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Use of shall and must

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Guest user Created:   Jun 28, 2021 Last commented:   Jun 29, 2021

Use of shall and must

Reaching out with a question after the recent purchase of the Toolkit w/ Extended Support. In the ISO 17025 the word “shall” is used. In the toolkit procedures the word “must” is used in place of the word “shall”. Is the word “must” an accepted term by accreditation bodies?

Up to this point, we are grateful for the purchase of the toolkit. With minor modifications to the quality manual and lab procedures, this is very effective and truly helpful to get us started in the right direction.

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ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Tracey Evans Jun 29, 2021

Yes, the use of the word "must" is an accepted term in your documentation. In the English language, both "shall" and "must" are verbal expressions that indicate that something is mandatory.  ISO International Standards, like ISO 17025, used for conformity assessment contain requirements and use "shall" to describe a mandatory requirement. For example, the laboratory shall document the competence requirements for each function.

ISO standards only use the word "must" to refer to an obligation on the user of the document (e.g ISO 17025) due to a country -unique condition or law, or law of nature;, not a requirement of the ISO standard. For example, all buildings in the active seismic area of Los Angeles must be earthquake-resistant.

This is by agreement of definitions in terms of an ISO directive.

In the English language "must" is typically used in everyday speech as a command, necessity or request. That is the reason why "must" is used in a procedure to instruct the user on what is necessary to comply with, so the laboratory can meet a mandatory ISO 17025 "shall "requirement.  For example, The laboratory manager must retain the records for determining the competence requirements.

IF you wish, you can define the use of the word “must” in your quality manual or procedures as a mandatory instruction to fulfil the ISO 17025 “shall” requirements.

Note too, that anywhere in your documents, you state something “is” or somethings “are” then this is also an mandatory expectation that needs to be met in terms of assessment  during internal auditing and for accreditation, i.e. the evidence “must” be available.

For more information on ISO 17025, see the White paper Clause-by-clause explanation of ISO 17025:2017 at https://info.advisera.com/17025academy/free-download/clause-by-clause-explanation-of-iso-17025

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