Expert Advice Community

Guest

Starting the Process of getting ISO 17025 Accreditation

  Quote
Guest
Guest user Created:   Jan 15, 2020 Last commented:   Jan 17, 2020

Starting the Process of getting ISO 17025 Accreditation

Thank you for providing this service. I am beginning the process of getting our laboratory ISO 17025 accreditation. I am hoping to gather a better understanding of the proof of systems in place an auditor is looking for. There are some areas that are easier understood, for example in section 6 having SOPs and documentation of training will show how our lab abides by such requirements. Yet, for example, how does one prove impartiality and demonstrate how it eliminates or minimizes such risks? Are there specific documents for these sections an auditor will be looking for?

I understand this is a very large question, but any help or advice would be greatly appreciated.

0 1

Assign topic to the user

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 Jan 17, 2020

To address your overall question of how to prove effective implementation of a system; it helps to ask the purpose of a specific requirement, i.e. why was it included in the ISO 17025 standard? This will help you work out what evidence you should provide.

Regarding the impartiality clause, the overall purpose is to protect all involved (interested) parties, whether a staff member, customer, company or another group; to ensure there is no unfair influence on any of the laboratory activities. This means that the laboratory must not engage in any activities that could compromise fairness.  It requires that conflicts of interest do not exist (for example the laboratory financial manager, who is also the director of one of the laboratory service providers, should not be responsible for the performance evaluations of service providers). 

The following are ways to demonstrate that all laboratory activities are undertaken in a fair manner, being unbiased and non-discriminatory:
1. Commitment to impartiality. Show this through the way the laboratory is organized (personnel structure), established ethics and quality policies and awareness discussions with personnel. Include impartiality on the agenda for regular quality meetings and management reviews. Establish and retain records of signed personnel declarations, training and minutes of meetings, including management reviews, as suitable evidence.
2. Management of risks to impartiality. Records of internal audits, management reviews, risk assessments and feedback from involved parties are suitable evidence that risks to impartiality are being managed.  Consider financial, commercial, or other pressures that may compromise impartiality. Organizational ownership, governance, marketing, contracts, finances and shared resources between departments must be assessed. You will show that the laboratory eliminates or minimizes risks to impartiality by separating conflicting activities through changing a process or changing personnel reporting lines and authorizations. Even if the initial risk assessment shows no apparent risks to treat, management is demonstrated by monitoring activities to identify possible threats to impartiality that may have arisen from laboratory or personnel relationships; on an ongoing basis. These must include regular customer and employment contract review to identify and treat new impartiality risks.

The following ISO 17025 article provides further insight on how to manage risks, applicable to impartiality as well:

Five-step laboratory risk management according to ISO 17025:2017 https://advisera.com/17025academy/blog/2019/12/05/iso-17025-risk-management-in-five-steps/ 

The following ISO 17025 toolkit procedure and template may be of interest: 

Addressing Risks and Opportunities Procedure at https://advisera.com/17025academy/documentation/addressing-risks-and-opportunities-procedure/
ISO 17025 document template: Registry of Key Risks and Opportunities at https://advisera.com/17025academy/documentation/registry-of-key-risks-and-opportunities/

Quote
0 1

Comment as guest or Sign in

HTML tags are not allowed

Jan 15, 2020

Jan 17, 2020

Suggested Topics

Guest user Created:   Nov 29, 2022 ISO 17025
Replies: 1
0 0

Implemention of ISO 17025

Guest user Created:   Nov 23, 2022 ISO 17025
Replies: 1
0 0

Question about pH meter