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Key positions in ISO 17025

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Guest user Created:   Sep 23, 2020 Last commented:   Sep 24, 2020

Key positions in ISO 17025

I have a question about organization chart for iso 17025.
we are small laboratory and I am wondering what are the key positions?

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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 Sep 24, 2020

Typically in a small laboratory the key positions would be a single person as Laboratory combined Quality Manager and then technicians (or analysts) where technical responsibilities would be divided between them.

Let’s look at the basic point that ISO 17025 requires the organisational and management structure to be defined. This means identifying personnel involved with operations and those who have management authority and overall responsibility for the laboratory (clause 5.2). Management can be one or more person. Their responsibility is to manage and communicate issues related to the management system; including impartiality, competence and consistent operation to meet the scope of ISO 17025.

Note that one of the changes from the previous version is that there is no requirement for a specific Technical Manager and Quality Manager position.  To support any laboratory operation however; as a minimum, certain management, technical  and support service functions are needed. The  emphasis is on specifying the authority, responsibility, and interrelationship of all personnel. If the laboratory operations will benefit from a single person in the role of  “technical manager”, then this functional role could assigned to a person employed as, for example, a Senior Analyst.

In terms of accreditation, there are two functional roles. You need at least one Authorised / Technical Signatory to take responsibility for the validity of results and sign the reports for your accredited tests. The Laboratory / Quality Manager would be the Representative who will liaise with the Accreditation body.

Defining the Human resources is covered in the Advisera Toolkit ISO 17025 document template: Competence, Training and Awareness Procedure at https://advisera.com/17025academy/documentation/competence-training-and-awareness-procedure/

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Sep 23, 2020

Sep 24, 2020