to a laboratory, which conveys formal demonstration of competency that implies a reliable and consistent level of quality across an operation for a well-defined parameter of tests, often referred to as the “Field of Testing”. There are several qualified organizations that accredit laboratories to the standard; these organizations are referred to as Accrediting Bodies and are responsible for assessing facilities for conformity to a given ISO standard.

Audit Preparation Guidance

Initial Accreditation: Considerations & Preparation

When a laboratory initially entertains applying for accreditation, several factors should be considered. The cost and time commitment required to become initially conformant, and the on-going resources required to maintain conformity should be thoroughly examined in an overall benefit analysis prior to applying for accreditation. Management should be fully aware of the investment and perpetual commitment of becoming an accredited facility. Accrediting Bodies (ABs) provide resources and literature that can help guide laboratories through the initial audit-preparation phase. However, creating the systematic application of these guidelines that balances the quality and operational objectives of the organization are unique from laboratory to laboratory. Simply put: There is no cookie-cutter approach to accreditation.

Consultant Considerations

Q Laboratories in Cincinnati, OH first embarked on the path to ISO 17025 accreditation in 2009. James Agin, director of regulatory compliance at Q Laboratories and member of the A2LA Laboratory Accreditation Council took the lead on preparing for the initial assessment eight years ago. Q Laboratories was initially unfamiliar with the process, so they hired a consultant who was also an assessor to walk them through the process. “We took about four to five months with a consultant,” says Agin,. “In addition to creating the necessary systems, we gathered the troops and did a deep training on what ISO 17025 is, why we were pursuing it, and why it was important to our business.” The Q Laboratory team created a deep sense of ownership during the education and training process from the supervisors to the bench analysts, which they credit to their ongoing success years later. Erin Crowley, chief scientific officer at Q Laboratories suggests new labs consider hiring a consultant to ease them through the process and get them audit-ready. “If you’re not accustomed to having certain systems in place, a consultant can provide clarity and help initiate processes,” says Crowley. “Having an open forum with an expert helped give our entire team confidence.”

A consultant can streamline the initial process and help avoid some of the pitfalls in creating a robust quality management system for the first time. Tim Osborne, senior director of training services at A2LA offers advice for organizations when vetting a consultant. “While certainly not required, a qualified consultant may be a good asset to have in your quiver,” says Osborne. “Look for industry references and pay close attention to involvement in the industry outside of its own laboratory. Does this person work for an accrediting body? What are the areas of analytical expertise? Does this person also provide training for an accrediting body? If so, it is likely the consultant will offer the quality of services you need to be successful.” It is important to note that assessors and consultants should be upfront with the accrediting body to avoid conflict of interest issues during the actual assessment. Impartiality is critical within the assessment process.

Application Process

Accrediting bodies publish their own “readiness” documents. Laboratories seeking accreditation should request an itemized guide that walks the organization through each phase of the process. The following is a general outline:

  • Obtain copy of ISO standard (17025, 17065, 17020, etc.). Review any specific requirements relevant to your field; these are generally available in a checklist format allowing the laboratory to prepare through an internal audit process.
  • Determine estimated costs with the accrediting body
  • Obtain a copy of the accrediting body s assessor checklist. This usually has to be completed as part of application process
  • Prepare the intended draft scope of accreditation (outlining, specific tests/test methods, calibration parameters/ranges, certification schemes)
  • Implement the management system, and ensure personnel are aware and accept the content
  • Perform an internal audit to verify compliance with the conformity assessment standard requirements, accrediting body requirements, your own management system requirements, and applicable technical requirements
  • Perform a management review
  • Foreign applicants may need to translate supporting application documents to English
  • Identify one specific individual to be responsible for accreditation efforts and interactions with the accrediting body. Identify the “quality manager” who is in charge of the management system
  • Obtain, prepare, and submit the application for accreditation to the accrediting body

Once the initial assessment is complete and the final response and corrections to any deficiencies is in, the laboratory will be reviewed and considered for accreditation through the accrediting body. When the decision is made in favor of accreditation, the laboratory will receive their accreditation certificate, which will correspond to a specific location and set of tests (commonly referred to as a Scope of Accreditation (“Scope”) for the Field of Testing (“FOT”) for which they were assessed). Depending on the accrediting body, the certificate may be valid for one to two years, and will require re-assessment and surveillance at defined frequencies. The laboratory is responsible to maintain conformance to the ISO 17025 standard in between assessments.

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