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ISO 17025 questions

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Guest user Created:   Feb 21, 2020 Last commented:   Feb 24, 2020

ISO 17025 questions

Assuming that I do the heavy lifting like completing your toolkit program and making sure pre-assessment checklists are covered... Couple questions I have:

1. IS this even possible with a 1 man operation? It seems like several processes require a few staff. Things like management structure, training documentation, impartiality...

2. Our scope is extremely limited, and there really are no datapoints, 99% are pass fail criteria based on interpretation. How do we handle stuff like proficiency? Our 17025 scope would be ANSI/an accredited furniture testing standard furniture testing standards, a minimum of 2, maximum of 6, and they are all composed of the same procedures...

IF you guys actually perform accreditation services:

3. Assuming we have all of our pre assesment checklist completed... How do we determine an overall cost, and can you give me a fairly wild ballpark right now?

4. What is the deposit and required steps to begin the process and pending letter of accreditation?

IF you DO NOT perform accreditation services, do you have a recommendation?  

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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.

Expert
Tracey Evans Feb 24, 2020

In responding to your comments and questions, I assume that the requirement will be accreditation to ISO 17025 as a testing laboratory, not a calibration laboratory. As an overall comment for clarity, calibration is always a requirement when checking equipment used in a Quality Managed process. Calibration laboratories require accreditation to ISO 17025, whilst not all testing laboratories require accreditation to ISO 17025. If however, the service you are offering does not involve you performing calibration, legislation or a specific standard may require your facility to be accredited as a Verification laboratory. In this case it is not to ISO 17025, but accordance with a recognised National Standard, where the accreditation demonstrates technical competency for that Standard  - a defined scope and the operation of a laboratory quality management system; not specifically ISO 17025. In trade arenas where there is no legal requirements (not legal metrology) an ISO 9001 management system and accreditation against an industry specific standard is sometimes accepted by the trade association. 

You asked 

1. IS this even possible with a 1 man operation? It seems like several processes require a few staff. Things like management structure, training documentation, impartiality...

ISO 17025 is suitable for any size laboratory. It is therefore possible the implement ISO 17025 for a single person operation. This is achieved by addressing the risks of your facility and safeguarding impartiality. By addressing these, you are justified to modify and simplify processes. You simply state this upfront. When the operations are straight forward, the processes and documents can be simplified within a management system.

2. Our scope is extremely limited, and there really are no datapoints, 99% are pass fail criteria based on interpretation. 

How do we handle stuff like proficiency? Our 17025 scope would be ANSI/an accredited furniture testing standard furniture testing standards, a minimum of 2, maximum of 6, and they are all composed of the same procedures...

Meeting the requirement of ISO 17025 to ensure the quality of test results is confirmed by the accreditation body which will audit your facility and grant your facility accreditation. Here practical restrictions are taken into account and other comparison means are accepted, by agreement. I suggest you contact your accreditation body and obtain their rules for Proficiency Testing and other Comparison Programme Requirements for ISO 17025 accredited facilities. Here again, the documented procedure and records can be customized accordingly. 

In reply to your question 3 and 4, we do not offer accreditation services. I recommend you contact your chosen accreditation body for their policies and procedures.

For more information, have a look at previously answered topics

You can also download the free demo: ISO 17025 Documentation Toolkit https://advisera.com/17025academy/iso-17025-documentation-toolkit/

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