TRILOGY USA

ISO 17025:2017 Accredited

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ISO 17034:2016 Accredited

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GMP+ International Registered

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ISO 9001:2015 Certified

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Florida Department of Agriculture
and Consumer Services

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What is ISO/IEC 17025 and what is the importance to me, the customer? 

First let’s start with the definition of ISO, which stands for the International Organization of Standardization. “ISO is an independent, non-governmental international organization with a membership of 167 national standards bodies” (https://www.iso.org/about-us.html) Companies or individuals are not members of ISO, which means that they are not involved in the decision making process of standard acceptance. This is considered a level of impartiality as well as peace of mind, business and individuals can only apply or certify to ISO standards.

The IEC is also an “independent, not-for-profit membership organization that develops international standards for all electrical, electronic and related technologies.” (https://www.iec.ch/faq) Because the ISO/IEC 17025 standard was developed with the objective of promoting confidence in the operation of laboratories,” and “enables them to demonstrate they operate competently and are able to generate valid results.” (Taken directly from the ISO/IEC 17025:2017 Introduction)

One of the biggest misunderstandings that customers face when choosing an ISO/IEC 17025 accredited laboratory is the scope of that laboratory’s accreditation. Which essentially means that a laboratory can be accredited for one analyte and not another but still represent themselves as accredited, which leads to misunderstandings and false expectations. Always check a laboratory’s scope of accreditation to verify if the analysis you plan to request is a method and technology that has been officially audited by an accrediting body. Trilogy will always make a current version of their accreditation certificate and scope available on their website or by direct request. You can also verify we’re doing the right thing by checking our accreditation status on our accrediting body’s website, we use ANAB. An organization’s accreditation is not contingent on a single audit, rather an annual schedule based on assessments, re-assessments, and surveillance audits. Search Directory Of Accredited Organizations 

ANAB is the organization or accrediting body, but how do we know they’re a credible group?

“ANAB complies with international standards and requirements for accreditation bodies and is a member of the International Accreditation Forum (IAF), International Laboratory Accreditation Cooperation (ILAC), InterAmerican Accreditation Cooperation (IAAC), and Asia Pacific Accreditation Cooperation (APAC).” (https://anab.ansi.org/about-anab/recognition/international)

Trilogy’s analytical laboratory is ISO/IEC 17025 accredited. How do I interpret or communicate that to other members of my own organization? 

Trilogy’s analytical laboratory is ISO/IEC 17025 accredited. How do I interpret or communicate that to other members of my own organization? 

ISO accreditation is a voluntary decision. The organization has the option to participate in the assessment process or choose to create a system of their own. The advantage of becoming ISO accredited is that the standard has a clear set of requirements in which the laboratory is required to demonstrate not only conformance but competence as well.

How does Trilogy conform to the requirements of the  ISO/IEC 17025 standard?

• Facilitating a culture of risk-based thinking
• Customer-first attitude
• Quality minded mentality
• Relevant communication
• Impartial processes
• Credible laboratory results

Is ISO 17034 different from ISO 17025?

Yes, the two accreditations are very different. ISO 17025 lays out the general requirements for the competent and impartial operations of laboratories to provide credible results. ISO 17034 is a completely different set of requirements for the competence and consistent production of all reference materials that are under the organization’s scope of accreditation.

What is the difference between a Reference Material and a Certified Reference Material?

Only organizations that hold ISO 17034 accreditation can produce a true Certified Reference Material, but only for a matrix and property that is under their scope of accreditation. Unfortunately, only companies that are accredited to ISO 17034 are regulated by the accrediting bodies to the types of statements that are made pertaining to a material’s certification. That can lead to misunderstandings when a company that does not hold ISO 17034 accreditation but is claiming to produce a Certified Reference Material. Be aware and always verify the certificate of analysis (CoA) and scope verbiage to find out what you’re buying. A Reference Material is the term used for any material used as a reference for qualitative or quantitative analysis. However, only an assigned value is required by the producer, it is up to the discretion of the producer to include uncertainty of the material and most importantly the Reference Material is not metrologically traceable.

Can you help me understand what metrologically traceable means?

Metrological traceability is a way or method to establish a claim of traceability for a measurement result. This essential means that when a company makes a claim that the result, achieved by a measurement procedure, is metrologically traceable that it was obtained using an unbroken chain of traceability back to a SI units. This can get complicated and is easy to misunderstand if someone is not audited and held accountable to internationally developed standards, it’s easy to misuse this statement. Always be aware that when a claim of metrological traceability is claimed that the organization holds accreditation from an independent third party for the specific parameter that they are claiming either a Certified Reference Material or metrological traceability.

What is GMP+?

GMP+ is an organization (gmpplus.org) who aims to bring feed safety full circle by creating committee devised standards and processes that organizations can be audited towards and receive types of certifications. This is very similar to how ISO operations, but these processes are specific to the food and feed supply industry. This organization was first adopted throughout Europe but has begun to make its way into North and South America.

What part of GMP+ is Trilogy certified?

Trilogy US has a process certificate for a GMP+ Feed Certification Scheme to the GMP+ B11 document which is the Protocol for GMP+ registration for laboratories. The scope of our certificate includes Aflatoxin B1 testing for feed additives and premixtures. 

Why does the scope for GMP+ seem more limited than your ISO 17025 scope of accreditation?

The GMP+ organization is newer and what they call their scheme documents are not as robust. There are very minimal analyte and matrix parameters that are available to be audited for. As their organization grows and broadens their offerings we can obtain further certifications.

For ISO 9001, is the organization accredited or certified?

An organization that has ISO 9001 is considered a certified organization.

The terms accreditation and certification are closely related and often used interchangeably, but when used in terms of ISO conformance it’s important to distinguish between the two. Accreditation is the higher assurance of conformity and is used when an organization is assessed to their competency and impartiality towards preforming a specific scope item. Accreditation has a clear distinction as to exactly what is included in an accredited organization’s scope. For example, an independent mycotoxin testing laboratory can be accredited for Aflatoxin analysis by LC-MS/MS method and not obtain accreditation for Aflatoxin analysis by HPLC. Certification, on the other hand, is an assessment of an organization’s conformity with the criteria outlined in a particular ISO standard.

What is a quick overview of the ISO 9001 standard and how does Trilogy conform to the requirements?

• ISO 9001 lays out criteria that defines a recognized Quality Management System utilizing the process approach to managing inputs and outputs for all operationally identified processes that fall under the ISO 9001 scope.
• Commitment to a continually evolving and improving system
• Customer-first attitude towards handling feedback and resolutions
• Leadership responsibility to encourage engagement and empowered personnel

What does this mean?

When a company in importing feed materials into Florida the bulk material must first be tested by an independent laboratory that is a pre-approved certified laboratory for the analytes of interest. If any analytes being tested are found to be above the reportable limit, the third party testing facility will notify the Florida Department of Ag directly.