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Why ISO/IEC 17025:2017 is Necessary for Hemp Labs
What is ISO/IEC 17025:2017?
The International Organization for Standardization (ISO) defines ISO/IEC 17025:2017 as the general requirements for laboratories' competence, impartiality, and consistent operation. ISO/IEC 17025:2017 applies to all organizations performing laboratory activities, regardless of the number of personnel. Laboratory customers, regulatory authorities, organizations, and schemes using peer assessment, accreditation bodies, and others use ISO/IEC17025:2017 to confirm or recognize laboratories' competence.
The ISO/IEC 17025:2017 standard is broken into eight sections. Through this blog series, you will get a general idea of only a few requirements a hemp test lab implements to maintain/gain ISO/IEC 17025:2017 accreditation:
Part 1: Impartiality/Confidentiality and Lab Structure
Part 2: Resource Requirements
Part 3: Process and Management Systems
Part 4: Accreditation and Marketing
Impartiality and Confidentiality:
There are two defined components under Section 4 General Requirements: Impartiality and Confidentiality. We don't believe it was an accident that these items were placed as the first requirements outlined within the standard. If a lab does not have impartiality and confidentiality within its operations, it is unnecessary to look at the other requirements; that lab shouldn’t be in business.
The Standard defines that a laboratory should:
- Safeguard impartiality within lab activities
- Verify management is committed to impartiality and confidentiality
- Not allow commercial, financial, or other pressures to compromise impartiality
- Hold all information confidentially
The hemp industry has had its fair share of fraudulent activity within labs and how individuals use them. The majority of the cases we have heard fall into the problem of lack of impartiality. Not only does ISO/IEC 17025:2017 go to great lengths to ensure impartiality, other established laboratory industries, like the grain inspection, have as well. In our sister lab, North Dakota Grain Inspection (NDGI), many of our compliance reviews and regulations are centered around verifying impartiality, as lab results mean nothing without it.
Below are some practical examples of ways labs implement procedures and practices in their lab to ensure impartiality and confidentiality. Not all of these items are mandatory by the Standard, but are here to give you an idea of ways labs can satisfy the requirements! Can also give you some ideas to ask labs you are vetting!
What processes can hemp labs implement to ensure impartiality and confidentiality?
- Conduct annual impartiality assessment where management and team review all facets of the business to find potential sources of impartiality
- Conflict of interest and confidentiality forms for all employees and owners
- This isn't mandatory, but we believe it is vital to maintaining impartiality! The biggest source of impartiality in labs is when they allow employees or owners to have vested interests in growing houses, dispensaries, processing, etc. It gives individuals a large incentive to alter results to financially benefit themselves.
- At AIT, we do not allow any source of conflict for any employee or owner and have actively turned down hemp/marijuana business partnerships to ensure we have the clearest impartiality possible!
- Analyze any potential sources of impartiality annually and implement procedures to mitigate them
What is structurally necessary for a hemp laboratory?
Section 5 of the ISO/IEC 17025:2017 standard outlines what a laboratory needs structurally. This happens to be one of the shortest sections, but you can rest assured that if a lab is ISO/IEC 17025:2017 accredited, it has gone through proper channels within its state and federal governments to be a legal company.
Below are a few items the Standard requires:
- Must be a legal entity through the government
- Identification of management and positions that are responsible for lab
- Definitions of responsibilities of personnel who may affect lab results
- Documentation on the range of all laboratory activities offered
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